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Recalls affecting Louisiana

Data last updated: September 10, 2026 at 1:16 PM UTC

16,895 recalls found
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Just announced

Straight from FDA press releases — not yet formally classified or risk-graded
UnclassifiedUndeclaredAnnounced September 4, 2026

Business Pill, Branch Manager for Men — dietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

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Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

Grant-Valkaria, Florida - SUPPLX.com is voluntarily recalling Business Pill and Branch Manager for Men, products marketed as dietary supplements for male sexual enhancement, because FDA laboratory analysis confirmed that both products contain yohimbine that is not declared on the product labels.

Company contact: (321) 341-9501 · SupplxRecall@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaAnnounced September 4, 2026

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

Foods Alive Inc of Angola, IN, is recalling its 8-ounce packages of organic moringa leaf powder because they have the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

B. Braun — 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

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Drugs

Recalling firm: B. Braun Medical Inc.

“On September 3, 2026 firm updated their press release to include additional contaminants.” FOR IMMEDIATE RELEASE – September 3, 2026– Bethlehem, PA, B. Braun Medical Inc (B. Braun) is voluntarily recalling three (3) lots of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container, to the hospital/healthcare facility/user level due to presence of particulate matter identified as iron…

Company contact: recalls@bbraunusa.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusE. coliAnnounced September 3, 2026

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

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Food & BeveragesFoodborne Illness

Recalling firm: Frutas y Hortalizas del Sur S.A.

September 02, 2026. Frutas y Hortalizas del Sur S.A., San Carlos, Chile expands its July 3, 2026, recall of frozen organic IQF blueberries to include one lot of Great Value frozen Organic Triple Berry Blend 10 OZ because of potential contamination with Escherichia coli O145:H28 (E. coli O145) .

Company contact: Info.foodsafety@comfrut.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

American Regent, Inc. — Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial

Presence of particulate matter and lack of sterility assurance

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Food & Beverages

Recalling firm: American Regent, Inc.

FOR IMMEDIATE RELEASE – September 3, 2026 – New Albany, OH, American Regent, Inc. is conducting a nationwide voluntary recall of three lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vials to the consumer level. Customer complaints were received for leaking and cracked vials, resulting in lack of assurance of sterility.

View FDA’s announcement (opens in a new tab)
UnclassifiedAllergenMilkUndeclaredAnnounced August 31, 2026

Little Temptations — Chocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

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Food & BeveragesAllergens

Recalling firm: Crystal Temptations

Crystal Temptations of North Arlington, NJ is recalling Halloween Chocolatey Eyeballs because they contain undeclared MILK allergens. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

View FDA’s announcement (opens in a new tab)
UnclassifiedUndeclaredAnnounced August 31, 2026

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

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Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

FOR IMMEDIATE RELEASE - August 27, 2026 - Davie, Florida – Ana Salazar Modela Tu Cuerpo Inc. is recalling Lipofit Extreme Fat Burner 2.0, Lot 25M12F, expiration date 09/2027, to the consumer level.

Company contact: (954) 305-1004 · yandrydy@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced August 31, 2026

Kofinas — Garlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

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Food & BeveragesIngredients

Recalling firm: LMSI LLC

Cincinnati, OH (Aug. 29, 2026) - LMSI LLC/ Kofinas Olive Oil is issuing a voluntary recall of its Garlic Mediterranean infused extra virgin olive oil for using a garlic essential oil not approved for culinary use. The flavored oil was bottled in glass bottles in 500 ml, 250 ml, and 100 ml sizes.

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaE. coliAnnounced August 29, 2026

Everything Sprouts — Robust Radish Mix, 5oz Cups

Potential to be contaminated with Shiga toxin-producing Escherichia coli (STEC) or Salmonella.

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

Everything Sprouts, LLC, based in Minneapolis, MN is expanding its voluntary recall of sprouts to include certain lots of Robust Radish Sprout Mix because it has the potential to be contaminated with Shiga toxin producing Escherichia coli (STEC) or Salmonella bacteria.

Company contact: everythingsproutsmn@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaAnnounced August 29, 2026

Martina — Mangoes

Potential contamination with Salmonella

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

MAMARONECK, NY, AUG. 28, 2026 - Panorama Produce is recalling 302 boxes of size 9 (nine) mangoes because they may be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled February 1, 2021

HNM Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.

There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
87274
Lot/product code:
Catalog Numbers HNM-31-150365 (lots 1017G, 1117B, 1217B, 0418C, 0518D, 0518H, 0618B, 0618D, 0818E, 1018J, 1018M, 1118J, 1218B, 1119B, 0420H, 0820H); HNM-31-150367 (lot 1117D); HNM-31-150368 (lot 1117D).
Recalling firm:
Bovie Medical Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 1, 2021

ConMed Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.

There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
87274
Lot/product code:
Catalog Numbers C3390A (lots 0317F, 0417B, 0517B, 0517D, 0517J, 0617D, 0617F, 0617H, 0617K, 0717A, 0717G, 0817B, 0917G, 0917J, 1017C, 1017E, 1017J, 1117B, 0418C); C3350A (lots 0317F, 0417B, 0517B, 0517G, 0717C, 0817D, 0917C, 0917E); C3350NA (lots 0317F, 0517G, 0817F); C2455NA (lots 0317F, 0517B, 0717E, 1017C, 1017E); C1860NA (lots 0317F, 0517B, 0717E, 0817F, 1017G, 0418E); C3390NA (lots 0317F, 0517G, 0817H, 1017J, 0418E, 0518F, 1218C).
Recalling firm:
Bovie Medical Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 1, 2021

Velocity Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.

There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
87274
Lot/product code:
Catalog Numbers 7201 (lots 0217H, 0317J, 0417B, 0417F, 0417H, 0618K, 0718B, 0718D, 0718F, 0419J, 0519J, 0120F, 0420B, 0720K, 0720M, 0820L, 0117D, 0117F, 1020L); 7205 (lots 0217B, 0317L); 7206 (lots 0217B, 0317L); 7201-01 (lots 0920B, 0920D, 0920H); 7203 (0217F, 0317B, 0317L, 0417H).
Recalling firm:
Bovie Medical Corporation
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled February 2, 2021

Enoxaparin Sodium Injection, USP 120 mg/ 0.8 mL Single Dose Syringes with Automatic Safety Device For Subcutaneous Injection 10 x 0.8 mL Single Dose Syringes Rx Only,Manufactured by: Gland Pharma Ltd. Hyderabad, India Manufactured for: Apotex Corp. Weston, FL 33326 NDC 60505-0796-4 UPC 360505079543 (carton) NDC 60505-0796-0 UPC (01)10360505079602 (label)

Labeling; Label Mixup; syringe barrels may contain markings for 100 mg/mL (corresponding to 100 mg/mL strength) instead of 150 mg/mL (corresponding to 120 mg/0.8mL strength)

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The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
D-0262-2021
Lot/product code:
Batch: CT003 Exp. 05/2022
Recalling firm:
Apotex Corp.
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled February 2, 2021

Enoxaparin Sodium Injection, USP 100 mg/mL Single Dose Syringes with Automatic Safety Device For Subcutaneous Injection 10 x 1 mL Single Dose Syringes Rx Only, Manufactured by: Gland Pharma Ltd. Hyderabad, India Manufactured for: Apotex Corp. Weston, FL 33326 NDC 60505-0795-4 UPC 360505079544 (carton) NDC 60505-0795-1 UPC (01)10360505079510 (label)

Labeling; Label Mixup; syringe barrels may containing markings for 150 mg/mL (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength)

ALL 50 STATES
▸Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
D-0261-2021
Lot/product code:
Batch: CS008 Exp. 04/2022
Recalling firm:
Apotex Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 3, 2021

Implantable cardioverter defibrillators (ICD): 1) Evera family: Evera XT DR, Evera S DR, Evera MRI XT DR, Evera MRI S DR, Evera XT VR, Evera S VR and Evera MRI S VR models; 2) Visia family: Visia AF ICD, Visia AF S ICD, Visia AF MRI ICD, and Visia AF MRI S ICD models. Implantable Cardioverter Defibrillators (ICDs) are implantable medical devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia.

A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-expected RRT observation

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
87261
Lot/product code:
1) Evera Family: MODEL NUMBER / NAME / GTIN: SERIAL NUMBERS: DDBB1D1 / ICD-DR DDBB1D1 EVERA XT US IS1/DF1 / 00643169018099: BWC231766H, BWC230184H, BWC230891H, BWC228489H, BWC232037H, BWC230770H, BWC231219H, BWC231215H, BWC231190H, BWC231202H, BWC231199H, BWC231780H, BWC231556H, BWC230255H, BWC230772H, BWC230906H, BWC231500H, BWC231572H, BWC231618H, BWC231655H, BWC231937H, BWC231942H, BWC230859H, BWC230949H, BWC231848H, BWC230918H, BWC231237H, BWC231580H, BWC230893H, BWC231576H, BWC230426H, BWC230475H, BWC230431H, BWC231494H, BWC230876H, BWC230776H, BWC228873H, BWC229321H, BWC230873H, BWC229698H, BWC230449H, BWC231452H, BWC230877H, BWC230720H, BWC231479H, BWC231482H, BWC231578H, BWC231498H, BWC229796H, BWC230863H, BWC230874H, BWC231239H, BWC230917H, BWC229337H, BWC230524H, BWC230887H, BWC231525H, BWC231240H, BWC230672H, BWC230769H, BWC232164H, BWC232196H, BWC230048H, BWC230520H, BWC231568H, BWC231671H, BWC231761H, BWC229598H, BWC230335H, BWC230889H, BWC231570H, BWC228859H, BWC230914H, BWC231346H, BWC230884H, BWC231501H, BWC229058H, BWC229697H, BWC228813H, BWC232165H, BWC230870H, BWC230901H, BWC231259H, BWC230872H, BWC231106H, BWC230195H, BWC230911H, BWC228448H, BWC229342H, BWC230535H, BWC230655H, BWC230919H, BWC231269H, BWC231480H, BWC231668H, BWC230044H, BWC228426H, BWC230910H, BWC227091H, BWC231456H, BWC229099H, BWC229101H, BWC231874H, BWC228336H, BWC230869H, BWC230730H, BWC230630H, BWC231872H, BWC231343H, BWC228800H, BWC228656H, BWC228666H, BWC229097H, BWC231944H, BWC226887H, BWC230885H, BWC231768H, BWC232133H, BWC227119H, BWC228318H, BWC229963H, BWC230899H, BWC228760H, BWC230159H, BWC230882H, BWC230381H, BWC228544H, BWC230098H, BWC231400H, BWC228205H, BWC228858H, BWC226830H, BWC230454H, BWC228816H, BWC230608H, BWC228988H, BWC227088H, BWC228586H, BWC226816H, BWC227609H, BWC228180H, BWC228449H, BWC229289H, BWC229600H, BWC230118H, BWC230732H, BWC232122H, BWC231241H, BWC228818H, BWC229317H, BWC229344H, BWC229118H, BWC230071H, BWC227808H, BWC232126H, BWC232191H, BWC232170H, BWC227125H, BWC227610H, BWC227114H, BWC230530H, BWC227067H, BWC227782H, BWC228871H, BWC228399H, BWC228427H, BWC231659H, BWC228044H, BWC228820H, BWC228206H, BWC229013H, BWC231037H, BWC231809H, BWC226906H, BWC229163H, BWC227324H, BWC228320H, BWC227017H, BWC227077H, BWC227034H, BWC227374H, BWC228469H, BWC231485H, BWC225637H, BWC227113H, BWC228867H, BWC231257H, BWC227047H, BWC227071H, BWC224560H, BWC226819H, BWC226824H, BWC226960H, BWC227129H, BWC228864H, BWC230020H, BWC231332H, BWC231458H, BWC226403H, BWC226833H, BWC227056H, BWC227062H, BWC227126H, BWC228869H, BWC226939H, BWC227326H, BWC230083H, BWC231865H, BWC229346H, BWC231669H, BWC227323H, BWC230503H, BWC231049H, BWC228832H, BWC229536H, BWC226805H, BWC226822H, BWC226914H, BWC231406H, BWC228248H, BWC225448H, BWC226799H, BWC227109H, BWC228132H, BWC229168H, BWC231459H, BWC231673H, BWC226801H, BWC226817H, BWC228812H, BWC231043H, BWC231192H, BWC229055H, BWC226987H, BWC231173H, BWC229988H, BWC226820H, BWC226831H, BWC230642H, BWC226798H, BWC229516H, BWC229886H, BWC231781H, BWC226832H, BWC225279H, BWC226809H, BWC226812H, BWC227130H, BWC228297H, BWC229806H, BWC226664H, BWC230704H, BWC231684H, BWC226998H, BWC230322H, BWC225786H, BWC226298H, BWC227032H, BWC230010H, BWC231324H, BWC224500H, BWC229757H, BWC230573H, BWC227008H, BWC230091H, BWC231550H, BWC225592H, BWC226988H, BWC227163H, BWC227322H, BWC224540H, BWC230309H, BWC232166H, BWC227025H, BWC230791H, BWC231036H, BWC227845H, BWC230784H, BWC232050H, BWC226416H, BWC226966H, BWC228943H, BWC228960H, BWC228978H, BWC231908H, BWC228014H, BWC228050H, BWC229537H, BWC226984H, BWC227330H, BWC231176H, BWC231412H, BWC229009H, BWC230481H, BWC226584H, BWC229898H, BWC225730H, BWC226415H, BWC226924H, BWC227316H, BWC227321H, BWC230411H, BWC226578H, BWC229981H, BWC230279H, BWC224159H, BWC225056H, BWC230137H, BWC229606H, BWC231774H, BWC225810H, BWC226471H, BWC227919H, BWC228962H, BWC229743H, BWC230565H, BWC228743H, BWC231660H, BWC225960H, BWC228522H, BWC232106H, BWC232113H, BWC225555H, BWC227536H, BWC228919H, BWC228974H, BWC208701H, BWC231047H, BWC226182H, BWC231976H, BWC226398H, BWC226639H, BWC229914H, BWC230318H, BWC230916H, BWC230937H, BWC231395H, BWC232174H, BWC226053H, BWC228270H, BWC225617H, BWC226923H, BWC228131H, BWC229142H, BWC230648H, BWC231137H, BWC224556H, BWC224377H, BWC225611H, BWC226587H, BWC228342H, BWC229758H, BWC230247H, BWC230404H, BWC224492H, BWC228171H, BWC228363H, BWC228582H, BWC229921H, BWC230590H, BWC230691H, BWC231024H, BWC231250H, BWC231392H, BWC232118H, BWC232181H, BWC222232H, BWC223575H, BWC226139H, BWC226703H, BWC227005H, BWC227196H, BWC228392H, BWC228969H, BWC229071H, BWC229414H, BWC230028H, BWC230181H, BWC231490H, BWC231729H, BWC231864H, BWC231997H, BWC232155H, BWC232206H, BWC225667H, BWC226056H, BWC226643H, BWC231184H, BWC232115H, BWC226299H, BWC227028H, BWC228060H, BWC227023H, BWC228445H, BWC229075H, BWC229787H, BWC232001H, BWC220805H, BWC225084H, BWC227612H, BWC227882H, BWC228414H, BWC230410H, BWC230774H, BWC231403H, BWC231549H, … (truncated, 3486040 characters total — see the official FDA record for the full value)
Recalling firm:
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 3, 2021

Implantable cardioverter defibrillators (ICD) with cardiac resynchronization therapy (CRT-D): 1) Viva family: Viva XT CRT-D, Viva XT Quad CRT-D, Viva S CRT-D, Viva Quad S CRT-D and Viva Quad C CRT-D models; 2) Claria family: Claria MRI CRT-D and Claria MRI Quad CRT-D models; 3) Amplia family: Amplia MRI CRT-D and Amplia MRI Quad CRT-D models; 4) Compia family: Compia MRI CRT-D model; 5) Brava family: Brava CRT-D and Brava Quad CRT-D models (OUS only); Implantable Cardioverter Defibrillators (ICDs) are implantable medical devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide cardiac resynchronization therapy, including sequential biventricular pacing (CRT-D devices).

A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-expected RRT observation

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
87261
Lot/product code:
1) Viva family: MODEL NUMBER / NAME / GTIN: SERIAL NUMBERS BLF244376H, BLF243732H, BLF244567H, BLF243795H, BLF244186H, BLF244478H, BLF243894H, BLF243453H, BLF244610H, BLF244627H, BLF243514H, BLF242936H, BLF244189H, BLF243735H, BLF243429H, BLF244637H, BLF235234H, BLF242865H, BLF243129H, BLF243389H, BLF242685H, BLF243087H, BLF243671H, BLF243888H, BLF243897H, BLF244660H, BLF242664H, BLF242935H, BLF243975H, BLF243028H, BLF243445H, BLF243396H, BLF243947H, BLF243377H, BLF242659H, BLF244047H, BLF243393H, BLF243714H, BLF242861H, BLF243366H, BLF243378H, BLF242874H, BLF243382H, BLF243750H, BLF242082H, BLF242682H, BLF243363H, BLF243386H, BLF243413H, BLF243450H, BLF243452H, BLF243752H, BLF243513H, BLF243181H, BLF242551H, BLF243371H, BLF243772H, BLF241960H, BLF243455H, BLF243258H, BLF243391H, BLF243398H, BLF243401H, BLF243408H, BLF243055H, BLF244654H, BLF241810H, BLF242439H, BLF244207H, BLF243460H, BLF244390H, BLF241286H, BLF242713H, BLF242875H, BLF243142H, BLF243439H, BLF244165H, BLF242857H, BLF241855H, BLF243385H, BLF244651H, BLF242395H, BLF243179H, BLF242005H, BLF243442H, BLF244061H, BLF243397H, BLF242133H, BLF243010H, BLF243418H, BLF243435H, BLF243464H, BLF244080H, BLF240020H, BLF242060H, BLF242096H, BLF242674H, BLF242711H, BLF243068H, BLF243171H, BLF243430H, BLF243444H, BLF241170H, BLF244117H, BLF243086H, BLF243936H, BLF242691H, BLF243136H, BLF240023H, BLF242666H, BLF243941H, BLF243877H, BLF241596H, BLF242696H, BLF240265H, BLF241136H, BLF243474H, BLF240009H, BLF243059H, BLF243935H, BLF240016H, BLF241267H, BLF242876H, BLF241795H, BLF242444H, BLF243432H, BLF241869H, BLF243407H, BLF241846H, BLF242068H, BLF243808H, BLF243019H, BLF242260H, BLF243518H, BLF243506H, BLF244134H, BLF240017H, BLF242923H, BLF243089H, BLF240406H, BLF242391H, BLF242658H, BLF243096H, BLF240648H, BLF241838H, BLF241848H, BLF243495H, BLF240003H, BLF242405H, BLF242663H, BLF240032H, BLF241760H, BLF242324H, BLF242657H, BLF242707H, BLF244003H, BLF239398H, BLF240010H, BLF236242H, BLF240008H, BLF243030H, BLF243082H, BLF243479H, BLF243480H, BLF238259H, BLF238700H, BLF239843H, BLF242063H, BLF243447H, BLF240024H, BLF240547H, BLF242348H, BLF243056H, BLF243090H, BLF243105H, BLF239263H, BLF241473H, BLF242940H, BLF239773H, BLF240033H, BLF242708H, BLF243231H, BLF243667H, BLF238847H, BLF242209H, BLF240083H, BLF242680H, BLF242709H, BLF239264H, BLF242784H, BLF240503H, BLF243138H, BLF242471H, BLF243406H, BLF239866H, BLF241016H, BLF240879H, BLF241839H, BLF243034H, BLF243369H, BLF244112H, BLF243419H, BLF243708H, BLF241847H, BLF243405H, BLF243491H, BLF241851H, BLF242075H, BLF240794H, BLF241091H, BLF243424H, BLF239117H, BLF239889H, BLF242080H, BLF243976H, BLF244652H, BLF239615H, BLF242014H, BLF240857H, BLF243168H, BLF243791H, BLF240782H, BLF240830H, BLF242100H, BLF242779H, BLF243426H, BLF243449H, BLF243648H, BLF244128H, BLF244497H, BLF239864H, BLF242009H, BLF239244H, BLF239351H, BLF241853H, BLF241824H, BLF242007H, BLF242035H, BLF242204H, BLF242811H, BLF243511H, BLF233474H, BLF242026H, BLF242062H, BLF242910H, BLF243583H, BLF244009H, BLF238616H, BLF239587H, BLF240472H, BLF241836H, BLF241850H, BLF242024H, BLF242507H, BLF243373H, BLF243415H, BLF244508H, BLF239718H, BLF242021H, BLF242453H, BLF242808H, BLF243988H, BLF244500H, BLF242011H, BLF243955H, BLF244225H, BLF244573H, BLF240691H, BLF244431H, BLF242669H, BLF242817H, BLF244592H, BLF242008H, BLF238801H, BLF243255H, BLF235186H, BLF242114H, BLF242458H, BLF242877H, BLF238492H, BLF240026H, BLF239089H, BLF241043H, BLF241675H, BLF244655H, BLF243212H, BLF242249H, BLF243134H, BLF235187H, BLF236322H, BLF240612H, BLF239475H, BLF240856H, BLF241021H, BLF244471H, BLF244400H, BLF241010H, BLF243715H, BLF237913H, BLF238189H, BLF243062H, BLF244126H, BLF238047H, BLF243496H, BLF242066H, BLF239803H, BLF243857H, BLF244274H, BLF244562H, BLF236223H, BLF241307H, BLF242386H, BLF243473H, BLF243874H, BLF244381H, BLF244646H, BLF241843H, BLF244658H, BLF237433H, BLF238074H, BLF242735H, BLF235855H, BLF236051H, BLF242715H, BLF243294H, BLF243434H, BLF243274H, BLF241507H, BLF243198H, BLF243392H, BLF243505H, BLF243563H, BLF244312H, BLF241458H, BLF243451H, BLF243458H, BLF240776H, BLF244203H, BLF236843H, BLF236967H, BLF243061H, BLF237015H, BLF240254H, BLF240662H, BLF243612H, BLF241809H, BLF242334H, BLF242448H, BLF242812H, BLF244326H, BLF242901H, BLF243271H, BLF243652H, BLF244555H, BLF231669H, BLF235896H, BLF236939H, BLF238586H, BLF240895H, BLF243113H, BLF243762H, BLF241104H, BLF243525H, BLF243675H, BLF234586H, BLF238437H, BLF243388H, BLF243481H, BLF236549H, BLF239751H, BLF242896H, BLF243994H, BLF236965H, BLF243336H, BLF242639H, BLF235829H, BLF236571H, BLF241570H, BLF243423H, BLF244191H, BLF242221H, BLF244536H, BLF244159H, BLF238282H, BLF238845H, BLF238846H, BLF239749H, BLF234862H, BLF244276H, BLF235394H, BLF237489H, BLF243818H, BLF244071H, BLF235640H, BLF242889H, BLF243960H, BLF241297H, BLF239566H, BLF243687H, BLF244215H, BLF235675H, BLF240908H, BLF241314H, BLF241478H, BLF242645H, BLF243582H, BLF243906H, BLF241715H, BLF244467H, BLF233023H, BLF239304H, BLF2434… (truncated, 2884485 characters total — see the official FDA record for the full value)
Recalling firm:
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 3, 2021

Dimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: used as an aid in the diagnosis of lipid disorders (such as diabetes mellitus), various liver and renal diseases, and in the assessment of risk for atherosclerosis and cardiovascular disease.

Siemens Healthcare Diagnostics Inc. has confirmed the potential for erroneous results due to discolored reagent observed in some wells 5 and 6 of Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridges lot 20062BA.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
87319
Lot/product code:
Product: DV HDLC; Lot #: 20062BA; UDI Number: 0084276802043820062BA21030210464340840
Recalling firm:
Siemens Healthcare Diagnostics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 4, 2021

Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

The ultrasound system averages the Mean Sac Diameter (MSD) and Gestational Sac Diameter (GSD) into the Estimated Date of Delivery (EDD) calculation. This may result in an incorrect EDD, which may influence patient management decisions regarding induction of labor and elective caesarean delivery, which may result in premature births.

AKALARAZCACTDEFLGAHIIAILINKSKYLAMAMDMIMNMOMSNCNENHNJNMNVNYOHOKORPAPRSCSDTNTXUTVAWAWIWVWY
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
87362
Lot/product code:
Model: 11148775  Equipment Serial Numbers (U.S.) 800015 800101 800103 800104 800105 800106 800107 800108 800109 800111 800112 800113 800116 800118 800119 800121 800134 800138 800139 800141 800142 800143 800149 800150 800151 800152 800153 800155 800157 800158 800161 800165 800168 800172 800174 800175 800176 800177 800178 800182 800183 800184 800185 800186 800189 800190 800191 800192 800193 800194 800195 800196 800198 800199 800201 800203 800204 800205 800208 800209 800210 800211 800215 800217 800220 800221 800223 800225 800226 800227 800228 800229 800232 800233 800234 800235 800237 800239 800241 800242 800243 800244 800247 800249 800251 800254 800256 800257 800258 800259 800260 800263 800265 800267 800268 800270 800273 800274 800278 800280 800281 800285 800286 800291 800292 800293 800295 800300 800301 800302 800303 800304 800305 800308 800313 800314 800317 800319 800320 800321 800324 800328 800333 800335 800336 800339 800341 800342 800348 800349 800355 800360 800361 800363 800366 800369 800370 800375 800376 800383 800390 800393 800397 800405 800408 800411 800418 800424 800427 800428 800429 800433 800435 800436 800440 800451 800462 800463 800464 800466 800467 800469 800473 800474 800475 800480 800481 800486 800489 800490 800495 800498 800505 800506 800509 800511 800515 800516 800518 800521 800523 800525 800528 800532 800535 800540 800546 800549 800550 800552 800555 800556 800559 800560 800564 800566 800567 800579 800581 800583 800590 800592 800594 800597 800598 800607 800609 800611 800618 800623 800627 800628 800630 800631 800634 800638 800639 800640 800645 800648 800650 800651 800652 800653 800657 800661 800662 800667 800668 800671 800672 800673 800674 800675 800677 800680 800683 800686 800688 800693 800694 800696 800701 800703 800707 800708 800735 800738 800739 800741 800742 800743 800745 800747 800749 800752 800754 800756 800758 800760 800761 800762 800763 800771 800775 800786 800787 800788 800789 800791 800800 800805 800806 800807 800809 800813 800821 800834 800835 800854 800859 800861 800862 800863 800865 800866 800868 800869 800870 800871 800873 800874 800876 800878 800879 800880 800881 800882 800883 800884 800885 800887 800889 800890 800896 800901 800903 800904 800906 800907 800908 800912 800913 800914 800915 800917 800918 800920 800931 800933 800936 800940 800944 800945 800947 800952 800955 800959 800961 800963 800964 800979 800980 800993 800994 800998 801002 801003 801004 801005 801006 801007 801008 801009 801010 801011 801013 801014 801015 801016 801017 801018 801019 801021 801022 801023 801025 801026 801033 801034 801047 801080 801084 801087 801088 801089 801116 801117 801121 801123 801124 801125 801126 801127 801128 801129 801130 801131 801133 801134 801135 801136 801137 801138 801139 801140 801141 801144 801145 801147 801150 801152 801153 801156 801165 801166 801174 801177 801178 801191 801192 801193 801194 801196 801200 801202 801209 801211 801213 801223 801225 801230 801232 801234 801244 801245 801247 801248 801249 801259 801261 801271 801278 801279 801286 801300 801302 801306 801310 801311 801313 801314 801315 801316 801321 801324 801325 801326 801328 801330 801334 801336 801339 801345 801346 801347 801348 801352 801353 801356 801357 801358 801360 801363 801365 801366 801371 801372 801378 801381 801386 801390 801396 801400 801402 801405 801406 801408 801413 801414 801421 801423 801424 801426 801427 801430 801432 801435 801436 801437 801439 801441 801442 801443 801444 801447 801449 801450 801451 801452 801454 801458 801462 801463 801464 801465 801470 801471 801473 801474 801475 801476 801481 801483 801484 801488 801491 801492 801494 801495 801497 801499 801501 801502 801503 801506 801509 801510 801514 801515 801516 801517 801519 801521 801524 801527 801528 801529 801530 801531 801532 801534 801535 801536 801537 801538 801539 801540 801541 801542 801543 801544 801545 801548 801549 801550 801552 801553 801554 801555 801556 801558 801559 801564 801565 801567 801572 801574 801576 801579 801594 801596 801598 801605 801609 801610 801611 801629 801631 801632 801636 801639 801641 801642 801643 801645 801647 801648 801649 801650 801655 801660 801663 801675 801678 801680 801685 801708 801714 801759 801760 801768 801771 801812 801903 801911 802004 802008 802017 802019 802022 802028 802029 802032 802033 802093 802109 802125 802128 802146 802164 802217 802245 802263  Equipment Serial Numbers (O.U.S.): 800344 800438 800932 801787 801851 801020 801927 801982 801988 802069 802073 802078 802079 802081 802083 802084 802086 802123 802131 802135 802140 802147 802180 802181 802183 802185 802186 802187 802188 802189 800114 800115 800117 800120 800122 800123 800126 800127 800129 800130 800133 800135 800136 800140 800147 800148 800159 800162 800163 800166 800167 800169 800170 800171 800181 800187 800197 800206 800207 800212 800214 800218 800219 800224 800230 800231 800236 800245 800246 800248 800250 800252 800264 800266 800271 800277 800279 800282 800284 800288 800298 800309 800311 800312 800315 800323 800329 800334 8… (truncated, 8288 characters total — see the official FDA record for the full value)
Recalling firm:
Siemens Medical Solutions USA, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 5, 2021

System INFX-8000V

The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles.

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▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
87419
Lot/product code:
Model: CAS-880A, CAS-830B
Recalling firm:
Canon Medical System, USA, INC.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 5, 2021

System INFX-8000F

The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
87419
Lot/product code:
Model: CAS-880A, CAS-830B
Recalling firm:
Canon Medical System, USA, INC.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 5, 2021

System INFX-8000C

The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
87419
Lot/product code:
Model: CAS-880A, CAS-830B
Recalling firm:
Canon Medical System, USA, INC.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 7, 2021

NM/CT 870 DR Nuclear Medicine / CT Scanners

GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could cause a shift in CT radiation exposure range of up to 5cm compared to the intended radiation exposure range of the planned scan under specific workflows. The issue occurs only on a hybrid whole-body continuous F3 protocol with Zoom < 1 where the scan range is set on the Smart Console. In some cases, this may also necessitate a re-scan of the patient, which would expose the patient to additional X-ray radiation.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
87811
Lot/product code:
GTIN*00840682140836
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 7, 2021

NM/CT 860 Nuclear Medicine / CT Scanners

GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could cause a shift in CT radiation exposure range of up to 5cm compared to the intended radiation exposure range of the planned scan under specific workflows. The issue occurs only on a hybrid whole-body continuous F3 protocol with Zoom < 1 where the scan range is set on the Smart Console. In some cases, this may also necessitate a re-scan of the patient, which would expose the patient to additional X-ray radiation.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
87811
Lot/product code:
GTIN*00840682140751
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 7, 2021

NM/CT 850 Nuclear Medicine / CT Scanners

GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could cause a shift in CT radiation exposure range of up to 5cm compared to the intended radiation exposure range of the planned scan under specific workflows. The issue occurs only on a hybrid whole-body continuous F3 protocol with Zoom < 1 where the scan range is set on the Smart Console. In some cases, this may also necessitate a re-scan of the patient, which would expose the patient to additional X-ray radiation.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
87811
Lot/product code:
GTIN*00840682140775
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 8, 2021

Mizuho CE IPX4, mode MOT-5602BW, 100-240, 50-60Hz, 400VA, REF 18-140-20 containing hand control Unit - Product Usage: intended to support a patient during surgical operations.

There is a potential that hand control units may cause the tabletop to slide in the opposite direction from that selected by the user. This could result in a delay in procedure.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
87318
Lot/product code:
S/N (Control unit) - S/N (Operating table): 10290134 - MEC-20195-0034, 10290135 - MEC-20195-0036, 10290136 - MEC-20195-0035, 10290137 - MEC-20195-0033, 10490143 - MEC-20198-0038, 10490144 - MEC-20198-0037, 10490145 - MEC-20198-0040, 10490147 - MEC-20198-0039, 10690148 - MEC-2019Y-0054, 10690149 - MEC-20199-0049, 10690150 - MEC-2019Y-0059, 10690153 - MEC-2019Y-0058, 10690154 - MEC-20199-0046, 10690155 - MEC-2019Y-0057, 10690156 - MEC-20199-0050, 10690157 - MEC-20199-0044, 10690159 - MEC-20199-0047, 10690160 - MEC-20199-0051, 10690161 - MEC-20199-0045, 10690162 - MEC-20199-0048, 10690163 - MEC-2019Y-0053, 10790167 - MEC-2019Y-0052, 10790169 - MEC-2019Y-0056, 10790170 - MEC-2019Y-0055, 211080129 - MEC-2018Z-0029, 11080130 - MEC-2018Z-0028
Recalling firm:
Mizuho OSI
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 11, 2021

Operating Table System

There is a potential for hydraulic leakage at the inclination function to occur resulting in an unintended Trendelenburg or anti-Trendelenburg movement of the table top depending on patient positioning which may lead to the patient having to be transferred to another OR table causing a delay in the procedure.

AKALARAZCACODEFLGAIAIDILINKSLAMAMDMEMIMNMOMSMTNCNHNJNMNVNYOHOKORPAPRSCTNTXUTVAWAWIWV
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
87386
Lot/product code:
Part Number: 118001A0, 118001B0, 118001B1, 118001B2, 118001B3, 118001B4, 118001C0, 118001D0. UDI code: 04046768031500, 04046768031531, 04046768040700, 04046768088351, 04046768088061, 04046768124752, 04046768031555, 04046768031579. Serial Number: 1 3402, 1 1028, 1 1264, 1 401, 3 74, 1 81, 2 1159, 2 - 762.
Recalling firm:
Getinge Group Logistics America, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 12, 2021

NUVASIVE PRECICE UNYTE System (Humerus and Tibia): PRECICE Trauma Nail System/PRECICE Unyte-Humerus Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 165 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 180 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 195 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 210 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 225 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 240 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 255 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 270 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 285 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 300 mm length; End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 0mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 2mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 5mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 10mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 15mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 0mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 2mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 5mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 10mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 15mm); 3.5 mm Locking Screw, 20 mm Length; 3.5 mm Locking Screw 25 mm Length; 3.5 mm Locking Screw 30 mm Length; 3.5 mm Locking Screw 35 mm Length; 3.5 mm Locking Screw 40 mm Length; 3.5 mm Locking Screw 45 mm Length; 3.5 mm Locking Screw 50 mm Length; 3.5 mm Locking Screw 55 mm Length; 3.5 mm Locking Screw 60 mm Length; Locking Screw, 3.5x65mm; Locking Screw, 3.5x70mm; Locking Screw, 3.5x75mm; 5.0 mm Locking Screw 20 mm Length; 5.0 mm Locking Screw 25 mm Length; 5.0 mm Locking Screw 30 mm Length; 5.0 mm Locking Screw 35 mm Length; 5.0 mm Locking Screw 40 mm Length; 5.0 mm Locking Screw 45 mm Length; 5.0 mm Locking Screw 50 mm Length; 5.0 mm Locking Screw 55 mm Length; 5.0 mm Locking Screw 60 mm Length; 5.0 mm Locking Screw 65 mm Length; 5.0 mm Locking Screw 70 mm Length; 5.0 mm Locking Screw 75 mm Length; 5.0 mm Locking Screw 20 mm Length; 5.0 mm Locking Screw 25 mm Length; 5.0 mm Locking Screw 30 mm Length; 5.0 mm Locking Screw 35 mm Length; 5.0 mm Locking Screw 40 mm Length; 5.0 mm Locking Screw 45 mm Length; 5.0 mm Locking Screw 50 mm Length; 5.0 mm Locking Screw 55 mm Length; 5.0 mm Locking Screw 60 mm Length; 5.0 mm Locking Screw 65 mm Length; 5.0 mm Locking Screw 70 mm Length; 5.0 mm Locking Screw 75 mm Length; 5.0 mm X 80 mm Locking Screw, Peg; 5.0 mm X 85 mm Locking Screw, Peg; 5.0 mm X 90 mm Locking Screw, Peg; 5.0 mm X 95 mm Locking Screw, Peg; 5.0 mm X 100 mm Locking Screw, Peg; PRECICE Trauma Nail System/Precice Unyte-Tibia Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 240 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 255 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 270 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 285 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 300 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 315 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 330 mm length; Orthopedic trauma intra

Due to not having the full complement of biological assessments for all potential patients and as a result the devices are not indicated for use in individuals under the age of 18 years old.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
87353
Lot/product code:
All Lots manufactured between April 2015 to February 2021.  PRECICE Unyte Product Codes (for Humerus):   Trauma intramedullary rod, humerus, 8.5 mm diameter:  CDH8.5-20L165; CDH8.5-20L180; CDH8.5-30L195; CDH8.5-50L210; CDH8.5-50M225; CDH8.5-50M240; CDH8.5-80M255; CDH8.5-80M270; CDH8.5-80M285; CDH8.5-80M300;    end cap for trauma intramedullary humeral nail:  HEC1-000; HEC2-000; HEC3-000; HEC4-000; HEC5-000;     Locking screws:  LSB3-020; LSB3-025; LSB3-030; LSB3-035; LSB3-040; LSB3-045; LSB3-050; LSB3-055; LSB3-060; LSB3-065; LSB3-070; LSB3-075; LSB5-020; LSB5-025; LSB5-030; LSB5-035; LSB5-040; LSB5-045; LSB5-050; LSB5-055; LSB5-060; LSB5-065; LSB5-070; LSB5-075; LSC5-020; LSC5-025; LSC5-030; LSC5-035; LSC5-040; LSC5-045; LSC5-050; LSC5-055; LSC5-060; LSC5-065; LSC5-070; LSC5-075; LSC5-080; LSC5-085; LSC5-090; LSC5-095; LSC5-100.  GTIN Number (for Humerus): 00812258022730; 00812258022747; 00812258022754; 00812258022761; 00812258022778; 00812258022785; 00812258022792; 00812258022808; 00812258022815; 00812258022822; 00812258028121; 00812258028138; 00812258028145; 00812258028152; 00812258028169; 00812258021337; 00812258021344; 00812258021351; 00812258021368; 00812258021375; 00812258021382; 00812258021399; 00812258021405; 00812258021412; 00887517936233; 00887517936240; 00887517936257; 00856719002886; 00856719002893; 00856719002909; 00856719002916; 00856719002923; 00856719002930; 00856719002947; 00856719002954; 00856719002961; 00856719002978; 00856719002985; 00856719002992; 00812258021511; 00812258021528; 00812258021535; 00812258021542; 00812258021559; 00812258021566; 00812258021573; 00812258021580; 00812258021597; 00812258021603; 00812258021610; 00812258021627; 00887517001030; 00887517001047; 00887517001054; 00887517001061; 00887517001078;  Precice Unyte Product Codes (for Tibia):   trauma intramedullary rod, 11.5 mm diameter:  CDT11.5-30T240; CDT11.5-30T255; CDT11.5-30T270; CDT11.5-30T285; CDT11.5-30T300; CDT11.5-30T315; CDT11.5-30T330; CDT11.5-30T345; CDT11.5-30T360; CDT11.5-30T375; CDT11.5C-30T240; CDT11.5C-30T255; CDT11.5C-30T270; CDT11.5C-30T285; CDT11.5C-30T300; CDT11.5C-30T315; CDT11.5C-30T330; CDT11.5C-30T345; CDT11.5C-30T360; CDT11.5C-30T375;   trauma intramedullary rod, 12.5 mm diameter:  CDT12.5-30T240; CDT12.5-30T255; CDT12.5-30T270; CDT12.5-30T285; CDT12.5-30T300; CDT12.5-30T315; CDT12.5-30T330; CDT12.5-30T345; CDT12.5-30T360; CDT12.5-30T375; CDT12.5C-30T240; CDT12.5C-30T255; CDT12.5C-30T270; CDT12.5C-30T285; CDT12.5C-30T300; CDT12.5C-30T315; CDT12.5C-30T330; CDT12.5C-30T345; CDT12.5C-30T360; CDT12.5C-30T375;    end cap for trauma intramedullary nail:  TEC1-000; TEC1-005; TEC1-010; TEC1-015; TEC1-020;  Locking screws:   TSA4.5-020; TSA4.5-025; TSA4.5-030; TSA4.5-035; TSA4.5-040; TSA4.5-045; TSA4.5-050; TSA4.5-055; TSA4.5-060; TSA4.5-065; TSA4.5-070; TSA4.5-075; TSA4-020; TSA4-022.5; TSA4-025; TSA4-027.5; TSA4-030; TSA4-032.5; TSA4-035; TSA4-037.5; TSA4-040; TSA4-042.5; TSA4-045; TSA4-047.5; TSA4-050; TSA4-055; TSA4-060; TSA4-065; TSA4-070; TSA4-075; TSA4-080; TSA4-085; TSA4-090; TSA4-095; TSA4-100; TSA4-100; TSA5-020; TSA5-020; TSA5-022.5; TSA5-022.5; TSA5-025; TSA5-025; TSA5-027.5; TSA5-027.5; TSA5-030; TSA5-030; TSA5-032.5; TSA5-032.5; TSA5-035; TSA5-035; TSA5-037.5; TSA5-037.5; TSA5-040; TSA5-040; TSA5-042.5; TSA5-042.5; TSA5-045; TSA5-045; TSA5-047.5; TSA5-047.5; TSA5-050; TSA5-050; TSA5-052.5; TSA5-055; TSA5-055; TSA5-057.5; TSA5-060; TSA5-060; TSA5-062.5; TSA5-065; TSA5-065; TSA5-067.5; TSA5-070; TSA5-070; TSA5-072.5; TSA5-075; TSA5-075; TSA5-080; TSA5-080; TSA5-085; TSA5-085; TSA5-090; TSA5-090; TSA5-095; TSA5-095; TSA5-100; TSA5-100; TSA5-105; TSA5-105; TSA5-110; TSA5-110.   GTIN Number (for Tibia): 00812258027322; 00812258027339; 00812258027346; 00812258027353; 00812258027360; 00812258027377; 00812258027384; 00812258027391; 00812258027407; 00812258027414; 00812258027421; 00812258027438; 00812258027445; 00812258027452; 00812258027469; 00812258027476; 00812258027483; 00812258027490; 00812258027506; 00812258027513; 00812258027520; 00812258027537; 00812258027544; 00812258027551; 00812258027568; 00812258027575; 00812258027582; 00812258027599; 00812258027605; 00812258027612; 00812258027629; 00812258027636; 00812258027643; 00812258027650; 00812258027667; 00812258027674; 00812258027681; 00812258027698; 00812258027704; 00812258027711; 00812258028039; 00812258028046; 00812258028053; 00812258028060; 00812258028077; 00887517936011; 00887517936028; 00887517936035; 00887517936042; 00887517936059; 00887517936066; 00887517936073; 00887517936080; 00887517936097; 00887517936202; 00887517936219; 00887517936226; 00887517000033; 00887517000040; 00887517000057; 00887517000064; 00887517000071; 00887517000088; 00887517000095; 00887517000101; 00887517000118; 00887517000125; 00887517000132; 00887517000149; 00887517000156; 00887517000163; 00887517000170; 00887517000187; 00887517000194; 00887517000200; 00887517000217; 00887517000224; 00887517000231; 00887517000248; 00887517000255; 00887517000255;… (truncated, 9699 characters total — see the official FDA record for the full value)
Recalling firm:
Nuvasive Specialized Orthopedics Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 12, 2021

Valiant Navion Thoracic Stent Graft System. For endovascular repair of lesions in the descending thoracic aorta (DTA).

Due to the presence of type IIIb endoleaks, stent fractures, and stent ring enlargement.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
87379
Lot/product code:
Model Number (REF): VNMC2020C94TE VNMC2020C94TJ VNMC2020C94TU VNMC2222C180TE VNMC2222C180TJ VNMC2222C180TU VNMC2222C94TE VNMC2222C94TJ VNMC2222C94TU VNMC2520C186TE VNMC2520C186TJ VNMC2520C186TU VNMC2525C180TE VNMC2525C180TJ VNMC2525C180TU VNMC2525C94TE VNMC2525C94TJ VNMC2525C94TU VNMC2822C207TE VNMC2822C207TJ VNMC2822C207TU VNMC2828C182TE VNMC2828C182TJ VNMC2828C182TU VNMC2828C90TE VNMC2828C90TJ VNMC2828C90TU VNMC3125C207TE VNMC3125C207TJ VNMC3125C207TU VNMC3131C182TE VNMC3131C182TJ VNMC3131C182TU VNMC3131C223TE VNMC3131C223TJ VNMC3131C223TU VNMC3131C90TE VNMC3131C90TJ VNMC3131C90TU VNMC3428C207TE VNMC3428C207TJ VNMC3428C207TU VNMC3434C182TE VNMC3434C182TJ VNMC3434C182TU VNMC3434C223TE VNMC3434C223TJ VNMC3434C223TU VNMC3434C52TE VNMC3434C52TJ VNMC3434C52TU VNMC3434C90TE VNMC3434C90TJ VNMC3434C90TU VNMC3731C207TE VNMC3731C207TJ VNMC3731C207TU VNMC3737C182TE VNMC3737C182TJ VNMC3737C182TU VNMC3737C223TE VNMC3737C223TJ VNMC3737C223TU VNMC3737C52TE VNMC3737C52TJ VNMC3737C52TU VNMC3737C90TE VNMC3737C90TJ VNMC3737C90TU VNMC4034C200TE VNMC4034C200TJ VNMC4034C200TU VNMC4040C175TE VNMC4040C175TJ VNMC4040C175TU VNMC4040C218TE VNMC4040C218TJ VNMC4040C218TU VNMC4040C55TE VNMC4040C55TJ VNMC4040C55TU VNMC4040C95TE VNMC4040C95TJ VNMC4040C95TU VNMC4337C200TE VNMC4337C200TJ VNMC4337C200TU VNMC4343C175TE VNMC4343C175TJ VNMC4343C175TU VNMC4343C218TE VNMC4343C218TJ VNMC4343C218TU VNMC4343C55TE VNMC4343C55TJ VNMC4343C55TU VNMC4343C95TE VNMC4343C95TJ VNMC4343C95TU VNMC4640C200TE VNMC4640C200TJ VNMC4640C200TU VNMC4646C175TE VNMC4646C175TJ VNMC4646C175TU VNMC4646C218TE VNMC4646C218TJ VNMC4646C218TU VNMC4646C55TE VNMC4646C55TJ VNMC4646C55TU VNMC4646C95TE VNMC4646C95TJ VNMC4646C95TU VNMF2020C96TE VNMF2020C96TU VNMF2222C185TE VNMF2222C185TU VNMF2222C96TE VNMF2222C96TJ VNMF2222C96TU VNMF2520C185TE VNMF2520C185TJ VNMF2520C185TU VNMF2525C185TE VNMF2525C185TJ VNMF2525C185TU VNMF2525C96TE VNMF2525C96TJ VNMF2525C96TU VNMF2822C173TE VNMF2822C173TJ VNMF2822C173TU VNMF2828C174TE VNMF2828C174TJ VNMF2828C174TU VNMF2828C97TE VNMF2828C97TJ VNMF2828C97TU VNMF3125C173TE VNMF3125C173TJ VNMF3125C173TU VNMF3131C174TE VNMF3131C174TJ VNMF3131C174TU VNMF3131C229TE VNMF3131C229TJ VNMF3131C229TU VNMF3131C97TE VNMF3131C97TJ VNMF3131C97TU VNMF3428C173TE VNMF3428C173TJ VNMF3428C173TU VNMF3434C174TE VNMF3434C174TJ VNMF3434C174TU VNMF3434C229TE VNMF3434C229TJ VNMF3434C229TU VNMF3434C59TE VNMF3434C59TJ VNMF3434C59TU VNMF3434C97TE VNMF3434C97TJ VNMF3434C97TU VNMF3731C173TE VNMF3731C173TJ VNMF3731C173TU VNMF3737C174TE VNMF3737C174TJ VNMF3737C174TU VNMF3737C229TE VNMF3737C229TJ VNMF3737C229TU VNMF3737C59TE VNMF3737C59TJ VNMF3737C59TU VNMF3737C97TE VNMF3737C97TJ VNMF3737C97TU VNMF4034C185TE VNMF4034C185TJ VNMF4034C185TU VNMF4040C103TE VNMF4040C103TJ VNMF4040C103TU VNMF4040C183TE VNMF4040C183TJ VNMF4040C183TU VNMF4040C223TE VNMF4040C223TJ VNMF4040C223TU VNMF4040C62TE VNMF4040C62TJ VNMF4040C62TU VNMF4337C185TE VNMF4337C185TJ VNMF4337C185TU VNMF4343C103TE VNMF4343C103TJ VNMF4343C103TU VNMF4343C183TE VNMF4343C183TJ VNMF4343C183TU VNMF4343C223TE VNMF4343C223TJ VNMF4343C223TU VNMF4343C62TE VNMF4343C62TJ VNMF4343C62TU VNMF4640C185TE VNMF4640C185TJ VNMF4640C185TU VNMF4646C103TE VNMF4646C103TJ VNMF4646C103TU VNMF4646C183TE VNMF4646C183TJ VNMF4646C183TU VNMF4646C223TE VNMF4646C223TJ VNMF4646C223TU VNMF4646C62TE VNMF4646C62TJ VNMF4646C62TU  GTIN: 00763000100520 00763000100537 00763000100544 00763000100551 00763000100568 00763000100575 00763000100582 00763000100599 00763000100605 00763000100612 00763000100629 00763000100636 00763000100643 00763000100650 00763000100667 00763000100674 00763000100681 00763000100698 00763000100704 00763000100711 00763000100728 00763000100735 00763000100742 00763000100759 00763000100766 00763000100773 00763000100780 00763000100797 00763000100803 00763000100810 00763000100827 00763000100834 00763000100841 00763000100858 00763000100865 00763000100872 00763000100889 00763000100896 00763000100902 00763000100919 00763000100926 00763000100933 00763000100940 00763000100957 00763000100964 00763000100971 00763000100988 00763000100995 00763000101008 00763000101015 00763000101022 00763000101039 00763000101046 00763000101053 00763000101060 00763000101077 00763000101084 00763000101091 00763000101107 00763000101114 00763000101121 00763000101138 00763000101145 00763000101152 00763000101169 00763000101176 00763000101183 00763000101190 00763000101206 00763000101213 00763000101220 00763000101237 00763000101244 00763000101251 00763000101268 00763000101275 00763000112790 00763000112806 00763000112813 00763000112820 00763000112837 00763000112844 00763000112851 00763000112868 00763000112875 00763000112882 00763000112899 00763000112905 00763000112912 00763000112929 00763000112936 00763000112943 00763000112950 00763000112967 00763000112974 00763000112981 00763000112998 00763000113001 00763000113018 00763000113025 00763000113032 00763000113049 00763000113056 00763000113063 00763000113070 00763000113087 00763000113094 00763000113100 00763000113117 00763000113124 0076300011313… (truncated, 343298 characters total — see the official FDA record for the full value)
Recalling firm:
Medtronic Vascular, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 12, 2021

PRECICE STRYDE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.

Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail segments.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
87352
Lot/product code:
All Lots affected.  Below are: Primary DI Number(GTIN)/Product Code (REF)/Product Description: -887517981370 BT10-100C360-5 Antegrade Tibia 10¿ Bend, 10.0mm x 360mm, 5/10cm ST; 887517981554 BT10-10A360-5 Retrograde Femur 10¿ Bend, 10.0mm x 360mm, 5/10cm ST; 887517981547 BT10-10A360-7 Retrograde Femur 10¿ Bend, 10.0mm x 360mm, 7/10cm ST; 887517981530 BT10-10A380-5 Retrograde Femur 10¿ Bend, 10.0mm x 380mm, 5/10cm ST; 887517981523 BT10-10A380-7 Retrograde Femur 10¿ Bend, 10.0mm x 380mm, 7/10cm ST; 887517981516 BT10-10A400-5 Retrograde Femur 10¿ Bend, 10.0mm x 400mm, 5/10cm ST; 887517981509 BT10-10A400-7 Retrograde Femur 10¿ Bend, 10.0mm x 400mm, 7/10cm ST; 887517981493 BT10-10B360-5 Antegrade Femur Piriformis Straight, 10.0mm x 360mm, 5/10cm ST; 887517981486 BT10-10B360-7 Antegrade Femur Piriformis Straight, 10.0mm x 360mm, 7/10cm ST; 887517981479 BT10-10B380-5 Antegrade Femur Piriformis Straight, 10.0mm x 380mm, 5/10cm ST; 887517981462 BT10-10B380-7 Antegrade Femur Piriformis Straight, 10.0mm x 380mm, 7/10cm ST; 887517981455 BT10-10B400-5 Antegrade Femur Piriformis Straight, 10.0mm x 400mm, 5/10cm ST; 887517981448 BT10-10B400-7 Antegrade Femur Piriformis Straight, 10.0mm x 400mm, 7/10cm ST; 887517981431 BT10-10BT360-5 Antegrade Femur Piriformis Straight, 10.0mm x 360mm, 5/10cm ST; 887517981424 BT10-10BT360-7 Antegrade Femur Piriformis Straight, 10.0mm x 360mm, 7/10cm ST; 887517981417 BT10-10BT380-5 Antegrade Femur Piriformis Straight, 10.0mm x 380mm, 5/10cm ST; 887517981400 BT10-10BT380-7 Antegrade Femur Piriformis Straight, 10.0mm x 380mm, 7/10cm ST; 887517981394 BT10-10BT400-5 Antegrade Femur Piriformis Straight, 10.0mm x 400mm, 5/10cm ST; 887517981387 BT10-10BT400-7 Antegrade Femur Piriformis Straight, 10.0mm x 400mm, 7/10cm ST; 887517981363 BT10-10C360-7 Antegrade Tibia 10¿ Bend, 10.0mm x 360mm, 7/10cm ST; 887517981356 BT10-10C380-5 Antegrade Tibia 10¿ Bend, 10.0mm x 380mm, 5/10cm ST; 887517981349 BT10-10C380-7 Antegrade Tibia 10¿ Bend, 10.0mm x 380mm, 7/10cm ST; 887517981332 BT10-10C400-5 Antegrade Tibia 10¿ Bend, 10.0mm x 400mm, 5/10cm ST; 887517981325 BT10-10C400-7 Antegrade Tibia 10¿ Bend, 10.0mm x 400mm, 7/10cm ST; 887517981318 BT10-10D360-5 Antegrade Femur Trochanter 10¿ Bend, 10.0mm x 360mm, 5/10cm ST; 887517981301 BT10-10D360-7 Antegrade Femur Trochanter 10¿ Bend, 10.0mm x 360mm, 7/10cm ST; 887517981295 BT10-10D380-5 Antegrade Femur Trochanter 10¿ Bend, 10.0mm x 380mm, 5/10cm ST; 887517981288 BT10-10D380-7 Antegrade Femur Trochanter 10¿ Bend, 10.0mm x 380mm, 7/10cm ST; 887517981271 BT10-10D400-5 Antegrade Femur Trochanter 10¿ Bend, 10.0mm x 400mm, 5/10cm ST; 887517981264 BT10-10D400-7 Antegrade Femur Trochanter 10¿ Bend, 10.0mm x 400mm, 7/10cm ST; 887517981257 BT10-10DT360-5 Antegrade Femur Trochanter 10¿ Bend, 10.0mm x 360mm, 5/10cm ST; 887517981240 BT10-10DT360-7 Antegrade Femur Trochanter 10¿ Bend, 10.0mm x 360mm, 7/10cm ST; 887517981233 BT10-10DT380-5 Antegrade Femur Trochanter 10¿ Bend, 10.0mm x 380mm, 5/10cm ST; 887517981226 BT10-10DT380-7 Antegrade Femur Trochanter 10¿ Bend, 10.0mm x 380mm, 7/10cm ST; 887517981219 BT10-10DT400-5 Antegrade Femur Trochanter 10¿ Bend, 10.0mm x 400mm, 5/10cm ST; 887517981202 BT10-10DT400-7 Antegrade Femur Trochanter 10¿ Bend, 10.0mm x 400mm, 7/10cm ST; 887517981196 BT10-10E360-5 Retrograde Femur Straight, 10.0mm x 360mm, 5/10cm ST; 887517981189 BT10-10E360-7 Retrograde Femur Straight, 10.0mm x 360mm, 7/10cm ST; 887517981172 BT10-10E380-5 Retrograde Femur Straight, 10.0mm x 380mm, 5/10cm ST; 887517981165 BT10-10E380-7 Retrograde Femur Straight, 10.0mm x 380mm, 7/10cm ST; 887517981158 BT10-10E400-5 Retrograde Femur Straight, 10.0mm x 400mm, 5/10cm ST; 887517981141 BT10-10E400-7 Retrograde Femur Straight, 10.0mm x 400mm, 7/10cm ST; 887517981134 BT10-10SA360-5 Retrograde Femur 5¿ Bend Three Holes, 10.0mm x 360mm, 5/10cm ST; 887517981127 BT10-10SA360-7 Retrograde Femur 5¿ Bend Three Holes, 10.0mm x 360mm, 7/10cm ST; 887517981110 BT10-10SA380-5 Retrograde Femur 5¿ Bend Three Holes, 10.0mm x 380mm, 5/10cm ST; 887517981103 BT10-10SA380-7 Retrograde Femur 5¿ Bend Three Holes, 10.0mm x 380mm, 7/10cm ST; 887517981097 BT10-10SA400-5 Retrograde Femur 5¿ Bend Three Holes, 10.0mm x 400mm, 5/10cm ST; 887517981080 BT10-10SA400-7 Retrograde Femur 5¿ Bend Three Holes, 10.0mm x 400mm, 7/10cm ST; 887517981073 BT10-10SB360-5 Recon Antegrade Femur Piriformis Straight, 10.0mm x 360mm, 5/10cm ST; 887517981066 BT10-10SB360-7 Recon Antegrade Femur Piriformis Straight, 10.0mm x 360mm, 7/10cm ST; 887517981059 BT10-10SB380-5 Recon Antegrade Femur Piriformis Straight, 10.0mm x 380mm, 5/10cm ST; 887517981042 BT10-10SB380-7 Recon Antegrade Femur Piriformis Straight, 10.0mm x 380mm, 7/10cm ST; 887517981035 BT10-10SB400-5 Recon Antegrade Femur Piriformis Straight, 10.0mm x 400mm, 5/10cm ST; 887517981028 BT10-10SB400-7 Recon Antegrade Femur Piriformis Straight, 10.0mm x 400mm, 7/10cm ST; 887517981011 BT10-10SD360-5 Recon Antegrade Femur Trochanter 10¿ Bend, 10.0mm x 360mm, 5/10cm ST; 88751… (truncated, 69135 characters total — see the official FDA record for the full value)
Recalling firm:
Nuvasive Specialized Orthopedics Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 12, 2021

PRECICE PLATE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.

Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail segments.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
87352
Lot/product code:
All Lots affected.  Below are: Primary DI Number(GTIN)/Product Code (REF)/Product Description: 00887517021915 LP4.5-DLF30 PRECICE Plate 4.5mm Distal Femur Plate, Left, 35mm, 0-Hole; 00887517021908 LP4.5-DLF31 PRECICE Plate 4.5mm Distal Femur Plate, Left, 35mm, 1-Hole; 00887517021892 LP4.5-DLF32 PRECICE Plate 4.5mm Distal Femur Plate, Left, 35mm, 2-Hole; 00887517021885 LP4.5-DLF3B PRECICE Plate 4.5mm Distal Femur Plate, Left, 35mm, Bump; 00887517021878 LP4.5-DLF40 PRECICE Plate 4.5mm Distal Femur Plate, Left, 45mm, 0-Hole; 00887517021861 LP4.5-DLF41 PRECICE Plate 4.5mm Distal Femur Plate, Left, 45mm, 1-Hole; 00887517021854 LP4.5-DLF42 PRECICE Plate 4.5mm Distal Femur Plate, Left, 45mm, 2-Hole; 00887517021847 LP4.5-DLF4B PRECICE Plate 4.5mm Distal Femur Plate, Left, 45mm, Bump; 00887517021830 LP4.5-DRF30 PRECICE Plate 4.5mm Distal Femur Plate, Right, 35mm, 0-Hole; 00887517021823 LP4.5-DRF31 PRECICE Plate 4.5mm Distal Femur Plate, Right, 35mm, 1-Hole; 00887517021816 LP4.5-DRF32 PRECICE Plate 4.5mm Distal Femur Plate, Right, 35mm, 2-Hole; 00887517021809 LP4.5-DRF3B PRECICE Plate 4.5mm Distal Femur Plate, Right, 35mm, Bump; 00887517021793 LP4.5-DRF40 PRECICE Plate 4.5mm Distal Femur Plate, Right, 45mm, 0-Hole; 00887517021786 LP4.5-DRF41 PRECICE Plate 4.5mm Distal Femur Plate, Right, 45mm, 1-Hole; 00887517021779 LP4.5-DRF42 PRECICE Plate 4.5mm Distal Femur Plate, Right, 45mm, 2-Hole; 00887517021762 LP4.5-DRF4B PRECICE Plate 4.5mm Distal Femur Plate, Right, 45mm, Bump; 00887517021755 LP4.5-MLT30 PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Left, 35mm, 0-Hole; 00887517021748 LP4.5-MLT31 PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Left, 35mm, 1-Hole; 00887517021731 LP4.5-MLT32 PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Left, 35mm, 2-Hole; 00887517021724 LP4.5-MLT3B PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Left, 35mm, Bump; 00887517021717 LP4.5-MLT40 PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Left, 45mm, 0-Hole; 00887517021700 LP4.5-MLT41 PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Left, 45mm, 1-Hole; 00887517021694 LP4.5-MLT42 PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Left, 45mm, 2-Hole; 00887517021687 LP4.5-MLT4B PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Left, 45mm, Bump; 00887517021670 LP4.5-MRT30 PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Right, 35mm, 0-Hole; 00887517021663 LP4.5-MRT31 PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Right, 35mm, 1-Hole; 00887517021656 LP4.5-MRT32 PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Right, 35mm, 2-Hole; 00887517021649 LP4.5-MRT3B PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Right, 35mm, Bump; 00887517021632 LP4.5-MRT40 PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Right, 45mm, 0-Hole; 00887517021625 LP4.5-MRT41 PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Right, 45mm, 1-Hole; 00887517021618 LP4.5-MRT42 PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Right, 45mm, 2-Hole; 00887517021601 LP4.5-MRT4B PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Right, 45mm, Bump; 00887517021595 LP4.5-PLF30 PRECICE Plate 4.5mm Proximal Femur Plate, Left, 35mm, 0-Hole; 00887517021588 LP4.5-PLF31 PRECICE Plate 4.5mm Proximal Femur Plate, Left, 35mm, 1-Hole; 00887517021571 LP4.5-PLF32 PRECICE Plate 4.5mm Proximal Femur Plate, Left, 35mm, 2-Hole; 00887517021564 LP4.5-PLF3B PRECICE Plate 4.5mm Proximal Femur Plate, Left, 35mm, Bump; 00887517021557 LP4.5-PLF40 PRECICE Plate 4.5mm Proximal Femur Plate, Left, 45mm, 0-Hole; 00887517021540 LP4.5-PLF41 PRECICE Plate 4.5mm Proximal Femur Plate, Left, 45mm, 1-Hole; 00887517021533 LP4.5-PLF42 PRECICE Plate 4.5mm Proximal Femur Plate, Left, 45mm, 2-Hole; 00887517021526 LP4.5-PLF4B PRECICE Plate 4.5mm Proximal Femur Plate, Left, 45mm, Bump; 00887517021519 LP4.5-PLT30 PRECICE Plate 4.5mm Proximal Tibia Plate, Left, 35mm, 0-Hole; 00887517021502 LP4.5-PLT31 PRECICE Plate 4.5mm Proximal Tibia Plate, Left, 35mm, 1-Hole; 00887517021496 LP4.5-PLT32 PRECICE Plate 4.5mm Proximal Tibia Plate, Left, 35mm, 2-Hole; 00887517021489 LP4.5-PLT3B PRECICE Plate 4.5mm Proximal Tibia Plate, Left, 35mm, Bump; 00887517021472 LP4.5-PLT40 PRECICE Plate 4.5mm Proximal Tibia Plate, Left, 45mm, 0-Hole; 00887517021465 LP4.5-PLT41 PRECICE Plate 4.5mm Proximal Tibia Plate, Left, 45mm, 1-Hole; 00887517021458 LP4.5-PLT42 PRECICE Plate 4.5mm Proximal Tibia Plate, Left, 45mm, 2-Hole; 00887517021441 LP4.5-PLT4B PRECICE Plate 4.5mm Proximal Tibia Plate, Left, 45mm, Bump; 00887517021434 LP4.5-PRF30 PRECICE Plate 4.5mm Proximal Femur Plate, Right, 35mm, 0-Hole; 00887517021427 LP4.5-PRF31 PRECICE Plate 4.5mm Proximal Femur Plate, Right, 35mm, 1-Hole; 00887517021410 LP4.5-PRF32 PRECICE Plate 4.5mm Proximal Femur Plate, Right, 35mm, 2-Hole; 00887517021403 LP4.5-PRF3B PRECICE Plate 4.5mm Proximal Femur Plate, Right, 35mm, Bump; 00887517021397 LP4.5-PRF40 PRECICE Plate 4.5mm Proximal Femur Plate, Right, 45mm, 0-Hole; 0… (truncated, 6067 characters total — see the official FDA record for the full value)
Recalling firm:
Nuvasive Specialized Orthopedics Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 12, 2021

NUVASIVE FREEDOM: End Cap for PRECICE Intramedullary Limb Lengthening System Implant; Packaged End Cap 8.5/10.7mm, +0mm; Packaged End Cap 8.5/10.7mm, +5mm; Packaged End Cap 8.5/10.7mm, +10mm; Packaged End Cap 8.5/10.7mm, +15mm; Packaged End Cap 8.5/10.7mm, +20mm; Packaged End Cap 12.5mm, +0mm; Packaged End Cap 12.5mm, +5mm; Packaged End Cap 12.5mm, +10mm; Packaged End Cap 12.5mm, +15mm; Packaged End Cap 12.5mm, +20mm; 4.0 mm Locking Screw 20 mm Length; 4.0 mm Locking Screw 25 mm Length; 4.0 mm Locking Screw 30 mm Length; 4.0 mm Locking Screw 35 mm Length; 4.0 mm Locking Screw 40 mm Length; 4.0 mm Locking Screw 45 mm Length; 4.0 mm Locking Screw 50 mm Length; 4.0 mm Locking Screw 55 mm Length; 4.0 mm Locking Screw 60 mm Length; 5.0 mm Locking Screw 20 mm Length; 5.0 mm Locking Screw 25 mm Length; 5.0 mm Locking Screw 30 mm Length; 5.0 mm Locking Screw 35 mm Length; 5.0 mm Locking Screw 40 mm Length; 5.0 mm Locking Screw 45 mm Length; 5.0 mm Locking Screw 50 mm Length; 5.0 mm Locking Screw 55 mm Length; 5.0 mm Locking Screw 60 mm Length; 5.0 mm Locking Screw 65 mm Length; 5.0 mm Locking Screw 70 mm Length; 5.0 mm Locking Screw 75 mm Length; 4.0 mm Locking Screw 20 mm Length; 4.0 mm Locking Screw 25 mm Length; 4.0 mm Locking Screw 30 mm Length; 4.0 mm Locking Screw 35 mm Length; 4.0 mm Locking Screw 40 mm Length; 4.0 mm Locking Screw 45 mm Length; 4.0 mm Locking Screw 50 mm Length; 4.0 mm Locking Screw 55 mm Length; 4.0 mm Locking Screw 60 mm Length; 4.0 mm X 65 mm Locking Screw, Peg; 4.0 mm X 70 mm Locking Screw, Peg; 4.0 mm X 75 mm Locking Screw, Peg; 4.0 mm X 80 mm Locking Screw, Peg; 4.0 mm X 85 mm Locking Screw, Peg; 4.0 mm X 90 mm Locking Screw, Peg; 4.0 mm X 95 mm Locking Screw, Peg; 4.0 mm X 100 mm Locking Screw, Peg; 5.0 mm Locking Screw 20 mm Length; 5.0 mm Locking Screw 25 mm Length; 5.0 mm Locking Screw 30 mm Length; 5.0 mm Locking Screw 35 mm Length; 5.0 mm Locking Screw 40 mm Length; 5.0 mm Locking Screw 45 mm Length; 5.0 mm Locking Screw 50 mm Length; 5.0 mm Locking Screw 55 mm Length; 5.0 mm Locking Screw 60 mm Length; 5.0 mm Locking Screw 65 mm Length; 5.0 mm Locking Screw 70 mm Length; 5.0 mm Locking Screw 75 mm Length; 5.0 mm X 80 mm Locking Screw, Peg; 5.0 mm X 85 mm Locking Screw, Peg; 5.0 mm X 90 mm Locking Screw, Peg; 5.0 mm X 95 mm Locking Screw, Peg; 5.0 mm X 100 mm Locking Screw, Peg; Orthopedic intramedullary limb lengthening rod, residual limb lengthener, 14 mm diameter, 130 mm length; Orthopedic surgical instrument - for use with the intramedullary limb lengthening rod, residual limb lengthener;

Due to not having the full complement of biological assessments for all potential patients and as a result the devices are not indicated for use in individuals under the age of 18 years old.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
87353
Lot/product code:
All Lots manufactured between April 2015 to February 2021.  NUVASIVE Freedom Product Codes:  End Caps:  CPA1-000; CPA2-000; CPA2-005; CPA2-010; CPA2-015; CPA2-020; CPA3-000; CPA3-005; CPA3-010; CPA3-015; CPA3-020;   Locking screws:  LSB4-020; LSB4-025; LSB4-030; LSB4-035; LSB4-040; LSB4-045; LSB4-050; LSB4-055; LSB4-060; LSB5-020; LSB5-025; LSB5-030; LSB5-035; LSB5-040; LSB5-045; LSB5-050; LSB5-055; LSB5-060; LSB5-065; LSB5-070; LSB5-075; LSC4-020; LSC4-025; LSC4-030; LSC4-035; LSC4-040; LSC4-045; LSC4-050; LSC4-055; LSC4-060; LSC4-065; LSC4-070; LSC4-075; LSC4-080; LSC4-085; LSC4-090; LSC4-095; LSC4-100; LSC5-020; LSC5-025; LSC5-030; LSC5-035; LSC5-040; LSC5-045; LSC5-050; LSC5-055; LSC5-060; LSC5-065; LSC5-070; LSC5-075; LSC5-080; LSC5-085; LSC5-090; LSC5-095; LSC5-100;  Limb lengthening intramedullary rod, residual limb lengthener:  R14-100A130;  Orthopedic surgical instrument - for use with the intramedullary limb lengthening rod, residual limb lengthener:  RLL1-000;  GTIN Numbers: 00812258020002; 00887517001139; 00887517001146; 00887517001153; 00887517001160; 00887517001177; 00887517001184; 00887517001191; 00887517001207; 00887517001214; 00887517001221; 00856719002763; 00856719002770; 00856719002787; 00856719002794; 00856719002800; 00856719002817; 00856719002824; 00856719002831; 00856719002848; 00856719002886; 00856719002893; 00856719002909; 00856719002916; 00856719002923; 00856719002930; 00856719002947; 00856719002954; 00856719002961; 00856719002978; 00856719002985; 00856719002992; 00812258021429; 00812258021436; 00812258021443; 00812258021450; 00812258021467; 00812258021474; 00812258021481; 00812258021498; 00812258021504; 00887517000958; 00887517000965; 00887517000972; 00887517000989; 00887517000996; 00887517001009; 00887517001016; 00887517001023; 00812258021511; 00812258021528; 00812258021535; 00812258021542; 00812258021559; 00812258021566; 00812258021573; 00812258021580; 00812258021597; 00812258021603; 00812258021610; 00812258021627; 00887517001030; 00887517001047; 00887517001054; 00887517001061; 00887517001078; 00812258024239; 00812258026479;
Recalling firm:
Nuvasive Specialized Orthopedics Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 12, 2021

Precice Bone Transport - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.

Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail segments.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
87352
Lot/product code:
All Lots affected.  Below are: Primary DI Number(GTIN)/Product Code (REF)/Product Description: 887517981370 BT10-100C360-5 Antegrade Tibia 10¿ Bend, 10.0mm x 360mm, 5/10cm ST; 887517981554 BT10-10A360-5 Retrograde Femur 10¿ Bend, 10.0mm x 360mm, 5/10cm ST; 887517981547 BT10-10A360-7 Retrograde Femur 10¿ Bend, 10.0mm x 360mm, 7/10cm ST; 887517981530 BT10-10A380-5 Retrograde Femur 10¿ Bend, 10.0mm x 380mm, 5/10cm ST; 887517981523 BT10-10A380-7 Retrograde Femur 10¿ Bend, 10.0mm x 380mm, 7/10cm ST; 887517981516 BT10-10A400-5 Retrograde Femur 10¿ Bend, 10.0mm x 400mm, 5/10cm ST; 887517981509 BT10-10A400-7 Retrograde Femur 10¿ Bend, 10.0mm x 400mm, 7/10cm ST; 887517981493 BT10-10B360-5 Antegrade Femur Piriformis Straight, 10.0mm x 360mm, 5/10cm ST; 887517981486 BT10-10B360-7 Antegrade Femur Piriformis Straight, 10.0mm x 360mm, 7/10cm ST; 887517981479 BT10-10B380-5 Antegrade Femur Piriformis Straight, 10.0mm x 380mm, 5/10cm ST; 887517981462 BT10-10B380-7 Antegrade Femur Piriformis Straight, 10.0mm x 380mm, 7/10cm ST; 887517981455 BT10-10B400-5 Antegrade Femur Piriformis Straight, 10.0mm x 400mm, 5/10cm ST; 887517981448 BT10-10B400-7 Antegrade Femur Piriformis Straight, 10.0mm x 400mm, 7/10cm ST; 887517981431 BT10-10BT360-5 Antegrade Femur Piriformis Straight, 10.0mm x 360mm, 5/10cm ST; 887517981424 BT10-10BT360-7 Antegrade Femur Piriformis Straight, 10.0mm x 360mm, 7/10cm ST; 887517981417 BT10-10BT380-5 Antegrade Femur Piriformis Straight, 10.0mm x 380mm, 5/10cm ST; 887517981400 BT10-10BT380-7 Antegrade Femur Piriformis Straight, 10.0mm x 380mm, 7/10cm ST; 887517981394 BT10-10BT400-5 Antegrade Femur Piriformis Straight, 10.0mm x 400mm, 5/10cm ST; 887517981387 BT10-10BT400-7 Antegrade Femur Piriformis Straight, 10.0mm x 400mm, 7/10cm ST; 887517981363 BT10-10C360-7 Antegrade Tibia 10¿ Bend, 10.0mm x 360mm, 7/10cm ST; 887517981356 BT10-10C380-5 Antegrade Tibia 10¿ Bend, 10.0mm x 380mm, 5/10cm ST; 887517981349 BT10-10C380-7 Antegrade Tibia 10¿ Bend, 10.0mm x 380mm, 7/10cm ST; 887517981332 BT10-10C400-5 Antegrade Tibia 10¿ Bend, 10.0mm x 400mm, 5/10cm ST; 887517981325 BT10-10C400-7 Antegrade Tibia 10¿ Bend, 10.0mm x 400mm, 7/10cm ST; 887517981318 BT10-10D360-5 Antegrade Femur Trochanter 10¿ Bend, 10.0mm x 360mm, 5/10cm ST; 887517981301 BT10-10D360-7 Antegrade Femur Trochanter 10¿ Bend, 10.0mm x 360mm, 7/10cm ST; 887517981295 BT10-10D380-5 Antegrade Femur Trochanter 10¿ Bend, 10.0mm x 380mm, 5/10cm ST; 887517981288 BT10-10D380-7 Antegrade Femur Trochanter 10¿ Bend, 10.0mm x 380mm, 7/10cm ST; 887517981271 BT10-10D400-5 Antegrade Femur Trochanter 10¿ Bend, 10.0mm x 400mm, 5/10cm ST; 887517981264 BT10-10D400-7 Antegrade Femur Trochanter 10¿ Bend, 10.0mm x 400mm, 7/10cm ST; 887517981257 BT10-10DT360-5 Antegrade Femur Trochanter 10¿ Bend, 10.0mm x 360mm, 5/10cm ST; 887517981240 BT10-10DT360-7 Antegrade Femur Trochanter 10¿ Bend, 10.0mm x 360mm, 7/10cm ST; 887517981233 BT10-10DT380-5 Antegrade Femur Trochanter 10¿ Bend, 10.0mm x 380mm, 5/10cm ST; 887517981226 BT10-10DT380-7 Antegrade Femur Trochanter 10¿ Bend, 10.0mm x 380mm, 7/10cm ST; 887517981219 BT10-10DT400-5 Antegrade Femur Trochanter 10¿ Bend, 10.0mm x 400mm, 5/10cm ST; 887517981202 BT10-10DT400-7 Antegrade Femur Trochanter 10¿ Bend, 10.0mm x 400mm, 7/10cm ST; 887517981196 BT10-10E360-5 Retrograde Femur Straight, 10.0mm x 360mm, 5/10cm ST; 887517981189 BT10-10E360-7 Retrograde Femur Straight, 10.0mm x 360mm, 7/10cm ST; 887517981172 BT10-10E380-5 Retrograde Femur Straight, 10.0mm x 380mm, 5/10cm ST; 887517981165 BT10-10E380-7 Retrograde Femur Straight, 10.0mm x 380mm, 7/10cm ST; 887517981158 BT10-10E400-5 Retrograde Femur Straight, 10.0mm x 400mm, 5/10cm ST; 887517981141 BT10-10E400-7 Retrograde Femur Straight, 10.0mm x 400mm, 7/10cm ST; 887517981134 BT10-10SA360-5 Retrograde Femur 5¿ Bend Three Holes, 10.0mm x 360mm, 5/10cm ST; 887517981127 BT10-10SA360-7 Retrograde Femur 5¿ Bend Three Holes, 10.0mm x 360mm, 7/10cm ST; 887517981110 BT10-10SA380-5 Retrograde Femur 5¿ Bend Three Holes, 10.0mm x 380mm, 5/10cm ST; 887517981103 BT10-10SA380-7 Retrograde Femur 5¿ Bend Three Holes, 10.0mm x 380mm, 7/10cm ST; 887517981097 BT10-10SA400-5 Retrograde Femur 5¿ Bend Three Holes, 10.0mm x 400mm, 5/10cm ST; 887517981080 BT10-10SA400-7 Retrograde Femur 5¿ Bend Three Holes, 10.0mm x 400mm, 7/10cm ST; 887517981073 BT10-10SB360-5 Recon Antegrade Femur Piriformis Straight, 10.0mm x 360mm, 5/10cm ST; 887517981066 BT10-10SB360-7 Recon Antegrade Femur Piriformis Straight, 10.0mm x 360mm, 7/10cm ST; 887517981059 BT10-10SB380-5 Recon Antegrade Femur Piriformis Straight, 10.0mm x 380mm, 5/10cm ST; 887517981042 BT10-10SB380-7 Recon Antegrade Femur Piriformis Straight, 10.0mm x 380mm, 7/10cm ST; 887517981035 BT10-10SB400-5 Recon Antegrade Femur Piriformis Straight, 10.0mm x 400mm, 5/10cm ST; 887517981028 BT10-10SB400-7 Recon Antegrade Femur Piriformis Straight, 10.0mm x 400mm, 7/10cm ST; 887517981011 BT10-10SD360-5 Recon Antegrade Femur Trochanter 10¿ Bend, 10.0mm x 360mm, 5/10cm ST; 887517… (truncated, 49623 characters total — see the official FDA record for the full value)
Recalling firm:
Nuvasive Specialized Orthopedics Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 12, 2021

NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System End Cap for PRECICE Intramedullary Limb Lengthening System Implant; Packaged End Cap 8.5/10.7mm, +0mm; Packaged End Cap 8.5/10.7mm, +5mm; Packaged End Cap 8.5/10.7mm, +10mm; Packaged End Cap 8.5/10.7mm, +15mm; Packaged End Cap 8.5/10.7mm, +20mm; Packaged End Cap 12.5mm, +0mm; Packaged End Cap 12.5mm, +5mm; Packaged End Cap 12.5mm, +10mm; Packaged End Cap 12.5mm, +15mm; Packaged End Cap 12.5mm, +20mm; 3.5 mm Locking Screw, 20 mm Length; 3.5 mm Locking Screw 25 mm Length; 3.5 mm Locking Screw 30 mm Length; 3.5 mm Locking Screw 35 mm Length; 3.5 mm Locking Screw 40 mm Length; 3.5 mm Locking Screw 45 mm Length; 3.5 mm Locking Screw 50 mm Length; 3.5 mm Locking Screw 55 mm Length; 3.5 mm Locking Screw 60 mm Length; Locking Screw, 3.5x65mm; Locking Screw, 3.5x70mm; Locking Screw, 3.5x75mm; 4.0 mm Locking Screw 20 mm Length; 4.0 mm Locking Screw 25 mm Length; 4.0 mm Locking Screw 30 mm Length; 4.0 mm Locking Screw 35 mm Length; 4.0 mm Locking Screw 40 mm Length; 4.0 mm Locking Screw 45 mm Length; 4.0 mm Locking Screw 50 mm Length; 4.0 mm Locking Screw 55 mm Length; 4.0 mm Locking Screw 60 mm Length; 5.0 mm Locking Screw 20 mm Length; 5.0 mm Locking Screw 25 mm Length; 5.0 mm Locking Screw 30 mm Length; 5.0 mm Locking Screw 35 mm Length; 5.0 mm Locking Screw 40 mm Length; 5.0 mm Locking Screw 45 mm Length; 5.0 mm Locking Screw 50 mm Length; 5.0 mm Locking Screw 55 mm Length; 5.0 mm Locking Screw 60 mm Length; 5.0 mm Locking Screw 65 mm Length; 5.0 mm Locking Screw 70 mm Length; 5.0 mm Locking Screw 75 mm Length; 4.0 mm Locking Screw 20 mm Length; 4.0 mm Locking Screw 25 mm Length; 4.0 mm Locking Screw 30 mm Length; 4.0 mm Locking Screw 35 mm Length; 4.0 mm Locking Screw 40 mm Length; 4.0 mm Locking Screw 45 mm Length; 4.0 mm Locking Screw 50 mm Length; 4.0 mm Locking Screw 55 mm Length; 4.0 mm Locking Screw 60 mm Length; 4.0 mm X 65 mm Locking Screw, Peg; 4.0 mm X 70 mm Locking Screw, Peg; 4.0 mm X 75 mm Locking Screw, Peg; 4.0 mm X 80 mm Locking Screw, Peg; 4.0 mm X 85 mm Locking Screw, Peg; 4.0 mm X 90 mm Locking Screw, Peg; 4.0 mm X 95 mm Locking Screw, Peg; 4.0 mm X 100 mm Locking Screw, Peg; 5.0 mm Locking Screw 20 mm Length; 5.0 mm Locking Screw 25 mm Length; 5.0 mm Locking Screw 30 mm Length; 5.0 mm Locking Screw 35 mm Length; 5.0 mm Locking Screw 40 mm Length; 5.0 mm Locking Screw 45 mm Length; 5.0 mm Locking Screw 50 mm Length; 5.0 mm Locking Screw 55 mm Length; 5.0 mm Locking Screw 60 mm Length; 5.0 mm Locking Screw 65 mm Length; 5.0 mm Locking Screw 70 mm Length; 5.0 mm Locking Screw 75 mm Length; 5.0 mm X 80 mm Locking Screw, Peg; 5.0 mm X 85 mm Locking Screw, Peg; 5.0 mm X 90 mm Locking Screw, Peg; 5.0 mm X 95 mm Locking Screw, Peg; 5.0 mm X 100 mm Locking Screw, Peg; Orthopedic intramedullary limb lengthening rod, retrograde femur 10 degree, 10.7 mm diameter, 170 mm length; Orthopedic intramedullary limb lengthening rod, antegrade tibia, 10.7 mm diameter, 160 mm length; Orthopedic intramedullary limb lengthening rod, antegrade femur trochanteric, 10.7 mm diameter, 170 mm length; Orthopedic intramedullary limb lengthening rod, universal femur, 10.7 mm diameter, 170 mm length; Orthopedic intramedullary limb lengthening rod, retrograde femur, 10 degree, 10.7 mm diameter, 215 mm length; Orthopedic intramedullary limb lengthening rod, retrograde femur, 10 degree, 10.7 mm diameter, 230 mm length; Orthopedic intramedullary limb lengthening rod, antegrade femur (piriformis), 10.7 mm diameter, 215 mm length; Orthopedic intramedullary limb lengthening rod, antegrade femur (piriformis), 10.7 mm diameter, 230 mm length; Orthopedic intramedullary limb lengthening rod, antegrade tibia, 10.7 mm diameter, 195 mm length; Orthopedic intramedullary limb lengthening rod, antegrade tibia, 10.7 mm diameter, 215 mm length; Orthopedic intramedullary limb lengthening

Due to not having the full complement of biological assessments for all potential patients and as a result the devices are not indicated for use in individuals under the age of 18 years old.

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FDA has not published a risk classification for this recall yet.

Recall #:
87353
Lot/product code:
All Lots manufactured between April 2015 to February 2021.  PRECICE Intramedullary Limb Lengthening (IMLL) Product Codes:  End caps: CPA1-000; CPA2-000; CPA2-005; CPA2-010; CPA2-015; CPA2-020; CPA3-000; CPA3-005; CPA3-010; CPA3-015; CPA3-020;  Locking screws:  LSB3-020; LSB3-025; LSB3-030; LSB3-035; LSB3-040; LSB3-045; LSB3-050; LSB3-055; LSB3-060; LSB3-065; LSB3-070; LSB3-075; LSB4-020; LSB4-025; LSB4-030; LSB4-035; LSB4-040; LSB4-045; LSB4-050; LSB4-055; LSB4-060; LSB5-020; LSB5-025; LSB5-030; LSB5-035; LSB5-040; LSB5-045; LSB5-050; LSB5-055; LSB5-060; LSB5-065; LSB5-070; LSB5-075; LSC4-020; LSC4-025; LSC4-030; LSC4-035; LSC4-040; LSC4-045; LSC4-050; LSC4-055; LSC4-060; LSC4-065; LSC4-070; LSC4-075; LSC4-080; LSC4-085; LSC4-090; LSC4-095; LSC4-100; LSC5-020; LSC5-025; LSC5-030; LSC5-035; LSC5-040; LSC5-045; LSC5-050; LSC5-055; LSC5-060; LSC5-065; LSC5-070; LSC5-075; LSC5-080; LSC5-085; LSC5-090; LSC5-095; LSC5-100;   Limb lengthening intramedullary rods 10.7 mm diameter:  P10.7-30H170; P10.7-30J160; P10.7-30K170; P10.7-30U170; P10.7-50A215; P10.7-50A230; P10.7-50B215; P10.7-50B230; P10.7-50C195; P10.7-50C215; P10.7-50C230; P10.7-50D215; P10.7-50D230; P10.7-50E215; P10.7-50E230; P10.7-50H190; P10.7-50J180; P10.7-50K190; P10.7-50M175; P10.7-50N160; P10.7-50P175; P10.7-50Q155; P10.7-50U190; P10.7-50V215; P10.7-50V230; P10.7-50X215; P10.7-50X230; P10.7-80A245; P10.7-80A275; P10.7-80A305; P10.7-80A335; P10.7-80A365; P10.7-80B245; P10.7-80B275; P10.7-80B305; P10.7-80B335; P10.7-80B365; P10.7-80C245; P10.7-80C275; P10.7-80C305; P10.7-80C335; P10.7-80C365; P10.7-80D245; P10.7-80D275; P10.7-80D305; P10.7-80D335; P10.7-80D365; P10.7-80E245; P10.7-80E275; P10.7-80E305; P10.7-80E335; P10.7-80E365; P10.7-80V245; P10.7-80V275; P10.7-80V305; P10.7-80V335; P10.7-80V365; P10.7-80X245; P10.7-80X275; P10.7-80X305; P10.7-80X335; P10.7-80X365;   Limb lengthening intramedullary rods 12.5 mm diameter:  P12.5-30H170; P12.5-30J160; P12.5-30K170; P12.5-30U170; P12.5-50A215; P12.5-50A230; P12.5-50B215; P12.5-50B230; P12.5-50C195; P12.5-50C215; P12.5-50C230; P12.5-50D215; P12.5-50D230; P12.5-50E215; P12.5-50E230; P12.5-50H190; P12.5-50J180; P12.5-50K190; P12.5-50U190; P12.5-50V215; P12.5-50V230; P12.5-50X215; P12.5-50X230; P12.5-80A245; P12.5-80A275; P12.5-80A305; P12.5-80A335; P12.5-80A365; P12.5-80B245; P12.5-80B275; P12.5-80B305; P12.5-80B335; P12.5-80B365; P12.5-80C245; P12.5-80C275; P12.5-80C305; P12.5-80C335; P12.5-80C365; P12.5-80D245; P12.5-80D275; P12.5-80D305; P12.5-80D335; P12.5-80D365; P12.5-80E245; P12.5-80E275; P12.5-80E305; P12.5-80E335; P12.5-80E365; P12.5-80V245; P12.5-80V275; P12.5-80V305; P12.5-80V335; P12.5-80V365; P12.5-80X245; P12.5-80X275; P12.5-80X305; P12.5-80X335; P12.5-80X365;   Limb lengthening intramedullary rods 8.5 mm diameter:  P8.5-30H170; P8.5-30J160; P8.5-30K170; P8.5-30U170; P8.5-50A215; P8.5-50A230; P8.5-50B215; P8.5-50B230; P8.5-50C195; P8.5-50C215; P8.5-50C230; P8.5-50D215; P8.5-50D230; P8.5-50E215; P8.5-50E230; P8.5-50H190; P8.5-50J180; P8.5-50K190; P8.5-50M165; P8.5-50N150 P8.5-50P165; P8.5-50Q155; P8.5-50U190; P8.5-50V215; P8.5-50V230; P8.5-50X215; P8.5-50X230; P8.5-80A245; P8.5-80A275; P8.5-80A305; P8.5-80A335; P8.5-80A365; P8.5-80B245; P8.5-80B275; P8.5-80B305; P8.5-80B335; P8.5-80B365; P8.5-80C245; P8.5-80C275; P8.5-80C305; P8.5-80C335; P8.5-80C365; P8.5-80D245; P8.5-80D275; P8.5-80D305; P8.5-80D335; P8.5-80D365; P8.5-80E245; P8.5-80E275; P8.5-80E305; P8.5-80E335; P8.5-80E365; P8.5-80V245; P8.5-80V275; P8.5-80V305; P8.5-80V335; P8.5-80V365; P8.5-80X245; P8.5-80X275; P8.5-80X305; P8.5-80X335; P8.5-80X365;    Limb lengthening intramedullary rods 10.5 mm diameter:  PR10.5-50A215; PR10.5-50A230; PR10.5-50B215; PR10.5-50B230; PR10.5-50C195; PR10.5-50C215; PR10.5-50C230; PR10.5-50D215; PR10.5-50D230; PR10.5-50E215; PR10.5-50E230; PR10.5-80A245; PR10.5-80A275; PR10.5-80A305; PR10.5-80A335; PR10.5-80A365; PR10.5-80B245; PR10.5-80B275; PR10.5-80B305; PR10.5-80B335; PR10.5-80B365; PR10.5-80C245; PR10.5-80C275; PR10.5-80C305; PR10.5-80C335; PR10.5-80C365; PR10.5-80D245; PR10.5-80D275; PR10.5-80D305; PR10.5-80D335; PR10.5-80D365; PR10.5-80E245; PR10.5-80E275; PR10.5-80E305; PR10.5-80E335; PR10.5-80E365;    Limb lengthening intramedullary rods 11.5 mm diameter:  PR11.5-50A215; PR11.5-50A230; PR11.5-50B215; PR11.5-50B230; PR11.5-50C195; PR11.5-50C215; PR11.5-50C230; PR11.5-50D215; PR11.5-50D230; PR11.5-50E215; PR11.5-50E230; PR11.5-80A245; PR11.5-80A275; PR11.5-80A305; PR11.5-80A335; PR11.5-80A365; PR11.5-80B245; PR11.5-80B275; PR11.5-80B305; PR11.5-80B335; PR11.5-80B365; PR11.5-80C245; PR11.5-80C275; PR11.5-80C305; PR11.5-80C335; PR11.5-80C365; PR11.5-80D245; PR11.5-80D275; PR11.5-80D305; PR11.5-80D335; PR11.5-80D365; PR11.5-80E245; PR11.5-80E275; PR11.5-80E305; PR11.5-80E335; PR11.5-80E365;   Limb lengthening intramedullary rods 12.5 mm diameter:  PR12.5-50A215; PR12.5-50A230; PR12.5-50B215; PR12.5-50B230; PR12.5-50C195; PR12.5-50C215; PR12.5-50C230; PR12.5-50D215; PR12.5-50D230; PR1… (truncated, 19741 characters total — see the official FDA record for the full value)
Recalling firm:
Nuvasive Specialized Orthopedics Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 18, 2021

RUSCH POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.

Teleflex is voluntarily recalling the products referenced above due to customers reporting that the laryngoscope handles develop cracks and/or break at the hinge.

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FDA has not published a risk classification for this recall yet.

Recall #:
87370
Lot/product code:
Model 44401 (GTIN: Each: 14026704662552 Box: 24026704662559 Case: 34026704662556; lots 197, 19A, 19F, 19J, 19P, 19W, 205, 207, 20C, 20H, 20T); Model 44402 (GTIN: Each: 14026704662569 Box: 24026704662566 Case: 34026704662563; lots 197, 19A, 19F, 19J, 19P, 19W, 205, 207, 20C, 20H, 20M, 20T);  Model 44403 (GTIN: Each: 14026704662576 Box: 24026704662573 Case: 34026704662570; lots 197, 19A, 19F, 19J, 207, 20C, 20H, 20M, 20T).
Recalling firm:
TELEFLEX MEDICAL INC
View official FDA record (opens in a new tab)