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Recalls affecting Vermont

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

16,253 recalls found

Just announced

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

Business Pill, Branch Manager for Mendietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

Full report
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 AliveMoringa Leaf Powder

Potential to be contaminated with Salmonella

Full report
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. Braun0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

Full report
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 ValueOrganic Triple Berry Blend

Possible E. Coli Contamination

Full report
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

Full report
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 TemptationsChocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

Full report
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

LipofitLipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

Full report
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

KofinasGarlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

Full report
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 SproutsRobust 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

MartinaMangoes

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 January 19, 2021

Captivator/Captiflex/Sensation Short Throw Single-Use Polypectomy Snares Outer box UPN, Inner pouch UPN: M00560311 (Box 5), M00560310; M00560321 (Box 5), M00560320; M00562651 (Box 5), M00562650; M00562652 (Box 20), M00562650; M00562671 (Box 5), M00562670; M00562672 (Box 20), M00562670; M00562673 (Box 40), M00562670; M00562691 (Box 5); M00562690; M00562692 (Box 20), M00562690; M00562693 (Box 40), M00562690.

Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.

ALL 50 STATES
Full report

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

Recall #:
87221
Lot/product code:
Outer box GTIN: 08714729283904 Inner pouch GTIN: 08714729747598 Lot/Batch#: 24818278, 24906823, 25042455  Outer box GTIN: 08714729283928 Inner pouch GTIN: 08714729747611 Lot/Batch#: 24685766, 24817145, 24899710, 24739786, 25006735, 24861901  Outer box GTIN: 08714729158110 Inner pouch GTIN: 08714729748069 Lot/Batch#: 24685764, 24890051, 24824132  Outer box GTIN: 08714729268802 Inner pouch GTIN: 08714729748069 Lot/Batch#: 25023345  Outer box GTIN: 08714729158141 Inner pouch GTIN: 08714729748083 Lot/Batch#: 24699718, 24939626, 24861739  Outer box GTIN: 08714729268819 Inner pouch GTIN: 08714729748083 Lot/Batch#: 24824134, 25006729, 24709534  Outer box GTIN: 08714729501664 Inner pouch GTIN: 08714729748083 Lot/Batch#: 25023203, 24697822, 24739587, 24942292, 24909214, 24824136  Outer box GTIN: 08714729158158 Inner pouch GTIN: 08714729748106 Lot/Batch#: 24856636, 24927642, 24699218  Outer box GTIN: 08714729268826 Inner pouch GTIN: 08714729748106 Lot/Batch#: 24835709, 24818605, 25023343  Outer box GTIN: 08714729501671 Inner pouch GTIN: 08714729748106 Lot/Batch#: 24909216, 24758832, 24872119, 24994171, 25048397, 2475126, 24929431, 24995438
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 19, 2021

Various reprocessed products: PROVISION, Reprocessed Smith and Nephew Arthroscopic Shavers, STERILE EO; PROVISION Reprocessed Depy Mitek Ablation Electrodes, VAPR COOLPULSE 90 deg; PROVISION Reprocessed Smith and Nephew Trocars/ Cannulas (Class I); PROVISION Reprocessed Conmed/ Linvatec Suture Retrievers/ Passers C6387 See updated product list attached for details.

Non-sterile product was shipped to customers labelled as sterile.

ALL 50 STATES
Full report

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

Recall #:
87258
Lot/product code:
Lot Number L-008926-16037 Lot numbers L-008918-16048, and L-008918-16045  Lot numbers L-008936-16275, and L-008933-16078
Recalling firm:
ReNovo, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 19, 2021

Enteral Infusion Pump

The potential for air appearing in the enteral feed pumping set tubing during set-up.

ALL 50 STATES
Full report

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

Recall #:
87281
Lot/product code:
Catalog Number: 612054, 613650, 614650, 672055, 673656, 673662, 674655, 674668, 674669, 716154, 762055, 763656, 763662, 765100, 765559, 772055, 773656, 773662, 775100, 775659, 776150
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 25, 2021

Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120. NDC: 29033-056-01

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0249-2021
Lot/product code:
Lot MET200601, 07/2022
Recalling firm:
Nostrum Laboratories Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 27, 2021

Spironolactone Tablets, USP, 50 mg, packaged in 30-count bottles, Rx only, Manufactured by: Frontida BioPharm, Inc., Philadelphia, PA 19124 USA, Repackaged by: Bryant Ranch Prepack, Inc., Burbank, CA 91504 USA, NDC 63629-1067-01

Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0304-2021
Lot/product code:
Lot #: 148992, Exp 5/31/2022
Recalling firm:
Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled January 27, 2021

Spironolactone Tablets, USP, 25 mg, packaged in: a) 30-count bottles (NDC 63629-1064-01), b) 60-count bottles (NDC 63629-1064-02), c) 90-count bottles (NDC 63629-1064-03), Rx only, Manufactured by: Frontida BioPharm, Inc., Philadelphia, PA 19124 USA, Repackaged by: Bryant Ranch Prepack, Inc., Burbank, CA 91504 USA

Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 25 mg may contain spironolactone 50 mg tablets.

ALL 50 STATES
Full report

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

Recall #:
D-0303-2021
Lot/product code:
a) Lot #: 148969, Exp 7/31/2022, b) Lot #: 148791, Exp 7/31/2022, c) Lot #: 148991, Exp 7/31/2022
Recalling firm:
Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 29, 2021

S-Series Equipment Management System; Model Number(s):0682400550; UDI: 07613327400502 Components that are affected within the S-Series Finished Good Model Number o P38198 - ASM, MFR CONTROLLER, FIXED STANDARD o P38199 - ASM, MFR CONTROLLER, LIFT STANDARD o P40553 - ASM, MFR HANDLE REPAIR, LIFTING, S-SERIES, STANDARD o P40554 - ASM, MFR HANDLE REPAIR, FIXED, S-SERIES, STANDARD o P46269 - ASSY, MFR CONTROLLER UPGRADE, STANDARD

The manufacturer has become aware that there is a likelihood that the S-Series Equipment Management System Capacitive Touch Controls on the MFRs rotational electrical magnetic brakes may disengage when an electrocautery device is in use.

ALL 50 STATES
Full report

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

Recall #:
87331
Lot/product code:
Serial Numbers: 2258046 2863490
Recalling firm:
Stryker Communications
View official FDA record (opens in a new tab)
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 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)
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)

ALL 50 STATES
Full report

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)
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 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 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 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.

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 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 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 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 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 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

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

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.

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 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)