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Recalls affecting Nevada

Data last updated: September 8, 2026 at 1:13 PM UTC

16,567 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/virusAnnounced 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/virusAnnounced 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)
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)
UnclassifiedAllergenUndeclaredAnnounced 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)
UnclassifiedBacteria/virusAnnounced 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/virusAnnounced 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 December 7, 2017

ESSENTIO SR Pacemaker

Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).

ALL 50 STATES
Full report

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

Recall #:
78787
Lot/product code:
Model L100
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 7, 2017

VALITUDE X4 CRT-P Pacemaker

Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).

ALL 50 STATES
Full report

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

Recall #:
78787
Lot/product code:
Model U128
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 7, 2017

VISIONIST CRT-P Pacemaker

Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).

ALL 50 STATES
Full report

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

Recall #:
78787
Lot/product code:
Model U225 and Model 226
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 7, 2017

ACCOLADE MRI DR Pacemaker

Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).

ALL 50 STATES
Full report

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

Recall #:
78787
Lot/product code:
Model L311
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 7, 2017

ALTRUA 2 SR Pacemaker

Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).

ALL 50 STATES
Full report

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

Recall #:
78787
Lot/product code:
Model S701
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 7, 2017

ACCOLADE MRI SR Pacemaker

Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).

ALL 50 STATES
Full report

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

Recall #:
78787
Lot/product code:
Model L310
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 7, 2017

ACCOLADE EL DR Pacemaker

Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).

ALL 50 STATES
Full report

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

Recall #:
78787
Lot/product code:
Model L321
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 7, 2017

ACCOLADE DR Pacemaker

Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).

ALL 50 STATES
Full report

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

Recall #:
78787
Lot/product code:
Model L301
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 18, 2017

ADVIA Centaur BNP (B-type Natriuretic Peptide), Catalog Numbers: 02816138 (100 tests), 02816634 (500 tests)

In certain scenarios the ADVIA Centaur CP, XP and XPT immunoassay analyzers may exhibit reduced dilution recovery or become inoperable when used with Multi-Diluent 15 and certain lots of BNP and TSH3RUL Assays.

Full report

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

Recall #:
79496
Lot/product code:
Lot Numbers ending in: 192,193,196
Recalling firm:
Siemens Healthcare Diagnostics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 18, 2017

ADVIA Centaur TSH3-Ultra (Thyroid Stimulating Hormone 3 Ultra), Catalog Numbers: 06491072 (100 tests), 06491080 (500 tests), 04862625 (2500 tests)

In certain scenarios the ADVIA Centaur CP, XP and XPT immunoassay analyzers may exhibit reduced dilution recovery or become inoperable when used with Multi-Diluent 15 and certain lots of BNP and TSH3RUL Assays.

Full report

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

Recall #:
79496
Lot/product code:
Lot Numbers ending in: 298 and 301
Recalling firm:
Siemens Healthcare Diagnostics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 28, 2017

NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile

Potential for stylet to protrude from the distal end of the catheter

ALL 50 STATES
Full report

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

Recall #:
88317
Lot/product code:
Reference Number 201-2430, Lot Numbers 16308139 (Expiration August 2022), 16308383 (Expiration October 2022)
Recalling firm:
Epimed International
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 28, 2017

HYPOTHERMIA SLIPPERS Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), SL3000 (b) Elasto-Gel(TM), SL3000LV (c) Elasto-Gel(TM), SL3001 (d) Elasto-Gel(TM), SL3007 (e) Elasto-Gel(TM), SL3008

Hypothermia mitts, hypothermia slippers, and hypothermia caps on the market are incorrectly labeled for use during chemotherapy treatments. Additionally, Southwest Technologies, Inc. was informed of 2 events of frostbite to digits in the last year while using the hypothermia mitts.

ALL 50 STATES
Full report

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

Recall #:
78877
Lot/product code:
US Distribution:  (a) SL3000, Lot Numbers:  110713C 122612D 091412C 070909D 052213E 080813D 020314D 031714D 071014B 101514B 120214B 011415B 030515C 041315C 071315C 091115C 100915C 020516D 030316D 041116D 060116B 062916C 081716B 101216D  OUS Distribution: (a) SL3000, Lot Numbers: 102909D 070909D 011110C 030210C 042110D 050610C 080910C 100610D 011911C 031111D 060211C 080911C 100611B 012512B 031912C 061212D 091412C 110712B 122612D 052213E 080813D 110713C 020314D 031714D 071014B 101514B 120214B 011415B 030515C 041315C 071315C 091115C 100915C 020516D 030316D 040816B 041116D 060116B 081716B 101216D 013117B 022017D 041917C  (b) SL3000LV, Lot Numbers: 022117C 032817C 050417B 061917C 071217B  (c) SL3001, Lot Numbers: 032410C, 110210B  (d) SL3007, Lot Numbers: 080510E, 102616D  (e) SL3008, Lot Numbers: 030110C
Recalling firm:
Southwest Technologies Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 28, 2017

NEO-KATH Epidural Catheter Set, REF 200-2430, Sterile

Potential for stylet to protrude from the distal end of the catheter

ALL 50 STATES
Full report

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

Recall #:
88317
Lot/product code:
Reference Number 200-2430, Lot Numbers 16308275 (Expiration August 2022), 16308382 (Expiration October 2022)
Recalling firm:
Epimed International
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 28, 2017

HYPOTHERMIA MITTS Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), TM7006 (b) Elasto-Gel(TM), TM7006LV (c) Elasto-Gel(TM), TM7007 (d) Elasto-Gel(TM), TM7008 (e) Elasto-Gel(TM), TM7008b (f) Elasto-Gel(TM), TM7009 (g) Elasto-Gel(TM), TM7010 (h) Elasto-Gel(TM), TM7011 (i) Elasto-Gel(TM), TM7012

Hypothermia mitts, hypothermia slippers, and hypothermia caps on the market are incorrectly labeled for use during chemotherapy treatments. Additionally, Southwest Technologies, Inc. was informed of 2 events of frostbite to digits in the last year while using the hypothermia mitts.

ALL 50 STATES
Full report

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

Recall #:
78877
Lot/product code:
US distribution: (a) TM7006, Lot numbers: 060805B, 050415D  (b) TM7008, Lot numbers: 031111B, 100511D, 012512C, 031912B, 071212D, 122612C, 021813C, 030513B, 031309D, 052213D, 090313E, 120613C, 022714D, 040114B  OUS distribution: (a) TM7006, Lot Numbers:  090909C 102209C 031710D 050510D 080910B 010611B 031111C 090811D 100511C 060612D 101212B 110712D 020613C 070213E 101713B 031414C 063014D 092914C 101614B 012115D 050415D 111015D 020316B 042116D 101116D  (b) TM7006LV, Lot Numbers: 022117B 032817B 050317D 061917D 071217C  (c) TM7007, Lot Numbers: 032410D, 110210D  (d) TM7008, Lot Numbers: 120709B 040210D 050610B 031111B 082311B 080911D 100511D 012512C 031912B 071212D 122612C 021813C 030513B 052213D 090313E 120613C 022714D 040114B 051414C 102714D 090814C 121614D 041015C 051815D 091115B 101715C 121015D 030316B 032116C 042016C 060116C 082316F 101116C 022017C 041817C  (e) TM7009, Lot Numbers: 080510C 120211E 092012C 101013C 042215B 102616C  (f) TM7010, Lot Numbers: 030110D  (g) TM7011, Lot Numbers: 030110E  (h) TM7012, Lot Numbers: 042110D
Recalling firm:
Southwest Technologies Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 28, 2017

HYPOTHERMIA CAP Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), CAP610 (b) Elasto-Gel(TM), CAP610LV (c) Elasto-Gel(TM), CAP613 (d) Elasto-Gel(TM), CAP617 (e) Elasto-Gel(TM), CAP619 (f) Elasto-Gel(TM), CAP619LV (g) Elasto-Gel(TM), CAP622

Hypothermia mitts, hypothermia slippers, and hypothermia caps on the market are incorrectly labeled for use during chemotherapy treatments. Additionally, Southwest Technologies, Inc. was informed of 2 events of frostbite to digits in the last year while using the hypothermia mitts.

ALL 50 STATES
Full report

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

Recall #:
78877
Lot/product code:
US distribution: (a) CAP610, Lot Numbers:  020613D 112912B 101312C 040813B 070213F 081513B 100113C 111413B 020314C 032516B 040514B 061014D 072214C 072214C 090914D 090914D 111814B 012115C 032715B 040915D 041615C 043015D 070915D 081815B 090115B 101215C 111315B 122115C 010616B 012116B 022316C 030116B 030515D 031016B 042516C 050616B 052016C 053116C 070816C 072516C 081216B 090216B 091416F 101316D    (b) CAP610LV, Lot Numbers:  121912D 041013E 070813B 102413B 121913C 031414D 082014C 091615D   OUS distribution: (a) CAP610, Lot Numbers: 011210B 012116B 020110B 020314C 022017B 022316C 030116B 030210B 030711D 032715B 040317C 040514B 040813B 042516C 043015D 050112C 052016C 053116C 060311B 070816C 070915D 072214C 072516C 072817d 081710B 082409B 090115B 091311B 101215C 101312C 101316D 111011B 111413B 111710C 111716L 111814B 112912B 172817d  (b) CAP610LV, Lot Numbers: 050610D 091710B 120110B 030711C 040211D 062711C 091311C 031912E 051712C 091112C 102912B 121912D 041013E 070813B 102413B 121913C 031414D 070914C 082014C 110714C 121114C 010815D 041615D 051315C 061615B 091615D 112315B 012116C 021516B 040716B 041516B 052416B 072816B 091616C 101816B 013117C 022117D 030217C 032817D 050317B 071117D  (c) CAP613, Lot Numbers: 093015B  (d) CAP617, Lot Numbers: 080510D 120211D 092012D 101013B 042215C 102616B  (e) CAP619, Lot Numbers: 062309B 051210C 091010C 101910C 112811E  (f) CAP619LV, Lot Numbers: 061212C 030513H 100113D 101713C 052114B 110714D 121114D 061515C 091715D 112315C 012116D 021516C 040716C 041516C 013117D 050317C 061217C  (g) CAP622, Lot Numbers: 110210C
Recalling firm:
Southwest Technologies Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 15, 2018

LEGION(TM) HEMI STEP TIBIAL WEDGE RK/HK, 5 MM, SIZE 3-4 LT.MDL/RT-LAT, REF 71423432 Product Usage: The constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e., medial collateral and/or lateral collateral ligament) are absent or incompetent.

The affected products were inadvertently packaged with an incorrect screw component.

ALL 50 STATES
Full report

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

Recall #:
83596
Lot/product code:
13KSL0038C
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 19, 2018

AutoMate 1200 Catalog Number ODL25120; AutoMate 1250 Catalog Number ODL25125; AutoMate 2500 Catalog Number ODL25250; AutoMate 2550 Catalog Number ODL25255

Belts on the x-axis (and on the y-axis, to a lesser extent) manufactured from 2015 are showing premature failure, posing the remote risk of cross-contamination.

ALL 50 STATES
Full report

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

Recall #:
79006
Lot/product code:
All systems up to the following Serial Numbers: ODL25120 Revision T; SN3101, ODL25125 Revision W; SN1508, ODL25250 Revision T; SN2416, ODL25255 Revision W; SN4617
Recalling firm:
Beckman Coulter Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 25, 2018

CMI (Collagen Meniscus Implant) device, Ivy Sports Medicine s collagen-based meniscus implant Product Usage: The CMI device, Ivy Sports Medicine s collagen-based meniscus implant, is comprised primarily of bovine type I collagen (nominally 99%) derived from tendon and small quantities of glycosaminoglycans (GAGs: chondroitin sulfate and sodium hyaluronate). The device functions as a resorbable scaffold that is replaced by the patient s own tissue.The CMI device is designed to function as an absorbable template to facilitate host meniscus tissue regeneration in patients who have an irreparable meniscus tear or loss of meniscus tissue. The CMI meniscus tissue through the implant s absorption and replacement by patient s native tissue.

The recalled products were shipped without the required temperature control packaging, therefore could potentially have been exposed to elevated temperatures during transit.

ALL 50 STATES
Full report

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

Recall #:
79030
Lot/product code:
Serial/Lot Number(s) Affected: 4600: 15J456; 4601: 16A463, 16G470, 17F510; 4607: 16A461, 16D465, 16E467, 16F468, 17E506, 17E507; 4612: 16A458, 16A459, 17D489, 17E503, 17E504
Recalling firm:
Stryker Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 29, 2018

Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 54mm, REF 804-07-540 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.

It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is much larger on the trails than on the implants

ALL 50 STATES
Full report

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

Recall #:
79241
Lot/product code:
All Serial Numbers
Recalling firm:
Encore Medical, Lp
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 29, 2018

Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 38mm, REF 804-07-380 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.

It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is much larger on the trails than on the implants

ALL 50 STATES
Full report

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

Recall #:
79241
Lot/product code:
All Serial Numbers
Recalling firm:
Encore Medical, Lp
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 29, 2018

Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 50mm, REF 804-07-500 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.

It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is much larger on the trails than on the implants

ALL 50 STATES
Full report

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

Recall #:
79241
Lot/product code:
All Serial Numbers
Recalling firm:
Encore Medical, Lp
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 29, 2018

Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 42mm, REF 804-07-420 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.

It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is much larger on the trails than on the implants

ALL 50 STATES
Full report

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

Recall #:
79241
Lot/product code:
All Serial Numbers
Recalling firm:
Encore Medical, Lp
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 29, 2018

Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 46mm, REF 804-07-460 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.

It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is much larger on the trails than on the implants

ALL 50 STATES
Full report

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

Recall #:
79241
Lot/product code:
All Serial Numbers
Recalling firm:
Encore Medical, Lp
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UnclassifiedRisk not yet known
Medical deviceRecalled February 2, 2018

Tissu-Trans Syringe Fill 360, Catalog 3-TT-SFILL 360, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.

The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch.

ALL 50 STATES
Full report

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

Recall #:
81837
Lot/product code:
61656
Recalling firm:
Shippert Medical Technologies
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UnclassifiedRisk not yet known
Medical deviceRecalled February 2, 2018

Tissu-Trans FILTRON 250, Catalog 3-TT-FILTRON 250, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.

The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch.

ALL 50 STATES
Full report

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

Recall #:
81837
Lot/product code:
Lot numbers 61507, 61578, 61682, 61689, 61849, 61879, 62011, 62088, and 62108
Recalling firm:
Shippert Medical Technologies
View official FDA record (opens in a new tab)