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Recalls affecting Louisiana

Data last updated: September 11, 2026 at 1:08 PM UTC

16,930 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

▸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 Alive — Moringa 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. 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

▸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 Temptations — Chocolatey 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

Lipofit — Lipofit 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

Kofinas — Garlic 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 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 December 3, 2025

MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1 and R12.1.

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

ALL 50 STATES
▸Full report

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

Recall #:
98111
Lot/product code:
MR systems with SW version R11.1 and R12.1. (1) Product Code (REF): 782120; UDI-DI: 00884838104112; Serial Numbers: 65019, 65060, 65066, 65065, 65051, 65038, 65005. (2) Product Code (REF): 782153; UDI-DI: 00884838112858; Serial Numbers: 68010, 68017.
Recalling firm:
Philips North America
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 3, 2025

Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1 and R12.1.

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

ALL 50 STATES
▸Full report

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

Recall #:
98111
Lot/product code:
MR systems with SW version R11.1 and R12.1. Product Code (REF): 782143. UDI-DI: 00884838108660. Serial Numbers: 42225.
Recalling firm:
Philips North America
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 3, 2025

Philips Incisive CT

Potential for incomplete scan due to unstable connection inside of floating sensor.

ALL 50 STATES
▸Full report

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

Recall #:
98238
Lot/product code:
N/A
Recalling firm:
Philips Healthcare (Suzhou) Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 3, 2025

Ingenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. MR systems with SW version R11.1 and R12.1.

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

ALL 50 STATES
▸Full report

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

Recall #:
98111
Lot/product code:
MR systems with SW version R11.1 and R12.1. (1) Product Code (REF): 781341; UDI-DI: 00884838055322; Serial Numbers: 70311, 84560, 84403, 84467, 84462, 70042, 84433. (2) Product Code (REF): 781396; UDI-DI: 00884838009820; Serial Numbers: 41356, 41354, 41370.
Recalling firm:
Philips North America
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 3, 2025

Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1.

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

ALL 50 STATES
▸Full report

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

Recall #:
98111
Lot/product code:
MR systems with SW version R11.1 and R12.1. Product Code (REF): 782108. UDI-DI: 00884838098343. Serial Numbers: 48669.
Recalling firm:
Philips North America
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 2, 2025

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609440 Software Version: N/A Product Description: Affixus 9 mm, Length 440 mm, Left, Trochanteric Nail Component: N/A

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

ALL 50 STATES
▸Full report

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

Recall #:
98069
Lot/product code:
Lot Code: Model No 815609440 ; UDI-DI (01)00887868144530(17)340819(10)66717607; Lot Number 66717607 Model No 815609440 ; UDI-DI (01)00887868144530(17)341025(10)67031553 ; Lot Number 67031553
Recalling firm:
Zimmer, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceBacteria/virusCampylobacterRecalled December 2, 2025

LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L

Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.

ALL 50 STATES
▸Full report

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

Recall #:
98079
Lot/product code:
UDI-DI: 10845357006476; Lot Numbers: 325-120-5, Additional lots added 12/22/25: 325-119-3, 325-119-6
Recalling firm:
Microbiologics Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 2, 2025

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609420 Software Version: N/A Product Description: Affixus 9 mm, Length 420 mm, Left, Trochanteric Nail Component: N/A

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

ALL 50 STATES
▸Full report

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

Recall #:
98069
Lot/product code:
Lot Code: Model No 815609420 ; UDI-DI (01)00887868144523(17)340818(10)66717606 ; Lot Number 66717606 Model No 815609420 ; UDI-DI (01)00887868144523(17)340913(10)66892905 ; Lot Number 66892905
Recalling firm:
Zimmer, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 2, 2025

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509300 Software Version: N/A Product Description: Affixus 9 mm, Length 300 mm, Right, Trochanteric Nail Component: N/A

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

ALL 50 STATES
▸Full report

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

Recall #:
98069
Lot/product code:
Lot Code: Model No 815509300 ; UDI-DI (01)00887868143519(17)340823(10)66717550 ; Lot Number 66717550
Recalling firm:
Zimmer, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 2, 2025

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509380 Software Version: N/A Product Description: Affixus 9 mm, Length 380 mm, Right, Trochanteric Nail Component: N/A

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

ALL 50 STATES
▸Full report

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

Recall #:
98069
Lot/product code:
Lot Code: Model No 815509380 ; UDI-DI (01)00887868143557(17)340822(10)66717554 ; Lot Number 66717554 Model No 815509380 ; UDI-DI (01)00887868143557(17)340822(10)66884564 ; Lot Number 66884564 Model No 815509380 ; UDI-DI (01)00887868143557(17)350421(10)67042197 ; Lot Number 67042197
Recalling firm:
Zimmer, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 2, 2025

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609400 Software Version: N/A Product Description: Affixus 9 mm, Length 400 mm, Left, Trochanteric Nail Component: N/A

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

ALL 50 STATES
▸Full report

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

Recall #:
98069
Lot/product code:
Lot Code: Model No 815609400 ; UDI-DI (01)00887868144516(17)340818(10)66717605 ; Lot Number 66717605 Model No 815609400 ; UDI-DI (01)00887868144516(17)340826(10)66892904 ; Lot Number 66892904 Model No 815609400 ; UDI-DI (01)00887868144516(17)341024(10)67031552 ; Lot Number 67031552
Recalling firm:
Zimmer, Inc.
View official FDA record (opens in a new tab)
Class IIILow risk
FoodRecalled December 2, 2025

Lost and Found Energy, Sour Gummy Bear, 12pck, 16oz Cans Case UPC: 850075595655 Can UPC: 850075595662 Aluminum Can Packaged

Recall is due to a misprint on the label that incorrectly identifies the total caffeine content on the can. The item contains 300mg of caffeine, instead of 150mg as provided on the can.

ALL 50 STATES
▸Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
H-0441-2026
Lot/product code:
LOT #: MO-00911 BB Date: 11/13/2027
Recalling firm:
Fazt & Loud LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 2, 2025

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509360 Software Version: N/A Product Description: Affixus 9 mm, Length 360 mm, Right, Trochanteric Nail Component: N/A

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

ALL 50 STATES
▸Full report

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

Recall #:
98069
Lot/product code:
Lot Code: Model No 815509360 ; UDI-DI (01)00887868143540(17)340917(10)66717553 ; Lot Number 66717553 Model No 815509360 ; UDI-DI (01)00887868143540(17)340823(10)66884563 ; Lot Number 66884563
Recalling firm:
Zimmer, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceBacteria/virusCampylobacterRecalled December 2, 2025

KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K

Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.

ALL 50 STATES
▸Full report

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

Recall #:
98079
Lot/product code:
UDI-DI: 30845357006463; Lot Numbers: 325-120-1, 325-120-4, 325-120-6, Additional Lots added 12/22/25: 325-119-2
Recalling firm:
Microbiologics Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 2, 2025

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609340 Software Version: N/A Product Description: Affixus 9 mm, Length 340 mm, Left, Trochanteric Nail Component: N/A

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

ALL 50 STATES
▸Full report

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

Recall #:
98069
Lot/product code:
Lot Code: Model No 815609340 ; UDI-DI (01)00887868144486(17)340904(10)66717602 ; Lot Number 66717602 Model No 815609340 ; UDI-DI (01)00887868144486(17)340904(10)66892901 ; Lot Number 66892901
Recalling firm:
Zimmer, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 2, 2025

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509320 Software Version: N/A Product Description: Affixus 9 mm, Length 320 mm, Right, Trochanteric Nail Component: N/A

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

ALL 50 STATES
▸Full report

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

Recall #:
98069
Lot/product code:
Lot Code: Model No 815509320 ; UDI-DI (01)00887868143526(17)340820(10)66717551 ; Lot Number 66717551 Model No 815509320 ; UDI-DI (01)00887868143526(17)340821(10)66884561; Lot Number 66884561
Recalling firm:
Zimmer, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 2, 2025

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609320 Software Version: N/A Product Description: Affixus 9 mm, Length 320 mm, Left, Trochanteric Nail Component: N/A

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

ALL 50 STATES
▸Full report

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

Recall #:
98069
Lot/product code:
Lot Code: Model No 815609320 ; UDI-DI (01)00887868144479(17)340826(10)66717601 ; Lot Number 66717601 Model No 815609320 ; UDI-DI (01)00887868144479(17)340820(10)66892900 ; Lot Number 66892900
Recalling firm:
Zimmer, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 2, 2025

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609380 Software Version: N/A Product Description: Affixus 9 mm, Length 380 mm, Left, Trochanteric Nail Component: N/A

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

ALL 50 STATES
▸Full report

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

Recall #:
98069
Lot/product code:
Lot Code: Model No 815609380 ; UDI-DI (01)00887868144509(17)340826(10)66717604 ; Lot Number 66717604 Model No 815609380 ; UDI-DI (01)00887868144509(17)340820(10)66892903 ; Lot Number 66892903
Recalling firm:
Zimmer, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 2, 2025

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509340 Software Version: N/A Product Description: Affixus 9 mm, Length 340 mm, Right, Trochanteric Nail Component: N/A

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

ALL 50 STATES
▸Full report

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

Recall #:
98069
Lot/product code:
Lot Code: Model No 815509340 ; UDI-DI (01)00887868143533(17)340822(10)66717552 ; Lot Number 66717552 Model No 815509340 ; UDI-DI (01)00887868143533(17)340826(10)66884562 ; Lot Number 66884562
Recalling firm:
Zimmer, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 2, 2025

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509420 Software Version: N/A Product Description: Affixus 9 mm, Length 420 mm, Right, Trochanteric Nail Component: N/A

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

ALL 50 STATES
▸Full report

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

Recall #:
98069
Lot/product code:
Lot Code: Model No 815509420 ; UDI-DI (01)00887868143571(17)340920(10)66717556 ; Lot Number 66717556 Model No 815509420 ; UDI-DI (01)00887868143571(17)340920(10)66884566 ; Lot Number 66884566
Recalling firm:
Zimmer, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 2, 2025

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609360 Software Version: N/A Product Description: Affixus 9 mm, Length 360 mm, Left, Trochanteric Nail Component: N/A

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

ALL 50 STATES
▸Full report

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

Recall #:
98069
Lot/product code:
Lot Code: Model No 815609360 ; UDI-DI (01)00887868144493(17)340820(10)66717603 ; Lot Number 66717603 Model No 815609360 ; UDI-DI (01)00887868144493(17)340905(10)66892902 ; Lot Number 66892902 Model No 815609360 ; UDI-DI (01)00887868144493(17)341030(10)67031550 ; Lot Number 67031550
Recalling firm:
Zimmer, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 2, 2025

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609300 Software Version: N/A Product Description: Affixus 9 mm, Length 300 mm, Left, Trochanteric Nail Component: N/A

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

ALL 50 STATES
▸Full report

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

Recall #:
98069
Lot/product code:
Lot Code: Model No 815609300 ; UDI-DI (01)00887868144462(17)340826(10)66717600 ; Lot Number 66717600
Recalling firm:
Zimmer, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 2, 2025

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509440 Software Version: N/A Product Description: Affixus 9 mm, Length 440 mm, Right, Trochanteric Nail Component: N/A

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

ALL 50 STATES
▸Full report

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

Recall #:
98069
Lot/product code:
Lot Code: Model No 815509440 ; UDI-DI (01)00887868143588(17)340820(10)66717557 ; Lot Number 66717557 Model No 815509440 ; UDI-DI (01)00887868143588(17)350422(10)67101279 ; Lot Number 67101279 Model No 815509440 ; UDI-DI (01)00887868143588(17)350419(10)67101280 ; Lot Number 67101280
Recalling firm:
Zimmer, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 2, 2025

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509400 Software Version: N/A Product Description: Affixus 9 mm, Length 400 mm, Right, Trochanteric Nail Component: N/A

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

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

Recall #:
98069
Lot/product code:
Lot Code: Model No 815509400 ; UDI-DI (01)00887868143564(17)340821(10)66717555 ; Lot Number 66717555 Model No 815509400 ; UDI-DI (01)00887868143564(17)340822(10)66884565 ; Lot Number 66884565 Model No 815509400 ; UDI-DI (01)00887868143564(17)350801(10)67379212 ; Lot Number 67379212
Recalling firm:
Zimmer, Inc.
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UnclassifiedRisk not yet known
Medical deviceBacteria/virusCampylobacterRecalled December 2, 2025

KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P

Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.

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

Recall #:
98079
Lot/product code:
UDI-DI: 20845357006459; Lot Numbers: 325-120-3, 325-120-7, Additional Lots added 12/22/25: 325-119-1, 325-119-5
Recalling firm:
Microbiologics Inc
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