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Recalls affecting Wyoming

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

16,268 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
Class IIModerate risk
FoodAllergenUndeclaredRecalled May 13, 2026

Nutrisystem, Chocolate Cheesecake, 2 oz (57g) packages, Flow Wrapped, 48 units per case, Keep frozen

Not listed on the label Allergen (Soy)

Full report

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

Recall #:
H-0947-2026
Lot/product code:
Product Code: 40007; Lot Code: CH030426
Recalling firm:
Nutrisystem Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 13, 2026

Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkinsonian tremor

A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.

ALL 50 STATES
Full report

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

Recall #:
98913
Lot/product code:
GTIN 00643169090866, Lot Number VA368G3; GTIN 00643169090866, Lot Number VA36V7T; GTIN 00643169936584, Lot Number VA3347Y; GTIN 00643169936584, Lot Number VA33481; GTIN 00643169936584, Lot Number VA33M8V; GTIN 00643169936584, Lot Number VA33M92; GTIN 00643169936584, Lot Number VA33T31; GTIN 00643169936584, Lot Number VA33T33; GTIN 00643169936584, Lot Number VA35B5D; GTIN 00643169936584, Lot Number VA35B5E; GTIN 00643169936584, Lot Number VA35WSP; GTIN 00643169936584, Lot Number VA35WSU; GTIN 00763000963040, Lot Number VA35TTU; GTIN 00763000963040, Lot Number VA35TTV; GTIN 00763000963040, Lot Number VA368FZ; GTIN 00763000963040, Lot Number VA368G3; GTIN 00763000963040, Lot Number VA36V7T; GTIN 00763000963040, Lot Number VA36V8Q; GTIN 00763000968427, Lot Number 0231980220; GTIN 00763000968427, Lot Number 0231980221; GTIN 00763000968427, Lot Number 0231980222; GTIN 00763000968434, Lot Number 0231493884; GTIN 00763000968434, Lot Number 0231493885; GTIN 00763000968434, Lot Number 0231494066; GTIN 00763000968434, Lot Number 0231928923; GTIN 00763000968434, Lot Number 0231929188; GTIN 00763000968434, Lot Number 0231929189; GTIN 00763000968434, Lot Number 0231929192; GTIN 00763000968441, Lot Number 0231367316; GTIN 00763000968441, Lot Number 0231367317.
Recalling firm:
Medtronic Neuromodulation
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodUndeclaredRecalled May 12, 2026

Adndale Magnesium Glycinate Gummies 400 mg. Plastic bottle containing 90 gummies. Net weight: 11.36 ounces. Serving size: 2 gummies. UPC: 860008784551 Firm name and address listed on label: Dkiru Ltd, Keepers Cottage, 3 Dublin Rd, Leixlip, Co. Kildare W23 H3C4, Ireland

Not listed on the label melatonin.

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 #:
H-1079-2026
Lot/product code:
LOT 190824 Expiration Date: 08/19/2026, LOT 240923 Expiration Date: 09/22/2026, and LOT 240929 Expiration Date: 09/28/2026
Recalling firm:
Dkiru LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 12, 2026

Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI (gastrointestinal) endoscopic procedure.

Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anticipated occurrence of the suction button sticking.

ALL 50 STATES
Full report

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

Recall #:
98970
Lot/product code:
GTIN 00840253111012, Lot 38400303, Exp. January 20, 2029
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 12, 2026

Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;

Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for the occurrence of Bicarby luer-lock leaks during manipulation of the frangible and tubing when preparing the product for use for treatment. This issue presents the potential of a slip and fall hazard associated with fluid on the floor.

ALL 50 STATES
Full report

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

Recall #:
98877
Lot/product code:
Model Number: RFP-400-G; UDI-DI: 00840861102839; 2. Model Number: RFP-401-G; UDI-DI: 00840861102853; 3. Model Number: RFP-402-G; UDI-DI: 00840861102822; 4. Model Number: RFP-404-G; UDI-DI: 00840861102914; 5. Model Number: RFP-407-G; UDI-DI: 00840861102846: 6. Model Number: RFP-456-G; UDI-DI: 00840861102945; All lots produced from January 13, 2025, through lot 26AG02019 on January 13, 2026
Recalling firm:
Fresenius Medical Care Holdings, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 12, 2026

Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software

Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.

ALL 50 STATES
Full report

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

Recall #:
98963
Lot/product code:
Programmer Model 3650; Software Model 3330; GTIN 05414734509725; Software Versions 25.0.1 - 28.7.1 in the United States (varies based on region)
Recalling firm:
Abbott Medical
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled May 12, 2026

DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose vials, Sterile, Rx only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol, Gujarat, India, NDC 72603-200-01.

Presence of Particulate matter: Particulate matter identified as glass.

ALL 50 STATES
Full report

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

Recall #:
D-0580-2026
Lot/product code:
Lot HAG2581B, expires: 05/31/2027
Recalling firm:
SUN PHARMACEUTICAL INDUSTRIES INC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 12, 2026

Octopus Evolution AS Tissue Stabilizer, Model TS2500

During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.

ALL 50 STATES
Full report

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

Recall #:
98966
Lot/product code:
UDI-DI: 00643169668904, 00613994764379; Serial Numbers: 0232670681 0232709164 0232709168 0232709194 0232709194 0232709199
Recalling firm:
Medtronic Perfusion Systems
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 12, 2026

fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3650 Victorie St N, Suite 900, Shoreview, MN, NDC 71139-6030-1.

Weaker than it should be Drug

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-0548-2026
Lot/product code:
Lot#: 20260310FEN-1, Exp. Date: 09/06/2026
Recalling firm:
IntegraDose Compounding Services LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 12, 2026

Octopus Evolution Tissue Stabilizer, Model TS2000

During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.

ALL 50 STATES
Full report

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

Recall #:
98966
Lot/product code:
UDI-DI: 00643169668911; Serial Numbers: 0232992409 0233010063 0233010115
Recalling firm:
Medtronic Perfusion Systems
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 12, 2026

Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;

Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for the occurrence of Bicarby luer-lock leaks during manipulation of the frangible and tubing when preparing the product for use for treatment. This issue presents the potential of a slip and fall hazard associated with fluid on the floor.

ALL 50 STATES
Full report

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

Recall #:
98877
Lot/product code:
Model Number: RFP-400-G; UDI-DI: 00840861102839; 2. Model Number: RFP-401-G; UDI-DI: 00840861102853; 3. Model Number: RFP-402-G; UDI-DI: 00840861102822; 4. Model Number: RFP-404-G; UDI-DI: 00840861102914; 5. Model Number: RFP-407-G; UDI-DI: 00840861102846: 6. Model Number: RFP-456-G; UDI-DI: 00840861102945; All lots produced from January 13, 2025, through lot 26AG02019 on January 13, 2026
Recalling firm:
Fresenius Medical Care Holdings, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 12, 2026

Octopus 4 Tissue Stabilizer, Model 29400

During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.

ALL 50 STATES
Full report

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

Recall #:
98966
Lot/product code:
UDI-DI: 00763000543679; Serial Numbers: 0231266463 0231468923 0231478249 0231478253 0231478260 0231651627 0231651634 0231651636 0231651637 0231651638 0231651639 0231651641 0231651642
Recalling firm:
Medtronic Perfusion Systems
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 12, 2026

Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmington, Made in S. Korea, NDC 65282-1605-1.

Not guaranteed to be germ-free

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-0554-2026
Lot/product code:
Lot#: AE4013, Exp 1/31/2027; AE5032 & AE5039, Exp 3/31/2028; AE5104, Exp 8/31/2028.
Recalling firm:
Spectra Medical Devices, Llc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 12, 2026

Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC 70954-531-20

Defective Container; packets were found to be either empty or partially full.

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-0543-2026
Lot/product code:
Lot M251109, exp Nov 2027
Recalling firm:
ANI Pharmaceuticals, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 11, 2026

Brand Name: Persona Revision Product Name: Persona Revision Trabecular Metal Femoral Distal Augment Model/Catalog Number: 42-5572-066-10 Software Version: N/A Product Description: Persona Revision Trabecular Metal Femoral Distal Augment Size 9, 9+ 10mm Thicknes Component: N/A

Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.

ALL 50 STATES
Full report

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

Recall #:
99073
Lot/product code:
Lot Code: Model No. 42-5572-066-10 ; UDI-DI (01)00889024561014(17)331103(10)66232947 ; Lot number 66232947
Recalling firm:
Zimmer, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 11, 2026

Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device

There is the potential for leakage along the drug pathway from the pump through the end of the catheter.

ALL 50 STATES
Full report

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

Recall #:
99063
Lot/product code:
GTIN 00850014110147, Serial Number 20175
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 11, 2026

Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/Catalog Number: 4063 Product Description: The Inspire Stimulation Lead (Model 4063) is designed to deliver stimulation to the hypoglossal nerve for the treatment of obstructive sleep apnea. The lead features a flexible, self-sizing cuff. Electrodes in the inner surface of the cuff deliver stimulation to the nerve. The lead incorporates a standard connector for coupling to the implantable pulse generator (IPG). Component: N/A

Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By Date may result in unplanned or premature revision surgery.

ALL 50 STATES
Full report

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

Recall #:
98990
Lot/product code:
Lot Code: Model 4063 (USA only lead); UDI-DI [4063] 10855728005793; Inspire part number [4063] 900-013-001; serial numbers D53393, D61104 Model 4063 (Global lead); UDI-DI [4063] 10810098650295, Inspire part number [4063] 900-013-003; serial numbers D89539, D89540, D89543, D89559, D89563, D89564, D89577, D8959
Recalling firm:
Inspire Medical Systems Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 11, 2026

Power Over Fiber Base Module

Device not certified - no laser product report was filed with CDRH prior to distribution. Product label incorrectly states device is "Class IV", although Class 1 is appropriate for device. Improperly labeled - omitted labels required under 21 CFR 1040.10 / IEC 60825-1 via LN#56. Missing certification and proper manufacturer's ID label. Was not accompanied by compliant User Information. Formalized quality control procedures and record keeping of QC testing was not performed to IEC 60825-1 nor 21 CFR 1040.10 standards. Sales information did not convey required class designation and warning statement

ALL 50 STATES
Full report

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

Recall #:
99382
Lot/product code:
Power Over Fiber Base Module Identification P/N 633232 P/N 622365 P/N 633383 P/N 633910 P/N 635731
Recalling firm:
Terex Utilities
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 11, 2026

Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sensing Lead Model/Catalog Number: 4340 Software Version: N/A Product Description: The Inspire Respiratory Sensing Lead (Model 4340) is designed to detect respiratory effort. The lead features a pressure sensitive membrane that converts the mechanical energy of respiration into an electrical signal. The lead incorporates a standard connector for coupling to the implantable pulse generator (IPG). Component: N/A

Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By Date may result in unplanned or premature revision surgery.

ALL 50 STATES
Full report

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

Recall #:
98990
Lot/product code:
Lot Code: Model No 4340 (USA only lead); UDI-DI [4340] 10855728005946; Inspire part number [4340] 900-014-003; serial numbers T18806, T45012, T45017, T49002, T67098, T67152, T69541, T69542, T69553, T69558, T69562 Model No 4340 (Global lead); UDI-DI [4340] 10810098650301; Inspire part number [4340] 900-014-005; serial numbers T91485, T91486, T91491, T91495, T91513, T91520, T91521, T91527, T91533, T91537, T91540, T91545, T96165, T96168, T96192, T96193, T96195, T96225, T96237, T98118, T98126, T98136, T98137, T98138, T98141, T98143, T98145, T98150, T98153, T98156, T98163, T98165, T98176, T98177, T98178, T98181, T98183, T98190, T96217
Recalling firm:
Inspire Medical Systems Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 11, 2026

Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.

Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.

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-0542-2026
Lot/product code:
Lot: KB5Y, Expires: 04/2028; MP4B, Expires: 05/2028; SS4F, Expires: 09/2028.
Recalling firm:
Haleon US Holdings LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 11, 2026

Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/Catalog Number: 4063 Product Description: The Inspire Stimulation Lead (Model 4063) is designed to deliver stimulation to the hypoglossal nerve for the treatment of obstructive sleep apnea. The lead features a flexible, self-sizing cuff. Electrodes in the inner surface of the cuff deliver stimulation to the nerve. The lead incorporates a standard connector for coupling to the implantable pulse generator (IPG). Component: N/A

Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By Date may result in unplanned or premature revision surgery.

ALL 50 STATES
Full report

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

Recall #:
98990
Lot/product code:
Lot Code: Model 4063 (USA only lead); UDI-DI [4063] 10855728005793; Inspire part number [4063] 900-013-001; serial numbers D53393, D61104 Model 4063 (Global lead); UDI-DI [4063] 10810098650295, Inspire part number [4063] 900-013-003; serial numbers D89539, D89540, D89543, D89559, D89563, D89564, D89577, D8959
Recalling firm:
Inspire Medical Systems Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 11, 2026

Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sensing Lead Model/Catalog Number: 4340 Software Version: N/A Product Description: The Inspire Respiratory Sensing Lead (Model 4340) is designed to detect respiratory effort. The lead features a pressure sensitive membrane that converts the mechanical energy of respiration into an electrical signal. The lead incorporates a standard connector for coupling to the implantable pulse generator (IPG). Component: N/A

Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By Date may result in unplanned or premature revision surgery.

ALL 50 STATES
Full report

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

Recall #:
98990
Lot/product code:
Lot Code: Model No 4340 (USA only lead); UDI-DI [4340] 10855728005946; Inspire part number [4340] 900-014-003; serial numbers T18806, T45012, T45017, T49002, T67098, T67152, T69541, T69542, T69553, T69558, T69562 Model No 4340 (Global lead); UDI-DI [4340] 10810098650301; Inspire part number [4340] 900-014-005; serial numbers T91485, T91486, T91491, T91495, T91513, T91520, T91521, T91527, T91533, T91537, T91540, T91545, T96165, T96168, T96192, T96193, T96195, T96225, T96237, T98118, T98126, T98136, T98137, T98138, T98141, T98143, T98145, T98150, T98153, T98156, T98163, T98165, T98176, T98177, T98178, T98181, T98183, T98190, T96217
Recalling firm:
Inspire Medical Systems Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 11, 2026

Brand Name: Persona Revision Product Name: Persona Revision Trabecular Metal Femoral Distal Augment Model/Catalog Number: 42-5572-066-10 Software Version: N/A Product Description: Persona Revision Trabecular Metal Femoral Distal Augment Size 9, 9+ 10mm Thicknes Component: N/A

Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.

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Full report

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

Recall #:
99073
Lot/product code:
Lot Code: Model No. 42-5572-066-10 ; UDI-DI (01)00889024561014(17)331103(10)66232947 ; Lot number 66232947
Recalling firm:
Zimmer, Inc.
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UnclassifiedRisk not yet known
Medical deviceRecalled May 11, 2026

5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions. 1. 5008X HD Pre-Flush Standard Blood Tubing Set; Model Number: 03-5110-6. 2. 5008X HD Pre-Flush With Twister Blood Tubing Set; Model Number: 03-5160-1. 3. 5008X HD/HDF Standard Blood Tubing Set; Model Number: 03-5300-3. 4. 5008X HD/HDF With CLiC Blood Tubing Set; Model Number: 03-5300-3C. 5. 5008X HD/HDF With Twister Blood Tubing Set; Model Number: 03-5350-8.

Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem.

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

Recall #:
99061
Lot/product code:
Sets manufactured after February 26, 2026 1. Model Number: 03-5110-6. UDI-DI: 00840861102556. 2. Model Number: 03-5160-1. UDI-DI: 00840861102563. 3. Model Number: 03-5300-3. UDI-DI: 00840861102518. 4. Model Number: 03-5300-3C. UDI-DI: 00840861102532. 5. Model Number: 03-5350-8. UDI-DI: 00840861102525.
Recalling firm:
Fresenius Medical Care Holdings, Inc.
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UnclassifiedRisk not yet known
Medical deviceRecalled May 8, 2026

Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Product Description: The GEM Premier 5000 system provides fast, accurate, quantitative measurements of heparinized whole blood pH, pCO2, pO2, Na+, K+, Cl-, Ca++, glucose, lactate, Hct, total bilirubin and CO-Oximetry (tHb, O2Hb, COHb, MetHb, HHb, sO2) from arterial, venous or capillary samples. Intelligent Quality Management 2 (iQM2) is used as the quality control and assessment system for the GEM Premier 5000 system. iQM2 is an active quality process control program designed to provide continuous monitoring of the analytical process before, during, and after sample measurement with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions, replacing the use of traditional external quality controls (QC). Facilities should follow local, state and federal regulatory guidelines to ensure that a total quality management system is followed. The GEM Premier 5000 system makes use of potentiometric sensors to measure pCO2, pH, Na+, K+, Cl-, and Ca++. It uses amperometric sensors to measure pO2, glucose, and lactate concentrations. Blood conductivity is the method used to measure hematocrit. CO-Oximetry and total bilirubin measurements involve chemically lysing the whole blood sample and then utilizing a broad spectrum spectrophotometer to evaluate the sample at a variety of wavelengths.

BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The root cause is a race condition introduced when the "price check" feature was disabled to reduce excess current draw. This causes buffered data from a previous scan to be transmitted instead of the most recent scan, populating a prior patient ID instead of the current one. This can result in erroneous results being attributed to the wrong patient, potentially leading to inappropriate clinical management.

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

Recall #:
99115
Lot/product code:
Lot Code: GEM Premier 5000: Part number: 00024019255 UDI: 08426950870227 Units distributed in United Kingdom: 67 affected BCR wands on the GEM Premier 5000 in the United Kingdom. GEM Premier 5000 Serial Nos.: 25110547, 25100462, 25110522, 25100472, 25101897, 25101920, 25101931, 25122029, 26012032, 25122030, 26012033, 26012043, 25110523, 25110536, 25120550, 25069638, 23101109, 24011137, 25081799, 25081797, 25091839, 25091840, 25091864, 25091870, 25091868, 25091873, 25091880, 25091876, 25101886, 25101889, 25101887, 25101891, 25101907, 25101904, 25101912, 25101905, 25101917, 25101921, 25101926, 25101929, 25101934, 25101927, 25111968, 25121986, 25121985, 25121981, 25121984, 25121994, 25121995, 25121982, 25121993, 25121991, 25121999, 25121996, 16030255, 17060782, 17060784, 17060785, 17060789, 17060790, 17060797, 17111126, 17121258, 18011414, 20054515, 20054516 and 22082271. Affected Accessory: Bar Code Reader (BCR) Wand Part number: 00024019255 UDI: 08426950870227 Units distributed in the United Kingdom: 67
Recalling firm:
Instrumentation Laboratory
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