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Recalls affecting Kansas

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

16,731 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 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 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)
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)
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)
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)
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)
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)
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)
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)
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)
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 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

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)
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 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: 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

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

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.

ALL 50 STATES
Full report

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.
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)
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 8, 2026

Giraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with Integrated Resuscitation System (iRes) Product Identifiers: M1118179, M1112198 Impacted only if service blender M1091607-R was installed during the last Preventative Maintenance.

Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient.

ALL 50 STATES
Full report

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

Recall #:
99036
Lot/product code:
UDI-DI of service blender component: 00813841020010 Affected devices were installed with the following serial numbers of affected service blender components: 002I08B 002X08B 008S10B 008Y09B 013S09B 016A09B 016R09B 018P10B 019J09B 028C08B 02X08B 033N09B 037E08B 038D10B 038N08B 042F10B 042S10B 042T10B 045808B 045M08B 047I08B 047J08B 054C10B 054I10B 054L10B 054N09B 054O09B 054U10B 055D09B 055V09B 057908B 061K09B 062C10B 068W10B 077M09B 078509B 078M09B 078S09B 084I10B 084J10B 092G08B 099F08B 1 B1405629 100E08B 100R08B 104A09B 12105790 133D08B 136708B 136W08B 141J09B 142009B 142W09B 144J08B 144N08B 149Q09B 163608B 169D08B 169G08B 169H08B 172308B 175P08B 185I08B 185Q08B 186208B 189808B 189A09B 189C08B 189F09B 193L08B 193N08B 195D09B 195E09B 195J09B 195K09B 198H08B 210K09B 210U09B 218N09B 219C09B 219K09B 220E08B 226F08B 244L09B 260X09B 266M08B 267808B 280F09B 281H09B 285J07B 295H09B 295J09B 295P08B 310I09B 338707B 338E07B 338K07B 352Y09B 355P09B 7979700385 B1003093 B1003112 B1003124 B1003140 B1003143 B1003147 B1003153 B1003343 B1003452 B1003550 B1003867 B1003944 B1004844 B1004861 B1004924 B1005029 B1005036 B1005044 B1005422 B1005534 B1005560 B1005571 B1005839 B1006102 B1006113 B1006304 B1006858 B1006935 B1006971 B1007078 B1007220 B1007262 B1007355 B1007360 B1007376 B1007383 B1007528 B1007605 B1101215 B1101224 B1101241 B1101445 B1101446 B1101547 B1101862 B1101869 B1101998 B1102011 B1102015 B1102153 B1102384 B1102405 B1102571 B1103145 B1103159 B1103251 B1103256 B1103422 B1103434 B1103576 B1103710 B1103844 B1103846 B1103850 B1103856 B1103968 B1104440 B1104441 B1104450 B1104651 B1104658 B1104764 B1105179 B1105180 B1105232 B1105244 B1105418 B1105548 B1105806 B1106117 B1106789 B1106804 B1106812 B1106823 B1107074 B1107357 B1107360 B1107581 B1107658 B1201350 B1201361 B1201601 B1201990 B1202187 B1202199 B1202740 B1203408 B1203414 B1203520 B1203557 B1203643 B1203892 B1203905 B1203909 B1203913 B1203917 B1204710 B1205518 B1205537 B1205804 B1205820 B1206201 B1206202 B1206224 B1206632 B1206909 B1206948 B1207178 B1207180 B1207181 B1207189 B1207201 B1207202 B1207215 B1207240 B1207308 B1207331 B1207515 B1207555 B1208045 B1208066 B1208067 B1208068 B1208069 B1208102 B1208104 B1208141 B1208296 B1208702 B1208729 B1208736 B1208739 B1208759 B1208979 B1208989 B1208991 B1209004 B1209089 B1209090 B1209099 B1209175 B1209181 B1209188 B1209197 B1209199 B1209432 B1209463 B1209467 B1209641 B1209642 B1209647 B1209796 B1209805 B1209956 B1211743 B1211784 B1211907 B1211913 B1212670 B1212683 B1212706 B1212817 B1300102 B1300110 B1300126 B1300416 B1300430 B1300445 B1300805 B1300812 B1300830 B1300834 B1300858 B1300919 B1302107 B1302132 B1302133 B1302180 B1302527 B1302530 B1302583 B1302593 B1302945 B1302982 B1302983 B1303084 B1303098 B1303452 B1303453 B1303454 B1303492 B1303581 B1303854 B1303868 B1303910 B1304069 B1304357 B1304374 B1304376 B1304450 B1304518 B1304564 B1304570 B1304574 B1304751 B1305163 B1305175 B1305213 B1305215 B1305337 B1305363 B1305523 B1306031 B1306066 B1306068 B1306078 B1306902 B1307502 B1307507 B1307514 B1307526 B1307553 B1307814 B1307820 B1307878 B1308177 B1308332 B1308340 B1308362 B1308367 B1308874 B1309123 B1309124 B1309135 B1309139 B1309150 B1309158 B1309683 B1309705 B1309706 B1309962 B1310226 B1310237 B1400022 B1400237 B1400243 B1400264 B1400278 B1400292 B1400688 B1400713 B1400760 B1400771 B1400946 B1401337 B1401342 B1401343 B1401757 B1401785 B1401893 B1402142 B1402162 B1402168 B1402196 B1402198 B1402224 B1402504 B1402565 B1402854 B1403053 B1403079 B1403128 B1403140 B1403155 B1403196 B1403216 B1403230 B1403366 B1403732 B1403769 B1403778 B1403880 B1403893 B1403911 B1403914 B1403934 B1403952 B1404215 B1404267 B1404291 B1404430 B1404469 B1404473 B1404480 B1404481 B1404495 B1404723 B1404738 B1404754 B1404760 B1404786 B1404925 B1404981 B1405020 B1405134 B1405213 B1405218 B1405542 B1405544 B1405553 B1405558 B1405574 B1405576 B1405577 B1405589 B1405601 B1405608 B1405621 B1405622 B1405629 B1405630 B1405649 B1405688 B1405909 B1405923 B1405998 B1406104 B1406186 B1406190 B1406191 B1406196 B1406197 B1406432 B1406441 B1406479 B1406482 B1406506 B1406507 B1406518 B1406518-2 B1406528 B1406537 B1406599 B1407065 B1407092 B1407755 B1407776 B1407777 B1407786 B1408337 B1408379 B1408525 B1408533 B1409022 B1409048 B1409051 B1409052 B1409053 B1409324 B1409328 B1409329 B1409366 B1409509 B1409533 B1409546 B1409569 B1409588 B1409590 B1409651 B1409722 B1409731 B1409759 B1501314 B1501349 B1501652 B1501657 B1501675 B1501686 B1501687 B1501693 B1502040 B1502054 B1502157 B1502195 B1502200 B1502616 B1502655 B1502656 B1502659 B1502668 B1502675 B1502822 B1502887 B1502888 B1502892 B1502894 B1502899 B1503153 B1503178 B1503210 B1503224 B1503229 B1503240 B1503274 B1503472 B1503476 B1503500 B1503608 B1503611 B1503644 B1503665 B1503667 B1503673 B1503687 B1503698 B1504073 B1504076 B1504078 B1504339 B1504538 B1504754 B1504755 B1504761 B1504765 B1504800 B1504919 B1504951 B1504999 B1505000 B1505085 B1505090 B1505091 B1505092 B1505093 B1505096 B1505276 B1505301 B1505304 … (truncated, 25337 characters total — see the official FDA record for the full value)
Recalling firm:
Datex-Ohmeda Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 8, 2026

Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (resuscitator) Product identifiers: 2082663-001, 2082663-002, M1241424 Product impacted only if service blender M1091607-R was installed during the last Preventative Maintenance

Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient.

ALL 50 STATES
Full report

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

Recall #:
99036
Lot/product code:
UDI-DI of service blender component: 00813841020010 Affected devices were installed with the following serial numbers of affected service blender components: 002I08B 002X08B 008S10B 008Y09B 013S09B 016A09B 016R09B 018P10B 019J09B 028C08B 02X08B 033N09B 037E08B 038D10B 038N08B 042F10B 042S10B 042T10B 045808B 045M08B 047I08B 047J08B 054C10B 054I10B 054L10B 054N09B 054O09B 054U10B 055D09B 055V09B 057908B 061K09B 062C10B 068W10B 077M09B 078509B 078M09B 078S09B 084I10B 084J10B 092G08B 099F08B 1 B1405629 100E08B 100R08B 104A09B 12105790 133D08B 136708B 136W08B 141J09B 142009B 142W09B 144J08B 144N08B 149Q09B 163608B 169D08B 169G08B 169H08B 172308B 175P08B 185I08B 185Q08B 186208B 189808B 189A09B 189C08B 189F09B 193L08B 193N08B 195D09B 195E09B 195J09B 195K09B 198H08B 210K09B 210U09B 218N09B 219C09B 219K09B 220E08B 226F08B 244L09B 260X09B 266M08B 267808B 280F09B 281H09B 285J07B 295H09B 295J09B 295P08B 310I09B 338707B 338E07B 338K07B 352Y09B 355P09B 7979700385 B1003093 B1003112 B1003124 B1003140 B1003143 B1003147 B1003153 B1003343 B1003452 B1003550 B1003867 B1003944 B1004844 B1004861 B1004924 B1005029 B1005036 B1005044 B1005422 B1005534 B1005560 B1005571 B1005839 B1006102 B1006113 B1006304 B1006858 B1006935 B1006971 B1007078 B1007220 B1007262 B1007355 B1007360 B1007376 B1007383 B1007528 B1007605 B1101215 B1101224 B1101241 B1101445 B1101446 B1101547 B1101862 B1101869 B1101998 B1102011 B1102015 B1102153 B1102384 B1102405 B1102571 B1103145 B1103159 B1103251 B1103256 B1103422 B1103434 B1103576 B1103710 B1103844 B1103846 B1103850 B1103856 B1103968 B1104440 B1104441 B1104450 B1104651 B1104658 B1104764 B1105179 B1105180 B1105232 B1105244 B1105418 B1105548 B1105806 B1106117 B1106789 B1106804 B1106812 B1106823 B1107074 B1107357 B1107360 B1107581 B1107658 B1201350 B1201361 B1201601 B1201990 B1202187 B1202199 B1202740 B1203408 B1203414 B1203520 B1203557 B1203643 B1203892 B1203905 B1203909 B1203913 B1203917 B1204710 B1205518 B1205537 B1205804 B1205820 B1206201 B1206202 B1206224 B1206632 B1206909 B1206948 B1207178 B1207180 B1207181 B1207189 B1207201 B1207202 B1207215 B1207240 B1207308 B1207331 B1207515 B1207555 B1208045 B1208066 B1208067 B1208068 B1208069 B1208102 B1208104 B1208141 B1208296 B1208702 B1208729 B1208736 B1208739 B1208759 B1208979 B1208989 B1208991 B1209004 B1209089 B1209090 B1209099 B1209175 B1209181 B1209188 B1209197 B1209199 B1209432 B1209463 B1209467 B1209641 B1209642 B1209647 B1209796 B1209805 B1209956 B1211743 B1211784 B1211907 B1211913 B1212670 B1212683 B1212706 B1212817 B1300102 B1300110 B1300126 B1300416 B1300430 B1300445 B1300805 B1300812 B1300830 B1300834 B1300858 B1300919 B1302107 B1302132 B1302133 B1302180 B1302527 B1302530 B1302583 B1302593 B1302945 B1302982 B1302983 B1303084 B1303098 B1303452 B1303453 B1303454 B1303492 B1303581 B1303854 B1303868 B1303910 B1304069 B1304357 B1304374 B1304376 B1304450 B1304518 B1304564 B1304570 B1304574 B1304751 B1305163 B1305175 B1305213 B1305215 B1305337 B1305363 B1305523 B1306031 B1306066 B1306068 B1306078 B1306902 B1307502 B1307507 B1307514 B1307526 B1307553 B1307814 B1307820 B1307878 B1308177 B1308332 B1308340 B1308362 B1308367 B1308874 B1309123 B1309124 B1309135 B1309139 B1309150 B1309158 B1309683 B1309705 B1309706 B1309962 B1310226 B1310237 B1400022 B1400237 B1400243 B1400264 B1400278 B1400292 B1400688 B1400713 B1400760 B1400771 B1400946 B1401337 B1401342 B1401343 B1401757 B1401785 B1401893 B1402142 B1402162 B1402168 B1402196 B1402198 B1402224 B1402504 B1402565 B1402854 B1403053 B1403079 B1403128 B1403140 B1403155 B1403196 B1403216 B1403230 B1403366 B1403732 B1403769 B1403778 B1403880 B1403893 B1403911 B1403914 B1403934 B1403952 B1404215 B1404267 B1404291 B1404430 B1404469 B1404473 B1404480 B1404481 B1404495 B1404723 B1404738 B1404754 B1404760 B1404786 B1404925 B1404981 B1405020 B1405134 B1405213 B1405218 B1405542 B1405544 B1405553 B1405558 B1405574 B1405576 B1405577 B1405589 B1405601 B1405608 B1405621 B1405622 B1405629 B1405630 B1405649 B1405688 B1405909 B1405923 B1405998 B1406104 B1406186 B1406190 B1406191 B1406196 B1406197 B1406432 B1406441 B1406479 B1406482 B1406506 B1406507 B1406518 B1406518-2 B1406528 B1406537 B1406599 B1407065 B1407092 B1407755 B1407776 B1407777 B1407786 B1408337 B1408379 B1408525 B1408533 B1409022 B1409048 B1409051 B1409052 B1409053 B1409324 B1409328 B1409329 B1409366 B1409509 B1409533 B1409546 B1409569 B1409588 B1409590 B1409651 B1409722 B1409731 B1409759 B1501314 B1501349 B1501652 B1501657 B1501675 B1501686 B1501687 B1501693 B1502040 B1502054 B1502157 B1502195 B1502200 B1502616 B1502655 B1502656 B1502659 B1502668 B1502675 B1502822 B1502887 B1502888 B1502892 B1502894 B1502899 B1503153 B1503178 B1503210 B1503224 B1503229 B1503240 B1503274 B1503472 B1503476 B1503500 B1503608 B1503611 B1503644 B1503665 B1503667 B1503673 B1503687 B1503698 B1504073 B1504076 B1504078 B1504339 B1504538 B1504754 B1504755 B1504761 B1504765 B1504800 B1504919 B1504951 B1504999 B1505000 B1505085 B1505090 B1505091 B1505092 B1505093 B1505096 B1505276 B1505301 B1505304 … (truncated, 25337 characters total — see the official FDA record for the full value)
Recalling firm:
Datex-Ohmeda Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 8, 2026

cimzia (certolizumab pegol), 2x200mg/mL PREFILLED SYRINGES (2 single-dose), Rx ONLY, Manufactured by: UCB Inc., Smyrna, GA 30080, a) NDC 50474-710-79, b) Professional sample, NDC 50474-710-80; c) 3 cartons, STARTER KIT, NDC 50474-710-81.

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-0546-2026
Lot/product code:
Lot: CVZFW, Exp.:2026-JUL-04; CVZYG, Exp.: 2026-AUG-19; CWSYT, Exp.: 2026-OCT-22; CWDZY, Exp.:2026-NOV-20; CWTSD, Exp.:2026-DEC-11; CVTFK, Exp.:2026-JUL-04; CVTSN, Exp.: 2026-AUG-19; CWVGP. Exp.:2026-DEC-11; CVWXT, CVWXV, CVWXW, Exp.:2026-JUL-04; CWHFF, Exp.: 2026-OCT-22; CWNDS, Exp.: 2026-DEC-11.
Recalling firm:
UCB Biosciences Inc.
View official FDA record (opens in a new tab)