Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

2901–2925 of 39824

HighFDA (Devices)·Z-0185-2026·2025-10-22
Eye and cataract packs recalled after being sterilized more than once
American Contract Systems is recalling cataract, eye, retinal and vitrectomy convenience packs that were re-gassed after a sterilization nonconformance.
Product
Medical convenience kits Item Number/Description BFCT04X CATARACT PACK - 205986 CMEY17AI EYE PACK - 213187 CMEY17AI EYE PACK - 213187 CMEY17AI EYE PACK - 213187 PERP25AQ PEI RETINAL PACK-206025 RFEY50AC EYE PACK-206026 UIVT47AS VITRECTOMY SUPPLY
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0181-2026·2025-10-22
Caesarean section packs recalled after being sterilized more than once
American Contract Systems is recalling C-section convenience packs that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.
Product
Medical convenience kits Item Number/Description FHCP08Y C SECTION PK HICS50I C-SECTION PACK HSCB90B C-SECTION BASIN PACK
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0160-2026·2025-10-22
Wound dressings recalled because foreign matter may be on the product
ConvaTec is recalling 80,980 DuoDERM Extra Thin dressings from one lot because the wound dressing may have foreign matter on the product.
Product
DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on dry to lightly exudating wounds. DuoDERM" Extra Thin dressings are particularly suitable in areas subject to friction and those requiring contouring, e.g., elbows, heels. DuoDERM"
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0155-2026·2025-10-22
Ultrasound systems recalled over inaccurate liver steatosis measurement values
GE is recalling 65 LOGIQ P10 series systems running software R4.5.7 because the Ultrasound-Guided Attenuation Parameter measurement may display inaccurate liver steatosis values.
Product
LOGIQ P10 series with software version R4.5.7 Model Number 5877534
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0158-2026·2025-10-22
Humidifier devices recalled because power loss alert sounds under two minutes
Fisher & Paykel is recalling 51,144 Airvo 2 and myAirvo 2 humidifiers because an unintentional power disconnection may sound an audible alert for less than 120 seconds.
Product
Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0157-2026·2025-10-22
LOGIQ P9 ultrasound systems recalled over inaccurate liver steatosis measurements
GE is recalling 37 LOGIQ P9 R4.5 ultrasound systems running software R4.5.7 because the Ultrasound-Guided Attenuation Parameter measurement may display inaccurate liver steatosis values.
Product
LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0196-2026·2025-10-22
Three valve filtered solution sets recalled because IV sets may leak
Baxter is recalling 8,368 CLEARLINK System Continu-Flo solution sets with three luer activated valves and a 0.2 micron filter from one lot because the IV sets may leak.
Product
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 102-inch (2.6 meters), Product Code 2C8593
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0140-2026·2025-10-22
CX preconnect pumps without InhibiZone recalled over inflation deflation issues
Boston Scientific is recalling CX Preconnect with TENACIO Pump without InhibiZone because of the potential for inflation or deflation performance issues or difficulties.
Product
CX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM IP), (2) 72404488 (21CM IP);
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0176-2026·2025-10-22
Cardiovascular procedure packs recalled after being sterilized more than once
American Contract Systems is recalling cardiovascular convenience kits that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.
Product
Medical convenience kits Item Number/Description ANCV78BC HEART PACK - 205947 HGCV05K CV SET UP PACK MHPP97AR PACEMAKER PACK- 206010 UDBH37AW BASIC HEART PACK - 206044 UHPP82AH PERIPHERAL PACK - 209533 UICD62AN CARDIOVASCUALR SUPPLY (PS 907285) UICT16F CARDIO THORACIC
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0191-2026·2025-10-22
Non-vented IV solution sets recalled from one lot because sets may leak
Baxter is recalling 1,440 CLEARLINK System non-vented solution sets from one lot because the IV sets may leak.
Product
CLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, 10 drops/mL, 100-inch (2.5 meters), Product Code 2C8425
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0204-2026·2025-10-22
Non-DEHP solution sets recalled from one lot because IV sets may leak
Baxter is recalling 18,720 CLEARLINK System non-DEHP Continu-Flo solution sets from one lot because the IV sets may leak.
Product
CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m), Product Code: 2H8519
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0141-2026·2025-10-22
LGX preconnect pumps without InhibiZone recalled over inflation deflation issues
Boston Scientific is recalling LGX Preconnect with TENACIO Pump without InhibiZone because of the potential for inflation or deflation performance issues or difficulties.
Product
LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12CM IP), (2) 72404407 (18CM IP);
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0145-2026·2025-10-22
Shoulder surgical planning software recalled over possible implant malalignment risk
Kico Knee Innovation Company is recalling 21 ARVIS Shoulder systems after a complaint identified an issue with the AI surgical planning software that may cause implant malalignment.
Product
Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27300, Arvis Surgical Planning Software Software Version: V2025.1.2 Product Description: Intended Use: The ARVIS" system is a computer-controlled navigation system intended to provide intra-operative mea
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0192-2026·2025-10-22
Continu-Flo solution sets recalled across six lots because sets may leak
Baxter is recalling 473,040 CLEARLINK System Continu-Flo solution sets across six lots because the IV sets may leak.
Product
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 112-inch (2.8 meters), Product Code 2C8519
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0135-2026·2025-10-22
Goniotomy instruments recalled over compromised sterile packaging integrity
Iantrek is recalling 198 C-Rex UNO Microinterventional Goniotomy Instruments over the potential for compromised integrity of the sterile packaging.
Product
C-Rex UNO Microinterventional Goniotomy Instrument. Model Number: CRX-120. Product Description: The C-Rex UNO Microinterventional Goniotomy Instrument is a sterile single use disposable manual surgical instrument used in ophthalmic procedures for ab interno goniotomy and inne
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0151-2026·2025-10-22
Ceramic femoral heads recalled over packaging that may compromise sterile barrier
BioPro is recalling 147 ceramic femoral heads over a potential packaging issue that could compromise the sterile barrier and present a risk of infection if implanted.
Product
BioPro Femoral Head (Ceramic heads 28-30) Product ID/Description 19023 HEAD FEMORAL CERAMIC 28MM -3 19024 HEAD FEMORAL CERAMIC 28MM +0 19025 HEAD FEMORAL CERAMIC 32MM -3 19026 HEAD FEMORAL CERAMIC 32MM +0 19027 HEAD FEMORAL CERAMIC 32MM +3
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0142-2026·2025-10-22
CX preconnect pumps recalled over inflation and deflation performance issues
Boston Scientific is recalling 2,288 CX Preconnect devices with TENACIO Pump and InhibiZone because of the potential for inflation or deflation performance issues or difficulties.
Product
CX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404430 (12CM PS IZ), (2) 72404431 (15CM PS IZ), (3) 72404432 (18CM PS IZ), (4) 72404433 (21CM PS IZ), (5) 72404434 (24CM PS IZ), (6) 72404435 (12CM IP IZ), (7) 72404436 (15CM IP IZ), (8) 72404437 (18CM IP IZ), (9)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0177-2026·2025-10-22
Central line insertion kits recalled after being sterilized more than once
American Contract Systems is recalling 32,433 adult central line insertion supply kits that were re-gassed after a nonconformance, without validation for multiple sterilization cycles.
Product
Medical convenience kits Item Number/Description UICL44P ADULT CENTRAL LINE INSERTION SUPPLY KIT UICL44R ADULT CENTRAL LINE INSERTION SUPPLY KIT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0187-2026·2025-10-22
Dilation and curettage packs recalled after being sterilized more than once
American Contract Systems is recalling D and C convenience packs that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.
Product
Medical convenience kits IHDC30R D AND C PACK
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0166-2026·2025-10-22
Cardiac Workstation 7000 recalled after pinched power module wire caused short
Philips is recalling 29 Cardiac Workstation 7000 units after environmental stress testing failed because a pinched power module wire inside the housing resulted in a short.
Product
Cardiac Workstation 7000; Model Number: 860441;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0137-2026·2025-10-22
Anesthesia sets recalled because they contain recalled leaking Clearlink IV sets
Medline is recalling 950 Adult Anesthesia Sets because specific lots may contain Clearlink IV sets that Baxter recalled following customer reports of leaking.
Product
Medline Adult Anesthesia Set, REF DYNJ39985G
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0201-2026·2025-10-22
Non-DEHP Continu-Flo sets recalled from one lot because sets may leak
Baxter is recalling 48,096 CLEARLINK System non-DEHP Continu-Flo solution sets from one lot because the IV sets may leak.
Product
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves. 10 drops/mL, 96-inch (2.4 meters). Non-DEHP, Product Code 2R8519
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0143-2026·2025-10-22
Preconnect pump devices recalled over inflation and deflation performance issues
Boston Scientific is recalling 172 CXR Preconnect devices with TENACIO Pump and InhibiZone because of the potential for inflation or deflation performance issues or difficulties.
Product
CXR Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404461 (12CM PS IZ), (2) 72404462 (14CM PS IZ), (3) 72404463 (16CM PS IZ), (4) 72404464 (18CM PS IZ), (5) 72404465 (10CM IP IZ), (6) 72404466 (12CM IP IZ), (7) 72404467 (14CM IP IZ), (8) 72404468 (16CM IP IZ), (9
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0182-2026·2025-10-22
Radiology procedure packs recalled after being sterilized more than once
American Contract Systems is recalling radiology convenience packs that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.
Product
Medical convenience kits Item Number/Description LKRA40G RADIOLOGY PACK
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0132-2026·2025-10-22
Omnipod 5 app recalled because magnifying a field duplicates typed digits
Insulet is recalling 174,013 units of the Omnipod 5 iOS app because using the iPhone magnifier on a manual entry field while typing can duplicate a digit.
Product
The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying feature of the iPhone, while simultaneously selecting a single number on the keyboard.
Category
Medical Device
Distribution
Distributed nationwide

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2901–2925 of 39824