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

2301–2325 of 27346

HighFDA (Devices)·Z-2471-2025·2025-09-03
Hysterectomy procedure packs recalled over unconfirmed sterilization assurance requirements
American Contract Systems robotic and vaginal hysterectomy packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 50 units are affected.
Product
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ROBOT HYST PACK, MODEL/ITEM NUMBER GRRB10E; 2) VAG HYST PACK, MODEL/ITEM NUMBER SPVH62P.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2472-2025·2025-09-03
Hip and knee procedure packs recalled over unconfirmed sterilization assurance requirements
American Contract Systems anterior hip, total knee and hip prosthesis packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 588 units are affected.
Product
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, MODEL/ITEM NUMBER AMAH40N; 2)TOTAL KNEE DAN MYER, MODEL/ITEM NUMBER CCKM67F; 3)HIP PROTHESIS PACK, MODEL/ITEM NUMBER HSTH03N; 4)DTC ANTERIOR HIP PACK (PS 209459), MODEL/ITEM NUM
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2443-2025·2025-09-03
Phantom Essential loupe kits recalled because nickel nose pads may cause allergy
Orascoptic Phantom Essential Kits are recalled because loupe nose pads containing nickel may cause an allergic reaction, following complaints. 74 kits are affected.
Product
Orascoptic Superior Visualization Phantom Essential kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2415-2025·2025-09-03
Infusion pumps recalled because degrading grease may cause excessive therapy delivery
Six Baxter Spectrum IQ Infusion Pumps are recalled because grease applied to the cam and motor gears may break down, causing premature wear and potentially excessive therapy.
Product
Spectrum IQ Infusion Pump, Product Code 3570009
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2465-2025·2025-09-03
Lap chole and laparoscopy packs recalled over unmet sterilization assurance requirements
American Contract Systems lap chole and laparoscopy packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 1,233 units are affected.
Product
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAP CHOLE PACK, Model/Item Number CILC69L; 2) LAP CHOLE PACK, Model/Item Number HNLC80J; 3) LAP CHOLE PACK, Model/Item Number JKLC55H; 4) LAPAROSCOPY PACK, Model/Item Number LLLA21K; 5) GENERAL
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2464-2025·2025-09-03
Heart and vascular packs recalled because sterilization rationale was not justified
American Contract Systems heart, vascular and off-pump CABG packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 31,506 units are affected.
Product
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) HEART PACK - 205947, MODEL/ITEM NUMBER ANCV78BC; 2) VASCULAR PACK - 232024, MODEL/ITEM NUMBER ANVA82AB; 3) OFF PUMP CABG PACK - 170316, MODEL/ITEM NUMBER BHOP48O; 4) OFF PUMP CABG PACK - 170316, M
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2444-2025·2025-09-03
Loupe nose pad kits recalled because nickel content may cause allergic reaction
Orascoptic Dragonfly Nose Pad Accessory Kits are recalled because loupe nose pads containing nickel may cause an allergic reaction, following complaints. 743 kits are affected.
Product
Orascoptic Superior Visualization Dragonfly Nose Pad Accessory Kit ( nose pad and screw) 1 pk and 20 pk.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2467-2025·2025-09-03
Perfusion and laparoscopy packs recalled over unjustified sterilization of certain components
American Contract Systems supplement, kidney perfusion and lapchol/appy packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 6,617 units are affected.
Product
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) A-C SUPPLEMENT PACK - 205946, Model/Item Number ANCV67X; 2) KIDNEY PERFUSION PACK - 208439, Model/Item Number ANKP15AD; 3) LAPCHOLAPPY PACK, Model/Item Number FYLA38G; 4) CYSTO PACK, Model/Item N
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2423-2025·2025-09-03
Limb salvage canal filling stems recalled after unidentified substance found on devices
ELEOS Bowed Canal Filling Stems are recalled because an unidentified substance of unknown impact was found on devices during a retrospective evaluation. 30 units are affected.
Product
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2470-2025·2025-09-03
Laparoscopy and pelviscopy packs recalled over unconfirmed sterilization assurance requirements
American Contract Systems laparoscopy and pelviscopy procedure packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 1,094 units are affected.
Product
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAPAROSCOPY PACK, MODEL/ITEM NUMBER EVLP61I; 2) PELVISCOPY, MODEL/ITEM NUMBER EVPV29G.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2441-2025·2025-09-03
Custom loupes with Phantom frames recalled over nickel nose pad allergy risk
Orascoptic custom loupes configured with Phantom frames are recalled because loupe nose pads containing nickel may cause an allergic reaction, following complaints. 10,611 units are affected.
Product
Orascoptic Superior Visualization Custom loupes configured with Phantom Frames
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2442-2025·2025-09-03
Dragonfly Essentials loupe kits recalled because nickel nose pads may cause allergy
Orascoptic Dragonfly Essentials Kits are recalled because loupe nose pads containing nickel may cause an allergic reaction, following complaints. 32 kits are affected.
Product
Orascoptic Superior Visualization Dragonfly Essentials Kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2451-2025·2025-09-03
Intraocular lenses recalled after off-power error produced wrong diopter strength
Two Akreos intraocular lenses from lot 1Q29212 are recalled after an off-power error produced a 16 diopter lens rather than the intended 3 diopter.
Product
Akreos, SKU: AO60P0300. Akreos intraocular lenses
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2445-2025·2025-09-03
Phantom nose pad kits recalled because nickel content may cause allergic reaction
Orascoptic Phantom Nose Pad Accessory Kits are recalled because loupe nose pads containing nickel may cause an allergic reaction, following complaints. 22 kits are affected.
Product
Orascoptic Superior Visualization Phantom Nose Pad Accessory Kit ( nose pad and screw) 1 pk. and 20 pk.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2440-2025·2025-09-03
Custom loupes with Dragonfly frames recalled over nickel nose pad allergy risk
Orascoptic custom loupes with Dragonfly frames are recalled because loupe nose pads containing nickel may cause an allergic reaction, following complaints. 15,245 units are affected.
Product
Orascoptic Superior Visualization Custom loupes with Dragonfly frames
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2425-2025·2025-09-03
Limb salvage stem extensions recalled after unidentified substance found on devices
ELEOS Segmental Limb Salvage System straight splined slotted stem extensions are recalled because an unidentified substance of unknown impact was found on devices during a retrospective evaluation. 554 units are affected.
Product
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2452-2025·2025-09-03
Surgery trays recalled because they contain recalled tourniquet cuffs
Medline General Surgery Trays are recalled because they contain recalled Stryker Color Cuff tourniquet cuffs whose flange may detach, compromising air pressure and risking tourniquet failure. 1,145 units are affected.
Product
The Medline General Surgery Tray is customized to meet requirements of the hospitals and health care professionals utilizing them. The kit is provided sterile, single-use and includes a range of components dependent upon the specific procedure. These kits will be assembled using
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2466-2025·2025-09-03
Cystoscopy and TUR packs recalled over unconfirmed sterilization assurance requirements
American Contract Systems cysto and TUR basin packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 1,127 units are affected.
Product
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) CYSTO, Model/Item Number ASCY24A; 2) CYSTO PACK, Model/Item Number BUCY78E; 3) CYSTO PACK, Model/Item Number LMCP22T; 4) TUR BASIN PACK, Model/Item Number LMTU31T; 5) CYSTO, Model/Item Number SA
Category
Medical Device
Distribution
2 states
CriticalFDA (Devices)·Z-2328-2025·2025-08-27
Hamilton C6 ventilators recalled over circuit board defect interrupting ventilation
Hamilton C6 ventilators are recalled over a mechanical defect on a printed circuit board that may cause the device to fail at startup or interrupt ventilation during use. 1,040 systems are affected.
Product
Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a ventilator intended to provide positive pressure ventilatory support to adults and pediatrics and optionally infants and neonates.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2327-2025·2025-08-27
RELIANCE 4-FRONT defibrillation leads recalled over rising LVSI measurements and coil calcification
RELIANCE 4-FRONT defibrillation leads are recalled because affected models may show gradually rising LVSI measurements linked to calcification of the defibrillation coils, which may lead to early lead replacement.
Product
RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lead, Permanent Defibrillator Electrodes; Model Nos. 0654, 0655, 0657, 0658, 0682, 0683, 0685, 0686, 0692, 0693, 0695, 0696
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2325-2025·2025-08-27
ENDOTAK RELIANCE defibrillation leads recalled over coil calcification and rising LVSI
ENDOTAK RELIANCE G/SG transvenous defibrillation leads are recalled because affected models may show gradually rising LVSI measurements linked to calcification of the defibrillation coils.
Product
ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter defibrillator (non-CRT); Model Nos. 0160, 0161, 0162, 0163, 0164, 0165, 0166, 0167, 0170, 0171, o182, 0173, 0174, 0175, 0176, 0177, 0180, 0182, 0183, 0184, 0185, 0186, 0187
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2326-2025·2025-08-27
ENDOTAK RELIANCE leads with 4-SITE connector recalled over coil calcification
ENDOTAK RELIANCE G/SG defibrillation leads with the 4-SITE connector are recalled because affected models may show gradually rising LVSI measurements linked to calcification of the defibrillation coils.
Product
ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead, Permanent Defibrillator Electrodes; Model Nos. 0282, 0283, 0285, 0286, 0292, 0293, 0295, 0296
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2338-2025·2025-08-27
Electrosurgical generators recalled over system error causing reboots during use
The ESG-410 Electrosurgical Generator is recalled because it may display an E0662 System Error followed by a single automatic reboot or a continuous reboot loop. 155 units are affected.
Product
Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SEP). Model Number: WA91327U. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2344-2025·2025-08-27
OtoLase starter kits recalled over potentially unsterilized product labeled as sterile
OtoLase Starter Kits, UPN AC-2003748, batches 32644549 and 32769567, are recalled because finished product labeled as sterile may not have been sterilized. 13 units are affected.
Product
OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2331-2025·2025-08-27
Bayonet injection needles recalled after showing elevated cytotoxicity in testing
Bayonet Luer-Lock injection needles, models 50-353-23 and 50-345-23, are recalled because affected product showed elevated cytotoxicity values, which may present a risk of intolerance or allergic reaction.
Product
Injection needle, bayonet, Luer-Lock, 1. Model no. 50-353-23, working length 25 cm, total length 31cm, nonsterile; 2. Model no. 50-345-23, working length 24 cm, total length 31 cm, non-sterile
Category
Medical Device
Distribution
Distributed nationwide

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2301–2325 of 27346