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

3251–3275 of 39987

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-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-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-2342-2025·2025-09-03
C-arm imaging systems recalled over missing lead tape in collimator covers
GE HealthCare OEC 9800 and OEC 9900 Elite C-arm systems are recalled because impacted units are missing the full layer of lead tape in the collimator covers, slightly increasing radiation exposure.
Product
GE HealthCare OEC 9900 Elite C-arm Systems.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2479-2025·2025-09-03
Surgical kits recalled because Foley tray inserts carry incorrect product information
Medline kits containing BD SureStep Foley Tray Systems are recalled because the trays include incorrect product information insert sheets. Four units were distributed, all from the LAVH MINOR SKU.
Product
Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: CDS984076J GYN ROBOTIC DYNJG001004A LAVH MINOR DYNJG901001B CRANIOTOMY DYNJ908819B KIT CRANIOTOMY (only units from SKU DYNJG001004A LAVH MINOR were distributed)
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2462-2025·2025-09-03
Foley catheters recalled because obstructed lumen may prevent bladder drainage
Bardex Lubri-Sil I.C. Foley catheters and related tray systems are recalled because the catheter may have an obstructed lumen, which may prevent the bladder from draining. 175,158 units are affected.
Product
Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Balloon, REF: 119314; SureStep Foley Tray System Lubri-Sil I.C. Complete Care, REF: A319514A; Bard Silver Lubri-Sil Foley Tray Temperature Sensing with Bard Hydrogel and
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2468-2025·2025-09-03
Craniotomy and shunt packs recalled over unjustified sterilization of certain components
American Contract Systems craniotomy and shunt procedure packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 204 units are affected.
Product
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) SFCH CRANI PACK (PS 132432), MODEL/ITEM NUMBER UICR10W; 2) SFCH SHUNT PACK (PS 139798), MODEL/ITEM NUMBER UISH55V.
Category
Medical Device
Distribution
2 states
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-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
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-2424-2025·2025-09-03
Canal filling stems recalled after unidentified substance found during retrospective evaluation
ELEOS Segmental Stem Canal Filling straight slotted splined 2/3 plasma implants are recalled because an unidentified substance of unknown impact was found on devices. 15 units are affected.
Product
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED SPLINED 2/3 PLASMA. Canal filling stem implants.
Category
Medical Device
Distribution
Distributed nationwide
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-2341-2025·2025-09-03
OEC 9800 C-arm systems recalled over missing collimator cover lead tape
GE HealthCare OEC 9800 C-arm systems are recalled because impacted units are missing the full layer of lead tape in the collimator covers, slightly increasing radiation exposure.
Product
GE HealthCare OEC 9800.
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-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-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-2469-2025·2025-09-03
Labor and delivery packs recalled over unconfirmed product sterilization assurance
American Contract Systems Born on Arrival kits and Labor & Delivery packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 781 units are affected.
Product
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON ARRIVAL KIT, Model/Item Number LLBN11C; 2) LABOR & DELIVERY PACK, Model/Item Number LLLD19I.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2420-2025·2025-09-03
Operating tables recalled because interference can leave them unresponsive to controls
Corin Operating Tables are recalled because interference, such as from high-frequency surgical equipment used at the same time, can leave the table unresponsive to both the remote control and the override panel.
Product
Corin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4) 770001B2, (5) 770001F0, (6) 770001F2; All Software Versions.
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-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-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-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-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
ModerateFDA (Devices)·Z-2475-2025·2025-09-03
Anti-Xa test kits recalled over potential contamination by fibrinogen reagents
STA-Liquid Anti-Xa 8 kits are recalled because of the potential for contamination by Stago Fibrinogen reagents in unfractionated and low molecular weight heparin applications. 126,200 units are affected.
Product
STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite analyzers, for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparin
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2421-2025·2025-09-03
Dental implant locating kits recalled over thread defect limiting full engagement
Atlantis IO FLO-S Kits are recalled because a thread defect stops the device fully engaging an implant or analog, engaging about two rotations instead of five. 102 units are affected.
Product
Brand Name: Atlantis IO FLO-S Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04B / 68020033 Software Version: n/a Product Description: The Atlantis intraoral feature locating object for suprastructures (IO FLO-S) is intended to support the prosthetic procedure wit
Category
Medical Device
Distribution
Distributed nationwide

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3251–3275 of 39987