The Recall Desk

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.

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3226–3250 of 39824

  • 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-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-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-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-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
  • 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-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-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-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-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-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-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-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-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
  • ModerateFDA (Devices)·Z-2477-2025·2025-09-03

    Medication dispensing stations recalled because antivirus software was not consistently installed

    BD Pyxis MedStation and Anesthesia Station devices are recalled because antivirus software was not consistently installed during implementation. 8,353 devices are affected, 6,738 of them in the US.

    Product
    BD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis" MedStation" 4000 Main / 10885403512629 / 303 BD Pyxis" MedStation" ES Tower / 10885403512674 / 352 BD Pyxis" Anesthesia Station ES / 10885403477836 / 327 BD Pyxis" MedStation" ES (Main) / 10885403512667 / 323
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2476-2025·2025-09-03

    Fibrinogen test kits recalled over potential cross-contamination in heparin assays

    STA-Fibrinogen 5 kits are recalled because of the potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in heparin applications. 829,800 units are affected, 245,200 of them in the US.

    Product
    STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 kit is intended for use with the analyzers of the STA-R, STA Compact and STA Satellite families for the quantitative determination of fibrinogen levels in human citrated plasma by the clotting method of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2453-2025·2025-09-03

    Drug transfer devices recalled for shipping without US instructions for use

    BD PhaSeal closed system drug transfer devices are recalled because they were shipped to the US market without a US version of the instructions for use. 3,884,670 units are affected.

    Product
    BD PhaSeal Injector Luer (N30C), REF: 515001 BD PhaSeal Injector Luer Lock (N35), REF: 515003 BD PhaSeal Injector Luer Lock (N35C), REF: 515004 BD PhaSeal Injector Lu63er Lock (N35C Multi), REF: 515005 BD PhaSeal Protector (P14), REF: 515100 BD PhaSeal Protector (P21), REF:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2418-2025·2025-09-03

    NovoTHOR Gen 3.0 unit recalled because gas strut may detach from canopy

    A single NovoTHOR Gen 3.0 Reg PRX unit, model S2189, is recalled because a failed welded nut may shear off, detaching a gas strut from the canopy and making the canopy difficult to lift.

    Product
    Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2189 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissu
    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
  • ModerateFDA (Devices)·Z-2417-2025·2025-09-03

    NovoTHOR XL devices recalled over failed welded nut detaching gas strut

    NovoTHOR XL devices, model S2190, are recalled because a failed welded nut may shear off, detaching a gas strut from the canopy and making the canopy difficult to lift. 55 units are affected.

    Product
    Brand Name: THOR Product Name: NovoTHOR XL Model/Catalog Number: S2190 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissue temperature
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2474-2025·2025-09-03

    Anti-Xa 4 test kits recalled over potential fibrinogen reagent contamination

    STA-Liquid Anti-Xa 4 kits are recalled because of the potential for contamination by Stago Fibrinogen reagents in unfractionated and low molecular weight heparin applications. 116,600 units are affected.

    Product
    STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. 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) heparins
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2461-2025·2025-09-03

    Surgical driver systems recalled over out of the box driver wobble

    IPC Powerease System units, REF 2300000, are recalled because of out of the box wobble of the driver. 214 units are affected.

    Product
    IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC POWEREASE System is indicated for drilling, tapping, and driving screws and working end attachments during spinal surgery, including open and minimally invasive procedures. The IPC POWEREASE S
    Category
    Medical Device
    Distribution
    25 states