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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10751–10775 of 13748

  • HighFDA (Devices)·Z-0243-2023·2022-11-23

    EasyStand Bantam standing devices may fail to maintain upright position

    Altimate Medical is recalling EasyStand Bantam Small and Extra Small standers due to a component defect that may prevent the leg assembly bracket from maintaining the non-supine position. No injuries have been reported.

    Product
    EasyStand Bantam, with the following sizes. a. Small; b. Extra Small. Used for assisting individual in standing.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0246-2023·2022-11-23

    OneLIF Torque Limiting Adapter Recalled for Potential Locking Failure

    Novapproach Spine is recalling OneLIF Torque Limiting Adapter components used in spinal surgery instruments because the adapter may not remain locked in the ratcheting handle once fully engaged. This could compromise surgical instrument function during use.

    Product
    OneLIF Torque Limiting Adapter, AO to 1/4 SQ, 2.25Nm Limit, Catalog #015-010-0000, a component of NovApproach Spine OneLIF Interbody System instrument kit, Catalog #OneLIF INS.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0214-2023·2022-11-23

    CareFusion Genesis Sterilization Containers Fail Aerosol Challenge Testing

    CareFusion Genesis sterilization containers have failed to consistently meet aerosol challenge testing, potentially leaving surgical instruments inadequately sterilized. 318 units distributed in the US and internationally.

    Product
    CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF CD3-6ST
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0206-2023·2022-11-23

    CareFusion GENESIS Sterilization Containers Fail Aerosol Challenge Testing

    CareFusion GENESIS sterilization containers have not consistently met aerosol challenge testing requirements. Approximately 1,132 units distributed to healthcare facilities in the U.S. and internationally are affected.

    Product
    CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 5" (12.7CM) DEEP STERRAD COMPATIBLE, REF CD1-5ST
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0240-2023·2022-11-23

    Simplex HV bone cement distributed under wrong part number

    Howmedica distributed bone cement under incorrect part number 6193-1-010 instead of ordered 6195-1-010. The distribution error affected 90 units shipped nationwide.

    Product
    Simplex HV With Gentamicin CE, 10 PACK-Bone cement with Gentomycin Catalog Number: 6193-1-010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0239-2023·2022-11-23

    Operating Table Extension Tabletop May Drop, Creating Patient Fall Hazard

    The back rest of Getinge operating table extension tabletops may drop unexpectedly, posing a fall hazard to patients. No injuries have been reported.

    Product
    Extension Tabletop for Operating Table System 1140, Model Nos. 1140.20F0 and 1140.20AN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0228-2023·2022-11-23

    TufTex Embolectomy Catheter Recalled for Inadequate Ligature Ties

    LeMaitre Vascular recalled three lots of TufTex Embolectomy Catheters with inadequate ligature ties. The defect risks the catheter tip breaking off and becoming lodged in a blood vessel.

    Product
    TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserted using a guidewire or introducer. The devices affected by this recall are 3F and 4F..
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0210-2023·2022-11-23

    CareFusion Genesis sterilization containers recalled for failed sterility testing

    CareFusion Genesis reusable sterilization containers are recalled after failing aerosol challenge testing requirements. No illnesses or injuries have been reported.

    Product
    CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF CD2-6ST
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0217-2023·2022-11-23

    CareFusion Genesis Sterile Containers Fail Sterilization Testing Requirements

    Reusable sterilization containers manufactured by Carefusion have not consistently met aerosol challenge testing requirements. 483 units distributed in the US and internationally are being recalled.

    Product
    CareFusion V.Mueller GENESIS SMALL CONTAINER 21 X 7" (53.3 X 17.8CM) 5-1/2" (14CM) DEEP STERRAD COMPATIBLE, REF CD4-5ST
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0234-2023·2022-11-23

    GentleWave System Posterior Procedure Instrument Recall for Erroneous Carton Labels

    Sonendo Inc is recalling 16 GentleWave System Posterior CleanFlow procedure instruments with lot number W2022080204R due to erroneous unit carton labels that could affect proper identification and use.

    Product
    GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0235-2023·2022-11-23

    Atrium Ocean Wet Suction Chest Drains recalled due to storage temperature excursions

    Atrium Medical Corporation is recalling Atrium Ocean Wet Suction Water Seal Chest Drains (Product Code 2002-000) distributed in the United States due to warehouse temperature excursions in July and August 2021. No patient harm has been reported.

    Product
    Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0233-2023·2022-11-23

    GentleWave System APM Procedure Instruments recalled for erroneous carton labels

    Sonendo Inc is recalling 15 GentleWave System APM Procedure Instruments (Model GW-APM-PI02) due to erroneous unit carton labels. The instruments were distributed worldwide, including Ohio and Canada.

    Product
    GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0202-2023·2022-11-23

    Urological Irrigation Kit Recalled for Illegible Barcode Labels

    Canadian Hospital Specialties is recalling MED-RX Urological Cysto/Bladder Irrigation Sets with illegible barcodes that prevent scanning. About 9,100 units distributed in the US are affected.

    Product
    MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET, REF 10-4001
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0224-2023·2022-11-16

    Medical Device Recall: ORISE Gel Submucosal Lifting Agent Due to Foreign Body Reactions

    Boston Scientific is recalling ORISE Gel Submucosal Lifting Agent due to higher incidence of foreign body reactions to retained gel. These reactions caused mass formations requiring surgical intervention.

    Product
    ORISE Gel Submucosal Lifting Agent--Indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or other suitable endoscopic device Packaged as
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0225-2023·2022-11-16

    ORISE Gel Syringe Recall Due to Foreign Body Reaction Risk

    Boston Scientific has recalled ORISE Gel Syringe kits used in gastrointestinal endoscopy due to higher incidence of foreign body reactions from remnant gel requiring surgical intervention.

    Product
    ORISE Gel Syringe Submucosal Lifting Agent Kits: indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or other suitable endoscopic device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0223-2023·2022-11-16

    Neonatal Endotracheal Tube Grip with Detachable Metal Clips Recalled

    CooperSurgical is recalling NEO-fit Neonatal Endotracheal Tube Grips due to metal clips that can become loose or detach. Eleven complaints include three cases of clip ingestion, three removals from the mouth, and one throat laceration.

    Product
    NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0226-2023·2022-11-16

    Medical Device Procedure Kits Recalled for Foreign Body Reaction Risk

    Boston Scientific recalls ORISE ProKnife Procedure Kits due to higher incidence of foreign body reactions to remnant gel post-procedure, which have required surgical intervention in affected patients.

    Product
    ORISE ProKnife Procedure Kits: indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or other suitable endoscopic device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0184-2023·2022-11-16

    FERNO POWER X1 ambulance cot batteries pose fire and burn risk

    Ferno-Washington is recalling 1,922 FERNO POWER X1 ambulance cots with 36V Li-Ion batteries that may become unstable and pose a fire or burn injury risk if dropped, power washed, or abused.

    Product
    FERNO POWER X1 AMBULANCE COT- Item #0015807/UDI-DI 00190790002183 with 36V Li-Ion Batteries Model Number #0822484/0822483 Note: Transcend Stair Chair Powertraxx (Item #0731403/UDI-DI 00190790004064) not included in this action).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0186-2023·2022-11-16

    Cardinal Health Reusable Gel Pack Contraindicated for Infants and Neonates

    Cardinal Health is recalling 409,738 reusable gel pack units because they should not be used on infants or neonates. The company is adding a caution statement to labeling.

    Product
    Cardinal Health GEL PACK REUSABLE, SMALL, Cat. 70204
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0188-2023·2022-11-16

    Cardinal Health Insulated Gel Pack recalled; not safe for infants

    Cardinal Health is recalling 1,209,260 INSULATED GEL PACK REUSABLE, LARGE units because the product is not safe for infants or neonates. The company is adding a warning label.

    Product
    Cardinal Health INSULATED GEL PACK REUSABLE, LARGE, Cat. 80104
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0199-2023·2022-11-16

    Scalpel and StatLock in HydroPICC kits expire before label indicates

    Access Vascular recalls 79 HydroPICC catheter kits because included scalpel and StatLock components have earlier expiration dates than stated on the package.

    Product
    Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0189-2023·2022-11-16

    Cardinal Health Insulated Gel Pack Recalled for Infant Safety

    Cardinal Health is recalling its insulated gel pack because it should not be used on infants or neonates. The product labeling will be updated with a caution statement.

    Product
    Cardinal Health INSULATED GEL PACK REUSABLE, SMALL, Cat. 80204A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0194-2023·2022-11-16

    Insulin Pump Cybersecurity Vulnerability Allows Unauthorized Remote Access

    MiniMed 600 series insulin pumps have a cybersecurity vulnerability that could allow unauthorized access, potentially resulting in delivery of too much or too little insulin. Users should disable the Remote Bolus feature.

    Product
    Insulin Pump/Model: MiniMed 620G/ MMT-1750 MiniMed 640G/ MMT-1711, MMT-1712, MMT-1751, MMT-1752
    Category
    Medical Device
    Distribution
    54 states
  • HighFDA (Devices)·Z-0182-2023·2022-11-16

    Sedecal Soltus Battery Mobile X-Ray Systems Recalled for Unintended Movement

    Sedecal Soltus battery mobile x-ray systems may move without operator command. The FDA is recalling 155 units distributed across the U.S. due to this safety hazard.

    Product
    Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mobile X-Ray System REF Soltus 500
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-0193-2023·2022-11-16

    Medtronic MiniMed Insulin Pumps Recalled for Cybersecurity Vulnerability

    Medtronic is recalling MiniMed 630G and 670G insulin pumps due to a cybersecurity vulnerability that could allow unauthorized access to the pump system, potentially resulting in incorrect insulin delivery.

    Product
    Insulin Pump/Model: MiniMed 630G/ MMT-1715, MMT-1755, MMT-1754; MiniMed 670G/ MMT-1780, MMT-1781, MMT-1782, MMT-1760, MMT-1761, MMT-1762, MMT-1740, MMT-1741, MMT-1742
    Category
    Medical Device
    Distribution
    54 states