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.

Filters

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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

10751–10775 of 13717

  • HighFDA (Devices)·Z-0201-2023·2022-11-23

    Endo Stitch V-Loc surgical sutures recalled due to needle breakage

    Covidien is recalling Endo Stitch V-Loc PBT non-absorbable surgical sutures due to 210 reports of needles breaking during use. Breaking needles may leave fragments in patients, potentially causing tissue injury or requiring additional imaging.

    Product
    Endo Stitch V-Loc PBT Non-Absorbable Reload, Models VLOCN004L, VLOCN006L, VLOCN008L, VLOCN204L, VLOCN206L, VLOCN208L, VLOCN304L, VLOCN306L, VLOCN308L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-0209-2023·2022-11-23

    CareFusion sterilization containers fail aerosol challenge testing

    CareFusion GENESIS sterilization containers have not consistently met aerosol challenge testing requirements. The FDA is recalling 510 units to prevent potential sterilization failures.

    Product
    CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 5" (12.7CM) DEEP STERRAD COMPATIBLE, REF CD2-5ST
    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
  • 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
  • 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
  • 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-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
  • 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
  • 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-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-0191-2023·2022-11-16

    Cardinal Health insulated gel pack recalled for infant contraindication

    Cardinal Health is recalling approximately 414,194 units of its insulated gel pack because the product should not be used on infants or neonates. The company will update product labeling with a clear warning.

    Product
    Cardinal Health INSULATED GEL PACK REUSABLE, EXTRA LARGE, Cat. 80600
    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-0183-2023·2022-11-16

    Zio AT Ambulatory ECG Monitoring System Documentation Labeling Update

    iRhythm Technologies is recalling clinical reference materials for the Zio AT cardiac monitoring system due to labeling deficiencies that may delay notification of arrhythmias to healthcare providers. Transmission limits could prevent critical cardiac event reporting.

    Product
    Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Information Pamphlet, Part: ALB0034. For Zio Ambulatory ECG monitoring system
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-0187-2023·2022-11-16

    Cardinal Health Reusable Gel Pack Restricted for Infants

    Cardinal Health is restricting use of 567,475 reusable hot and cold gel packs (Model M) on infants and neonates due to thermal injury risk. Updated labeling will warn against use on this vulnerable population.

    Product
    Cardinal Health HOT AND COLD GEL PACK REUSABLE, M, Cat. 70304
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0185-2023·2022-11-16

    Reusable gel pack recalled due to infant use contraindication

    Cardinal Health is recalling approximately 1.9 million reusable gel packs (Cat. 61115) because the product should not be used on infants or neonates. A caution statement is being added to the product labeling.

    Product
    Cardinal Health GEL PACK REUSABLE, EXTRA SMALL, Cat. 61115
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0222-2023·2022-11-16

    X-Guide X-Mark Probe Tool Recall: Missing Weld Creates Aspiration Risk

    X-NAV Technologies is recalling the X-Guide X-Mark Probe Tool because a critical weld may be missing, potentially allowing the probe tip to detach and fall into a patient's mouth during use, creating a risk of aspiration or swallowing.

    Product
    X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P010673
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-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-0195-2023·2022-11-16

    Sterile Medical Extension Sets Distributed Without Expiration Dates

    Avanos Medical is recalling sterile extension sets distributed without expiration dates. Without proper dating, healthcare providers cannot verify sterility assurance, creating a potential patient safety risk.

    Product
    Y-CONNECTOR: 6" Small Kink Resistant Tubing Bifurcated Connector /2 Male Luer Locks, 1 Female Luer Lock, Labeled as: SUMMIT MEDICAL PRODUCTS, REF 220227; MPS Acacia CAT NO: BC-006-04; MEDICAL PRODUCTS SPECIALISTS EXTENSION SET, Catalog Number BC00604, pain control pump accessor
    Category
    Medical Device
    Distribution
    11 states