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 the agency’s own highest classification or reported deaths or serious injuries, 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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9901–9925 of 27441

  • HighFDA (Devices)·Z-1201-2022·2022-06-08

    Swab drug products recalled due to inadequate test method validation

    Busse Hospital Disposables is recalling convenience kits containing swab drug products manufactured by Professional Disposables International due to uncertainty about the adequacy of test methods used in manufacturing.

    Product
    Female SS 3.5MM Pellet Insertion Tray Catalog Number: B9175R1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1196-2022·2022-06-08

    Busse Hospital Disposables Recalls Convenience Kits with Swab Products

    Busse Hospital Disposables is recalling Convenience kits containing swab products due to uncertainty about manufacturing validation adequacy. The kits were distributed nationwide.

    Product
    Pellet Insertion Tray Catalog Number: B1654
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1160-2022·2022-06-08

    Nerve Block Tray Recalled Due to Manufacturing Validation Uncertainty

    Busse Hospital Disposables is recalling Nerve Block Trays containing swab and swabstick products due to uncertainty about manufacturing test method validation. Affected lot numbers should be discontinued.

    Product
    Nerve Block Tray Catalog Number: 9342
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1206-2022·2022-06-08

    Medtronic cardiac catheter system recalled due to sterility barrier defect

    Medtronic recalls its C304-HIS cardiac catheter device due to potential sterility barrier defects in certain manufacturing lots. Approximately 1,385 devices distributed worldwide were affected.

    Product
    The C304-HIS device features a guide wire to access the vein, a valve to reduce blood loss during the implant procedure, a deflectable catheter to introduce a transvenous device, a catheter dilator to facilitate deflectable catheter passage, and a guide catheter slitter to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1176-2022·2022-06-08

    Core Biopsy Tray Recall Due to Manufacturing Validation Uncertainty

    Busse Hospital Disposables is recalling Core Biopsy Trays (Catalog 8673R4) distributed nationwide because the test methods used to validate manufacturing processes may not have been adequately validated. The affected 285 units may lack proper quality verification.

    Product
    Core Biopsy Tray Catalog Number: 8673R4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1157-2022·2022-06-08

    I.V. Start Kit Recall Due to Uncertain Manufacturing Process Validation

    Busse Hospital Disposables is recalling I.V. Start Kit (Catalog 8172) due to inadequate validation of manufacturing processes for the included swab drug products. The recall affects 4,218 units distributed nationwide.

    Product
    I.V. Start Kit Catalog 8172
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1152-2022·2022-06-08

    Busse Single Shot Epidural Tray recalled for test method validation uncertainty

    Busse Hospital Disposables is recalling Single Shot Epidural Trays nationwide due to uncertainty about the adequacy of test method validation used to manufacture swab components. The FDA classified this as a Class II recall.

    Product
    Single Shot Epidural Tray Catalog 1292
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1203-2022·2022-06-08

    FDA Recalls Pellet Insertion Trays Due to Validation Method Uncertainty

    Busse Hospital Disposables is recalling 3.2MM Pellet Insertion Trays due to inadequate validation of manufacturing test methods. The recall affects 150 units distributed nationwide.

    Product
    3.2MM Pellet Insertion Tray Catalog Number: B9743
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1219-2022·2022-06-08

    MEDLINE Polyurethane Bedside Cleaning Kits Recalled Due to Microbial Contamination

    MEDLINE is recalling certain lots of its Polyurethane Bedside Cleaning Kits due to confirmed microbial contamination on the foam sponge. The kits were distributed in the US and Panama.

    Product
    MEDLINE Polyurethane Bedside Cleaning Kit, REF DYK500FSAW
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1174-2022·2022-06-08

    Single Shot Epidural Tray Kits Recalled Due to Manufacturing Validation Uncertainty

    Busse Hospital Disposables recalls Single Shot Epidural Tray kits due to uncertainty about the adequacy of test method validation in manufacturing. No illnesses reported.

    Product
    Single Shot Epidural Tray - 18G Catalog Number: 8139R2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1143-2022·2022-06-08

    Baxter Peritoneal Dialysis Manifold Sets Recalled for Lack of FDA Clearance

    Baxter Healthcare Corporation is recalling 180 units of 5 Prong Manifold Sets used in peritoneal dialysis. These products were distributed without FDA regulatory clearance to facilities across nine US states.

    Product
    5 Prong Manifold Set (with Luer Connectors)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1225-2022·2022-06-08

    Hip Stem Prosthetic Missing Plasma Coating in Manufacturing Lot

    MicroPort Orthopedics is recalling one manufacturing lot of PROFEMUR PLASMA Z CLASSIC hip stem prosthetics due to missing plasma-spray coating in the proximal region of the implant stem.

    Product
    PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1217-2022·2022-06-08

    MEDLINE Enzymatic Cleaning Sponges Recalled Due to Microbial Contamination

    MEDLINE Polyurethane Foam Enzymatic Cleaning Sponges (REF DYK1000TSE) are being recalled due to microbial contamination identified on certain lots. The affected product was distributed in the US and Panama.

    Product
    MEDLINE Polyurethane Foam Enzymatic Cleaning Sponge, REF DYK1000TSE
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1098-2022·2022-06-01

    Sara Plus Active Floor Lift Recalled for Smoke and Ignition Risk

    The FDA is recalling approximately 4,449 Sara Plus Active Floor Lift devices due to a fire hazard. The devices may emit smoke or ignite, posing a risk to users and staff.

    Product
    Sara Plus Active Floor Lift
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1130-2022·2022-06-01

    Invacare TDX SP2 Power Wheelchairs May Lose Power Due to Battery Harness Disconnection

    Invacare TDX SP2 power wheelchairs may experience battery harness disconnection during shipment or use, resulting in loss of power. Approximately 133 affected devices have been distributed in the U.S. and Canada.

    Product
    Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1123-2022·2022-06-01

    Vanta INS Neurostimulator May Fail to Communicate with Programmer Systems

    Medtronic has recalled certain Vanta INS Implantable Neurostimulator devices that may fail to communicate with clinical or patient programmer systems, preventing proper monitoring and therapy adjustments.

    Product
    Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with AdaptiveStim Technology Neurostimulator with Surescan MRI technology, part of a neurostimulator system for pain therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1136-2022·2022-06-01

    Medical beds recalled for potential motorized wheel system failure

    Umano Medical is recalling 355 adjustable medical beds because an electrical system component failure could cause the motorized wheel system to move uncontrollably, risking patient injury.

    Product
    AC-powered adjustable medical beds with built-in electric DC actuators and controls.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1140-2022·2022-06-01

    Medical Calcium Reagent Shipped Without Required Refrigeration; QC Failure Risk

    A medical lab reagent (ABX Pentra Calcium AS CP) was shipped at room temperature instead of refrigerated, causing probable quality control failure. Affected patients may experience diagnostic delays and require repeat testing.

    Product
    ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1128-2022·2022-06-01

    Medtronic Percept BrainSense Neurostimulator Cannot Communicate with Programmer Systems

    Medtronic is recalling 14,164 Percept BrainSense Implantable Neurostimulators (Model B35200) worldwide because the devices cannot communicate with clinical or patient programmer systems, preventing proper device monitoring and adjustment.

    Product
    Percept BrainSense Implantable Neurostimulator (INS), Model B35200
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1129-2022·2022-06-01

    Percept PC BrainSense Implantable Neurostimulator Recalled for Communication Failure

    Medtronic has recalled the Percept PC BrainSense Implantable Neurostimulator Model B35200 due to communication failures with programmer systems. The device cannot reliably communicate with clinical or patient programmer systems.

    Product
    Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1127-2022·2022-06-01

    Teleflex Breathing Tubes Recalled Due to Reports of Tearing

    Teleflex Medical Inc is recalling four models of breathing tubes following reports of torn corrugated tubes. Approximately 290,809 units are affected worldwide.

    Product
    (1) Teleflex Flex tube, Product #20011, sterile; (2) Teleflex Smooth-Flo Flex with Double Swivel, Product #22511, sterile; (3) Teleflex Smooth-Flo Flex with Double Swivel, Product #22512, non-sterile; (4) Teleflex Smooth-Flo Flex, Product #22552, non-sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1135-2022·2022-06-01

    Medical beds with motorized wheels face uncontrolled motion risk

    Umano Medical recalls 228 adjustable hospital beds due to potential electrical system failure that could cause uncontrolled movement of the motorized wheel system.

    Product
    AC-powered adjustable medical beds with built-in electric DC actuators and controls.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1120-2022·2022-06-01

    Protekt Sharps Safety Knives with Incorrect Size Label

    International Science & Technology is recalling Protekt Sharps Safety Knives (PG 44620MU) because some handles are labeled with an incorrect blade size of 2.5mm when the actual size is 2.2mm.

    Product
    Outer Packaging Label: Protekt Sharps Safety Knives - REF: PG 44620MU, Sterile R, Multi-Use 2.2mm Double Bevel Slit, Angled 6 units, Individual Packaging Label: ProTekt Sharps Safety Knives - REF: PG 44620MU,2.2mm double Bevel Slit, Sterile R, Angled 1 unit, Handle…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1131-2022·2022-06-01

    Medtronic Cardioblate Gemini-s Surgical Ablation System Recalled for Fractured Jaw Tips

    Medtronic is recalling 1,236 units of the Cardioblate Gemini-s surgical ablation system due to an increase in complaints about fractured jaw tips. The device is used in cardiac ablation procedures worldwide.

    Product
    Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is placed in a plastic tray with a snap on plastic lid, the tray is placed in protective wrap, then into a sterile pouch, 1 device per carton, 1 carton per box.
    Category
    Medical Device
    Distribution
    Distributed nationwide