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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11701–11725 of 13802

  • HighFDA (Devices)·Z-1188-2022·2022-06-08

    Busse Convenience Kits Recalled Due to Manufacturing Test Validation Uncertainty

    Busse Hospital Disposables is recalling convenience kits containing swab and swabstick products due to uncertainty regarding the adequacy of manufacturing test method validation. Affected lot numbers are 2110127 and 2110269.

    Product
    SS 4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1363R1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1187-2022·2022-06-08

    Busse Convenience Kit Swab Products Recalled Due to Manufacturing Test Validation Issue

    Busse Convenience kits containing swab/swabstick products manufactured by Professional Disposables International have been recalled due to uncertainty about the adequacy of manufacturing test method validation.

    Product
    SS 4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1363
    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-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
  • ModerateFDA (Devices)·Z-1194-2022·2022-06-08

    Busse Convenience Kits Recalled Due to Inadequate Manufacturing Test Validation

    Busse Hospital Disposables is recalling Convenience kits containing swab/swabstick drug products due to uncertainty about the validation of manufacturing test methods. The FDA classified this as a Class II recall.

    Product
    Female SS 3.5MM Pellet Insertion Tray Catalog Number: B1568
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1183-2022·2022-06-08

    Busse Hospital Swab Products Recalled for Manufacturing Validation Uncertainty

    Busse Hospital Disposables is recalling swab and swabstick drug products due to uncertainty about whether manufacturing test methods were adequately validated. No illnesses or injuries have been reported.

    Product
    SS 3.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1354
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1149-2022·2022-06-08

    Cervical Tray Catalog 1089 Recalled for Manufacturing Test Method Validation

    Busse Hospital Disposables, Inc. is recalling Cervical Tray Catalog 1089 convenience kits due to uncertainty regarding adequate validation of manufacturing test methods. No illnesses or injuries have been reported.

    Product
    Cervical Tray Catalog 1089
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1177-2022·2022-06-08

    Busse Convenience Kits with Swabs Recalled Due to Manufacturing Validation Uncertainty

    Busse Convenience kits containing swab/swabstick drug products are recalled due to uncertainty about whether test methods used to validate manufacturing were adequately validated. Distributed nationwide.

    Product
    Bone Marrow Biopsy Tray Catalog Number: 8917R1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1142-2022·2022-06-08

    Locking Cap for PD Catheter Adapter Distributed Without FDA Clearance

    Baxter Healthcare is recalling locking caps for peritoneal dialysis catheters that were distributed without FDA regulatory clearance. These devices were released into the U.S. market in error.

    Product
    Locking Cap for PD Catheter Adapter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1224-2022·2022-06-08

    Medical Device Patient Interface Recalled Due to Software Anomaly

    Medtronic is recalling the NIM Vital Patient Interface 4.0 due to a software anomaly identified in the device. The recall affects 29 units distributed worldwide, including in the US and France.

    Product
    NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1168-2022·2022-06-08

    Cervical Tray Recalled for Manufacturing Test Method Validation Uncertainty

    Busse Hospital Disposables is recalling Cervical Tray Catalog Number 3765R2 units containing swab products due to uncertainty about the adequacy of manufacturing test method validation. Lot Numbers 2031213S and 2130221S are affected.

    Product
    Cervical Tray Catalog Number: 3765R2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1147-2022·2022-06-08

    I.V. Start Kit with Swab Products Recalled for Manufacturing Validation Issues

    Busse Hospital Disposables is recalling I.V. Start Kits containing swab products due to inadequate validation of manufacturing test methods. Approximately 2,475 units nationwide may be affected.

    Product
    I.V. Start Kit - Tegaderm Dressing - Catheter Securement - Prevantics Catalog Number: 822
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1150-2022·2022-06-08

    Lumbar Tray with Swab Products Recalled Due to Manufacturing Validation Uncertainty

    Busse Hospital Disposables is recalling Lumbar Tray units nationwide because test methods used during manufacturing could not be adequately validated. The recall affects swab/swabstick products used in medical procedures.

    Product
    Lumbar Tray Catalog 1091
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1146-2022·2022-06-08

    FDA recalls APD Drain Manifold units lacking regulatory clearance

    Baxter Healthcare is recalling 180 APD Drain Manifold units distributed in nine US states because certain product codes lack FDA regulatory clearance. Patients using affected units should contact Baxter Healthcare immediately.

    Product
    APD Drain Manifold
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1159-2022·2022-06-08

    Single Shot Epidural Tray Recalled Due to Test Validation Uncertainty

    Single Shot Epidural Trays made by Busse Hospital Disposables are being recalled nationwide due to inadequate validation of the test methods used to manufacture the product. The recall affects 400 units.

    Product
    Single Shot Epidural Tray Catalog Number: 8417
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1181-2022·2022-06-08

    Medical swab insertion tray recalled due to manufacturing validation uncertainty

    Busse Hospital Disposables recalls swab insertion trays due to uncertainty about manufacturing test method validation. The Class II recall affects products nationwide.

    Product
    SS 3.5Mm Pellet Insertion Tray with large Gloves Catalog Number: B1352
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1164-2022·2022-06-08

    Busse Convenience Kits Swabs Recalled Due to Testing Validation Uncertainty

    Busse Hospital Disposables is recalling Busse Convenience Kits containing medical swabs and swabsticks due to uncertainty about test method validation in manufacturing. No illnesses reported.

    Product
    Pain Tray Catalog Number: 9883
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1195-2022·2022-06-08

    Convenience Kits with Drug Swab Products Recalled for Validation Uncertainty

    Busse Convenience kits containing swab/swabstick drug products are being recalled nationwide due to uncertainty about the adequacy of the validation of manufacturing test methods.

    Product
    Male SS 4.5MM Pellet Insertion Tray Catalog Number: B1570
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1223-2022·2022-06-08

    Medtronic NIM Vital Console 4.0 Surgical Nerve Monitoring Device Software Anomaly Recall

    Medtronic Xomed is recalling 18 units of the NIM Vital Console 4.0 surgical nerve monitoring device due to an identified software anomaly. Distribution was confirmed in Texas, Colorado, New Jersey, and France.

    Product
    NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1213-2022·2022-06-08

    Abbott FIRMap Catheter Recalled for Incorrect Product Labeling

    Abbott is recalling 40 units of FIRMap® Catheter, 60mm Basket due to incorrect product labeling. The recall affects devices distributed in Missouri, California, Ohio, Washington and internationally in Italy and Netherlands.

    Product
    FIRMap" Catheter, 60mm Basket
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1218-2022·2022-06-08

    MEDLINE Polyurethane Foam Bedside Cleaning Kit Recalled for Microbial Contamination

    MEDLINE has recalled its Polyurethane Foam Bedside Cleaning Kit (REF DYK500FS) in the United States and Panama after sporadic reports of discoloration. The discoloration has been identified as microbial contamination.

    Product
    MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK500FS
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1165-2022·2022-06-08

    Stereo Breast Biopsy Tray Recalled for Manufacturing Test Validation Uncertainty

    Busse Hospital Disposables recalls stereo breast biopsy trays due to uncertainty about the adequacy of manufacturing test validation. The recall affects 23 units distributed nationwide.

    Product
    Stereo Breast Biopsy Tray Catalog Number: 2383R1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1182-2022·2022-06-08

    Busse Convenience Kits Recalled for Manufacturing Test Method Validation Uncertainty

    Busse Convenience kits containing swab and swabstick products manufactured by Professional Disposables International are recalled by the FDA due to uncertainty regarding the validation of manufacturing test methods.

    Product
    SS 3.5Mm Pellet Insertion Tray with large Gloves Catalog Number: B1352R1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1178-2022·2022-06-08

    Procedural Accessory Kit Recalled for Manufacturing Validation Uncertainty

    Busse Hospital Disposables is recalling Procedural Accessory Kits containing swabs due to uncertainty regarding the validation of manufacturing test methods. No illnesses or injuries have been reported.

    Product
    Procedural Accessory Kit Catalog Number: 9665R2
    Category
    Medical Device
    Distribution
    Distributed nationwide