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

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All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

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

Clear filters

10676–10700 of 40095

  • HighFDA (Devices)·Z-1077-2023·2023-02-15

    Sterile Surgical Trays Recalled for Blade Puncture of Packaging

    Medline Industries is recalling sterile surgical trays used in plastic and reconstructive surgery because blades within the kits can puncture the outer foil packaging, potentially compromising sterility. Approximately 15,009 units were distributed nationwide and internationally.

    Product
    Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINOPLASTY CDS d. ACH PLASTICS BREAST-LF e. NE BREAST RECON CDS f. PLASTIC SURGERY CDS g. MINOR PLASTIC CDS h. GROTH BREAST CDS i. BREAST ABD j. MINOR/U-BAR…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1084-2023·2023-02-15

    Sterile Procedural Trays Recalled Due to Potential Packaging Puncture

    Medline Industries is recalling sterile procedural trays because sterile blades may puncture the outer packaging foil, potentially compromising sterility. No injuries have been reported.

    Product
    Sterile Procedural Trays, labeled as the following: MINOR BASIC PACK-LF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1105-2023·2023-02-15

    Roche cobas Influenza Test Recall Due to False Negative Results

    Roche Molecular Systems is recalling its cobas Influenza A/B & SARS-CoV-2 test because it has reported false negative results for Influenza A, which may delay diagnosis and treatment.

    Product
    cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems; Material Number 09446125190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1081-2023·2023-02-15

    Sterile Procedural Trays Recalled Due to Potential Blade Puncture of Packaging

    Medline Industries recalls sterile procedural trays (Wound Closure Tray and Wound Pack) distributed worldwide because sterile blades may puncture the outer foil packaging.

    Product
    Sterile Procedural Trays, labeled as the following: a. WOUND CLOSURE TRAY b. WOUND PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1088-2023·2023-02-15

    Medline Sterile Surgical Trays Recalled Due to Blade Puncture Risk

    Medline Industries recalls sterile surgical procedural trays because sterile blades within the kits may puncture the outer foil packaging, potentially compromising sterility. No injuries or illnesses have been reported.

    Product
    Sterile Procedural Trays, labeled as the following: a. AV SHUNT CDS b. ZALE V-P SHUNT CDS c. NEURO CDS-LF d. MAJOR NEURO e. NEURO PACK-LF f. CUSTOM NEURO PACK-LF g. NEURO PACK-LF h. NEURO PACK-LF i. NEURO PACK-LF j. NEURO PACK-LF k. NEURO/LAMINECTOMY BASIN PK-LF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1089-2023·2023-02-15

    Sterile surgical trays recalled due to packaging puncture risk

    MEDLINE INDUSTRIES is recalling six models of sterile surgical trays due to a potential for blades within the kits to puncture the sterile packaging. Affected trays were distributed worldwide.

    Product
    Sterile Procedural Trays, labeled as the following: a. GYN LAPAROTOMY HARPER PACK-LF b. OB GYN LAP PACK-LF c. VAGINAL HYSTERECTOMY PACK d. DELTA PACK e. MAJOR VAGINAL-LF f. GYN LAPAROSCOPY II
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1092-2023·2023-02-15

    Sterile Procedural Trays With Blades That May Puncture Packaging

    Medline recalls sterile surgical trays because internal blades can puncture the outer protective foil packaging, potentially compromising sterility.

    Product
    Sterile Procedural Trays, labeled as the following: a. C-SECTION OR 30 CDS b. C-SECTION CDS c. C-SECTION CDS d. C-SECTION CDS e. MAJOR ORTHO CDS-LF f. C-SECTION CDS g. C-SECTION CDS h. C-SECTION PROCEDURE i. C-SECTION CDS-LF j. C-SECTION CDS k. C-SECTION CDS l.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1067-2023·2023-02-15

    Sterile Procedural Trays Recalled Due to Blade Puncture Risk

    Medline Industries is recalling sterile procedural trays because sterile blades within the kits may puncture the protective foil packaging. Approximately 12,964 cases (23,379 units) distributed worldwide are affected.

    Product
    Sterile Procedural Trays, labeled as the following: a. EP LAB PACEMAKER PACK b. OPEN HEART CDS c. OPEN HEART CDS d. AAA CDS e. OPEN HEART CDS f. PACEMAKER CDS g. HEART CDS h. VALVE PACK i. OPEN HEART CDS-3 j. OPEN HEART PACK k. OPEN HEART PACK l. OPEN HEART ADULT m. OPEN HEART…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1073-2023·2023-02-15

    Sterile Procedural Trays Recalled for Potential Blade Puncture

    Medline sterile procedural trays for minor and breast biopsies are being recalled because sterile blades may puncture the outer foil packaging, compromising sterility. The recall affects 237 cases (1,242 units) distributed worldwide.

    Product
    Sterile Procedural Trays, labeled as the following: a. MINOR/BREAST BIOPSY-LF b. BREAST BIOPSY-LF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1083-2023·2023-02-15

    Medline Sterile Procedural Trays Recalled for Potential Blade Puncture in Packaging

    Medline Industries is recalling sterile procedural trays because blades in the kits may puncture the outer foil sterile packaging, compromising sterility. No injuries have been reported.

    Product
    Sterile Procedural Trays, labeled as the following: a. MAJOR CDS-LF b. BURN PACK-LF c. BURN PACK d. SMALL BURN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1062-2023·2023-02-15

    Medline sterile procedural trays recalled for blade packaging puncture

    Medline is recalling sterile procedural trays (Lot 22IBG550) because sterile blades can puncture the foil packaging, compromising sterility. Units were distributed worldwide.

    Product
    LOCAL PACK. Sterile Procedural Tray.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1099-2023·2023-02-15

    Spinal Cement System Recalled for Incorrect Expiration Date

    TEKNIMED SAS is recalling HIGH V+ Spinal Cement System (236 units) due to mislabeling showing expiration date of February 28, 2027 instead of the correct date February 28, 2025.

    Product
    HIGH V+ Spinal Cement System REF T040321K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1103-2023·2023-02-15

    Thoracic Navigation System Recalled for Incorrect Cable Causing Grainy Imaging

    Olympus is recalling the SPiN Thoracic Navigation System (model SYS-4000) due to an incorrect DVI cable that produces grainy images during bronchoscopy procedures, requiring extended troubleshooting time.

    Product
    SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D)
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-1064-2023·2023-02-15

    Sterile Procedural Trays Recalled Over Potential Blade Puncture of Packaging

    Medline Industries is recalling sterile procedural trays because sterile blades inside could puncture the outer foil packaging, compromising sterility. The recall affects units distributed worldwide.

    Product
    UNIVERSAL CORE DR RUNNELS PACK. Sterile Procedural Tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1098-2023·2023-02-15

    Zimmer Identity Shoulder Resection Planer Units Recalled for Malfunction

    Zimmer, Inc. is recalling 84 units of the Identity Shoulder System Resection Planer due to defects discovered during training testing. Some units are unusable, potentially affecting surgical performance in shoulder procedures.

    Product
    Identity Shoulder System Resection Planer 35mm Resection Planer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1104-2023·2023-02-15

    Roche cobas Flu/COVID assay recalled for false negative influenza results

    Roche Molecular Systems recalls cobas SARS-CoV-2 & Influenza A/B assay kits used in clinical laboratories. The kits may produce false negative Influenza A results, potentially delaying accurate diagnosis.

    Product
    cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems; Material number 09233474190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1076-2023·2023-02-15

    Sterile Procedural Trays Recalled Due to Blade Puncture Risk

    Medline Industries is recalling sterile procedural trays (ENDOSCOPY-LF and SEPTO/ENDO) because sterile blades may puncture the outer foil layer of the sterile packaging. The recall affects units distributed nationwide and internationally.

    Product
    Sterile Procedural Trays, labeled as the following: a. ENDOSCOPY-LF b. SEPTO/ENDO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1052-2023·2023-02-15

    NuVasive Pulse III Multimodality System remote monitoring connection failure

    An incorrect security key prevents the NuVasive Pulse III system from connecting to remote monitoring during spinal, thoracic, and extremity surgeries. Affected facilities should contact NuVasive for corrective action.

    Product
    NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1059-2023·2023-02-15

    Face Masks Packaged in Incorrect Dispenser Boxes with Mismatched Labeling

    73 cases of FLUIDSHIELD 3 procedure masks were placed in dispenser boxes labeled for masks with ties, when the actual masks have ear loops. Distributed to IL, NC, NY, OH, and PA.

    Product
    FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Devices)·Z-0965-2023·2023-02-08

    CADD Infusion Administration Set Recalled for Delivery Failure and False Alarms

    Smiths Medical is recalling CADD Administration Sets due to tubing occlusion that can prevent medication delivery and false pump alarms. This FDA Class I recall affects 214,668 units worldwide.

    Product
    CADD Administration Set, List Numbers: a) REF 21-7600-24, b) REF 21-7609-24, c) REF 21-7624-24, d) REF 21-7649-24, e) REF 21-7600-24JP, f) REF 21-7609-24JP, g) REF 21-7624-24JP, h) REF 21-7649-24JP Computerized Ambulatory Delivery Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0964-2023·2023-02-08

    CADD Infusion Administration Sets Recalled for Delivery Failure and Alarms

    FDA recalls 726,878 CADD Infusion Administration Sets due to potential tubing occlusion causing delivery failure and false alarm warnings.

    Product
    CADD Administration Set, List Numbers: a) REF 21-7308-24, b) REF 21-7309-24, c) REF 21-7310-24, d) REF 21-7308-24JP, e) REF 21-7309-24JP. Computerized Ambulatory Delivery Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0963-2023·2023-02-08

    CADD Infusion Administration Sets Recalled for Tubing Occlusion and False Alarms

    Smiths Medical is recalling CADD Administration Sets for two issues: tubing may become blocked, preventing medication delivery, and devices may show false alerts about disposable attachment status.

    Product
    CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24 3) REF 21-7302-24, 4) REF 21-7321-24, 5) REF 21-7322-24, 6) REF 21-7323-24, 7) REF 21-7324-24, 8) REF 21-7333-24, 9) REF 21-7336-24, 10) REF 21-7339-24, 11) REF 21-7343-24, 12) REF 21-7349-24…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0966-2023·2023-02-08

    CADD Administration Sets recall for delivery failure and false alarms

    Smiths Medical is recalling CADD Administration Sets due to potential tubing occlusion causing medication underdelivery and false alarm errors. The FDA classified this as a Class I recall affecting nearly 48 million units worldwide.

    Product
    CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24, 3) REF 21-7302-24, 4) REF 21-7308-24, 5) REF 21-7309-24, 6) REF 21-7310-24, 7) REF 21-7322-24, 8) REF 21-7323-24, 9) REF 21-7324-24, 10) REF 21-7333-24, 11) REF 21-7343-24, 12) REF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0962-2023·2023-02-08

    CADD Administration Set recall: medication underdelivery and false alarms

    Smiths Medical is recalling 1.6 million CADD Infusion System Administration Sets due to tubing occlusion causing medication underdelivery and false alarm conditions affecting patients worldwide.

    Product
    CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0929-2023·2023-02-08

    SARS-CoV-2 Antigen Rapid Test Kits Recalled for Lack of FDA Authorization

    Universal Meditech Inc. is recalling approximately 56,300 SARS-CoV-2 Antigen Rapid Test Kits distributed without FDA approval, clearance, or Emergency Use Authorization. Products were distributed nationwide in California and Texas.

    Product
    Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 20 TESTS/1 KIT Green and white box under the brand DiagnosUS, and, White box without brand name labeled as "SARS -COV-2 ANTIGEN DEVELOPMENT MADE IN USA ORAL SWAB…
    Category
    Medical Device
    Distribution
    Distributed nationwide