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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25951–25975 of 27686

  • HighFDA (Devices)·Z-2226-2013·2013-09-25

    Smith & Nephew Recalls OSTEORAPTOR Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling OSTEORAPTOR 2.9 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    OSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture, White; Part Number: 72202165 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2241-2013·2013-09-25

    GE Healthcare recalls READY View fMRI software due to incorrect maps

    GE Healthcare is recalling READY View software because it may compute and display incorrect fMRI activation maps.

    Product
    GE Healthcare, Advantage Workstation, READY View Application. Image analysis software.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2200-2013·2013-09-25

    Medtronic Recalls T8 Removal Heads Due to Incorrect Hardness Specification

    Medtronic is recalling nine T8 Removal Heads used in spinal surgery due to incorrect hardness specifications that could cause the tool to fail during implant removal.

    Product
    T8 REMOVAL HEAD, REF 8910641, QTY: 1 EA, Product Usage: The non-sterile T8 Removal Diriver is used with the Spire and Spire Z Spinal System in conjunction with the set screwdriver to remove the implant during removal surgery. The set screw driver is attached to the end of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2256-2013·2013-09-25

    GE Healthcare Recalls CARESCAPE Monitor B650 Due to Potential Issues

    GE Healthcare is recalling CARESCAPE Monitor B650 units due to potential issues. No injuries or illnesses have been reported.

    Product
    GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2224-2013·2013-09-25

    Smith & Nephew Recalls OSTOSTEORAPTOR Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling OSTOSTEORAPTOR 2.9 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    OSTOSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Blue; Part Number: 72201994 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2244-2013·2013-09-25

    Instrumentation Laboratory Recalls ACL TOP Analyzers Due to Carryover Issue

    Instrumentation Laboratory is recalling 929 ACL TOP analyzers because a potential carryover issue may cause shortened APTT clotting times.

    Product
    ACL TOP (Base); PN 0000280000 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems…
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2251-2013·2013-09-25

    Churchill Medical Recalls Vygon 14 Microbore Extension Sets

    Churchill Medical Systems is recalling 13,100 Vygon 14 Microbore Extension Sets because the tubing may disconnect from the male luers.

    Product
    Vygon 14 Microbore Extension Set with Bionector, CMS-814-1. The CMS-814-1 is a 14 inch extension set used to administer IV fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2160-2013·2013-09-25

    Villa Radiology Juno DRF Mobile X-ray System Recalled for Display Errors

    Villa Radiology Systems LLC is recalling 22 Juno DRF mobile X-ray systems because displayed radiation dose values may be inaccurate by more than 35%.

    Product
    Juno DRF System. Mobile X-ray system These are general, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-2234-2013·2013-09-25

    Smith & Nephew Recalls TWINFIX ULTRA Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling TWINFIX ULTRA suture anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    TWINFIX ULTRA PLLA/HA 5.5 mm Suture Anchor with 3 ULTRABRAID Suture: Part Number: 72202603 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2228-2013·2013-09-25

    Smith & Nephew Recalls OSTEORAPTOR Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling OSTEORAPTOR suture anchors because pinholes in primary pouches may breach the sterile barrier. The recall covers 10,296 units distributed worldwide.

    Product
    OSTEORAPTOR CURVED 2.3 mm Suture Anchor SA ULTRABRAID COBRAID Suture, Blue; Part Number: 72203290 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2250-2013·2013-09-25

    Instrumentation Laboratory ACL TOP 500 CTS Recall for Carryover Issue

    Instrumentation Laboratory is recalling ACL TOP 500 CTS analyzers due to a potential carryover issue that may cause shortened APTT clotting times.

    Product
    ACL TOP 500 CTS; PN 0000280040 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems…
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2249-2013·2013-09-25

    Instrumentation Laboratory ACL TOP 300 Analyzers Recalled for Carryover Issue

    Instrumentation Laboratory is recalling 662 ACL TOP 300 and ACL TOP 300 CTS analyzers worldwide due to a potential carryover issue that may cause shortened APTT clotting times.

    Product
    ACL TOP 300 and ACL TOP 300 CTS (Japan); PN 0000280060 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or…
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2220-2013·2013-09-25

    Smith & Nephew Recalls OSTEORAPTOR Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling OSTEORAPTOR 2.3 mm suture anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    OSTEORAPTOR 2.3 mm Suture Anchor with ULTRABRAID COBRAID Suture, Blue; Part Number: 72201993 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2247-2013·2013-09-25

    Instrumentation Laboratory Recalls ACL TOP 700 LAS Analyzers for Carryover Issue

    Instrumentation Laboratory is recalling 56 ACL TOP 700 LAS analyzers due to a potential carryover issue that can cause shortened APTT clotting times.

    Product
    ACL TOP 700 LAS; PN 0000280030 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems…
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2257-2013·2013-09-25

    GE Healthcare Recalls Seno Advantage Workstations Due to Patient Mismatch Risk

    GE Healthcare is recalling 179 Seno Advantage workstations because a software issue may cause patient mismatch without a warning message, potentially impacting patient safety.

    Product
    GE Healthcare, Seno Advantage, 5183685, 5183685-2, 5183685-3, 5183685-4, 5183685-5, 5183685-6, 5183685-7, 5183685-8, 5183685-9, 5342425, 5342425-2, 5342425-3, 5342425-4, 5342425-5. Seno Advantage is a medical image review station that allows easy selection, processing…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2229-2013·2013-09-25

    Smith & Nephew Recalls TWINFIX Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling TWINFIX Ultra HA 4.5 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue; Part Number: 72202597 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2214-2013·2013-09-25

    Ebi Recalls Cypher MIS Screw System Due to Screw Head Splay

    Ebi, LLC is recalling 427 units of the Cypher MIS Screw System because several complaints reported screw head splay.

    Product
    Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054. The Cypher MIS Screw System is a non-cervical spinal fixation device. 1)Screw Tower - REF 14-501660 2) Rod Reduce - REF 14-501661 3) Counter Torque - REF 14-501662
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2246-2013·2013-09-25

    Instrumentation Laboratory Recalls ACL TOP CTS Analyzers Due to Carryover Issue

    Instrumentation Laboratory is recalling 486 ACL TOP CTS analyzers because a potential carryover issue may cause shortened APTT clotting times.

    Product
    ACL TOP CTS; PN 0000280020 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems…
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2219-2013·2013-09-25

    Smith & Nephew Recalls Bioraptor Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling Bioraptor 2.9 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    BIORAPTOR 2.9 mm Suture Anchor, pack of 1 ULTRABRAID Suture: 72200689 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2252-2013·2013-09-25

    Churchill Medical Systems Recalls Central Dressing Change Kits

    Churchill Medical Systems is recalling 3,040 Central Dressing Change Kits because microbore tubing may disconnect from male luers on the extension sets.

    Product
    Central Dressing Change Kit; AMS-8464CP- 6. Vygon Central Dressing Change Kit contains: 1 Pair Nitrile Gloves W/Wallet, Powderfree 1 Face Mask 1 Polylined Drape, 13" X 18" 1 ChloraPrep***, 3ml Applicator W/Insert 1 Pkg. Alcohol Swabsticks (3/Pkg.) 1 14" Extension Set…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2222-2013·2013-09-25

    Smith & Nephew Recalls OSTEORAPTOR Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling OSTEORAPTOR 2.3 mm suture anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    OSTEORAPTOR 2.3 mm with 1 ULTRABRAID Suture, White; Part Number: 72201991 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2236-2013·2013-09-25

    Smith & Nephew Recalls TWINFIX Ultra Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling 1,643 TWINFIX Ultra suture anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    TWINFIX Ultra PLLA/HA 6.5 mm with 3 ULTRABRAID Suture; Part Number: 72202610 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2210-2013·2013-09-25

    Philips Brilliance CT Scanners Recalled for Footswitch Cover Defect

    Philips is recalling Brilliance CT scanners because the footswitch cover may impinge on the footswitch, causing the patient support to move unexpectedly.

    Product
    Brilliance CT 6, M/N 728256; Brilliance CT 16 M/N 728246; Brilliance CT 40, M/N 728235 & Brilliance CT 64 M/N 728231, Philips Healthcare, Cleveland, OH 44143. Intended to produce cross-sectional images of the body by computer reconstruction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2239-2013·2013-09-25

    Smith & Nephew Recalls TWINFIX Ultra Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling TWINFIX Ultra 5.5 mm PLLA-HA Suture Anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    TWINFIX Ultra 5.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles; Part Number: 72202616 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2248-2013·2013-09-25

    Instrumentation Laboratory ACL TOP 700 CTS Analyzer Recall for Carryover Issue

    Instrumentation Laboratory is recalling 185 ACL TOP 700 CTS analyzers due to a potential carryover issue that may cause shortened APTT clotting times.

    Product
    ACL TOP 700 CTS; PN 0000280050 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems…
    Category
    Medical Device
    Distribution
    46 states