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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Minimum severity

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

Clear filters

37401–37425 of 40325

  • 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
  • HighFDA (Devices)·Z-2238-2013·2013-09-25

    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, posing a risk of infection.

    Product
    TWINFIX" Ultra 4.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID") with Needles; Part Number: 72202612 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2235-2013·2013-09-25

    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 6.5 mm with 2 ULTRABRAID" Suture, White / Black: Part Number: 72202608 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2213-2013·2013-09-25

    Rauland-Borg Recalls Responder 5 Nurse Call Systems Due to Counterfeit Parts

    Rauland-Borg is recalling Responder 5 nurse call systems because counterfeit electronic components may cause the devices to lose communication functionality.

    Product
    Responder 5 is a nurse call communication system that connects patients with staff in a hospital. The nurse call system also connects team members and departments from radiology, physical therapy, transport, environmental services and more. Responder 5 is used in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2215-2013·2013-09-25

    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 with 2 ULTRABRAID Suture; Part Number: 72200775 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2243-2013·2013-09-25

    Synthes Cannulated Distal Femoral Nail Recalled Due to Prior Recall Scope

    Synthes USA is recalling one unit of a Cannulated Distal Femoral Nail because it was distributed despite being within the scope of a previous recall.

    Product
    Synthes Cannulated Distal Femoral Nail (Trauma Nail), Part Number 450.851S, 420MM-Sterile. Orthppedic implant device.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2216-2013·2013-09-25

    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 with 1 ULTRABRAID Suture; Part Number: 72200774 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2231-2013·2013-09-25

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

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

    Product
    TWINFIX Ultra HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202626 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2217-2013·2013-09-25

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

    Smith & Nephew is recalling 1,735 Bioraptor 2.9 mm suture anchors because pinholes in the primary pouches may breach the sterile barrier.

    Product
    BIORAPTOR 2.9 mm Suture Anchor with DURABRAID" Suture; Part Number: 72200783 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2245-2013·2013-09-25

    Instrumentation Laboratory Recalls ACL TOP 700 Analyzers for Carryover Issue

    Instrumentation Laboratory is recalling 311 ACL TOP 700 analyzers due to a potential carryover issue that may cause shortened APTT clotting times.

    Product
    ACL TOP 700; PN 0000280010 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-2233-2013·2013-09-25

    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 2 ULTRABRAID Suture, White / Black: Part Number: 72202602 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2199-2013·2013-09-25

    Tornier Recalls Aequalis Reversed II and Fracture Impactors

    Tornier is voluntarily recalling Aequalis Reversed II and Fracture Impactors because the tip may separate during surgery.

    Product
    AEQUALIS Reversed II or AEQUALIS Reversed Fracture Impactor. These products are contained within the Aequalis reversed II Instrument set tray no.YKAD83 and the Aequalis reversed fracture instrument set tray no.YKAD95. The items affected are MWD21, MWD023, MWD024 and MWD025.…
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Devices)·Z-2225-2013·2013-09-25

    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 2 ULTRABRAID Suture, White / Black; Part Number: 72201996 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2221-2013·2013-09-25

    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 2 ULTRABRAID Suture, White / Blue ; Part Number: 72201995 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2232-2013·2013-09-25

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

    Smith & Nephew is recalling 708 TWINFIX Ultra HA suture anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    TWINFIX Ultra HA 6.5 mm with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202631 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide