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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Minimum severity

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

Clear filters

19301–19325 of 40124

  • ModerateFDA (Devices)·Z-0052-2020·2019-10-16

    K2M Special Connector Instruments Recalled for Regulatory Filing Deficiencies

    K2M, Inc. is recalling 503 Special Connector Instruments because they were developed without adequate consideration for a new regulatory filing.

    Product
    K2M Special Connector Instruments (Special Connector, Special Adaptor, and Quick Adaptor) Product Usage: Special Connector Instruments include an additional feature on their shafts that enable surgeon users to combine them with non-K2M navigation systems as part of their…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0046-2020·2019-10-16

    Leica Biosystems Recalls Three Aperio CS2 CE IVD Scanners

    Leica Biosystems is recalling three Aperio CS2 CE IVD scanners due to incorrect sensors that may affect image quality and analysis results.

    Product
    Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0060-2020·2019-10-16

    BD Microtainer PST Tubes Recalled for Damaged Reservoirs

    Becton Dickinson is recalling BD Microtainer PST Tubes with Lithium Heparin because damaged reservoirs may cause insufficient sample volume and erroneous test results.

    Product
    BD Microtainer PST Tubewith LH (Lithium Heparin) - Amber Part/Catalog Number: 365987
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0058-2020·2019-10-16

    BD Microtainer SST- Amber Tubes Recalled for Damaged Reservoirs

    Becton Dickinson is recalling specific lots of BD Microtainer SST- Amber tubes because damaged reservoirs may cause insufficient sample volumes and erroneous test results.

    Product
    BD Microtainer SST- Amber Part/Catalog Number: 365978
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0050-2020·2019-10-16

    Baxter Recalls Exactamed Oral Dispensers Due to Mixed Sizes

    Baxter Healthcare is recalling Exactamed 5 mL Oral Dispensers because pharmacy packs may contain 3 mL dispensers, risking inaccurate dosing.

    Product
    EXACTAMED Oral Dispensers, 5mL, AMBER: (a) PHARMACY PACK, REF H9388105, x 100; (b) PHARMACY PACK, REF H9388505, x 500; (c) COST CONTAINMENT, REF H93884205, x 1500 - Product Usage: Oral Liquid Dispensers are intended for the accurate dose measurement and clean intermittent…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0053-2020·2019-10-16

    Arrow Pediatric Central Venous Catheter Kit Recalled for Labeling Error

    Arrow International Inc. is recalling 3,143 Pediatric Two-Lumen Central Venous Catheterization Kits due to a labeling error on the lidstock.

    Product
    Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, REF AK-25502 Product Usage; Provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0045-2020·2019-10-16

    Helena Laboratories Recalls SPIFE ImmunoFix-6 Kits Due to Missing Control Wells

    Helena Laboratories is recalling 24 SPIFE ImmunoFix-6 kits because the plates lack control wells in the patient 1 area.

    Product
    SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0113-2020·2019-10-16

    GE Healthcare Recalls Achilles Express Bone Sonometers Due to Power Cord Issue

    GE Healthcare is recalling 241 Achilles Express Bone Sonometers because they were shipped with power cords that do not meet local safety requirements for protective earth connection.

    Product
    Achilles Express Bone Sonometer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0109-2020·2019-10-16

    Roche Tina-quant sTfR Assay Recalled for Rheumatoid Factor Interference

    Roche Diagnostics is recalling Tina-quant Soluble Transferrin Receptor (sTfR) assays due to updated claims regarding rheumatoid factor interference.

    Product
    cobas c 701 and 702 Analyzer/Module-RF interference claims for the sTfR assay Catalog Number: 05950821190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0048-2020·2019-10-16

    Ethicon Recalls STRATAFIX Spiral Sutures Due to Strength Testing Failures

    Ethicon, Inc. is recalling 852 units of STRATAFIX Spiral PDS Plus Violet 27 sutures because they do not meet internal strength testing specifications.

    Product
    STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle Product code: SXPP1B401 suture
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-0061-2020·2019-10-16

    BD Microtainer Tubes Recalled Due to Damaged Reservoirs

    Becton Dickinson is recalling specific lots of BD Microtainer Tubes with FE Glycolytic Inhibitor because damaged reservoirs may cause insufficient sample volumes and erroneous test results.

    Product
    BD Microtainer Tubes with FE (Sodium Fluoride / Disodium EDTA) Glycolytic Inhibitor Part/Catalog Number: 365992
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0110-2020·2019-10-16

    K2M Recalls Yukon Polyaxial Screws Due to Manufacturing Error

    K2M, Inc. is recalling Yukon Polyaxial Screws because a manufacturing error may prevent them from mating with the screw inserter or set screw as intended.

    Product
    YUKON Polyaxial Screws (3.5 X 12 mm, Owning Site: Leesburg USA 3.5 X 14 mm, 3.5 X 32 mm, 3.5 X 34 mm, 3.5 X 38 mm, 3.5 X 40 mm, 4.0 X 16 mm, 4.0 X 18 mm, 4.0 X 20 mm, 4.0 X 22 mm, 4.0 X 24 mm, 4.0 X 26 mm, 4.0 X 28 mm, 4.0 X 30 mm, 5.0 X 22 mm, 5.0 X 28 mm, 5.0 X 30 mm)…
    Category
    Medical Device
    Distribution
    20 states
  • ModerateFDA (Devices)·Z-0047-2020·2019-10-16

    Ethicon Recalls STRATAFIX Spiral PDS Plus Violet Sutures

    Ethicon, Inc. is recalling 416 units of STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle sutures because the product does not meet internal strength testing specifications.

    Product
    STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle Product code: SXPP1B430 suture
    Category
    Medical Device
    Distribution
    18 states
  • CriticalFDA (Devices)·Z-2565-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters

    Medtronic Vascular is recalling 12 units of the SHERPA NX Active Guiding Catheter due to a potential for extensive loss of primary segment material, which exposes underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL1.0 110CM .070", REF SA6AL10A. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2727-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 9 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F RELAXED MOD HSII, .070", REF SA6RMHSII. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2725-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters for Material Loss

    Medtronic Vascular is recalling 16 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.0 SH, .070", REF SA6MAC30SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2660-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 409 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F 3DRIGHT, .070", REF SA63DRIGHT. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2696-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 37 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F JL6.0 SH, .070", REF SA6JL60SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2751-2019·2019-10-09

    Medtronic Recalls SHERPA NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 3 units of SHERPA NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F LCB 90CM, .070", REF SA6LCBD. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2618-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 15,603 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F JR4.0, .070", REF SA6JR40. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2682-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 62 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F MP2, .070", REF SA6MP2. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2630-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 90 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F JR4.5, .070", REF SA6JR45. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2709-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 8 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL1.5 SH, .070", REF SA6SAL15SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2715-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 57 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F JR6.0, .070", REF SA6JR60. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2603-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 55 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F, RBU3.5 SH, 100CM, 070", REF SA6RBU35SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states