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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14651–14675 of 27500

  • HighFDA (Devices)·Z-0522-2020·2019-12-04

    Zimmer Biomet Recalls Hennessy Left Constrained Glenoid Shoulder Implants

    Zimmer Biomet is recalling Hennessy Left Constrained Glenoid Humeral Shoulder Implants due to elevated bacterial endotoxin and residual debris caused by a cleaning issue.

    Product
    HENNESSY LEFT CONST GLENOID HA, Item No. PM555360 UDI (01)00880304819597(17)260425(10)664030 Product Usage: Constrained Shoulder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0531-2020·2019-12-04

    Zimmer Biomet Recalls Guide Wires Due to Bacterial Endotoxin and Debris

    Zimmer Biomet is recalling 2.0mm Ball Nose Guide Wires because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.

    Product
    2.0MM BALL NOSE GUIDE WIRE, Item Nos. 281017006 - Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0530-2020·2019-12-04

    Zimmer Biomet Recalls Ball Nose Guide Wires Due to Cleaning Issues

    Zimmer Biomet is recalling Ball Nose Guide Wires because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.

    Product
    BALL NOSE GUIDE WIRE 80CM, 100CM. Item Nos. 281001080 281001100 Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0580-2020·2019-12-04

    Boston Scientific Recalls Rebel Monorail Coronary Stent Systems

    Boston Scientific is recalling 14,145 Rebel Monorail PtCr Coronary Stent Systems because they may be missing a hydrophilic coating step.

    Product
    Rebel Monorail PtCr Coronary Stent System, REF / Catalog No. H7493927324300, Rebel MR OUS 3.0mm x 24mm. The Rebel Monorail (MR) Stent System is a balloon expandable Platinum Chromium (PtCr) Alloy stent pre-mounted on a Monorail Catheter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0583-2020·2019-12-04

    GN Hearing Recalls Behind-the-Ear Hearing Aids Due to Software Bug

    GN Hearing is recalling 590 behind-the-Ear hearing aids because a software bug in a repair tool altered sound amplification specifications, potentially increasing gain.

    Product
    Behind-the-Ear hearing aids, Model Numbers: Q962-DRW, T561-DRW, T562-DRW, T762-DRW, T777-DW, AMZ964-DRW, ET588-DWH, ET598-DW, ET788-DWH, ET798-DW, ET988-DWH, ET998-DW, FT861-DRW, FT862-DRW, RE561-DRWC, RE762-DRW, RE961-DRWC, RE962-DRW, PZ862-DRW, LT561-DRW, LT561-DRWZ…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0524-2020·2019-12-04

    Zimmer Biomet Recalls HHR Tess Cleats Due to Bacterial Endotoxin

    Zimmer Biomet is recalling Comprehensive HHR Tess Cleats because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.

    Product
    Comprehensive HHR Tess Cleat, Item Nos. 110260 110261 110262 110263 Product Usage: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0516-2020·2019-12-04

    Beckman Coulter Recalls UniCel DxH Slidemaker Stainer Devices Due to Bent Probe Risk

    Beckman Coulter is recalling UniCel DxH Slidemaker Stainer devices because a bent dispense probe may cause cell carryover, leading to erroneous lab results and potential inappropriate patient treatment.

    Product
    UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II (DxH SMS II) - Product Usage: The intended use is as follows: The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0575-2020·2019-12-04

    Abbott Recalls Alinity c Carbon Dioxide Reagent Kits Due to CO2 Absorption

    Abbott is recalling Alinity c Carbon Dioxide Reagent Kits because atmospheric carbon dioxide can be absorbed into the reagent, potentially causing incorrect test results.

    Product
    Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I. Inc. Prince Edward Island Canada
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0542-2020·2019-12-04

    Endotronix Recalls myCordella Patient Kits for Unexpected Power-Downs

    Endotronix is recalling 58 myCordella Patient Kits because the devices have been reported to power down without user interaction.

    Product
    myCordella Patient Kit without ECG, The Cordella System is a comprehensive at-home heart failure management platform that provides the clinician tools to monitor the progression of heart failure.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0525-2020·2019-12-04

    Zimmer Biomet Recalls Comprehensive RS Cleat CAP Due to Contamination

    Zimmer Biomet is recalling Comprehensive RS Cleat CAP devices because elevated levels of bacterial endotoxin and residual debris remain on the products due to a cleaning issue.

    Product
    Comprehensive RS Cleat CAP, Item No. 110300
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0527-2020·2019-12-04

    Zimmer Biomet Recalls Copeland HA Resurfacing Heads Due to Cleaning Issues

    Zimmer Biomet is recalling Copeland HA Resurfacing Heads because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.

    Product
    Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0529-2020·2019-12-04

    Zimmer Biomet Recalls Guide Wires Due to Bacterial Endotoxin and Debris

    Zimmer Biomet is recalling specific Aim/Art Guide Wires because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.

    Product
    GUIDE WIRE 2.2MM X 28IN, Aim/Art Guide wire, Item No. 809222028 - Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0577-2020·2019-12-04

    Boston Scientific Recalls Emerge Monorail PTCA Catheters Due to Coating Defect

    Boston Scientific is recalling Emerge Monorail PTCA Dilatation Catheters because they may lack a required hydrophilic coating. The recall covers 14,145 devices distributed nationwide and in Canada.

    Product
    Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493919308200 EMERGE MR, OUS 2.00mm X 8mm; 2. REF/Catalog No. H7493918912200, EMERGE MR US 2.00MM X 12MM; 3. REF/Catalog No.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0518-2020·2019-12-04

    Becton Dickinson Recalls Site~Rite 8 Ultrasound Systems Due to Battery Indicator Defect

    Becton Dickinson is recalling 2,215 Site~Rite 8 Ultrasound Systems because the battery indicator may falsely show charge, causing abrupt shutdowns without warning.

    Product
    Site~Rite 8 Ultrasound Systems-intended for diagnostic ultrasound imaging of the human body. Site~Rite 8 Ultrasound System, Catalog No.9770500 Refurbished, Site~Rite¿ 8 System, Catalog No.9770500R Site~Rite 8 Ultrasound System, Catalog No.9770501 Refurbished Site~Rite¿ 8…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0532-2020·2019-12-04

    Zimmer Biomet Recalls Total Elbow Replacement Devices Due to Cleaning Issues

    Zimmer Biomet is recalling specific total elbow replacement devices because elevated levels of bacterial endotoxin and residual debris remain on them due to a cleaning issue.

    Product
    LT DISC ULNA - HA/PC; RT DISC ULNA - HA/PC; LT DISC HMRL- HA/PC; RT DISC HMRL- HA/PC; DISC XS ULNA POR; DISC SEG ULNA POR; and Custom devices Item Nos. 114754 114755 114744 114745 114704 114705 114756 114757 114714 114715 114746 114747 114706 114707…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0456-2020·2019-11-27

    CVS Health Lubricating Gel Drops Recalled for Sterility Assurance Issues

    Altaire Pharmaceuticals is recalling CVS Health Lubricating Gel Drops due to a lack of assurance of sterility. Consumers should stop using the product and return it to the pharmacy.

    Product
    CVS Health Lubricating Gel Drops for Anytime Use, Item#: 563420, Product Size: 10 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0479-2020·2019-11-27

    Altaire Recalls Nano Tears Lubricant Gel Drops Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling specific lots of Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops because the agency could not ensure the product was sterile.

    Product
    Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops, Twin Pack 2 x 10 mL, Mfd. by: Altaire Pharmaceuticals, Inc., Aquebogue, NY 11931, NDC 59390-144-51
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0420-2020·2019-11-27

    Edwards Lifesciences Recalls EZ Glide Aortic Cannula Due to Connector Separation Risk

    Edwards Lifesciences is recalling EZ Glide Aortic Cannulae because the cannula may separate from its connector, potentially causing significant blood loss during surgery.

    Product
    EZ Glide Aortic Cannula, 24 Fr. (8.0mm) x 37.6 cm (14.8") 3/8" (9.5 mm) vented connector , RX Only, Sterile EC, Made in Mexico, UDI: 00690103172119 for the following REF #s (UDI): EZC21A (00690103174182), EZC21TA (00690103174199), EZC24A (00690103714401), EZC24TA…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0498-2020·2019-11-27

    Philips HeartStart XL+ Defibrillator Recall Due to Switch Failure

    Philips is recalling HeartStart XL+ Defibrillators because a faulty switch may cause the device to fail or deliver incorrect shock energy.

    Product
    HeartStart XL+ Defibrillator/Monitor, Model 861290
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0454-2020·2019-11-27

    CVS Health Lubricant Gel Drops Recalled for Sterility Assurance Issues

    Altaire Pharmaceuticals is recalling CVS Health Extra Strength Lubricant Gel Drops due to a lack of assurance of sterility.

    Product
    CVS Health Extra Strength Lubricant Gel Drops Twin Pack, Item#: 258587, Product Size: 2 x 15 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0472-2020·2019-11-27

    Altaire Recalls Nano Tears Lubricant Gel Drops Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops because the product lacks assurance of sterility.

    Product
    Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops Twin Pack, Product Size: 2 x 10 mL, NDC 59390-144-51
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0510-2020·2019-11-27

    Applied Medical Recalls GelPOINT Path Transanal Procedural Packs Due to Insulation Shift

    Applied Medical Resources Corp is recalling GelPOINT Path Transanal Procedural Packs because the tip insulation on the electrosurgical probes may shift unintentionally.

    Product
    GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with Smoke Evacuation, 4x5.5cm and 5mm x 42cm REF TA211 Product Usage: The GelPOINT Path Transanal Access Platform is indicated for multiple instrument or camera access through the anus to perform…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0489-2020·2019-11-27

    Cook Torcon NB Advantage Catheters Recalled for Potential Sterility Compromise

    Cook Inc. is recalling Torcon NB Advantage Catheters due to potential sterility compromise from undersealed packaging pouches.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide