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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18776–18800 of 40124

  • LowFDA (Devices)·Z-0607-2020·2019-12-11

    Theralase Laser Power Pack Recalled for Missing UDI and False CE Mark

    Theralase Inc. is recalling 306 TLC-2002 Power Packs for the TLC-2000 Therapeutic Medical Laser System because they were shipped without a Unique Device Identification (UDI) label and incorrectly labeled as CE Marked.

    Product
    TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary relief of knee pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0521-2020·2019-12-04

    Zimmer Biomet Recalls Acromium Flange Sets Due to Cleaning Issues

    Zimmer Biomet is recalling Acromium Flange Sets because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.

    Product
    ACROMIUM FLANGE SET (Custom product) Item No. PM555148 - Product Usage: Arcomium replacement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0536-2020·2019-12-04

    Helena Laboratories Recalls Platelet Aggregation Kits Due to Contamination

    Helena Laboratories is recalling Platelet Aggregation Kits because the Collagen Reagent vials may contain particulate matter or microbial growth.

    Product
    Platelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studies, Contains: 2X1 mL ADP Reagent containing adenosine diphosphate, 2X 1 mL Collagen Reagent containing collagen (equine tendon), 2 x 1 mL Epinephrine Reagent containing L-epinephrine, FOR IN-VITRO…
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-0517-2020·2019-12-04

    Zimmer Biomet Recalls 73 Calcar Trimmer Shafts for Mating Failure

    Zimmer Biomet is recalling 73 units of the ASI 2.0 Calcar Trimmer Shaft because the shaft end may fail to mate effectively with the broach.

    Product
    ASI 2.0 Calcar Trimmer Shaft for Use with Biomet¿ Rasp, Model Number 110032331
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0519-2020·2019-12-04

    Zimmer Biomet Recalls Compress Mini Compress Devices Due to Cleaning Issues

    Zimmer Biomet is recalling Compress Mini Compress devices because elevated bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.

    Product
    Compress, Mini Compress; Item Nos. 178350 178351 178352 178353 178354 178355 178356 178357 178358 178359 178360 178361 178362 178363 178364 178365 178366 178367 178368 178369 178370 178371 178372 178373 178464 178472 178480 178488 178496 178504…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0581-2020·2019-12-04

    Siemens Atellica CH 930 Analyzer Recalled for Calibration Error

    Siemens Healthcare Diagnostics is recalling 1,432 Atellica CH 930 Analyzers due to a potential calibration error that may cause results to be five times higher than expected.

    Product
    Atellica CH 930 Analyzer
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-0526-2020·2019-12-04

    Zimmer Biomet Recalls Custom Medical Devices Due to Cleaning Issues

    Zimmer Biomet is recalling various custom medical devices because elevated levels of bacterial endotoxin and residual debris remain on the products due to a cleaning issue.

    Product
    Various Custom Products, Item Nos. CP102940 CP102941 CP102942 CP102943 CP102944 CP102945 CP102946 CP102947 CP102948 CP112662 CP112663 CP112664 CP112674 CP112675 CP113771 CP113777 CP113778 CP113782 CP113783 CP114083 CP114090 CP114112 CP114118 CP114148…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0584-2020·2019-12-04

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

    GN Hearing is recalling 285 in-the-ear hearing aids because a software bug in a repair tool altered sound amplification specifications, potentially increasing gain.

    Product
    In-the-Ear hearing aids, Model Numbers: T9ITC-DW-LP, FT6ITC-D-MP, FT6ITE-D-MP, FT8CIC-MP, FT8ITC-W-HP, FT8ITC-W-LP, FT8ITC-W-MP, FT8ITE-DW-HP, FT8MIH-W-HP, FT8MIH-W-MP, LT5CIC-MP, LT5CIC-UP, LT5IIC-LP, LT5ITC-DW-MP, LT5ITC-DW-UP, LT5ITE-DW-HP, LT5ITE-DW-MP, LT5ITE-DW-UP…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0520-2020·2019-12-04

    Zimmer Biomet Recalls Shoulder Baseplates Due to Cleaning Issues

    Zimmer Biomet is recalling COMP RVRS Shoulder Baseplates because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.

    Product
    COMP RVRS Shoulder Baseplates, including Custom Products, Item numbers 115331S 115331 115330S 115330 110040610 110040620 010000589 CP561861 PM0001456 PM551047 PM551063 PM555137 PM555160 PM555209 PM555322 PM555406 PM555415 UDI…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0533-2020·2019-12-04

    Zimmer Biomet Recalls Custom Shoulder Implants Due to Cleaning Issues

    Zimmer Biomet is recalling specific custom shoulder replacement implants because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.

    Product
    BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products Item Nos. PM0000097 PM555140 PM555147 PM555319 PM555418 113867 113865 113863 Product Usage: Total Shoulder Replacement
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0528-2020·2019-12-04

    Zimmer Biomet Recalls HA Pins and Hoffman/Colles Pins Due to Cleaning Issues

    Zimmer Biomet is recalling HA Pins and Hoffman/Colles Pins because elevated bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.

    Product
    HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit) Item Nos: HAA60-09030 HAA60-09040 HAA60-10030 HAA60-10040 HAA60-11030 HAA60-11040 HAA60-11050 HAA60-12040 HAA60-12060 HAA60-13030 HAA60-13040 HAA60-13050 HAA60-13060 HAA60-13070…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0523-2020·2019-12-04

    Zimmer Biomet Recalls Hip Systems Due to Cleaning Issues

    Zimmer Biomet is recalling various hip arthroplasty systems because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.

    Product
    Various Hip systems, Item Nos. 104207 104212 104215 11-162809 11-162810 11-162811 11-162812 11-162813 21-103202 21-103203 21-103204 21-103205 21-103206 21-103207 21-103208 21-103209 21-103210 21-103211 21-103212 21-103215 21-104109 21-104110 21-104111…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0547-2020·2019-12-04

    V-Twin In Vitro Diagnostic Instruments Recalled for Sample Mismatch Risk

    Vital Scientific N.V. is recalling 732 V-Twin instruments in New York due to a risk of aspirating samples from the wrong container, which could lead to incorrect patient reports.

    Product
    V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180
    Category
    Medical Device
    Distribution
    1 state
  • 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