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.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

24101–24125 of 40299

ModerateFDA (Devices)·Z-1612-2018·2018-05-09
Roche OMNI S6 Analyzer Software Defect Recalled by FDA
Roche Diagnostics is recalling 1,026 OMNI S6 analyzers because a software defect prevents scheduled AutoQC measurements from starting.
Product
cobas b 221<6>Roche OMNI S6 system; Catalog numbers: 3337154001 and 3337154692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1589-2018·2018-05-09
Philips Allura Xper and UNIZ Systems Recalled for Monitor Freezing
Philips is recalling 682 Allura Xper and UNIZ interventional fluoroscopic x-ray systems because the large screen monitor may freeze for 15 seconds after continuous operation.
Product
Allura Xper R8.x.25.5 and UNIZ systems (only with a FlexVision large screen monitor), Interventional fluoroscopic x-ray system Product Usage: The Allura Xper ED series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging…
Category
Medical Device
Distribution
44 states
ModerateFDA (Devices)·Z-1494-2018·2018-05-09
Beijing Syntech Laser surgical lasers recalled for missing certification label
Beijing Syntech Laser Co., Ltd is recalling seven Nice Station Light Based Platform surgical lasers because the required laser safety certification label was not affixed to the product.
Product
Beijing Syntech Laser Nice Station Light Based Platform surgical lasers
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1599-2018·2018-05-09
Stryker 6381 M-1 Cot Fastener Recalled for Missing Manual Warnings
Stryker is recalling three 6381 M-1 Cot Fasteners because their manuals contain incorrect information and missing warnings.
Product
6381 M-1 Cot Fastener, catalog no. 6381000000
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1615-2018·2018-05-09
IntroMedic Recalls Miriam Capsule Endoscope System Due to Battery Indicator Error
IntroMedic Co., Ltd. is recalling 82 units of the Miriam Capsule Endoscope System because the battery indicator may incorrectly display orange when the battery is fully charged.
Product
Miriam Capsule Endoscope System. Model MR1100 Product Usage: MiroCam Capsule Endoscope System is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1544-2018·2018-05-09
BD MAX DNA MMK Recalled for Incorrect Package Insert Volume Instructions
Becton Dickinson is recalling BD MAX DNA MMK (SPC) because the package insert lists the wrong volume of diluent, which could affect assay results.
Product
BD MAX DNA MMK (SPC) For Laboratory Use, catalog no. 442829
Category
Medical Device
Distribution
8 states
LowFDA (Devices)·Z-1542-2018·2018-05-09
Ameditech Recalls Alere iScreen Dx Urine Drug Screen Cards for Labeling Error
Ameditech is recalling Alere iScreen Dx Urine Drug Screen Cards because the box label incorrectly lists Phencyclidine (PCP) instead of Tricyclic Antidepressants (TCA).
Product
Alere iScreen Dx Urine Drug Screen Card
Category
Medical Device
Distribution
9 states
LowFDA (Devices)·Z-1488-2018·2018-05-09
Beijing Syntech Laser Diode Surgical Lasers Recalled for Missing Certification Label
Beijing Syntech Laser Co., Ltd is recalling 13 Diode Laser surgical lasers because the required certification label was not affixed to the products.
Product
Beijing Syntech Laser Diode Laser surgical lasers
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-1490-2018·2018-05-09
Beijing Syntech Laser Trixel 11 CO2 Laser Recalled for Missing Label
Beijing Syntech Laser Co., Ltd is recalling three Trixel 11 CO2 surgical lasers because the required certification label was not affixed to the products.
Product
Beijing Syntech Laser Trixel 11 C02 Laser surgical lasers
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1532-2018·2018-05-02
BD Vacutainer Push Button Blood Collection Set Recalled for Sterility Issues
Becton Dickinson is recalling BD Vacutainer Push Button Blood Collection Sets because they do not meet the labeled sterility assurance level.
Product
BD Vacutainer¿ Push Button Blood Collection Set 0.8 x 19 mm x 305 mm 21G x ¿ x 12 Catalog 367344
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1477-2018·2018-05-02
Ion Beam Applications Recalls Proteus Proton Beam Therapy Systems
Ion Beam Applications is recalling five Proteus proton beam therapy systems because a software error may cause under-irradiation or additional X-ray exposure.
Product
Proteus 235, ProteusPLUS or Proteus ONE produces and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1531-2018·2018-05-02
BD Vacutainer Push Button Blood Collection Set Recalled for Sterility Failure
Becton Dickinson & Company is recalling BD Vacutainer Push Button Blood Collection Sets because they do not meet the labeled sterility assurance level.
Product
BD Vacutainer¿ Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x ¿ x 12 (Catalog no 367342)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1505-2018·2018-05-02
Stryker T4 Zipper Toga sterile garments recalled for layer separation
Stryker is recalling T4 Zipper Toga sterile personal protection garments because material layers may separate, creating a risk of exposure to contaminants.
Product
T4 Zipper Toga (S/M); Catalog Number: 0400-810-000 Sterile personal protection garment
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1471-2018·2018-05-02
Zimmer Biomet Recalls Pressure Sentinel Guide Wires Due to Sterile Seal Failure
Zimmer Biomet is recalling 19,483 Pressure Sentinel Intramedullary Reaming System Guide Wires because the sterile packaging seal may fail, potentially compromising sterility.
Product
Pressure Sentinel Intramedullary Reaming System Guide Wire Bullet Tip 2.4 mm Diameter; Item Number: 00-2228-024-00
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1472-2018·2018-05-02
Zimmer Biomet Recalls Natural Nail System Guide Wires Due to Sterile Seal Failure
Zimmer Biomet is recalling 19,483 Natural Nail System Tear Drop Guide Wires because the sterile packaging seal may fail, potentially compromising sterility.
Product
Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 100 cm Length; Diameter; Item Number: 47-2490-097-01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1487-2018·2018-05-02
Integra LifeSciences Recalls TCC-EZ Total Contact Cast System
Integra LifeSciences is recalling 250 units of the TCC-EZ Total Contact Cast System because a quarantined lot may produce excessive heat.
Product
TCC-EZ, Total Contact Cast System, Model No. TCC2-4051
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1523-2018·2018-05-02
Sofradim Versatex Monofilament Mesh Recalled for Hernia Recurrence Reports
Sofradim Production is recalling Versatex Monofilament Mesh due to patient reports of abdominal hernia recurrence following repair. The firm has updated instructions to warn surgeons about risks in specific procedures.
Product
Versatex Monofilament Mesh 50 x 50cm, Product No. VTX5050M The device is made out of a macroporous three-dimensional monofilament polyester textile. Its intended use is for the repair of abdominal wall hernias or other fascial deficiencies that require the addition of a…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1507-2018·2018-05-02
Stryker T5 Zipper Toga Sterile Garment Recall for Layer Separation
Stryker is recalling T5 Zipper Toga sterile garments because material layers may separate, posing a risk of exposure to contaminants.
Product
T5 Zipper Toga with Peel-Away Face Shield, (L/XL); Catalog number: 0400-820-100 Sterile personal protection garment
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1500-2018·2018-05-02
Stryker T4 Pullover Toga Recalled for Potential Material Separation
Stryker is recalling T4 Pullover Toga sterile garments because material layers may separate, posing a risk of exposure to contaminants.
Product
T4 Pullover Toga, (S/M); Catalog Number: 0400-710-000 Sterile personal protection garment
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1510-2018·2018-05-02
Stryker T5 Zipper Toga Sterile Garment Recall for Layer Separation
Stryker is recalling T5 Zipper Toga sterile garments because material layers may separate, posing a risk of exposure to contaminants.
Product
T5 Zipper Toga with Peel-Away Face Shield, (XL/T); Catalog number: 0400-850-100 Sterile personal protection garment
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1476-2018·2018-05-02
Zimmer Biomet Recalls ZMS Intramedullary Fixation Smooth Guide Wires
Zimmer Biomet is recalling ZMS Intramedullary Fixation Smooth Guide Wires due to potential failure of the sterile packaging seal.
Product
ZMS Intramedullary Fixation Smooth Guide Wire Bullet Tip 3.0 mm Diameter, 100 cm Length; Item Number: 47-2237-038-00
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1468-2018·2018-05-02
Zimmer Biomet Recalls Natural Nail System Tear Drop Guide Wires
Zimmer Biomet is recalling 19,483 Natural Nail System Tear Drop Guide Wires due to a potential failure of the sterile packaging seal.
Product
Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 70 cm length; Item Number: 47-2490-098-01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1528-2018·2018-05-02
EEA Hemorrhoid Stapler Recalled for Potential Welding Defect
FDA is recalling EEA Hemorrhoid and Prolapse Stapler Sets due to a potential welding defect that could cause bleeding or anastomotic leak.
Product
EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 4.8MM, Product Number HEM3348, GTIN Number 1 - 10884521047563, GTIN Number 2 - 20884521047560 Product Usage: The EEA Hemorrhoid and prolapse stapler set with DST Series Technology (instrument) is designed…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1465-2018·2018-05-02
Zimmer Biomet Recalls Humeral Guide Wires Due to Packaging Seal Failure
Zimmer Biomet is recalling 19,483 M/DN Intramedullary Fixation Humeral Guide Wires because the sterile packaging seal may fail, potentially compromising sterility.
Product
M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 cm Length Single Use Only; Item Number: 00-2255-025-00
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1513-2018·2018-05-02
BioFire FilmArray BCID Panel Recalled for False Positive Proteus Results
BioFire Diagnostics is recalling the FilmArray BCID Panel because it may produce false positive Proteus results when used with specific BD BACTEC blood culture bottles.
Product
FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RFIT-ASY-0126 (30 test kit) and RFIT-ASY-0127 (6 test kit), when used with all lots of BD BACTEC Blood Culture Bottles, Catalog numbers 442020, 442021, 442023, 442192, 442265, 442194, 442022, 442193…
Category
Medical Device
Distribution
Distributed nationwide

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24101–24125 of 40299