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

15726–15750 of 39988

LowFDA (Devices)·Z-0471-2021·2020-11-25
Ortho VITROS Chemistry Performance Verifier II Recalled for Product Instability
Ortho Clinical Diagnostics is recalling VITROS Chemistry Products Performance Verifier II due to product instability that causes biased ALKP values.
Product
VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0401-2021·2020-11-25
Merz Recalls COAPTITE Injectable Implant Due to Documentation Mismatch
Merz North America is recalling 2,051 units of COAPTITE Injectable Implant because the Instructions for Use do not match post-approval study data.
Product
COAPTITE Injectable Implant, injectable, sterile, non-pyrogenic implant composed of spherical particles (75-125 microns in diameter of calcium hydroxylapatite (CaHA), suspended in aqueous based gel carrier. Gel carrier is composed of sodium carboxymethylcellulose, sterile water…
Category
Medical Device
Distribution
48 states
LowFDA (Devices)·Z-0470-2021·2020-11-25
Micro-Tech Elastic Traction Device Recalled for Regulatory Classification Issues
Micro-Tech USA is recalling Elastic Traction Devices because they are not appropriately classified as Class I and require 510(k) clearance.
Product
Elastic Traction Device, 11mm Lower. UPN: ER56041 Reference Number: ETD-D-26-235-C-N - Product Usage: indicated for use in flexible Endoscopy to provide retraction to assist in tissue resection, exposure, and removal of tissue within the gastrointestinal tract.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0425-2021·2020-11-18
Puritan Bennett 980 Ventilator Recalled for Battery Overheating Risk
Covidien is recalling Puritan Bennett 980 ventilators due to battery overheating and thermal damage risks that could cause burns or smoke exposure.
Product
Puritan Bennett 980 (PB980) Ventilator Series - Product Usage: for use on patient population sizes from Neonatal (NICU) through Adult who require respiratory support or mechanical ventilation SKU: 980X1ENDIUU 980X1ENDIUU 980X3FRAIQC 980X3DEDRAC 980X3ENNISB 980X3NLDRAC…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0430-2021·2020-11-18
Stereotaxis Niobe ES System Recalled for Potential Fire Hazard
Stereotaxis Inc is recalling 121 Niobe ES Systems due to a potential fire risk in the internal computer cabinet.
Product
Niobe ES System, Models 001-006000-1 and 001-006100-1
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0431-2021·2020-11-18
Stryker Recalls Cranial Perforators Due to Potential Metal Fragment Risk
Stryker is recalling Zyphr Disposable Cranial Perforators because a crack in the inner bit could release metal fragments into the surgical site or cause delayed disengagement.
Product
Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use cutting accessory intended for cutting an 11 mm diameter access hole through the cranium of adult patients. Catalog Number: 5100-060-001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0439-2021·2020-11-18
Fresenius Liberty Select Cycler Software Recall for Inadequate Dialysis Risk
Fresenius Medical Care is recalling Liberty Select Cycler devices with software version 2.9.0 because a software error may cause the device to fail to recognize extra fluid, potentially leading to inadequate dialysis.
Product
Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0446-2021·2020-11-18
United Imaging uCT 550 CT Scanners Recalled for Timer Display Error
Shanghai United Imaging Healthcare is recalling five uCT 550 CT scanners because an incorrect delay timer display may expose operators to unnecessary radiation.
Product
Computed Tomography X-Ray System, Model uCT 550, Rx, CE, GTIN: 06971576831036 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0445-2021·2020-11-18
United Imaging uCT 530 CT Scanner Recalled for Incorrect Timer Display
Shanghai United Imaging Healthcare Co., Ltd. is recalling four uCT 530 CT scanners because an incorrect delay timer may display, potentially exposing operators to unnecessary radiation.
Product
Computed Tomography X-Ray System, Model uCT 530, Rx, CE, GTIN: 06971576831012 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0427-2021·2020-11-18
Boston Scientific AMS 700 MS Pump Recall for Activation Difficulties
Boston Scientific is recalling AMS 700 MS Pumps due to reports of difficulty activating the device to inflate cylinders.
Product
AMS 700 MS Pump with and without InhibiZone, sold as individual units and also pre-connected to AMS 700 cylinders. Inflatable Penile Prosthesis
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0447-2021·2020-11-18
United Imaging uCT 760 CT Scanner Recalled for Timer Display Error
Shanghai United Imaging Healthcare is recalling five uCT 760 CT scanners because a display error may cause operators to receive unnecessary radiation exposure.
Product
Computed Tomography X-Ray System, Model uCT 760, Rx, CE, GTIN: 06971576831043 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0428-2021·2020-11-18
Quidel SARS Antigen Test Kits Recalled for False Positive Results
Quidel is recalling 8,628 SARS Antigen FIA test kits due to false positive results. The affected units were distributed to 24 U.S. states.
Product
QUIDEL Sofia SARS Antigen FIA IVD REF 20374
Category
Medical Device
Distribution
23 states
HighFDA (Devices)·Z-0448-2021·2020-11-18
United Imaging uMI 550 PET/CT System Recalled for Incorrect CT Scan Delay Timer
Shanghai United Imaging Healthcare is recalling nine uMI 550 PET/CT systems because an incorrect CT scan delay timer may display, potentially exposing operators to unnecessary radiation.
Product
Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN: 06971576832026 - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0432-2021·2020-11-18
Inpeco FlexLab Automation System Recalled for Potential Sample Dilution
Inpeco S.A. is recalling 93 FlexLab Automation Systems with Aliquoter Modules because a software error may cause samples to be diluted with water, leading to erroneous test results.
Product
FlexLab (FLX) Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0443-2021·2020-11-18
Maquet BMU 40 Blood Monitoring Units Recalled for Electrical Safety Non-Compliance
Maquet Cardiovascular is recalling 51 Blood Monitoring Units (BMU 40) because the printed circuit boards do not meet IEC electrical safety standards for creepage distance.
Product
Blood Monitoring Unit (BMU 40), model no. 701040852 - Product Usage: is to monitor blood parameters during cardiopulmonary bypass (CPB) or similar procedures with extracorporeal circulation, which require continuous monitoring of the arterial and/or venous blood parameters…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0434-2021·2020-11-18
Inpeco Aptio Automation System Recall for Potential Sample Dilution
Inpeco S.A. is recalling 104 Aptio Automation Systems with Aliquoter Modules because a software error may cause samples to be diluted with water, leading to erroneous test results.
Product
Aptio Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0433-2021·2020-11-18
Inpeco Accelerator a3600 Aliquoter Module Recall for Sample Dilution Risk
Inpeco S.A. is recalling 136 Accelerator a3600 Automation Systems with Aliquoter Modules due to a software error that may dilute samples with water, leading to erroneous test results.
Product
Accelerator a3600 Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0444-2021·2020-11-18
Aesthetics Biomedical Recalls Vivace Electrosurgical System for Regulatory Violation
Aesthetics Biomedical is recalling 623 Vivace Electrosurgical Systems because a high-frequency output was not cleared for U.S. distribution.
Product
SUNG HWAN E&B VIVACE Shenb Innovation of Beauty Technologyt - Product Usage: intended for use in the dermatologic and surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0438-2021·2020-11-18
Merete Medical Recalls OsteoBridge Humerus Nails Due to Mislabeled Product
Merete Medical GmbH is recalling 144 units of OsteoBridge Intramedullary Diaphysis Segment Fixation nails for the humerus because the product may be mislabeled.
Product
OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (humerus)
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-0435-2021·2020-11-18
Merete Medical Recalls OsteoBridge Knee Arthrodesis Nails for Mislabeled Product
Merete Medical GmbH is recalling 306 units of OsteoBridge Intremedullary Knee Arthrodesis nails because the product may be mislabeled.
Product
OsteoBridge Intremedullary Knee Arthrodesis (IKA) nails
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-0436-2021·2020-11-18
Merete Medical Recalls OsteoBridge Femoral Nails Due to Labeling Errors
Merete Medical GmbH is recalling 354 OsteoBridge Intramedullary Diaphysis Segment Fixation nails for the femur because the product may be mislabeled.
Product
OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (femur)
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-0437-2021·2020-11-18
Merete Medical Recalls Tibia Nails Due to Potential Mislabeling
Merete Medical GmbH is recalling 215 OsteoBridge Intramedullary Diaphysis Segment Fixation nails for the tibia because the product may be mislabeled.
Product
OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (tibia)
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-0426-2021·2020-11-18
Epitope Diagnostics Recalls COVID-19 IgG ELISA Kits Due to Water Use
Epitope Diagnostics is recalling 2,886 units of its Novel Coronavirus COVID-19 IgG ELISA Kit because deionized water was used instead of distilled water during manufacturing.
Product
EDI Novel Coronavirus COVID-19 IgG ELISA Kit, REF: KT-1032 Per label: This kit is intended for qualitative detection of human anti-COVID-19 IgG antibody in human serum. This kit is to be used as an aid for the detection of novel COVID-19. Patients with suspected clustering…
Category
Medical Device
Distribution
20 states
LowFDA (Devices)·Z-0429-2021·2020-11-18
XTANT Medical Recalls Cervical Implants Due to Incorrect Titanium Grade Labeling
XTANT Medical is recalling 508 units of cervical implants because the labels incorrectly identify the grade of titanium used in the devices.
Product
XTANT Medical, ## mm x ## mm x # mm x # ,Lordotic/Packaged InTice - C, Sterile R, Single Use Only, for the following Reference numbers/ Primary DI Number/Material Grade on Label: Ref: X098-0106-STR DI Number: M697X0980106STR1 Mat.: CP Ti Grade 3, Ref: X098-0107-STR DI…
Category
Medical Device
Distribution
5 states
LowFDA (Devices)·Z-0441-2021·2020-11-18
Hardy Diagnostics Recalls Strep B Carrot Broth Due to Incorrect Expiration Date
Hardy Diagnostics is recalling Strep B Carrot Broth One-Step units because the outer box displays an incorrect expiration date of 2021-11-10 instead of 2020-11-10.
Product
Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499
Category
Medical Device
Distribution
22 states

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15726–15750 of 39988