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

16251–16275 of 39988

HighFDA (Devices)·Z-2973-2020·2020-09-23
Inpeco FlexLab Laboratory Automation System Recalled for Sample ID Errors
Inpeco S.A. is recalling FlexLab laboratory automation systems because firmware issues may cause sample ID mis-association, leading to incorrect or delayed test results.
Product
FlexLab (FLX) with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Laboratory Automation system - Product Usage: The FlexLab 3.6 Automation is a modular system designed to automate Pre-Analytical and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2974-2020·2020-09-23
Inpeco FlexLab 3.6 Automation Recalled for Potential Sample ID Mis-association
Inpeco S.A. is recalling 8 FlexLab 3.6 Automation systems because firmware issues may cause sample ID mis-association, leading to incorrect or delayed clinical chemistry results.
Product
Accelerator a3600 system with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Clinical Chemistry Test Systems - Product Usage: The FlexLab 3.6 Automation is a modular system designed to automate…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2954-2020·2020-09-23
Integra Padgett Dermatome Set Recalled Due to Cable Melting
Integra LifeSciences is recalling 13 dermatome sets because the handpiece cable melts after sterilization, posing a risk to patients and staff.
Product
Integra Padgett Dermatome Set - Product Usage: are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. These instruments are intended only for professional use in hospitals and similar medical facilities, where the patient will be…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2960-2020·2020-09-23
Terumo Ultrasonic Air Sensor Recall Due to Backwards Crimped Wire
Terumo is recalling three Ultrasonic Air Sensors because a crimped wire was installed backwards, potentially causing false air bubble alarms during extracorporeal procedures.
Product
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x1/16 UAS BLK, Catalog Number 5785 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2956-2020·2020-09-23
Novarad Recalls NovaPACS Diagnostic Viewer Software Due to Image Placement Error
Novarad Corporation is recalling NovaPACS Diagnostic Viewer software because the cross-localization feature may inaccurately place reference lines on asymmetrical images.
Product
NovaPACS Diagnostic Viewer. NovaPACS is a picture archiving and communication system software that retrieves, distributes, and display images and data from different modalities including CT, MR, US, CR/DX, NM, PT, and XA.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2978-2020·2020-09-23
Life Technologies Recalls TaqPath RT-PCR COVID-19 Kit Software
Life Technologies is recalling the TaqPath RT-PCR COVID-19 Kit due to software issues that may cause invalid, inconclusive, or false test results.
Product
The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v1.2 for 7500 RTPCR instruments, includes the assays and controls for a multiplex real-time RT-PCR test for the qualitative detection of RNA from SARS-CoV-2 in upper respiratory specimens and…
Category
Medical Device
Distribution
45 states
HighFDA (Devices)·Z-2961-2020·2020-09-23
Terumo Ultrasonic Air Sensor Recalled for Intermittent Connection Defect
Terumo is recalling two Ultrasonic Air Sensors because a manufacturing defect may cause intermittent connections and false air bubble alarms during extracorporeal procedures.
Product
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x3/32, Catalog Number 5791 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2979-2020·2020-09-23
Life Technologies Recalls TaqPath RT-PCR COVID-19 Kit Software
Life Technologies is recalling the TaqPath RT-PCR COVID-19 Kit due to software issues that may cause invalid, inconclusive, or false test results.
Product
The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v2.0 or v2.2 (used with the QuantStudio Real-Time PCR platforms), includes the assays and controls for a multiplex real-time RT-PCR test for the qualitative detection of RNA from SARS-CoV-2…
Category
Medical Device
Distribution
45 states
HighFDA (Devices)·Z-2972-2020·2020-09-23
Imactis Patient Fiducial Recalled Due to Component Separation Risk
Imactis is recalling Patient Fiducial components because they may separate from the body, potentially causing navigation inaccuracies or improper needle trajectory.
Product
Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (REF J02000/J00180)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2966-2020·2020-09-23
Randox Ammonia Reagent Recall Due to Positive Bias in Patient Samples
Randox Laboratories is recalling 143 kits of the AM1054 Ammonia reagent because it shows a positive bias of up to 140 µmol/l on patient samples.
Product
AM1054 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-2952-2020·2020-09-23
Longhorn PrimeStore Molecular Transport Medium Tubes Recalled for Cyanide Risk
Longhorn Vaccines and Diagnostic is recalling PrimeStore Molecular Transport Medium tubes because the solution may produce cyanide gas when exposed to bleach.
Product
PrimeStore Molecular Transport Medium (PS-MTM), Model Numbers LH-1-2, LH-1-3, LH-1-4, LH-1-5, LH-1-5CC, LH-1-15CC - Product Usage: intended for stabilization, transportation, and inactivation of infectious unprocessed nasal washes, nasopharyngeal, oral/throat swabs* suspected of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2955-2020·2020-09-23
Integra Padgett Electric Dermatome Set Recalled Due to Cable Melting
Integra LifeSciences is recalling 2 units of the Padgett Electric Dermatome Set because the handpiece cable melts after sterilization.
Product
Integra Padgett Electric Dermatome Set - Product Usage: are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. These instruments are intended only for professional use in hospitals and similar medical facilities, where the patient…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2963-2020·2020-09-23
Randox Lactate Dehydrogenase Reagent Recall for Carryover Avoidance
Randox Laboratories is recalling Lactate Dehydrogenase P-L reagent to address reagent carryover issues on RX instruments that may cause erroneous test results.
Product
Lactate Dehydrognease P-L, (UV), Catalog Number LD3818 - Product Usage: device intended for the quantitative in vitro determination of Lactate Dehydrogenase (LD) activity in serum and plasma. This product is suitable for use on the RX series instruments which includes the RX…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2971-2020·2020-09-23
Cook Medical Recalls Universa Soft Ureteral Stent Sets Due to Packaging Error
Cook Inc. is recalling 20 units of Universa Soft Ureteral Stent Sets because they were incorrectly placed in boxes labeled for the Firm version.
Product
Cook Medical Universa Soft Ureteral Stent Sets-5 FR 26 cm Reference part Number: UFH-526 - Product Usage: Used for temporary internal drainage from the ureteropelvic junction to the bladder
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2981-2020·2020-09-23
Roche Recalls Anti-TPO Assay Kits Due to Updated Interference Claim
Roche Diagnostics is recalling 11,870 Elecsys Anti-TPO Assay kits because internal studies found the radio frequency interference claim no longer met for specific cobas e analyzers.
Product
Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 06368590190
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2967-2020·2020-09-23
Tosoh Bioscience Recalls AIA-PACK HCG Calibrator Sets Due to Stability Issues
Tosoh Bioscience is recalling five lots of AIA-PACK HCG Calibrator Sets because decreased stability may cause measured HCG concentrations to be up to 20% lower than actual.
Product
Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for BHCG Part number 020361 The AIA-Pack BHCG Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK BHCG assay
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2958-2020·2020-09-23
Boston Scientific Recalls Mislabeled WallFlex Biliary Stent Systems
Boston Scientific is recalling 40 units of WallFlex Biliary RX stents that were mislabeled as fully covered devices. The error involves the 10mm x 60mm size.
Product
WallFlexTM Biliary RX Fully Covered Stent System RMV (10mmx60mm Stent) UPN: M00570370 - Product Usage: is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2959-2020·2020-09-23
Terumo Ultrasonic Air Sensor Recall Due to Intermittent Connection
Terumo is recalling 100 Ultrasonic Air Sensors because a manufacturing defect may cause false air bubble alarms during extracorporeal procedures.
Product
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32, Catalog Number 5773 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2968-2020·2020-09-23
Tosoh Bioscience Recalls AIA-PACK BHCG Calibration Sets Due to Stability Issues
Tosoh Bioscience is recalling 39 boxes of AIA-PACK BHCG Calibration Sets due to decreased stability that may cause inaccurate HCG concentration measurements.
Product
Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Diagnostic for BHCG-pregnancy Part number: 020661 The AIA-Pack BHCG Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK BHCG assay
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2980-2020·2020-09-23
Medtronic Guardian Connect iOS App Recall Due to Data Upload Failure
Medtronic is recalling the Guardian Connect iOS app because a software update stopped automatic data uploads to the CareLink Personal website.
Product
The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a compatible consumer mobile device.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2962-2020·2020-09-23
Randox Lactate Dehydrogenase Reagent Recalled for Carryover Avoidance Steps
Randox Laboratories is recalling Lactate Dehydrogenase reagents to update technical bulletins with additional pipette wash steps to prevent reagent carryover and erroneous test results.
Product
Lactate Dehydrogenase L-P, (LDH) (NAO), Catalog Number LD3842 - Product Usage: device intended for the quantitative in vitro determination of Lactate Dehydrogenase (LD) activity in serum and plasma. This product is suitable for use on the RX series instruments which includes the…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2977-2020·2020-09-23
Oxford Immunotec T-SPOT.TB50 Tuberculosis Test Kits Recalled for Labeling Error
Oxford Immunotec is recalling T-SPOT.TB50 tuberculosis test kits due to incorrect expiration dates on the test kit and substrate labels.
Product
Model No:T-SPOT.TB50, Catalogue No.: TB.50; UDI: 1505171600004 - Product Usage: intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection by detecting effector T cells that respond to stimulation by M. tuberculosis antigens ESAT-6 and CFP10, and…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2957-2020·2020-09-23
Maquet Rotaflow System Console Instructions for Use Recall
Maquet Cardiovascular is recalling Instructions for Use for the Rotaflow System Console because the documents reference an incorrect serial number.
Product
Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) - Product Usage: Instructions for Use - Centrifugal Pump System is a device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit Material Number: 701043292
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2976-2020·2020-09-23
Oxford Immunotec Recalls T-SPOT.TB8 Kits Due to Incorrect Expiration Dates
Oxford Immunotec is recalling 583 T-SPOT.TB8 test kits because they have incorrect expiration dates on the labeling.
Product
Model No:T-SPOT.TB8, Catalogue No.: TB.300; UDI: 1505171600030 - Product Usage: intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection by detecting effector T cells that respond to stimulation by M. tuberculosis antigens ESAT-6 and CFP10, and…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2909-2020·2020-09-16
CareFusion Alaris System PC Unit Model 8015 Recalled for Keypad Defect
CareFusion is recalling Alaris System PC Unit Model 8015 infusion pumps because fluid ingress can cause unresponsive or stuck keypad keys, potentially delaying or interrupting medication infusions.
Product
Alaris System PC Unit Model 8015
Category
Medical Device
Distribution
52 states

How to read this listing

Filters

16251–16275 of 39988