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 deaths or serious injuries are reported, 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

12751–12775 of 13802

ModerateFDA (Devices)·Z-0149-2022·2021-10-27
Heparin Activity Assay Labeling Correction: Reduced On-Board Stability
Instrumentation Laboratory is recalling HemosIL Liquid Anti-Xa kits due to a labeling correction. The on-board stability window has been reduced from 7 to 5 days.
Product
HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems, (ACL TOP¿ Family, ACL TOP Family 50 Seriest and ACL Elite¿/E
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0126-2022·2021-10-27
Plastic Tenaculum Surgical Instruments Recalled for Unconfirmed Manufacturing Standards
Stradis Medical is recalling plastic tenaculum surgical instruments because the manufacturer cannot confirm they were produced in accordance with required design and manufacturing standards. Approximately 2,483 kits were distributed nationwide and to Canada.
Product
Tenaculum, Plastic
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0120-2022·2021-10-27
Diagnostic Control Material Outside Expected Range, Potential for Delayed Results
Ortho Clinical Diagnostics is recalling VITROS Anti-SARS-CoV-2 Immunodiagnostic Controls that may be outside the expected control range, potentially delaying diagnostic test results in laboratory systems.
Product
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD)- For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used with the VITROS Immunodiagnostic Products Anti-SA
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0151-2022·2021-10-27
HemosIL Liquid Anti-Xa Assay On-Board Stability Issue Recall
Instrumentation Laboratory is recalling HemosIL Liquid Anti-Xa, a coagulation assay measuring heparin activity, due to reduced on-board instrument stability from 7 days to 5 days.
Product
HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems, (ACLTOP¿ Family, ACL TOP Family 50 Seriest and ACL Elite¿/E
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0007-2022·2021-10-20
Abbott Alinity m SARS-CoV-2 Test Kit Recalled for Potential False Positives
Abbott Molecular recalls its Alinity m SARS-CoV-2 Amp Kit (Non-US Assay), an in vitro diagnostic test, due to potential for false positive results. Approximately 11,408 units were distributed worldwide.
Product
Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0090-2022·2021-10-20
FDA Recalls Ultrasound Gel for Possible Bacterial Contamination
Red Medical Supplies is recalling EcoGel 100 ultrasound gel due to possible bacterial contamination. Approximately 639 units were sold nationwide through Amazon.com.
Product
EcoGel 100 - RED Medical Supplies Green Ultrasound Gel, Model No. 250UG-GLU
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0068-2022·2021-10-20
Ultrasound gel products recalled for potential bacterial contamination
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. Products distributed nationwide in the U.S., Canada, and other locations have been recalled.
Product
ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser Btl
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0008-2022·2021-10-20
Abbott Respiratory Diagnostic Kit Recalled for Potential False Positive Results
Abbott Molecular is recalling the Alinity m Resp-4-Plex AMP Kit due to potential false positive results. The recall affects 5,855 units distributed worldwide.
Product
Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0067-2022·2021-10-20
FDA Recalls Ultrasound Gels and Lotions for Potential Bacterial Contamination
Ultrasound gels and lotions from National Distribution & Contracting Inc are being recalled due to potential bacterial contamination. About 25,103 units distributed nationwide and in Canada are affected.
Product
ECO 85CB Lotion Ultrasound 8.5 oz 24/cs ECO 40JBC Gel Ultrasound Transmission Clr 8.5 oz BTL 24/cs ECO 40JMC Gel Ultrasound Transmission Clr 5L 4/cs NDC P301008 ProAdvantage Gel Ultrasound Transmission 8.5 oz 12/cs NDC P301105 ProAdvantage Gel Ultrasound Transmission 5 Liter
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0004-2022·2021-10-20
Abbott SARS-CoV-2 Diagnostic Kit Recalled for Risk of False Positive Results
Abbott Molecular is recalling 60,563 units of the Alinity m SARS-CoV-2 Amp Kit due to potential false positive test results. The affected kits were distributed worldwide from September 2021 through January 2023.
Product
Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0006-2022·2021-10-20
Abbott Alinity m SARS-CoV-2 Amp Kit Recalled for Potential False Positive Results
Abbott Molecular has recalled 71,314 units of the Alinity m SARS-CoV-2 Amp Kit due to potential false positive results. The kit was distributed worldwide.
Product
Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0088-2022·2021-10-20
Eco-Med Ultrasound Gel Recalled for Bacterial Contamination Risk
Eco-Med Pharmaceutical's ultrasound gel products are recalled due to potential bacterial contamination. The FDA advises healthcare providers to stop using the affected product.
Product
EcoGel 200 - RED Medical Supplies Blue Ultrasound Gel, Model No. 250UG-BMU
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0005-2022·2021-10-20
Abbott Alinity m Resp-4-Plex Respiratory Diagnostic Kit Recalled for False Positive Results
Abbott is recalling the Alinity m Resp-4-Plex AMP Kit, an in vitro diagnostic used for respiratory pathogen testing, due to potential for false positive results affecting approximately 8,469 units distributed worldwide.
Product
Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0089-2022·2021-10-20
FDA recalls Eco-Med ultrasound gels due to bacterial contamination risk
FDA recalls ultrasound gels manufactured by Eco-Med Pharmaceutical due to possible bacterial contamination. Healthcare providers and facilities should stop use immediately.
Product
EcoGel 200 - RED Medical Supplies Clear Ultrasound Gel, Model No. 250UG-CMU
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0110-2022·2021-10-20
United Orthopedics USTAR II knee implant component recalled for specification failures
Uoc Usa Inc recalls 3 United Orthopedics USTAR II knee components that fail to meet manufacturing specifications for concentricity and dynamic fatigue testing. These defects could affect implant performance.
Product
United Orthopedics USTAR II Knee System USTAR II Knee System Segment Part, RHS, 25 mm Length, Catalog # 2915-1025
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0100-2022·2021-10-20
Smiths Medical Antishunt Sets Recalled Due to Pressure and Reading Errors
Smiths Medical ASD Inc. is recalling approximately 20,800 Antishunt blood sampling sets due to reported pressure shifts and incorrect pressure readings. The affected model was distributed in Austria, France, Germany, Great Britain, and Saudi Arabia.
Product
smiths medical medex CBSS-5ML Antishunt set, (172/15cm), Model Number DPSHC0091
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0078-2022·2021-10-20
Philips HeartStart Defibrillator Recall: Previous Recall Notifications Not Sent
Philips HeartStart FR2+ Defibrillators (models M3860A and M3861A) were not accompanied by notifications about previous recalls. Affected customers should contact Philips for information about prior safety issues.
Product
Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A
Category
Medical Device
Distribution
12 states
HighFDA (Devices)·Z-0104-2022·2021-10-20
K2M Surgical Removal Tool Recalled for Missing Pins
K2M, Inc. is recalling 23 units of the Chesapeake Anterior Lumbar Removal Tool because units may arrive with missing pins or in disassembled condition. Pins could dislodge during surgery and enter the surgical cavity, requiring intraoperative removal or revision surgery.
Product
Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-0105-2022·2021-10-20
Thoraguard Chest Tube Kit 20 Fr Recalled for Adhesive Joint Failure
Centese Inc. is recalling Thoraguard Chest Tube Kits (20 Fr) because an adhesive joint in the SmartValve component can fail, causing fluid to leak. The affected kits were distributed to a single facility in California.
Product
Thoraguard Chest Tube Kit, 20 Fr
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0109-2022·2021-10-20
Babylog VN500 Ventilator Firmware Defect May Cause Brief Ventilation Interruption
A software defect in the Babylog VN500 Ventilator may cause it to restart, interrupting ventilation and losing PEEP for about 8 seconds. The issue affects 2,169 units distributed nationwide.
Product
Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the ventilation of neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight. Catalog Number: 8417400
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0117-2022·2021-10-20
Beckman Coulter Power Processor 3K Recalled for Missing Splash Guard
Beckman Coulter is recalling Power Processor 3K laboratory equipment due to a missing splash guard that may expose users to hazardous materials. Approximately 271 units were distributed in the U.S. and internationally.
Product
Power Processor 3K, 3K High Speed Stockyards Module Nameplate: PP 3K Stockyard (Refrig) 9707 REF A88116
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0096-2022·2021-10-20
Smiths Medical LogiCal Blood Sampling Sets Recalled for Pressure Reading Errors
Smiths Medical ASD Inc. is recalling 870 units of LogiCal blood sampling sets distributed across Europe and Saudi Arabia due to reported pressure shifts and incorrect pressure readings.
Product
smiths medical medex CBSS 5 ml, dreifach proximaler Entnahmeport 60 cm, Model number DPSHC0082
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0108-2022·2021-10-20
Evita V500 Ventilator Software Defect May Cause Temporary Ventilation Loss
Draeger's Evita V500 ventilator software version 2.51 and lower may restart unexpectedly, briefly stopping ventilation and breathing support. 6,797 units are affected nationwide.
Product
Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients. Catalog Number: 8416400
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0106-2022·2021-10-20
Ion Flexison Biopsy Needle recalled for potential sheath tip separation
Intuitive Surgical recalled 1,625 Ion Flexison Biopsy Needles due to potential sheath tip separation from the shaft. Affected units are distributed across 29 US states and China; no injuries have been reported.
Product
Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDI:00886874115978
Category
Medical Device
Distribution
26 states
HighFDA (Devices)·Z-0101-2022·2021-10-20
Blood sampling system sets recalled for pressure reading and measurement errors
Smiths Medical is recalling its medex blood sampling system sets due to pressure shifts and incorrect readings that may affect sample collection accuracy.
Product
smiths medical medex CBSS-5ML, Triple set, (172/15cm), Model Number DPSHC0092
Category
Medical Device
Distribution
0 states

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12751–12775 of 13802