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

8026–8050 of 13731

HighFDA (Devices)·Z-0317-2024·2023-11-22
Oasis Water Seal Chest Drains Recalled for Inadequate Setup Instructions
Atrium Medical's Oasis Dry Suction Water Seal Chest Drains are recalled because Instructions for Use do not adequately explain proper setup of catheter and patient tube connections on single collection chamber models.
Product
Oasis Dry Suction Water Seal Chest Drains (Oasis): (1)3600-100 DRAIN, OASIS SINGLE W/AC; (2)3612-100 DRAIN, OASIS PEDI A/C; (3)3650-100 DRAIN, OASIS BRU W/AC;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0305-2024·2023-11-22
Defibrillator battery pins may loosen, affecting power
Physio-Control LIFEPAK 15 defibrillators (serial numbers 48433670 and 48744028) may experience battery pin loosening, potentially causing power issues. Two units were distributed in AZ, CA, NC, NJ, and NY.
Product
LIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0312-2024·2023-11-22
Medline Recalls Central Line Blood Culture Kits Over Expired Components
Medline Industries is recalling 1,600 Central Line Blood Culture kits due to component expiration prior to the listed kit expiration date. Expired materials could compromise blood culture test accuracy.
Product
CENTRAL LINE BLOOD CULTURE DRA, REF DYNDH1562
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0302-2024·2023-11-22
LIFEPAK 15 Defibrillator Recalled for Loose Battery Pins Causing Power Loss
Physio-Control is recalling LIFEPAK 15 defibrillators due to a potential for battery pins to become loose, which could cause power failure.
Product
LIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0309-2024·2023-11-22
Medical Device Reagent Recalled for Unreliable Test Results
Beckman Coulter's Transferrin reagent lot 2573 does not maintain stability as claimed, causing unreliable patient test results and control failures. The company confirmed the issue affects diagnostic accuracy.
Product
AU/DxC AU Chemistry Transferrin REF: OSR6152 Immune complexes formed in solution scatter light in proportion to their size, shape and concentration. Turbidimeters measure the reduction of incident light due to reflection, absorption, or scatter. In the procedure, the measurement
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0316-2024·2023-11-22
Ocean Chest Drains Recalled for Inadequate Assembly Instructions
Atrium Medical recalls Ocean chest drains due to insufficient precaution instructions for proper catheter and tube connection setup. Improper assembly could compromise device function.
Product
Ocean Water Seal Chest Drains (Ocean): Products REF Number Product Name (1)2002-000 DRAIN, OCEAN SINGLE W/AC,S; (2)2002-040 DRAIN, OCEAN SINGLE,PEDI CONNECTOR; (3)2002-100 DRAIN, OCEAN SINGLE W/AC; (4)2002-300 DRAIN, OCEAN SINGLE W/S; (5) 2002-400 DRAIN, OCEAN SINGLE ;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0303-2024·2023-11-22
LIFEPAK 15 Defibrillator Recall: Loose Battery Pins May Cause Power Loss
Physio-Control is recalling 8 LIFEPAK 15 defibrillators due to loose battery pins that may cause power loss. Affected units were distributed in Arizona, California, North Carolina, New Jersey, and New York.
Product
LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0294-2024·2023-11-22
CT Scanner Image Fusion Software Error Affecting Radiation Therapy Planning
A software bug in Philips Brilliance CT scanners causes image-fusion errors, resulting in incorrect radiation therapy coordinates and potential treatment planning failures.
Product
Brilliance CT Big Bore Oncology with software version V4.8.0.10421 Model:728243 CT scanner and simulator designed for radiation oncology and therapy.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0298-2024·2023-11-22
LIFEPAK 15 Defibrillator Recall: Loose Battery Pins May Cause Power Failure
Physio-Control is recalling LIFEPAK 15 defibrillators due to loose battery pins that may cause power failure. Users should verify device functionality immediately.
Product
LIFEPAK 15, REF: 99577-000061, Part Number V15-2-000067
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0319-2024·2023-11-22
CT Scanner Software Bug May Cause Gantry to Move to Wrong Position
Philips Spectral CT on Rails software version 5.1.0 may fail to move the needle position to the desired location during scans. This could cause the gantry to move unexpectedly and potentially collide with the user or needle.
Product
Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0315-2024·2023-11-22
Cardiovascular Convenience Kit Recalled for Inadequate Chest Drain Instructions
ROi CPS LLC is recalling Regard CV PK cardiovascular convenience kits due to insufficient instructions for proper chest drain catheter and tube connection setup. 134 units were distributed in Missouri.
Product
Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0296-2024·2023-11-22
LIFEPAK 15 Defibrillator Recall for Battery Pin Loosening
Physio-Control, Inc. is recalling LIFEPAK 15 defibrillators (Part Number V15-2-000051) because battery pins may loosen and cause power failure. Affected devices should not be used until repaired.
Product
LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0295-2024·2023-11-22
IBA Proton Therapy System Patient Positioning Can Move Unexpectedly
The IBA Proton Therapy System's patient positioning system can perform unexpected motions, risking patient crushing. Five US units and nine international units are affected.
Product
IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured with Orion Patient Positioning System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0313-2024·2023-11-22
Blood Culture Kits Recalled Due to Expired Internal Components
Medline Industries is recalling 3,160 units of 24 Blood Culture Kits because components within the kit have expired before the overall kit's stated expiration date. Expired components may compromise device performance or test result accuracy.
Product
24 BLOOD CULTURE KIT, REF DYNDH1632
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0292-2024·2023-11-22
Philips Big Bore RT CT Scanner Defect May Cause Incorrect Treatment Planning
A software defect in Philips Big Bore RT CT scanners may cause incorrect coordinates in radiation therapy planning systems, affecting 56 units distributed nationwide and internationally.
Product
Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator designed for radiation oncology and therapy.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0314-2024·2023-11-22
Blood culture kit recalled due to expired internal components
Medline's blood culture kit is being recalled because components inside the kit have expired before the kit's stated expiration date. This could affect the kit's ability to function properly.
Product
BLOOD CULTURE KIT, REF DYNDH1647B
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0223-2024·2023-11-22
Siemens Mobilett Mira wireless x-ray systems recalled for buzzer mounting defect
Four Siemens Mobilett Mira wireless mobile x-ray systems are recalled due to incorrect buzzer component mounting that prevents acoustic signals during x-ray activation. The systems remain fully functional with visual LED indicators available for operator monitoring.
Product
Mobilett Mira wireless (VA20) mobile x-ray system(s)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0189-2024·2023-11-15
Five Olympus Bronchovideoscope Models Recalled for Endobronchial Combustion Risk
Olympus is recalling 15,942 bronchovideoscope units nationwide due to endobronchial combustion risk during cauterization procedures with oxygen supply. The hazard occurs when the electrode of the surgical accessory is positioned too close to the scope's distal end.
Product
BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T150, BF-1T60, BF-P150 BF-P60 and EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number XT160
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0190-2024·2023-11-15
Olympus Bronchovideoscope Recall for Combustion Risk with Electrosurgery
Olympus is recalling 1,154 EVIS EXERA II bronchovideoscope units due to risk of endobronchial combustion during high-frequency electrosurgical procedures when oxygen is supplied and electrode placement is inappropriate.
Product
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number Q180-AC
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0151-2024·2023-11-15
Novum IQ Syringe Pump may falsely indicate infusion completion
Baxter's Novum IQ Syringe infusion system may display a false 'Infusion Complete' alarm after multiple occlusion events, leaving uninfused fluid in the syringe and risking incomplete medication delivery.
Product
Novum IQ Syringe infusion system, Product Code 40800BAXUS
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0188-2024·2023-11-15
StealthStation S8 Surgical Navigation System Software Anomaly Recall
Medtronic is recalling StealthStation S8 and FlexENT systems with software versions 2.0 and 2.0.1 due to a software anomaly that could cause surgical planning data to shift to an unintended location.
Product
StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation Cranial software, is intended as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. The StealthStation FlexENT
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0191-2024·2023-11-15
Olympus Bronchovideoscope Recalled for Fire Risk During Cauterization
Olympus Corporation recalls 13,950 EVIS EXERA II bronchovideoscopes due to risk of endobronchial combustion when high-frequency cauterization is performed with oxygen supplied while the electrode is positioned too close to the endoscope.
Product
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T180, BF-1TQ180, BF-P180
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0193-2024·2023-11-15
Olympus Bronchovideoscope Recalled Due to Combustion Risk
Olympus is recalling 719 EVIS EXERA b Bronchovideoscope Model BF-XT190 devices due to risk of endobronchial combustion during high-frequency cauterization when oxygen is supplied or the electrode is too close to the device tip.
Product
EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-XT190
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0194-2024·2023-11-15
FDA Recalls Olympus EVIS EXERA III Bronchovideoscope for Combustion Risk
Olympus Corporation is recalling 3,948 EVIS EXERA III bronchovideoscope units nationwide due to risk of combustion during electrosurgical procedures when high-frequency cauterization is used with oxygen supply.
Product
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0186-2024·2023-11-15
Alaris PCA Module 8120 Infusion Pump Syringes Labeling Contains Unvalidated Products
CareFusion is recalling the Alaris PCA Module 8120 infusion pump because its labeling lists compatible syringes that have not been validated for use with the device.
Product
Alaris PCA Module 8120
Category
Medical Device
Distribution
Distributed nationwide

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