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

8776–8800 of 40056

ModerateFDA (Devices)·Z-0370-2024·2023-11-29
Orthopedic Anchor Plugs Recalled for Metal Burrs Preventing Proper Installation
Biomet is recalling Compress Device Segmental Anchor Plugs due to metal burrs in transverse holes that may prevent drills or pins from passing through, potentially extending surgical procedures.
Product
Compress Device Segmental Anchor Plug, 10 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178400
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0354-2024·2023-11-29
Medtronic Intellis Neurostimulator Controller firmware misconfiguration affects user interface language
Medtronic Neuromodulation is recalling 26 units of Model 97745 Controller distributed to South Korea and Turkey with incorrect firmware, resulting in user interface displayed in English rather than local language.
Product
Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0379-2024·2023-11-29
Compress Device Short Anchor Plug recalled for potential metal burrs
Biomet recalls Compress Device Short Anchor Plug devices due to potential metal burrs in transverse holes that may prevent proper drill and pin placement during orthopedic surgery, affecting units distributed worldwide.
Product
Compress Device Short Anchor Plug, 12 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178554
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0318-2024·2023-11-22
Express Dry Seal Chest Drains Recalled for Insufficient Setup Instructions
Atrium Medical Corporation is recalling Express Dry Seal Chest Drains (models 4000-100N and 4050-100N) due to inadequate instructions for proper catheter and patient tube connection setup. No injuries have been reported.
Product
Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRU
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-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-0301-2024·2023-11-22
LIFEPAK 15 Defibrillator Recalled for Loose Battery Pins Causing Power Loss
Physio-Control is recalling LIFEPAK 15 defibrillators due to potential loose battery pins that could cause power failure. Four affected units have been distributed to Arizona, California, North Carolina, New Jersey, and New York.
Product
LIFEPAK 15, REF: 99577-001955, Part Number V15-5-000584 and V15-7-000020
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0297-2024·2023-11-22
LIFEPAK 15 Defibrillator Recall: Loose Battery Pins May Cause Power Loss
Physio-Control is recalling LIFEPAK 15 defibrillators due to potential loose battery pins that could result in power loss. Affected devices were distributed in AZ, CA, NC, NJ, and NY.
Product
LIFEPAK 15, REF: 99577-000055, Part Number V15-2-000061
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-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-0308-2024·2023-11-22
Laboratory Culture Disks Recalled for Aspergillus Flavus Contamination
Microbiologics Inc is recalling LYFO-DISK P. venetum laboratory culture disks (lot 794-142) found contaminated with Aspergillus flavus during complaint investigation. The product was distributed worldwide.
Product
LYFO-DISK, P. venetum, Catalog number 0794L
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-0293-2024·2023-11-22
Philips Brilliance CT Big Bore May Send Incorrect Coordinates During Radiation Therapy Planning
Philips Brilliance CT Big Bore units with software V4.8.0.10421 may produce inaccurate image position data when offset reconstruction is used. This could lead to incorrect radiation therapy planning or diagnosis.
Product
Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and simulator designed for radiation oncology and therapy.
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-0311-2024·2023-11-22
Medline Peripheral Blood Culture Draw Kits Recalled Due to Expired Components
Medline is recalling 1,770 Peripheral Blood Culture Draw kits because components within the kits have expired before the kit's stated expiration date.
Product
PERIPHERAL BLOOD CULTURE DRAW, REF DYNDH1561
Category
Medical Device
Distribution
Distributed nationwide
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-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-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-0291-2024·2023-11-22
Atrium Advanta V12 Covered Stent System Recalled for Weld Failure
Atrium Medical Corporation is recalling 141 units of the Advanta V12 Covered Stent System due to a balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment. Affected units were distributed to eleven countries.
Product
Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring and improving the patency of the iliac andrenal arteries. Renal approval includes 5mm, 6mm and 7mm diameter Advanta V12 covered stent sizes. In Canada, the Advanta V12 Covered Stent indicat
Category
Medical Device
Distribution
0 states
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-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-0304-2024·2023-11-22
LIFEPAK 15 Defibrillators Recalled Due to Potential Loose Battery Pins
Physio-Control has recalled LIFEPAK 15 defibrillators because battery pins may become loose, causing power issues. Owners should contact the manufacturer for instructions on how to proceed.
Product
LIFEPAK 15, REF: 99577-001958, Part Number: V15-7-000023
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0299-2024·2023-11-22
LIFEPAK 15 defibrillator recalled for potential battery power loss
Physio-Control is recalling 5 LIFEPAK 15 defibrillators due to a potential defect where battery pins may become loose, resulting in power loss. No illnesses or injuries have been reported.
Product
LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602
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

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8776–8800 of 40056