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

7926–7950 of 13683

HighFDA (Devices)·Z-0342-2024·2023-11-29
Sigmoidovideoscope models recalled due to improper channel drying process
Aizu Olympus sigmoidovideoscope (model PCF-S) units are being recalled due to an unvalidated channel drying process. Some repaired units returned with water in channels, risking contamination and infection.
Product
Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum and sigmoid colon). Model Number: PCF-S.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0375-2024·2023-11-29
Biomet Compress Device Anchor Plugs Recalled for Metal Burrs
Biomet is recalling Compress Device Segmental Anchor Plugs due to metal burrs in transverse holes that may prevent proper device function during surgery. The defect could result in extended surgical time.
Product
Compress Device Segmental Anchor Plug, 20 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178410
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0398-2024·2023-11-29
Robotic patient positioning system may move unexpectedly after interruption
The ORION System robotic arm used in radiation therapy may suddenly accelerate or move unexpectedly when motion resumes after an interruption, creating a risk of collision with stationary equipment.
Product
ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Number: 1SOPT00003
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0378-2024·2023-11-29
Biomet Compress Device Anchor Plugs recalled for metal burrs in transverse holes
Biomet is recalling Compress Device Short Anchor Plugs due to potential metal burrs in the transverse holes that may prevent proper placement of drill pins during surgery, potentially extending surgical time.
Product
Compress Device Short Anchor Plug, 10 MM-Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement Item Number: 178552
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0356-2024·2023-11-29
Stryker Sage PrimaFit Female Urine Management Systems recalled for undeclared latex adhesive
Sage Products is recalling approximately 174,960 Stryker Sage PrimaFit External Urine Management Systems in three lots because a small percentage may contain tape with undeclared natural rubber latex adhesive.
Product
stryker Sage PrimaFit External Urine Management System for the Female Anatomy
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0371-2024·2023-11-29
Compress Device Anchor Plugs recalled due to metal burrs
Biomet is recalling Compress Device Segmental Anchor Plugs due to metal burrs in transverse holes that may prevent drill or pins from passing through, potentially extending surgical time.
Product
Compress Device Segmental Anchor Plug, 12 MM -For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178402
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0341-2024·2023-11-29
Colonoscopes recalled over unvalidated channel drying process
Aizu Olympus colonoscopes are being recalled because the air drying process for the instrument channel was not properly validated. Some units returned after repair had moisture in the channel, creating a risk of contamination and infection.
Product
Colonoscope-indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve). Model Numbers: PCF-H180AI, PCF-H180AL, PCF-H190DI, PCF-H190DL, PCF-H190I, PCF-H190L, PCF-H190TI, PCF-H190TL, PCF-HQ190I, PCF-HQ190L, PCF-PH190I
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0361-2024·2023-11-29
Ventlab AirFlow Manual Resuscitators Recalled for CO2 Rebreathing Risk
SunMed Holdings is recalling Ventlab AirFlow manual resuscitators nationwide due to a backwards leak in the integrated manometer that allows CO2 rebreathing. Users should immediately discontinue use and contact the manufacturer.
Product
Ventlab, LLC AirFlow manual resuscitator devices with integrated manometer, multiple accessory configurations to include: 1. AirFlow Adult Resuscitator REF #s: AF1140MB-M5, AF1140MB-D5, AF5142OB, AF5142MB, AF5142MB-D235, AF1142MBP, AF5142MBP, AF5140MB, AF5140MB-2, AF5140MB-D6
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0383-2024·2023-11-29
Biomet Compress Device Anchor Plug Recalled for Metal Burrs
Biomet is recalling Compress Device Short Anchor Plugs (20 MM) because metal burrs in transverse holes prevent surgical instruments from passing through, potentially extending surgery time.
Product
Compress Device Short Anchor Plug, 20 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178562
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0399-2024·2023-11-29
ORION Robotic Arm Recalled for Sudden Acceleration and Collision Risk
The FDA recalls ORION robotic positioning arms used in radiation and radiology due to sudden acceleration or unintended movement that could cause patient collision with treatment room equipment. No injuries reported.
Product
ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Number: 1SOPT00009
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0373-2024·2023-11-29
Biomet Compress Device Segmental Anchor Plugs Recalled for Metal Burrs
Biomet has recalled certain Compress Device Segmental Anchor Plugs (16 MM) due to metal burrs in the transverse holes. These burrs may prevent the drill or pins from passing through, potentially extending surgical time.
Product
Compress Device Segmental Anchor Plug, 16 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178406
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0387-2024·2023-11-29
Biomet Compress Device Short Anchor Plug recalled for metal burrs
Biomet is recalling the Compress Device Short Anchor Plug due to metal burrs in transverse holes that may prevent proper insertion of drill or pins, potentially extending surgical time. No injuries have been reported.
Product
Compress Device Short Anchor Plug, 26 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178568
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0393-2024·2023-11-29
Philips MRI systems recalled for potential gradient coil fire hazard
Philips is recalling 102 Intera 1.5T MRI systems worldwide due to a potential gradient coil failure that could produce smoke and fire. The affected devices are identified by product numbers 781195 and 781295.
Product
Intera 1.5T
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0323-2024·2023-11-29
DBX Demineralized Bone Matrix Putty fill volume mislabeled
DBX Demineralized Bone Matrix Putty units labeled as 10cc contain only 1cc of product, which may result in prolonged surgery. Affected units distributed in PA, TX, and WA.
Product
DBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. Model Number: 038100
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-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-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
ModerateFDA (Devices)·Z-0380-2024·2023-11-29
Compress Device Short Anchor Plugs recalled due to metal burrs
Biomet is recalling Compress Device Short Anchor Plugs (14 MM) due to potential metal burrs in transverse holes that may prevent proper insertion during surgery. The defect may extend surgical time.
Product
Compress Device Short Anchor Plug, 14 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178556
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0306-2024·2023-11-22
Philips Spectral CT on Rails Software Crash During Fluoroscopy Operations
Philips is recalling the Spectral CT on Rails (Model 728334, Software Version 5.1.0) due to a software crash that occurs when CCT Fluoroscopy mode and foot pedal are activated simultaneously. The crash requires system restart.
Product
Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
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-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-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-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-0300-2024·2023-11-22
LIFEPAK 15 Defibrillator Recall: Loose Battery Pins Risk Power Loss
Physio-Control is recalling LIFEPAK 15 defibrillators due to a potential defect where battery pins may become loose, causing power issues.
Product
LIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002
Category
Medical Device
Distribution
Distributed nationwide

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7926–7950 of 13683