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 13652

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-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-0388-2024·2023-11-29
Biomet Compress Device Short Anchor Plug recalled due to metal burrs
Biomet is recalling Compress Device Short Anchor Plugs (28 MM, Item 178570) due to potential metal burrs in transverse holes that may prevent surgical instruments from passing through, extending surgery duration.
Product
Compress Device Short Anchor Plug, 28 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178570
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0359-2024·2023-11-29
Blood Gas Analyzer Cartridges Recalled for Falsely Elevated Oxygen Readings
Instrumentation Laboratory recalls GEM Premier 3000 PAK blood gas analyzer cartridges due to measurement errors in low oxygen detection. The devices may falsely indicate normal oxygen levels when levels are dangerously low, potentially delaying treatment.
Product
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate, Part Numbers 00024315009, 00024330009, 00024345009, 00024360009
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0385-2024·2023-11-29
Biomet Compress Device Short Anchor Plug Recalled Due to Metal Burrs
Biomet is recalling Compress Device Short Anchor Plugs (23 MM) due to potential metal burrs in transverse holes that may prevent proper insertion of surgical instruments, potentially extending surgery time. Distribution includes US and multiple international countries.
Product
Compress Device Short Anchor Plug, 23 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178565
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0390-2024·2023-11-29
Philips Achieva 1.5T MRI Device Recalled for Gradient Coil Fire Risk
Philips is recalling 68 Achieva 1.5T MRI machines due to potential gradient coil component failure that could produce smoke and fire. No injuries have been reported.
Product
Achieva 1.5T Conversion
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0335-2024·2023-11-29
Hysteroscope Model HYF-1T recalled due to moisture in device channels
Aizu Olympus is recalling Hysteroscope Model HYF-1T devices because the channel air drying process after repair was not validated. Some returned units had residual moisture that could allow contamination and infection.
Product
Hysteroscope-For endoscopic diagnosis within the uterus Model Number: HYF-1T.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0336-2024·2023-11-29
Hysterovideoscope Models Recalled Due to Improper Channel Drying Risk
Aizu Olympus is recalling Hysterovideoscope Model HYF-V units (27 devices) because the channel air drying process was not validated. Water remaining in device channels could pose an infection risk.
Product
Hysterovideoscope-For endoscopic diagnosis within the uterus Model Number: HYF-V.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0325-2024·2023-11-29
IRON assay kits recalled for inaccurate diagnostic results
Sentinel CH SpA is recalling IRON assay kits (Reference Numbers 6K95-41 and 6K95-30) that may produce falsely elevated results. Affected lots could cause inaccurate iron measurements and delays in patient test reporting.
Product
IRON assay, Reference Numbers 6K95-41 and 6K95-30
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0320-2024·2023-11-29
Medtronic Mo.Ma Ultra cerebral protection device labeling error recalled
Medtronic is recalling 2,767 units of the Mo.Ma Ultra Proximal Cerebral Protection Device due to labeling errors on the manifold that result in incorrect identification of inflation and deflation ports.
Product
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6
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-0384-2024·2023-11-29
Compress Device Short Anchor Plugs Recalled for Metal Burrs
Biomet is recalling Compress Device Short Anchor Plugs (22 MM) used in orthopedic surgery because they may contain metal burrs in the transverse holes that could prevent drill or pin passage and extend surgical procedures.
Product
Compress Device Short Anchor Plug, 22 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178564
Category
Medical Device
Distribution
Distributed nationwide
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-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
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-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-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-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-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-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-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-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-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-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

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7926–7950 of 13652