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

8001–8025 of 13731

HighFDA (Devices)·Z-0350-2024·2023-11-29
BD Gravity Infusion Sets Labeled DEHP-Free But Contain DEHP
BD gravity blood infusion sets labeled as free of DEHP (di(2-ethylhexyl) phthalate) actually contain the substance. The recall affects products distributed worldwide through July 31, 2026.
Product
BD gravity sets (Product Name, Catalog #) 32-IN GRAV SET W/0.2 MICRON FILTER BAG ACCESS PORT SS VALVE TEXIUMTM LOW ABSORPTION, Catalog # 4030B-07T and BD GRAVITY BLOOD SET 15 DROP 180 MICRON FILTER SmartSiteTM VALVE NONVENTED, Catalog # 42081E.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0326-2024·2023-11-29
Alinity c Iron Reagent Recalled for Falsely Elevated Test Results
The FDA is recalling Alinity c Iron Reagent lots due to inaccurate results. The reagent produces falsely elevated patient iron values and may prevent proper quality control verification.
Product
Alinity c Iron Reagent, Reference Number 08P3920
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0360-2024·2023-11-29
Avanos BALLARD Closed Suction System mislabeled for DEHP content
Certain lots of AVANOS BALLARD Closed Suction System for Adults were labeled as DEHP-free but contain DEHP in tubing components. These units are used for mechanical ventilation and distributed in the US and South Africa.
Product
AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on mechanical ventilation
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0397-2024·2023-11-29
EXALT Model D Single-Use Duodenoscope Recalled for Lens Fluid Ingress
Boston Scientific is recalling EXALT Model D Single-Use Duodenoscopes due to fluid ingress in the lens, which causes poor image quality during procedures.
Product
EXALT Model D Single-Use Duodenoscope, 2 pack: Outer box UPN# M00542421, Inner box UPN # M00542420 & Outer box UPN# M0054242CE1, Inner box UPN # M0054242CE0.
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-0366-2024·2023-11-29
Manual resuscitators recalled due to carbon dioxide rebreathing defect
SunMed Holdings recalls Ventlab STAT-Check manual resuscitators due to a backwards leak in the integrated manometer allowing CO2 rebreathing, which may impair ventilation. Multiple models (Adult, Infant, Pediatric) are affected and distributed nationwide.
Product
Ventlab, LLC STAT-Check manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. STAT-Check Adult Resuscitator REF #: SC9101B; 2. STAT-Check Infant Resuscitator RES #s: SC7101B & SC7101B-M0; 3. STAT-Check Pediatric Resuscitator R
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0381-2024·2023-11-29
Biomet Compress Device Anchor Plugs Recalled for Metal Burrs
Biomet is recalling Compress Device Short Anchor Plugs due to metal burrs that may prevent proper surgical installation and extend operation time. Distribution includes US nationwide and eight other countries.
Product
Compress Device Short Anchor Plug, 16 MM- Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement Item Number: 178558
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0351-2024·2023-11-29
BD Extension Sets Mislabeled as DEHP-Free Despite Containing Phthalates
Certain BD Extension Sets sold as free of DEHP (di(2-ethylhexyl) phthalate) actually contain this restricted phthalate. The products have been distributed worldwide.
Product
BD Extension Sets (Product Name, Catalog #) BD SmartSite Filter Extension Set PE lined Standard bore 1 SmartSite bonded 0.2um Large PES Filter 1 PC RLL. L: 16 in PV: 4mL, Catalog # 10013902 BD EXTENSION SET TRI-PORT SMALLBORE TUBING CHECK VALVE 3 SmartSite" VALVES, Catalog
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
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-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-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-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-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-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-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-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-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-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-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-0310-2024·2023-11-22
Medline Blood Culture Collection Kits Recalled for Expired Internal Components
Medline is recalling 4,850 adult blood culture collection kits (lot numbers 23EMI373, 23EMF712, 23DMF155, 23CMH026) because components inside expired before the kit's labeled expiration date.
Product
ADLT BLOOD CULTURE COLLECT KIT, REF DYNDH1245
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0307-2024·2023-11-22
Medical Device Recall: KWIKSTIK Microbiological Reagent Contaminated with Aspergillus
Microbiologics Inc recalls KWIKSTIK microbiological reagent kits due to Aspergillus flavus contamination in bulk pellets. Affected products were distributed worldwide, including the US, Italy, France, Turkey, Peru, and Mexico.
Product
KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack)
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

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