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

8651–8675 of 40007

HighFDA (Devices)·Z-0376-2024·2023-11-29
Compress Device Anchor Plugs Recalled for Metal Burrs in Surgical Holes
Biomet is recalling Compress Device Segmental Anchor Plugs due to metal burrs that may prevent surgical instruments from passing through properly. The defect may result in extended surgery time.
Product
Compress Device Segmental Anchor Plug, 22 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178412
Category
Medical Device
Distribution
Distributed nationwide
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-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-0333-2024·2023-11-29
Gastroscope Devices Recalled for Inadequate Channel Drying Process
Aizu Olympus recalls 680 gastroscope-EUS devices due to unvalidated channel drying. Water remaining in the channels poses contamination and infection risks.
Product
Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for endoscopic surgery within the upper digestive tract. Model Numbers: GF-UC140P-AL5, GF-UCT180, GF-UE160-AL5.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0382-2024·2023-11-29
Biomet Compress Device Anchor Plug Recall - Metal Burrs May Extend Surgery
Biomet is recalling Compress Device Short Anchor Plugs due to metal burrs that may prevent surgical instruments from passing through, potentially extending operative time.
Product
Compress Device Short Anchor Plug, 18 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178560
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0372-2024·2023-11-29
Surgical Anchor Plug Devices Recalled for Potential Metal Burrs
Biomet is recalling Compress Device Segmental Anchor Plugs due to metal burrs in transverse holes that may prevent surgical drill passage and extend surgery time.
Product
Compress Device Segmental Anchor Plug, 14 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178404
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-0348-2024·2023-11-29
Uretero-reno fiberscopes recalled due to inadequate channel drying
Aizu Olympus is recalling uretero-reno fiberscopes because the channel air drying process was not validated. A small percentage of repaired devices had residual water in the channels, creating a risk of contamination and infection.
Product
Uretero-reno fiberscope-For endoscopic diagnosis and treatment within the ureter and kidney. Model Numbers: URF-P7, URF-P7R, URF-V2, URF-V2R, URF-V3, URF-V3R.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0349-2024·2023-11-29
BD Alaris Pump Infusion Sets Contain Undisclosed DEHP
BD Alaris Pump infusion sets labeled as DEHP-free actually contain di(2-ethylhexyl) phthalate. The worldwide recall affects multiple catalog numbers distributed throughout the US and internationally.
Product
BD Alaris Pump infusion sets (Product Name, Catalog #) BD AlarisTM Pump Infusion Set Vented syringe adapter Smallbore Tubing, Catalog # 10010483; BD AlarisTM Pump Infusion Set 1.2 Micron Filter Low Sorbing Tubing (PE Lined) SmartSiteTM Y-site, Catalog # 10010453; BD Alar
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0322-2024·2023-11-29
Medtronic Mo.Ma Ultra Cerebral Protection Device manifold stickers mislabeled
Medtronic has recalled the Mo.Ma Ultra Proximal Cerebral Protection Device due to mislabeled manifold stickers. Both sides of affected units were labeled identically, potentially causing confusion about which ports control the proximal versus distal balloons.
Product
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130068X5
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0364-2024·2023-11-29
RescuMed Manual Resuscitators Recalled for CO2 Rebreathing Risk
SunMed Holdings recalls RescuMed manual resuscitators due to a backwards leak in the manometer allowing CO2 rebreathing. Affected models distributed nationwide across 32 US states.
Product
Ventlab, LLC RescuMed manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. RescuMed Adult Resuscitator REF #s: BVM510-F, BVMB510-10, BVMB510-F, BVMB510S-F; 2. RescuMed Infant Resuscitator REF #s: BVMB710 & BVMB710-F; 3. RescuMe
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-0321-2024·2023-11-29
Medtronic Mo.Ma Ultra Cerebral Protection Device Labeling Error
Medtronic is recalling 173 units of the Mo.Ma Ultra Proximal Cerebral Protection Device due to incorrect labeling that prevents proper identification of inflation and deflation ports on the device manifold.
Product
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6
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-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-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-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-0330-2024·2023-11-29
Choleodochoscope Models Recalled Due to Unvalidated Air Drying Process
Aizu Olympus choleodochoscopes with unvalidated air drying processes may retain water in the channel after repair, risking microbial contamination and patient infection. Affected models: CHF-BP30, CHF-CB30L, CHF-P60.
Product
Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0391-2024·2023-11-29
Philips Achieva 1.5T MRI Systems Recalled for Gradient Coil Fire Risk
Philips is recalling Achieva 1.5T MRI systems because the gradient coil component could fail and produce smoke or fire. The recall affects 2 units distributed worldwide.
Product
Achieva 1.5T Initial System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0358-2024·2023-11-29
Blood Gas Analyzer Cartridges Recalled for Potential Oxygen Measurement Errors
The FDA is recalling GEM Premier 3000 PAK cartridges manufactured by Instrumentation Laboratory because they may incorrectly report high oxygen levels in patients with low blood oxygen, potentially delaying critical treatment.
Product
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 00024345007, 00024360007
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0395-2024·2023-11-29
Philips MRI Gradient Coil Recall Due to Fire and Smoke Risk
Philips is recalling SmartPath to dStream 1.5T MRI systems due to a potential gradient coil failure that could produce smoke or fire. The recall affects 119 units distributed nationwide and internationally.
Product
SmartPath to dStream for 1.5T
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0328-2024·2023-11-29
Ultrasonic Bronchoscopes Recalled Due to Inadequate Drying Validation
Aizu Olympus is recalling 823 ultrasonic bronchoscopes (models BF-UC180F, BF-UC190F) because the channel air drying process was not validated, and some repaired units retained water that could cause contamination and infection.
Product
Bronchoscope - Ultrasonic: endoscopic real-time ultrasonic imaging, ultrasound guided needle aspiration and other endoscopic procedures within the airways, trancheobronchial tree, esophagus and surrounding organs Model Numbers: BF-UC180F, BF-UC190F.
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-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-0338-2024·2023-11-29
Tracheal Fiberscope Airway Management Devices Recalled for Inadequate Channel Drying
Aizu Olympus is recalling 65 tracheal fiberscope units worldwide due to an unvalidated air drying process. Moisture remaining in device channels after repair could allow contamination and pose an infection risk.
Product
Tracheal fiberscope-airway management, which includes observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Numbers: LF-DP, LF-GP, LF-TP.
Category
Medical Device
Distribution
Distributed nationwide

How to read this listing

Filters

8651–8675 of 40007