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

8751–8775 of 40056

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-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-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-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-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-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-0343-2024·2023-11-29
Small intestinal videoscope recalled due to inadequate channel drying process
Aizu Olympus is recalling small intestinal videoscopes (Model SIF-Q180) because the channel air drying process was not properly validated. Water remaining in the channels could cause contamination and infection risk.
Product
Small intestinal videoscope-For endoscopy and endoscopic surgery within the upper digestive tract (including the esophagus, stomach, duodenum, and small intestine) by oral insertion or the lower digestive tract (including the anus, rectum, sigmoid colon, colon, ileocecal valve, a
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-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-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-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
HighFDA (Devices)·Z-0362-2024·2023-11-29
BreathTech Manual Resuscitators Recalled for Integrated Manometer Leak
SunMed Holdings is recalling BreathTech manual resuscitators because the integrated manometer can leak, allowing patients to rebreathe exhaled CO2 during emergency airway management.
Product
Ventlab, LLC BreathTech manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. BreathTech Adult Resuscitator REF #s: BT5107F & BT5104P; 2. BreathTech Child Resuscitator REF #s: BT3030, BT3034, & BT3025; 3. BreathTech Infant Res
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0347-2024·2023-11-29
Ureteralscopes recalled due to unvalidated drying process and contamination risk
Aizu Olympus is recalling 1577 ureteralscope units due to an unvalidated channel air drying process that left some units with residual water after repair, creating a contamination and infection risk.
Product
Ureteralscope- for endoscopic diagnosis and treatment within the ureter, kidney and biliary tract (common bile duct and hepatic duct). Model Numbers: URF-P6, URF-P6R.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0367-2024·2023-11-29
V-Care manual resuscitators recalled for CO2 rebreathing defect
SunMed's Ventlab V-Care manual resuscitators are being recalled due to a backwards leak in the integrated manometer that allows CO2 rebreathing. Affected devices were distributed nationwide.
Product
Ventlab, LLC V-Care manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. V-Care Child Resuscitator REF #s: VN4100MB, VN4100MCFB-3, VN4100MCP; 2. V-Care Infant Resuscitator REF #s: VN3100OB, VN3100MB-2, VN3100MB-M01, VNW3100MB-2, V
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0329-2024·2023-11-29
Colonoscopes Recalled for Unvalidated Channel Drying Process and Infection Risk
Aizu Olympus is recalling certain colonoscope models because the channel air drying process was not validated. A small percentage of repaired units had water remaining in the channel, which could lead to infection risk.
Product
Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve). Model Numbers: CF-2T160I, CF-2T160L, CF-H170I, CF-H170L, CF-H180AI, CF-H180AL, CF-H180DI, CF-H180DL, CF-H190I, CF-H190L, CF-
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0368-2024·2023-11-29
Curaplex Manual Resuscitators Recalled for Potential CO2 Rebreathing Risk
SunMed Holdings is recalling Curaplex manual resuscitators with integrated manometers due to a backwards leak in the patient valve that allows carbon dioxide rebreathing. All units manufactured from September 2018 to present and distributed nationwide are affected.
Product
Curaplex manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Curaplex Adult Premium BVM with Bag Reservoir, Manometer, Filter, Peep Valve & Mask, REF # 2442-BVMPAD; 2. Curaplex Child Premium BVM with Bag Reservoir, Manometer, 2
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0389-2024·2023-11-29
Philips Achieva 1.5T MRI systems recalled for potential gradient coil fire risk
Philips is recalling Achieva 1.5T MRI systems due to potential gradient coil failure that could produce smoke and/or fire. Approximately 520 units have been distributed nationwide and internationally.
Product
Achieva 1.5T
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-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-0396-2024·2023-11-29
Boston Scientific EXALT Model D Duodenoscope Recall: Fluid Ingress in Lens
Boston Scientific is recalling certain EXALT Model D Single-Use Duodenoscopes worldwide due to fluid ingress in the lens, which causes poor image quality. Affected devices should not be used; contact the manufacturer.
Product
EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242CE0.
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-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-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-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
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

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8751–8775 of 40056