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

7876–7900 of 13683

HighFDA (Devices)·Z-0334-2024·2023-11-29
Gastrointestinal videoscopes recalled due to unvalidated channel drying process
Aizu Olympus is recalling 3,627 gastrointestinal videoscopes because the channel air drying process was not validated. A small percentage of devices returned after repair had wet channels, creating potential for contamination and risk of infection.
Product
Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model Numbers: GIF-1TH190, GIF-1TQ160, GIF-2T160, GIF-2TH180, GIF-H170, GIF-H180, GIF-H180J, GIF-H190, GIF-HQ190, GIF-LV1, GIF-N180, GIF-Q150, GIF-Q16
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-0377-2024·2023-11-29
Biomet Anchor Plugs Recalled: Metal Burrs Prevent Proper Assembly
Biomet's Compress Device Segmental Anchor Plugs are being recalled due to metal burrs in assembly holes. The defect prevents drill pins from passing through, potentially extending surgical time during implantation procedures.
Product
Compress Device Segmental Anchor Plug, 24 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178414
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0386-2024·2023-11-29
Surgical implant anchor plugs may contain metal burrs affecting insertion
Biomet's Compress Device Short Anchor Plugs may contain metal burrs in the transverse holes, which can prevent proper insertion of surgical tools and extend surgery time. The affected devices are distributed nationwide and internationally.
Product
Compress Device Short Anchor Plug, 24 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178566
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-0339-2024·2023-11-29
Tracheal Videoscope Recall Due to Unvalidated Drying Process
Aizu Olympus is recalling 61 tracheal videoscopes (Model LF-V) due to an unvalidated air drying process that left water in channels after repair. Water in the endoscope channels may become contaminated and pose an infection risk.
Product
Tracheal videoscope- For airway management, which includes observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Number: LF-V.
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-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-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-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-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-0345-2024·2023-11-29
Ultrasonic Gastrovideoscope Model TGF-UC180J Recalled for Inadequate Channel Drying
Aizu Olympus is recalling ultrasonic gastrovideoscopes due to an unvalidated channel drying process that left some scopes with water in the channels after repair. Water remaining in the device poses a risk of contamination and infection.
Product
Ultrasonic gastrovideoscope-Real time ultrasound imaging,ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs Model Number: TGF-UC180J.
Category
Medical Device
Distribution
Distributed nationwide
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-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-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-0324-2024·2023-11-29
Solea Laser Surgical Instrument Models 2.0 and 3.0 Recall for Unintended Activation
Convergent Dental is recalling 39 Solea laser surgical instruments due to potential unintended laser activation without foot pedal depression. No injuries have been reported.
Product
Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foot pedal CUS-00226 Rev. K reworked
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
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-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-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-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-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-0369-2024·2023-11-29
Medline Manual Resuscitators Recalled for Backwards Manometer Leak
Medline manual resuscitators are recalled due to a backwards leak in the integrated manometer that allows CO2 rebreathing. The defect affects multiple models used in respiratory care distributed nationwide.
Product
Medline manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Adult Resuscitator REF #s: CPRM1116FPM, CPRM1116FPM4, CPRM1116M, CPRM1116MC, CPRM1116PM, CPRM1116PMT, CPRM1126FM, CPRM1126FPM, CPRM1126FPWM, CPRM1126M; 2. Infant Resus
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-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

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7876–7900 of 13683