Product category · Updated Jul 2, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
Medical Devices accounts for 40,372 recalls, about 39.7% of the federal recall archive, of which 9% of graded records are high-severity.
The FDA, CPSC and NHTSA have published 40,372 medical devices recalls between 2000 and 2026 - roughly 39.7% of the 101,704-record archive. Of the 40,372 records graded for severity, 9% are high-severity. Most are issued by FDA Devices. Counts reflect market size and reporting activity, not a product's inherent danger.
- 40,372 total recalls
- 39.7% of the archive
- 9% graded high-severity
- FDA Devices top agency
Category snapshot
Medical Devices accounts for 40,372 recalls, about 39.7% of the 101,704-record federal archive, with 3,538 graded high-severity, most issued by FDA Devices.
- 40,372
- total recalls
- 9%
- graded high-severity
- FDA Devices
- top issuing agency
- 2000–2026
- years covered
Medical Devices recalls by year
2000–2026
Severity distribution
Graded records only
- High severity 3,538
High severity
3,538 recalls
- Moderate
Moderate
35,780 recalls
- Lower severity 1,054
Lower severity
1,054 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,096 recalls
- FDA Drug 934
FDA Drug
934 recalls
- CPSC 307
CPSC
307 recalls
- FDA Food 35
FDA Food
35 recalls
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Recalls in Medical Devices
Newest first · Page 158 of 808
TruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 in (173cm) PXAVMP3: x3 (3cc)/VAMP PXVK0364:(3cc)/VAMP 96in (241cm); P…
Edwards Lifesciences, LLC
FloTrac Sensor with Vamp System, REF: MHD6AZ, MHD6AZ5 , MHD6C502 STIRLEEO, Rx only. For use in intravascular pressure monitoring.
Edwards Lifesciences, LLC
Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, Rx only, Sterile EO. For use in intravascular pressure monitoring.
Edwards Lifesciences, LLC
GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
Aizu Olympus Co., Ltd.
AuDX PRO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-AUP
PATH
Compress Device Short Anchor Plug, 26 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Numb…
Biomet, Inc.
Compress Device Short Anchor Plug, 24 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Numb…
Biomet, Inc.
Compress Device Short Anchor Plug, 14 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Numb…
Biomet, Inc.
VariSoft infusion set, Model Number 1002828
Unomedical A/S
stryker Sage PrimaFit External Urine Management System for the Female Anatomy
Sage Products Inc
Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum and sigmoid colon). Model Numb…
Aizu Olympus Co., Ltd.
Tracheal fiberscope-airway management, which includes observation to access airway anatomy, endotracheal/endobronchial intubation and management. M…
Aizu Olympus Co., Ltd.
Compress Device Short Anchor Plug, 28 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Numb…
Biomet, Inc.
Medline manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Adult Resuscitator REF #s: CPRM1116FPM, …
SunMed Holdings, LLC
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 00024345007, 00024360007
Instrumentation Laboratory
Ventlab, LLC AirFlow manual resuscitator devices with integrated manometer, multiple accessory configurations to include: 1. AirFlow Adult Resusc…
SunMed Holdings, LLC
Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for endoscopic surgery within the upper digestive tract. Model Numb…
Aizu Olympus Co., Ltd.
EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242CE0.
Boston Scientific Corporation
Compress Device Segmental Anchor Plug, 18 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item …
Biomet, Inc.
Compress Device Segmental Anchor Plug, 20 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item …
Biomet, Inc.
Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60.
Aizu Olympus Co., Ltd.
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6
Medtronic Inc
Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ…
Aizu Olympus Co., Ltd.
Rhinolaryngoscope-for endoscopic diagnosis and treatment within the nasal lumens and airway anatomy (including nasopharyngeal and trachea). Model …
Aizu Olympus Co., Ltd.
Compress Device Short Anchor Plug, 12 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Numb…
Biomet, Inc.
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130068X5
Medtronic Inc
Colonoscope-indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve). Model Number…
Aizu Olympus Co., Ltd.
Ventlab, LLC BreathTech manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. BreathTech Adult Resuscit…
SunMed Holdings, LLC
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004
Instrumentation Laboratory
Compress Device Segmental Anchor Plug, 14 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item …
Biomet, Inc.
EXALT Model D Single-Use Duodenoscope, 2 pack: Outer box UPN# M00542421, Inner box UPN # M00542420 & Outer box UPN# M0054242CE1, Inner box UPN # M005…
Boston Scientific Corporation
Compress Device Segmental Anchor Plug, 10 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item …
Biomet, Inc.
Bronchoscope - Ultrasonic: endoscopic real-time ultrasonic imaging, ultrasound guided needle aspiration and other endoscopic procedures within the ai…
Aizu Olympus Co., Ltd.
Ureteralscope- for endoscopic diagnosis and treatment within the ureter, kidney and biliary tract (common bile duct and hepatic duct). Model Numbers…
Aizu Olympus Co., Ltd.
Ventlab, LLC STAT-Check manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. STAT-Check Adult Resusci…
SunMed Holdings, LLC
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6
Medtronic Inc
Ventlab, LLC SafeSpot manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. SafeSpot Infant Resuscitato…
SunMed Holdings, LLC
Transnasal esophagovideoscope-For endoscopy and endoscopic surgery within the esophagus and stomach. Model Number: PEF-V.
Aizu Olympus Co., Ltd.
Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foot pedal CUS-00226 Rev. K reworked
Convergent Dental
Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311, 501 and 502; INTEGRA 400 p…
Roche Diagnostics Operations, Inc.
DBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgically created osseous defects or osseous defects created from traumatic inju…
Musculoskeletal Transplant Foundation, Inc.
SmartPath to dStream for 1.5T
Philips North America Llc
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-07…
Becton Dickinson & Company
Cystonephroscope-endoscopic diagnosis and treatment within the bladder, urethra, and kidney Model Numbers: CYF-5, CYF-VH, CYF-VHR.
Aizu Olympus Co., Ltd.
Tracheal videoscope- For airway management, which includes observation to access airway anatomy, endotracheal/endobronchial intubation and management…
Aizu Olympus Co., Ltd.
IRON assay, Reference Numbers 6K95-41 and 6K95-30
Sentinel CH SpA
Ingenia 1.5T CX
Philips North America Llc
Ventlab, LLC V-Care manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. V-Care Child Resuscitator REF…
SunMed Holdings, LLC
ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radio…
LEONI CIA CABLE SYSTEMS
Achieva 1.5T
Philips North America Llc
What to do with this
Monitoring medical devices? Start here.
- Check a specific product against the full federal archive before you use or buy it. Recall checker
- Most medical devices recalls come from FDA Devices - browse that agency's full feed. FDA Devices recalls
- Sort the whole archive by severity to see the highest-risk active recalls first. Rankings
Recall categorization follows the issuing agency's product taxonomy; always confirm specifics on the official notice.
Nearby categories
Adjacent product categories that share hazard patterns or regulatory oversight.
Data sources
- Source: FDA - openFDA Enforcement API (food, drug, and device recalls)
- Source: CPSC - Consumer Product Safety Commission Recalls
- Source: NHTSA - National Highway Traffic Safety Administration Recalls (vehicles & equipment)
Category data as of Jul 2, 2026.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Category counts and the year trend are computed across the full archive for medical devices. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of Jul 2, 2026.