Product category · Updated Jun 3, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
Medical Devices accounts for 40,478 recalls — about 40.4% of the federal recall archive, of which 9% of graded records are high-severity.
The FDA, CPSC and NHTSA have published 40,478 medical devices recalls between 2000 and 2026 — roughly 40.4% of the 100,165-record archive. Of the 40,478 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.
- 40,478 total recalls
- 40.4% of the archive
- 9% graded high-severity
- FDA Devices top agency
Category snapshot
Medical Devices accounts for 40,478 recalls — about 40.4% of the 100,165-record federal archive, with 3,549 graded high-severity, most issued by FDA Devices.
- 40,478
- 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 3,549
High severity
3,549 recalls
- Moderate
Moderate
35,871 recalls
- Lower severity 1,058
Lower severity
1,058 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,096 recalls
- FDA Drug 882
FDA Drug
882 recalls
- CPSC 441
CPSC
441 recalls
- FDA Food 59
FDA Food
59 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 42 of 810
Cardiac Workstation 5000; Model Number: 860439;
Philips North America
BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads Part ID/Description: 18593 HEAD FEMORAL 22MM -3 18594 HEAD FEMO…
BioPro, Inc.
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-i…
Baxter Healthcare Corporation
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-AC
Olympus Corporation of the Americas
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D; cardiac catheter
Abbott
Model Number L209 PROPONENT DR (VDD) SL Pacemaker
Boston Scientific Corporation
BRONCHOVIDEOSCOPE OLYMPUS BF-1TQ170
Olympus Corporation of the Americas
Medical convenience kits Item number/ Product description AHLD15X LABOR DELIVERY PACK - 213387 AKDV96B VAGINAL DELIVERY AKDV96B VAGINAL DELIVE…
American Contract Systems Inc.
Model Number U226, VISIONIST CRT-P EL
Boston Scientific Corporation
BRONCHOFIBERSCOPE OLYMPUS BF TYPE PE2
Olympus Corporation of the Americas
Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec In…
Percussionaire Corporation
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190
Olympus Corporation of the Americas
Product: STA Liatest D-Di; REF: 00515;
Diagnostica Stago, Inc.
TENACIO Pump with InhibiZone; UPN: 72404429;
Boston Scientific Corporation
Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0893-01 Software Version: N/A Pro…
Spacelabs Healthcare, Inc.
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 120-inch (3.0 meters), No…
Baxter Healthcare Corporation
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180
Olympus Corporation of the Americas
PROPONENT SR SL (Model L200)
Boston Scientific Corporation
Model Number U228, VISIONIST CRT-P EL MRI
Boston Scientific Corporation
LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12CM IP), (2) 72404407 (18CM IP);
Boston Scientific Corporation
CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m), Product Code: 2H8519
Baxter Healthcare Corporation
Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27300, Arvis Surgical Planning Software Software Version: V2025.1.2 Prod…
Kico Knee Innovation Company
Model Number L221 PROPONENT DR EL Pacemaker
Boston Scientific Corporation
Medical convenience kits IHDC30R D AND C PACK
American Contract Systems Inc.
CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and CLEARLINK Luer Activated Valve, 0.2 Micron Filter, CLEARLINK Luer Acti…
Baxter Healthcare Corporation
CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, Plus 4-Way Stopcock Extension Set with two CLEARLINK Luer…
Baxter Healthcare Corporation
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 44-inch (111 centime…
Baxter Healthcare Corporation
Basic Biopsy Tray, Item Number NMBP44L
American Contract Systems Inc.
CLEARLINK System Non_DEHP Extenstion Set, Straight-Type Extension Set, Standard Bore, 1.2 Micron Filter, CLEARLINK Luer Activated Valve, 19-inch (47…
Baxter Healthcare Corporation
Model Number L131, ESSENTIO DR EL MRI Pacemaker
Boston Scientific Corporation
ACCOLADE DR EL MRI (Model L331)
Boston Scientific Corporation
Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-12 Software Version: N/A Pro…
Spacelabs Healthcare, Inc.
C-Rex UNO Microinterventional Goniotomy Instrument. Model Number: CRX-120. Product Description: The C-Rex UNO Microinterventional Goniotomy Instr…
Iantrek Inc.
Medical convenience kits Item Number/Description ANSH14AF SHOULDER PACK - 205962 EVAH76H ANTERIOR HIP PACK FDSA15M SHOULDER ARTHROSCOPY GRTS9…
American Contract Systems Inc.
BRONCHOVIDEOSCOPE OLYMPUS BF-H1100
Olympus Corporation of the Americas
Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part Numbers ZTA2-P-40-117-W ZTA2-P-40-167 ZTA2-P-40-167-W ZTA2-P-4…
Cook Medical Incorporated
Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723
Fisher & Paykel Healthcare, Ltd.
BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T150
Olympus Corporation of the Americas
Cyclopen Microinterventional Cyclodialysis System. Model Number: CP-300. Product Description: The CycloPen Microinterventional Cyclodialysis devic…
Iantrek Inc.
Model Number L121 ESSENTIO DR EL Pacemaker
Boston Scientific Corporation
LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533
GE Medical Systems, LLC
Basic Biopsy Tray; Item Number/Description: AKRB26D ROBOTIC, AMGL09AA GENERAL LAPAROSCOPY, ANLC35AD LAP CHOLE PACK - 205956, ANLP25AJ LAPROS…
American Contract Systems Inc.
Model Number L110, ESSENTIO SR SL MRI Pacemaker
Boston Scientific Corporation
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 112-inch (2.8 meters), Prod…
Baxter Healthcare Corporation
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190
Olympus Corporation of the Americas
The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the m…
Insulet Corporation
Model Number U225 VISIONIST CRT-P EL
Boston Scientific Corporation
EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190
Olympus Corporation of the Americas
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 102-in…
Baxter Healthcare Corporation
Model Number L210 PROPONENT SR SL Pacemaker
Boston Scientific Corporation
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 Jun 3, 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 Jun 3, 2026.