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 138 of 808
Centurion STERILE ROUND EAR SPECULUM SET (3, 4, 5), Product Code I68505
MEDLINE INDUSTRIES, LP - Northfield
Centurion Manual surgical kits labeled as: a) HEGAR UTERINE DILATOR, 11-12MM, STERILE, Product Code HUD112ST; b) STERILE UTERINE DILATOR 1MM/2MM…
MEDLINE INDUSTRIES, LP - Northfield
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTS
Covidien, LP
Centurion manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product Code TRI55405; b) SUTURE REMOVAL SET, Product Code 60265 MEDLINE ma…
MEDLINE INDUSTRIES, LP - Northfield
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
Exactech, Inc.
BD Phoenix NMIC-306 Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene panel (tray) containing contr…
Becton Dickinson & Co.
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, LEFT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-…
Exactech, Inc.
Centurion manual surgical kits labeled as: a) ST. VIRTUS SPLINTER FORCEP 6" (SF8246), Product Code 66580; b) DEBRIDEMENT TRAY, Product Code I8663…
MEDLINE INDUSTRIES, LP - Northfield
Centurion Manual surgical kits labeled as: a) 15ML SAMPLING TUBE WITH CAP, Product Code 15MLVLCP; b) STERILE 9X12 RECLOSABLE BAG, Product Code M…
MEDLINE INDUSTRIES, LP - Northfield
Centurion Curette kits labeled as: a) STERILE BUCK EAR CURETTE "00" (25697), Product Code 66745; b) STERILE "1" EAR CURETTE (505629), Product Cod…
MEDLINE INDUSTRIES, LP - Northfield
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314…
Exactech, Inc.
Centurion scalpel handle kits labeled as: a) STERILE # 3 SCALPEL HANDLE, Product Code 66825; b) STERILE PAS #3 BLADE HANDLE (BH3PAS), Product Code…
MEDLINE INDUSTRIES, LP - Northfield
HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride, (Concentration = 0.2mg/ml) 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windso…
SCA Pharmaceuticals, LLC
stay-safe /Luer Lock Adapter 4 in
Fresenius Medical Care Holdings, Inc.
Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit
Bio-Rad Laboratories
Thermalon Stye Compress, Item Number 24352
Bruder Healthcare Company, LLC
Baxter Supple Peri-Guard Repair Patch (legacy product codes): a) PC0404SNBIO, b) PC0608NSBIO, c) PC0814SNBIO, d) PC1016SNBIO
Baxter Healthcare Corporation
Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C
Medivance Inc.
IV Start Kit, containing 1 Saline Syringe 5ml, REF 74654, 100 kits/case, Sterile.
Medical Action Industries, Inc. 306
stay-safe /Luer Lock Catheter Ext. 18 in
Fresenius Medical Care Holdings, Inc.
Epix Universal Clip Applier, REF: CA500, STERILEEO
Applied Medical Resources Corp
SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pak Surgical Procedure Packs, Products: 18018-06, 3865-44, 5675-76, 13554…
Alcon Research, LLC
stay-safe /Luer Catheter Ext. 6 in
Fresenius Medical Care Holdings, Inc.
RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graft system, IFU, and patient tracking card, sterile: (a) Part number 28…
Bolton Medical Inc.
Thermalon Sinus Compress (French), Item Number 24332F
Bruder Healthcare Company, LLC
Thermalon Back Wrap, Item Number 24312
Bruder Healthcare Company, LLC
Baxter Peri-Guard Repair Patch (new product codes): a) PG0404, b) PG0608, c) PG0814, d) PG1016, e) PG1225
Baxter Healthcare Corporation
Thermalon Sinus Compress, Item Number 24332
Bruder Healthcare Company, LLC
Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010
Boston Scientific Corporation
OptiCross Coronary Imaging Catheter, REF H749518080120
Boston Scientific Corporation
Insufflation unit, UHI-4.
Olympus Corporation of the Americas
GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY TRACECART
DeRoyal Industries Inc
VITROS Performance Verifier I
Ortho-Clinical Diagnostics
SOLTIVE Pro SuperPulsed Laser (TFL-SLS )
Olympus Corporation of the Americas
Thermalon Neck Wrap, Item Number 24322
Bruder Healthcare Company, LLC
InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus surgery. Model Number: LCS1500UNOL LCS1…
Olympus Corporation of the Americas
Epix Universal Clip Applier, REF: CA500, STERILEEO included within the following kit Reference Numbers: GK1003, AME Kit 54562 GK1004, KIT LAP CHOL …
Applied Medical Resources Corp
Access Substrate, REF 81906, For use with the Access Immunoassay Systems
Beckman Coulter, Inc.
Baxter Peri-Guard Repair Patch (legacy product codes): a) PC0404NBIO, b) PC0608NBIO, c) PC0814NBIO, d) PC1016NBIO
Baxter Healthcare Corporation
SOLTIVE Premium SuperPulsed Laser (TFL-PLS )
Olympus Corporation of the Americas
CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version Number C.03.X
Philips North America
Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and 866424 (PIC iX Hardware) running Software Version Number 4.X
Philips North America
Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog Number: CVS 2…
Randox Laboratories Ltd.
Baxter Supple Peri-Guard Repair Patch (new product codes): a) SPG0404, b) SPG0406, c) SPG0608, d) SPG0814, e) SPG1016
Baxter Healthcare Corporation
O.T.D - Optimum Traction Device - Street Orange. Single use traction splint.
Emergency Products & Research
VITROS Performance Verifier II
Ortho-Clinical Diagnostics
stay-safe /Luer Lock Catheter Ext. 12 in
Fresenius Medical Care Holdings, Inc.
Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system
Boston Scientific Corporation
HydroFlock Sterile Flocked Collection Device, Part Number 25-3317-H.
Puritan Medical Products Company, Llc
stay-safe /Safe Lock Catheter Ext. 12 in
Fresenius Medical Care Holdings, Inc.
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.