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 147 of 808
Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 BLK 7X…
Covidien LP
PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-411
Howmedica Osteonics Corp.
SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #11 -Intended for knee replacement Part Number: 73-0110
Howmedica Osteonics Corp.
EZDilate Wire Guided Balloon 6-7-8. indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years) M…
Olympus Corporation of the Americas
Intera 1.5T Achieva Nova. Model (REF) Numbers 781172.
Philips North America
LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-631
Howmedica Osteonics Corp.
EZDilate Wire Guided Balloon 16-17-18. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years)…
Olympus Corporation of the Americas
smiths medical Medfusion Model 3500 Syringe pump
Smiths Medical ASD Inc.
MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1723
MEDLINE INDUSTRIES, LP - Northfield
Philips Azurion system, Interventional fluoroscopic x-ray system. System Product Name - Model Numbers Azurion 3M12 -722063, 722221; Azurion 3M15 -…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3710
Howmedica Osteonics Corp.
SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #9 -Intended for knee replacement Part Number: 73-2910
Howmedica Osteonics Corp.
Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053
AtriCure, Inc.
GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and fluid flow analysis
GE HEALTHCARE AUSTRIA GMBH & CO
MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1622C
MEDLINE INDUSTRIES, LP - Northfield
SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #7 -Intended for knee replacement Part Number: 73-2710
Howmedica Osteonics Corp.
SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3110
Howmedica Osteonics Corp.
EZDilate Fixed Wire Balloon 6-7-8. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD…
Olympus Corporation of the Americas
Procedural convenience kits and trays, cardiac, labeled as: a) EP LAB BI V IMPLANT PACK, kit number AGBI64J; b) LAB DEVICE IMPLANT, kit number A…
American Contract Systems, Inc.
Custom procedural convenience kits and trays, ear, nose & throat, labeled as: a) T AND A PACK AGH ASC, kit number AGTA48J; b) OPSC EAR PACK, kit…
American Contract Systems, Inc.
Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.
XTANT Medical Holdings, Inc
DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-911
Howmedica Osteonics Corp.
Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LavH, kit number BBLV21C; b) LAP HYST 247540, ki…
American Contract Systems, Inc.
SCORPIO RECESSED PATELLA- Intended for Knee Replacement Part Number: 3044-0026
Howmedica Osteonics Corp.
MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1714A
MEDLINE INDUSTRIES, LP - Northfield
SmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782129.
Philips North America
SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0028
Howmedica Osteonics Corp.
smiths medical Medfusion Model 4000 syringe pump
Smiths Medical ASD Inc.
Volar Bearing Plate. REF: VBEAL-3-7N, VBEAL-5-7N, VBEAL-3-7S, VBEAL-5-7S, VBEAL-7-7S, VBEAL-3-7W, VBEAL-5-7W, VBEAR-3-7N, VBEAR-5-7-N, VBEAR-3-7S…
TriMed Inc.
SCORPIO RECESSED PATELLA-Intended for knee repalcment Part Number: 3044-0032
Howmedica Osteonics Corp.
Custom procedural convenience kits and trays, cardiac, labeled as: a) CENTRAL LINE INSERTION PACK, kit number LLCE52; b) Adult Central Line Inse…
American Contract Systems, Inc.
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0321
Howmedica Osteonics Corp.
Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-028
Howmedica Osteonics Corp.
SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0030
Howmedica Osteonics Corp.
DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-609
Howmedica Osteonics Corp.
EZDilate Fixed Wire Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). …
Olympus Corporation of the Americas
Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056
AtriCure, Inc.
Ingenia 3.0T CX. Model (REF) Numbers 781271, 782105.
Philips North America
Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25
Vortex Surgical Inc.
HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-32J
Howmedica Osteonics Corp.
EZDilate Fixed Wire Balloon 18-19-20. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model:…
Olympus Corporation of the Americas
EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002
Datex-Ohmeda, Inc.
Achieva 1.5T. Model (REF) Numbers 781196, 781343, 781296.
Philips North America
SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #7 -Intended for knee replacement Part Number: 73-0710
Howmedica Osteonics Corp.
Terragene Bionova PCD (PCD222-C)
TERRAGENE S.A.
SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #9 -Intended for knee replacement Part Number: 73-0910
Howmedica Osteonics Corp.
DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-611
Howmedica Osteonics Corp.
SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3308
Howmedica Osteonics Corp.
Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210
FX SHOULDER
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.