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 149 of 808
EvAir CPRSR Kit Upgrade: a) DISS/CEE 7/7 230V 50/60 HZ, Model Number M1230849; b) DISS/NEMA 5-15 115V 60 HZ, Model Number M1230847; c) NIST/BS…
Datex-Ohmeda, Inc.
SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3910
Howmedica Osteonics Corp.
Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number: 82-2-0910
Howmedica Osteonics Corp.
Sofsilk Braided Silk sutures: CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 GS-831 SOFSILK* 4-0 BLK 75CM V20 X36 S-176 SOFSILK* 0 BLK 12X45CM PCT X24 S-182…
Covidien LP
RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product Number: 6637-0-831
Howmedica Osteonics Corp.
LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-231
Howmedica Osteonics Corp.
EZDilate Wire Guided Balloon 18-19-20. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years…
Olympus Corporation of the Americas
EVair air compressor, model numbers: M1230849 and M1230847
Datex-Ohmeda, Inc.
Custom procedural convenience kits and trays, anesthesia, labeled as: a) HEART ANESTHESIA BUNDLE NS, Kit Number LMHA01V; b) OR/Anesthesia Centra…
American Contract Systems, Inc.
Intera 1.5T Achieva Nova-Dual. Model (REF) Number 781173.
Philips North America
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0510
Howmedica Osteonics Corp.
Atlan, Gas Machine for Anesthesia or Analgesia, Catalog numbers 8621500 (Atlan A350) and 8621600 (Atlan A350 XL)
Draegerwerk Ag & Co. Kgaa
SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0515
Howmedica Osteonics Corp.
Custom procedural convenience kits and trays, Ophthalmic use, labeled as: a) EYE PACK, kit number LVEY27; b) Laminectomy, kit number UIOL34AG
American Contract Systems, Inc.
SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #5 -Intended for knee replacement Part Number: 73-0510
Howmedica Osteonics Corp.
TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600
MICROVENTION INC.
Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number: 82-2-0908
Howmedica Osteonics Corp.
MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1626B
MEDLINE INDUSTRIES, LP - Northfield
SCORPIO TS TIB INSERT. Intended for knee replacement Part Number: 72-4-7518
Howmedica Osteonics Corp.
SCORPIO TS TIB INSERT -Intended for knee replacment Part Number: 72-4-7516
Howmedica Osteonics Corp.
EZDilate Fixed Wire Balloon 11-12-13. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model:…
Olympus Corporation of the Americas
SmartPath to dStream for 1.5T. Model (REF) Numbers 781260, 782112.
Philips North America
LARGE PRIMARY REV.TIB.INSERT- DURACON Intended for knee replacement Product Number: 6637-4-231
Howmedica Osteonics Corp.
Custom procedural convenience kits and trays, Othopedic use, labeled as: a) HIP FRACTURE, kit number AHHF15C; b) HIP FRACTURE, kit number AHHF15…
American Contract Systems, Inc.
Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-32J
Howmedica Osteonics Corp.
SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3508
Howmedica Osteonics Corp.
Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0908
Howmedica Osteonics Corp.
EZDilate Fixed Wire Balloon 16-17-18. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model:…
Olympus Corporation of the Americas
DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-709
Howmedica Osteonics Corp.
Bard¿ Nasogastric Sump Tube with ENFit, 14Fr., 48in Long, REF EN0042140
C.R. Bard Inc
Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 18Fr., 48in Long, REF EN0046180
C.R. Bard Inc
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrators, Ca…
Ortho-Clinical Diagnostics, Inc.
Bard¿ Nasogastric Sump Tube with ENFit, 18Fr., 48in Long, REF EN0042180
C.R. Bard Inc
Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 14Fr., 48in Long, REF EN0046140
C.R. Bard Inc
Bard¿ Nasogastric Sump Tube and PreVent¿ Filter and Lopez Valve¿ with ENFit, 14Fr., 48in Long, REF EN0056140
C.R. Bard Inc
Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit", 12Fr., 48in Long, REF EN0046120
C.R. Bard Inc
Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947
Beckman Coulter, Inc.
iQ200 Series Urine Microscopy Analyzers, Part Numbers: a) 700-3320, b) 700-3370, c) 700-3345, d) 700-3347, e) C10683, f) 700-3375, g) 7…
Beckman Coulter, Inc.
Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002
Ossur H / F
TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile.
St. Jude Medical, Atrial Fibrillation Division, Inc.
Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 10Fr., 36in Long, REF EN0046100
C.R. Bard Inc
Bard¿ Lopez Valve¿ with ENFit, REF EN0056000
C.R. Bard Inc
iQ Waste Well Adapter, Part Number: 700-3393
Beckman Coulter, Inc.
Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DWJ001, L: 7mm, Cementless Sterile.
Tornier, Inc
PANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic acid testing system which fully automates all steps necessary t…
Hologic, Inc.
Achieva 3.0T, Model No. 781177
Philips North America
EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic
Phadia Ab
Bard¿ Nasogastric Sump Tube and PreVent¿ Anti-Reflux Filter and Lopez Valve¿ with ENFit, 18Fr., 48in Long, REF EN0056180
C.R. Bard Inc
Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 16Fr., 48in Long, REF EN0046160
C.R. Bard 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.