Product category · Updated Jul 29, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
Medical Devices ranks #1 of 12 among PlainRecalls categories by recall count (40,910 notices, 39.3% of the archive); 9% of graded records are high-severity.
The FDA, CPSC and NHTSA have published 40,910 medical devices recalls between 2000 and 2026 - roughly 39.3% of the 104,158-record archive. Among 12 product categories, that is #1 of 12. Of the 40,910 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.
- 40,910 total recalls
- #1 of 12 among categories
- 9% graded high-severity
- FDA Devices top agency
Category snapshot
According to PlainRecalls' category ranking (distinct recall events, same sort as /category), Medical Devices is #1 of 12 (1st of 12) with 40,910 recalls, about 39.3% of the 104,158-record federal archive, with 3,645 graded high-severity, most issued by FDA Devices.
- 40,910
- total recalls
- #1 of 12
- category rank by events
- 9%
- graded high-severity
- FDA Devices
- top issuing agency
Medical Devices recalls by year
2000–2026
Severity distribution
Graded records only
- High severity 3,645
High severity
3,645 recalls
- Moderate
Moderate
36,211 recalls
- Lower severity 1,054
Lower severity
1,054 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,635 recalls
- FDA Drug 934
FDA Drug
934 recalls
- CPSC 306
CPSC
306 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 340 of 819
ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Num…
Siemens Medical Solutions USA, Inc
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X40MM, Item Number 810M6540 - Product Usage: are non-cervical spinal fixation devices …
Zimmer Biomet, Inc.
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X55MM, Item Number 810M6555 - Product Usage: are non-cervical spinal fixation devices …
Zimmer Biomet, Inc.
da Vinci SP surgical system
Intuitive Surgical, Inc.
safeCLINITUBES Blood Sampler;REF 942-969;D957P-70-45x1
Radiometer Medical ApS
Sterile Custom Packs to be used in surgical procedures.
American Contract Systems
OSTEOVATION RMX Injectable BVF 5CC . REF/UDI: 390-6001/ /00813845021082 - Product Usage: The product provides a bone void filler that is replaced by …
Osteomed, LLC
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X35MM, Item Number 810M4535 - Product Usage: are non-cervical spinal fixation devices …
Zimmer Biomet, Inc.
Accelerator a3600 Automation System using the Aliquoter Module (Inpeco P/N FLX-212) - Product Usage: The systems consolidate multiple Analytical inst…
Inpeco S.A.
Multifire VersaTrack Auto Suture Hernia Stapler, 4.0mm, Part No. 174021 - Product Usage: has application in endoscopic general surgery procedures for…
Covidien Llc
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X45MM, Item Number 810M7545 - Product Usage: are non-cervical spinal fixation devices …
Zimmer Biomet, Inc.
Sterile Custom Packs to be used in surgical procedures.
American Contract Systems
OSTEOVATIONEX 5CC INJECT FORMULA. REF/UDI: 390-0005/00813845020023 - Product Usage: The product provides a bone void filler that is replaced by bone …
Osteomed, LLC
Gambro Cartridge Blood Set Prime Line - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.
Baxter Healthcare Corporation
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X30MM, Item Number 810M4530 - Product Usage: are non-cervical spinal fixation devices …
Zimmer Biomet, Inc.
Sterile Custom Packs to be used in surgical procedures.
American Contract Systems
Sterile Custom Packs to be used in surgical procedures.
American Contract Systems
Sterile Custom Packs to be used in surgical procedures.
American Contract Systems
System, Tomography Computed Emmission
GE Healthcare, LLC
safeCLINITUBES Blood Sampler;REF 942-892;D957P-70-100x1
Radiometer Medical ApS
OSTEOVATION 10CC INJECT FORMULA. REF/UDI: 390-2010/00813845020061 - Product Usage: The product provides a bone void filler that is replaced by bone d…
Osteomed, LLC
Multifire Endo Hernia 0 12mm Stapler with 4.8mm Disposable Loading Unit , Part No. 174025 - Product Usage: has application in endoscopic general surg…
Covidien Llc
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X55MM, Item Number 810M7555 - Product Usage: are non-cervical spinal fixation devices …
Zimmer Biomet, Inc.
EQUISTREAM¿ XK Long-Term Hemodialysis Catheter. REF/UDI:5913190/(01)00801741013836; 16F
Bard Peripheral Vascular Inc
Aptio Automation System using the Aliquoter Module (Inpeco P/N FLX-212) - Product Usage: The systems consolidate multiple Analytical instruments into…
Inpeco S.A.
Custom Packs to be used in surgical procedures.
American Contract Systems
FlexLab Augomation System using the Aliquoter Module (Inpeco P/N FLX-212) The systems consolidate multiple Analytical instruments into a unified work…
Inpeco S.A.
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X35MM, Item Number 810M6535 - Product Usage: are non-cervical spinal fixation devices …
Zimmer Biomet, Inc.
Sterile Custom Packs to be used in surgical procedures.
American Contract Systems
Beckman Coulter Access Immunoassay Systems, Access Free T3 Triiodothyronine, REF A13422 (UDI: 15099590201661) for use with the Access Family of Immu…
Beckman Coulter Inc.
OSTEOVATION 5CC INJECT FORMULA. REF/UDI: 390-2005/00813845020054 - Product Usage: The product provides a bone void filler that is replaced by bone du…
Osteomed, LLC
Gambro Cartridge Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatment using Dial…
Baxter Healthcare Corporation
Type S Extension For use with Varian, CIVCO, Prescription Only - Product Usage: Device is intended for patient positioning.
Med Tec Inc
Xhibit Central, Model No. 96102 - Product Usage: intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patie…
Spacelabs Healthcare, Inc.
Sterile Custom Packs to be used in surgical procedures.
American Contract Systems
OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer
Olympus Corporation of the Americas
Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin Antibody II, REF A32898 (UDI: 15099590202910) for use with the Access Family of Im…
Beckman Coulter Inc.
Centrella Smart+ Bed, Catalog Number P7900
Hill-Rom, Inc.
OSTEOVATION 10 CC IMPACT FORMULA. REF/UDI: 390-2110/ /00813845021092 - Product Usage: The product provides a bone void filler that is replaced by bon…
Osteomed, LLC
Magnetic Resonance Imaging Diagnostic Device accessory - Product Usage: The chest pneumograph (also referred to as the pneumatic bellows, respiration…
Philips North America, LLC
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X40MM, Item Number 810M4540 - Product Usage: are non-cervical spinal fixation devices …
Zimmer Biomet, Inc.
OSTEOVATION RMX 10 CC Injectable. REF/UDI: 390-6002/ /00813845021099 - Product Usage: The product provides a bone void filler that is replaced by bon…
Osteomed, LLC
OSTEOVATIONEX 2CC INJECT FORMULA. REF/UDI: 390-0002/00813845020009 - Product Usage: The product provides a bone void filler that is replaced by bone …
Osteomed, LLC
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X55MM, Item Number 810M5555 - Product Usage: are non-cervical spinal fixation devices …
Zimmer Biomet, Inc.
Multifire Endo Hernia 0 12mm Stapler with 4.0mm Disposable Loading Unit , Part No. 174027 - Product Usage: has application in endoscopic general surg…
Covidien Llc
Sterile Custom Packs to be used in surgical procedures.
American Contract Systems
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X45MM, Item Number 810M6545 - Product Usage: are non-cervical spinal fixation devices …
Zimmer Biomet, Inc.
OSTEOVATION 3CC IMPACTFORMULA. REF/UDI: 390-2103/00813845020078 - Product Usage: The product provides a bone void filler that is replaced by bone dur…
Osteomed, LLC
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X50MM, Item Number 810M7550 - Product Usage: are non-cervical spinal fixation devices …
Zimmer Biomet, Inc.
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X40MM, Item Number 810M5540 - Product Usage: are non-cervical spinal fixation devices …
Zimmer Biomet, 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 29, 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 29, 2026.