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
Where Medical Devices sits among all 12 categories
Distinct recall-event inventory across every PlainRecalls product category. Medical Devices is marked; archive size reflects reporting volume, not inherent product danger.
Medical Devices vs all categories by recall count
Where this category's archive sits among every tracked product class
40,910 1st of 12 the highest of 12 categories
Categories, banded by distinct recall-event inventory
Each bar is a band; taller bars hold more categories. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source FDA · CPSC · NHTSA federal recall filings · 2026-08-26
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 552 of 819
CaviWipes1 Extra Large, Part No. 13-5150 The brand name of the device is CaviWipes1 Extra Large, a surface disinfectant. The device has been assigne…
Metrex Research, LLC.
The UNI-CP System; Model Number: 330230SND.
Integra LifeSciences Corp.
Apollo EZ; Model: 9784152036 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedur…
Villa Sistemi Medicali S.P.A.
MEVATRON KD-2, accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray …
Siemens Medical Solutions USA, Inc
MEVATRON M 6700 (MX) Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver …
Siemens Medical Solutions USA, Inc
Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI.
Merge Healthcare, Inc.
RSP Impaction Fixture
Encore Medical, Lp
Biograph 6 TruePoint, Material Number 10097290 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care profes…
Siemens Medical Solutions USA Inc.
Roth Net Polyp Retrieval
US Endoscopy Group Inc
DR Systems Unity PACS software, now known as Merge Unity PACS
Merge Healthcare, Inc.
A-series lift - A625 Manual w/Load Cell & Wi-Fi, Omni Part No. 324124. Prism Medical.
ErgoSafe Products, LLC (DBA) Prism Medical
DR Systems Unity PACS software, now known as Merge Unity PACS. Product Usage: Merge Unity PACS is a medical image and information management syst…
Merge Healthcare, Inc.
Nasal Pack, part number PSS2186
Windstone Medical Packaging, Inc.
Micropuncture Check-Flo Performer Introducer Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended …
Cook Inc.
Upper Torso Tray, part number PSS1554(B
Windstone Medical Packaging, Inc.
General Surgery Pack, part number PSS1380(A
Windstone Medical Packaging, Inc.
Minor/General/Ortho Pack, part number PSS3258(B
Windstone Medical Packaging, Inc.
Surgical Pack, part number PSS3540(A
Windstone Medical Packaging, Inc.
Major Pack (1345), part number AMS6565
Windstone Medical Packaging, Inc.
Ortho Pack, part number PSS3466(A
Windstone Medical Packaging, Inc.
Orbitofacial Pack, part number AMS5850(A
Windstone Medical Packaging, Inc.
Knee Pack, part number AMS4211
Windstone Medical Packaging, Inc.
Transvaginal Pack, part number CMP1767
Windstone Medical Packaging, Inc.
Major Kit, part number PHC1307(A
Windstone Medical Packaging, Inc.
Total Hip Pack, part number PSS2956
Windstone Medical Packaging, Inc.
Laparotomy Pack, part number 006268-9 Laparotomy Pack, part number AMS4418(A Laparotomy Pack, part number PSS2190(A
Windstone Medical Packaging, Inc.
Laparoscopy Pack (1184), part number AMS6562
Windstone Medical Packaging, Inc.
Vascular Pack, part number AMS4030 Vascular Pack, part number AMS4030(A
Windstone Medical Packaging, Inc.
HSG Pack, part number PSS3287
Windstone Medical Packaging, Inc.
Basic Setup Tray, part number AMS6414
Windstone Medical Packaging, Inc.
Newport Coast Basic Pack, part number 007484-1
Windstone Medical Packaging, Inc.
Arthroscopy Pack, part number AMS6559
Windstone Medical Packaging, Inc.
General Pack, part number AMS2967(A General Pack, part number AMS3239(A General Pack, part number AMS3709(B General Pack, part number AMS5341 Gen…
Windstone Medical Packaging, Inc.
TriForce Peripheral Crossing Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The TriForce Peripheral Crossing Set is i…
Cook Inc.
Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 04800735, SMN 10285904 (6 pack) Cat No. 04800840, …
Siemens Healthcare Diagnostics, Inc
C-Tray Pack, part number PSS2707(A
Windstone Medical Packaging, Inc.
Basic Pack, part number AMS1868(B Basic Pack, part number AMS2608(A Basic Pack, part number AMS3861 Basic Pack, part number AMS4309 Basic Pack, p…
Windstone Medical Packaging, Inc.
Major Laparotomy Pack - NS, part number AMS4347
Windstone Medical Packaging, Inc.
Plastic Pack, part number PSS2462 Plastic Pack, part number PSS3319 Plastic Pack, part number PSS3319(A
Windstone Medical Packaging, Inc.
Custom Venous Kit, part number TVS4024(C
Windstone Medical Packaging, Inc.
D & C Kit, part number CMP1466(A
Windstone Medical Packaging, Inc.
Eye Plastic Tray, part number PSS1931(A
Windstone Medical Packaging, Inc.
Robotic Pack, part number AMS4389
Windstone Medical Packaging, Inc.
Lap Band Pack, part number AMS1785(A
Windstone Medical Packaging, Inc.
Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 04800735, SMN 10285904 (6 pack) Cat No. 04800840, …
Siemens Healthcare Diagnostics, Inc
Custom Pack, part number AMS4776 Custom Pack, part number AMS4776(A Custom Pack, part number AMS5643 Custom Pack, part number AMS5643(A Custom Pa…
Windstone Medical Packaging, Inc.
Bayview Breast Pack, part number 009080-2
Windstone Medical Packaging, Inc.
Minor Pack, part number AMS3782(B Minor Pack, part number AMS3782(C Minor Pack, part number CMP1560 Minor Pack, part number PSS3518(B Minor Pack,…
Windstone Medical Packaging, Inc.
Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software Application Card, Model 8840 N'Vision Clinician…
Medtronic Neuromodulation
Major Breast Pack, part number AMS3409(B
Windstone Medical Packaging, 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.