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 · 2026-08-27
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 577 of 819
Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 Smart-hopping (2.4GHz) Product Number: 865351 Worldwide Except USA Exchange part: 453…
Philips Electronics North America Corporation
Minor Lithotomy Pack, Kit number 002650-7 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Endoscopic Articulating Linear Cutter, ATB35. Standard 35 MM. The ENDOPATH ETS-Flex Endoscopic Articulating Linear Cutter has application in general…
Ethicon Endo-Surgery Inc
Total Hip Pack, Kit number PSS2956 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Basic Setup Pack, kit part number AMS1787(A convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Dr. Newman Surgical Procedure Pack, kit numbers PSS1689 PSS1689(A convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 WMTS Smart-hopping (1.4GHz) Product Number: 865350 Exchange part: 453564262491 453564…
Philips Electronics North America Corporation
VITROS Chemistry Products LAC Slides, REF/Product Codes 843 3880 (300 slides per sales unit) and 815 0112 (90 slides per sales unit), Unique Device I…
Ortho-Clinical Diagnostics
Hand Tray PSS2365(A, PSS2365(B, PSS2365(C, PSS2365(D PSS2365(E, convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Facial Plastic Pack, Kit numbers AMS2533, AMS2533(A, and AMS3327 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Calix P PEEK Lumbar System, PLIF Rasp
X Spine Systems Inc
Plastic Pack , Kit number AMS1833(A convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
General Plastic Pack, Kit number PSS2432, PSS2432(A, PSS2717, PSS2717(A, and PSS2717(B. convenience custom kits used for general surgery in hospital…
Windstone Medical Packaging, Inc.
General Plastics Pack, Kit number 008617-1 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Lap Band Pack, Kit number AMS1785(A convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
General Pack I, Kit number CMP1811(B convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
25 gauge VersaVit 2.0 Vitrectomy Cutter, Product/Part Number 70935, packaged in a Tyvek/Mylar double pouch configuration.
Synergetics Inc
CORE¿ Suction Irrigation Handpiece Y-Tubing set, with 5mm x 32cm Length Probe for Single Solution or Dual Bags, Catalog Number CD8200 The CORE Sucti…
ConMed Corporation
Local Pack, Kit number AMS1544 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Total Knee Pack, Kit number AMS4010(A convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Podiatry Pack, Kit number AMS1541, AMS2778, PSS2645, and PSS3422 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Laparoscopy Kit, Kit number PSS1038(A and PSS1038(B convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
DND Pack, Kit number AMS3846 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Dr. Fetters Hand Pack, Kit number AMS3690 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Basic Pack, Kit part numbers AMS1388(A, AMS1520, AMS1868, AMS1868(A, AMS1868(B, AMS2608, AMS2608(A, AMS2728, AMS2728(A, AMS2758, AMS2758(A, AMS2972,…
Windstone Medical Packaging, Inc.
VITROS Chemistry Products URIC Slides, REF/Product Code 194 3927 (300 slides per sales unit), Unique Device Identifier No. 10758750000340, Rx ONLY, …
Ortho-Clinical Diagnostics
Calix T PEEK Lumbar System, TLIF Rasp
X Spine Systems Inc
General Pack, Kit numbers: AMS2334, AMS2334(A, AMS2967, AMS2967(A, AMS3239, AMS3709, and AMS3709(A. convenience custom kits used for general surgery…
Windstone Medical Packaging, Inc.
CADstream software Product Usage: CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of m…
Merge Healthcare, Inc.
Upper Extremity Pack, Kit number AMS2536 and AMS2536(A convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Lap/Pelviscopy Pack, Kit number AMS4151, PSS3256, PSS3256(A convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Ortho Kit, Kit number PSS1039(A and PSS1039(B convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Basic Extended Pack, kit part number AMS4421. convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Fusion Workstation.; Indicated for the transmission and review of radiological images.
Merge Healthcare, Inc.
Pelviscopy/Laparoscopy Pack, Kit number PSS3342 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Facial Tray, Kit number PSS1558(A convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Endoscopy Pack, Kit number PSS1646 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
D & C Kit, Kit number CMP1466 and CMP1466(A convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
25 gauge VersaVit 2.0 Procedure Pack with Mid-Field Illuminator, Product/Part Number 70025S, packaged in HIPS rigid tray with a Tyvek lid sterile bar…
Synergetics Inc
Morris Hysto Pack, Kit number PSS3198 and PSS3198(A convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
General Male Pack, Kit number AMS1580 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Uniflex Humeral Nail: 467265 G-PIN 2.8BL 3.2PL 60CM 2PK Pin, Fixation, Smooth A 467265-01 Ball Tip Guide Pin is used to guide reamers down the hu…
Zimmer Biomet, Inc.
Endoscopic Articulating Linear Cutter, 38ATW35. VASCULAR/THIN 35MM The ENDOPATH ETS-Flex Endoscopic Articulating Linear Cutter has application in ge…
Ethicon Endo-Surgery Inc
Peri GYN, Kit number PSS2193(A convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Sagittal Blade 18.0X0.97X90MM, Model Number: 6118-097-090 Product Usage: Heavy duty Sagittal Blades are used to cut bone and bone related tissue …
Stryker Instruments Div. of Stryker Corporation
Minor Pack AMS1374(A, CMP1560, PSS3517, PSS3517(A, PSS3518, PSS3518(A, PSS3541, and PSS3541(A. convenience custom kits used for general surgery in h…
Windstone Medical Packaging, Inc.
Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 802.11a/b/g Product Number: 865352 Exchange part: 453564262491 453564262511 453564615…
Philips Electronics North America Corporation
Plastic Kit, Kit number CMP1084(B convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Lower Extremity Pack, Kit number AMS1375(A, AMS2540, AMS2540(A, and AMS4669. convenience custom kits used for general surgery in hospital operating …
Windstone Medical Packaging, Inc.
Laparoscopic Pack, Kit number AMS2499 convenience custom kits used for general surgery in hospital operating room
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.