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 · 2026-08-28
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 623 of 819
EndoVive 3s Low Profile Balloon Kits Part Number: M00548380 (XMD P/N 70-0050-514) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00548310 (XMD P/N 70-0050-A12) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
Convenience Kits from Centurion that contain an In-Vision- Plus Needleless IV Connector, Model: code RYM5001 InVision-Plus¿ Needless IV Connector…
Centurion Medical Products Corporation
CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous uncemented various sizes The CPT Hip System is indicated for cemented use …
Zimmer Biomet, Inc.
EndoVive 3s Low Profile Balloon Kits Part Number: M00548570 (XMD P/N 70-0050-816) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00548370 (XMD P/N 70-0050-414) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00548280 (XMD P/N 70-0050-712) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
BCS Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10454728 (BCS RECONDITIONED),…
Siemens Healthcare Diagnostics, Inc.
EndoVive 3s Low Profile Balloon Kits Part Number: M00548640 (XMD P/N 70-0050-F16) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
Olympus, Model No. PCF-160AL, flexible scope, large diameter, video colonoscope
Integrated Medical Systems Inc
NKII CSTI Porous Femoral NKII NP Femoral prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer variou sizes Pr…
Zimmer Biomet, Inc.
Specify 5-6-5 Lead, Specify 2x8 Lead, Model Numbers: 39565, 39286. Spinal cord stimulation leads. Part of a neurostimulation system for treating ch…
Medtronic Neuromodulation
EndoVive 3s Low Profile Balloon Kits Part Number: M00549420 (XMD P/N 70-0050-C22) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00549430 (XMD P/N 70-0050-D22) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00548930 (XMD P/N 70-0050-C20) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
Olympus, Model No. CF-H180AL, flexible scope, large diameter, video colonoscope
Integrated Medical Systems Inc
Stryker, Gamma Guide Pin, 4x400 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Stryker Howmedica Osteonics Corp.
EndoVive 3s Low Profile Balloon Kits Part Number: M00549510 (XMD P/N 70-0050-724) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
Philips IntelliVue Measurement Module X1 Model: M3001A
Philips Electronics North America Corporation
Bipolar Shell prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented various sizes Use of the MultiPolar Bip…
Zimmer Biomet, Inc.
Stryker, T2 K-Wire, 3x285 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Stryker Howmedica Osteonics Corp.
WARM STEAM Personal Steam Inhaler-Adjustable control to regulate flow of steam Soft touch facial & nasal masks" Product labeling reads in part: "Wel…
Bigwall Enterprises
EndoVive 3s Low Profile Balloon Kits Part Number: M00549380 (XMD P/N 70-0050-822) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
HipLOC CHS Plate/Lag Screw Introducer
Biomet, Inc.
Stryker, T2 Guidewire, Smooth-Tipped, 2.2 x 800mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Stryker Howmedica Osteonics Corp.
EndoVive 3s Low Profile Balloon Kits Part Number: M00548490 (XMD P/N 70-0050-G14) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M005489490 (XMD P/N 70-0050-524) The EndoVive 3s Low Profile Balloon is intended to provide gas…
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00548250 (XMD P/N 70-0050-412) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00548820 (XMD P/N 70-0050-120) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00548360 (XMD P/N 70-0050-314) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00548760 (XMD P/N 70-0050-B18) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
Olympus, Model No. GIF-XQ140, flexible scope, large diameter, video gastroscope
Integrated Medical Systems Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00548530 (XMD P/N 70-0050-416) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00548590 (XMD P/N 70-0050-A16) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
VERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacement for the following: severe hi…
Zimmer Biomet, Inc.
EndoVive 3s Low Profile Balloon Kits Part Number: M00548260 (XMD P/N 70-0050-512) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00549320 (XMD P/N 70-0050-222) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
Single Lumen Pressure Monitoring Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Pr…
Cook Inc.
Olympus, Model No. CF-140L, flexible scope, large diameter, video colonoscope
Integrated Medical Systems Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00549360 (XMD P/N 70-0050-622) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
Shuttle Select Slip-Cath Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and …
Cook Inc.
Stryker Aero-AL Impaction handle Catalog Number 48921007. Stryker Spine Manufactured by : Stryker Spine SAS France Used to facilitate insertion …
Stryker Spine
Femoral Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated c…
Cook Inc.
Olympus, Model No. CF-Q180AL, flexible scope, large diameter, video colonoscope
Integrated Medical Systems Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00548630 (XMD P/N 70-0050-E16) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00548550 (XMD P/N 70-0050-616) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
Philips IntelliVue Module Measurement X2 Model: M3002A
Philips Electronics North America Corporation
Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures.
Stryker Howmedica Osteonics Corp.
Flow-i Anesthesia System Product Usage: The indication for the Flow-i Anesthesia System is administering inhalation anesthesia while controlling …
Maquet Cardiovascular Us Sales, Llc
PRCT MIS CR MOB PLT prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing various sizes This device is indicated …
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.