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 · 2026-08-24
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 499 of 819
731 Series Ventilators running software version 05.20.00 The devices in the ZOLL ventilator are indicated for use in the management of infant thr…
ZOLL Medical Corporation
Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code H93876105
Baxter Healthcare Corporation
OptiView Amplification Kit, Ventana Part Number 760-099, Roche GMMI 06396518001 in vitro diagnostic
Ventana Medical Systems Inc
ultraView SISH DNP Detection Kit US, Ventana Part Number 760-098, Roche GMMI 05572037001 in vitro diagnostic
Ventana Medical Systems Inc
AVID TruCustom NEURO PK convenience kits, Item Code: LGHM021-08
Avid Medical, Inc.
VITROS Chemistry Products Performance Verifier is used as an assayed control to monitor the performance on VITROS 250/350/5, 1 FS and 4600 Chemistry …
Ortho Clinical Diagnostics Inc
DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants are intended for use in total shoulder or hemi-shoulder replac…
DePuy Orthopaedics, Inc.
ST AIA-PACK¿ PROG III, Progesterone III Assay, Part Number: 025240
Tosoh Bioscience Inc
Vis-U-All High Temp 18"x22" Self Seal Pouch 100 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pou…
Steris Corporation
Vis-U-All High Temp 18"x22" Heat Seal Pouch 100 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pou…
Steris Corporation
ADVIA Centaur¿ T3 ADVIA Centaur T3: For in vitro diagnostic use in the quantitative determination of triiodothyronine (T3) in serum using the ADVI…
Siemens Healthcare Diagnostics, Inc
Alcon 25+¿ TOT ALPLUS¿ Vitrectomv Pak Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision System.
Alcon Research, LTD.
Foot Controls impacted for the following devices: OAKWORKS¿ Medical CFPM 300 Imaging Table OAKWORKS¿ Medical CFPM 301 Imaging Table OAKWORKS¿ Me…
Oakworks Inc
1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Gravity Tube Set is intended to deliver irrigation fluid from irrigation containers to the…
DePuy Mitek, Inc., a Johnson & Johnson Co.
AVID TruCustom EXTREMITY PACK convenience kits, Item Code: MADN012-01 and MADN012-02
Avid Medical, Inc.
Integrity R1.2
Elekta Limited
AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO¿ is intended to be used for X-ray computed tomography applications for ana…
Mobius Imaging, LLC
AVID TruCustom OBSTETRICAL PACK convenience kits, Item Code: HLDH008-04
Avid Medical, Inc.
Ultra Renew Plus
Accord Media, LLC
Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Po…
Steris Corporation
Agility with Integrity R3.2
Elekta Limited
979195 Loaner Kit for femoral intramedullary nail. Orthopedic instrument.
Zimmer Biomet, Inc.
Vis-U-All High Temp 3"x8" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch…
Steris Corporation
Wills-Oglesby Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding
Cook Inc.
Custom Pak¿ (Custom Pak in which Alcon 25+¿ TOTALPLUS¿ Vitrectomy Pak is a component.) Includes all necessary items for a core vitrectomy procedu…
Alcon Research, LTD.
3M Surgical Clipper Professional 9681
3M Company - Health Care Business
AVID TruCustom PLASTIC BASIN PACK convenience kits, Item Code: MADN008-03
Avid Medical, Inc.
Vis-U-All High Temp 8"x16" Heat Seal Pouch 100 pouches per box; 9 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouc…
Steris Corporation
REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring.
LifeCell Corporation, A Wholly Owned Subsidiary of Allergan PLC
MOOG Curlin Infusion Administration Set, Ref 340-4133, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and Needleless Injection Port (Positive Pr…
Zevex Incorporated (dba Moog Medical Medical Devices Group)
OTTO BOCK Kenevo knee joints Model 3C60=ST
Otto Bock Healthcare Product
AVID TruCustom PACEMAKER PACK convenience kits, Item Code: LGHM030-06
Avid Medical, Inc.
AVID TruCustom ORTHO TRAY convenience kits, Item Code: LGHM004-07 and LGHM004-08
Avid Medical, Inc.
Vis-U-All High Temp 16"x16" Self Seal Pouch 100 pouches per box; 6 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pou…
Steris Corporation
AVID TruCustom CATH PACK convenience kits, Item Code: LGHM036-14
Avid Medical, Inc.
Ultrasound Transducer, Model Number: UST-5550-R, is used in conjunction with a diagnostic ultrasound system evaluation during robotic and non-robotic…
Hitachi Medical Systems America Inc
Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouc…
Steris Corporation
Intellivue iX Information Center Software - All PIIC iX Surveillance stations including: 866023 IntelliVue Info Center iX A.0 866117 PIIC Classic U…
Philips Electronics North America Corporation
Destination Guiding Sheath catheter introducer, Catalog Number: RSR06 Product Usage: The Destination¿ Guiding Sheath is designed to be used for t…
Terumo Medical Corporation
AVID TruCustom PACEMAKER PACK (CARDIOLOGY) convenience kits, Item Code: VAMK016
Avid Medical, Inc.
Surgical punch; sealed pouches packed in punch shelf box Intended for use by trained surgeons to create circular cuts in soft tissue or openings …
Alto Development Corp
**Recall Expanded to add these models: Bigger Better-Bladder cardiopulmonary bypass blood reservoir; Models: BBB38 (individual, sterile, pouched) and…
Circulatory Technology Inc
OTTO BOCK Kenevo knee joints Model 3C60
Otto Bock Healthcare Product
Allura Xper FD and and Xper FD ORT - Philips X-ray Systems Product Usage: The Allura Xper FD10 and Alllura Xper FD10/10 is intendd for: Cardiov…
Philips Electronics North America Corporation
CINtec PLUS Cytology Kit (CE-IVD), Ventana Part Number 605-100, Roche GMMI 06889565001 in vitro diagnostic
Ventana Medical Systems Inc
Zimmer Segmental System, ZSS Distal Femur. Sizes as follows: a. Size B-LT (Item No. 00585001201); b. Size B-RT (Item No. 00585001202); c. S…
Zimmer Biomet, Inc.
Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare Ceiling Mounted Surgical Light System.
Stryker Communications
Artis zee and Artis zeego model Interventional fluoroscopic x-ray foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.
Siemens Medical Solutions USA, Inc
AVID TruCustom LOWER EXTREMITY convenience kits, Item Code: LGHM038-03 and LGHM038-04
Avid Medical, Inc.
MOOG Curlin Infusion Administration Set, Ref 340-4134, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and Y-Site with Check Valve, packaged 20/b…
Zevex Incorporated (dba Moog Medical Medical Devices Group)
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.