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 · 2026-08-22
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 456 of 819
Overhead Counterpoise Systems (OCS), OCS CONF,STD CEIL MNT, STD HORZ ARM, Catalog # OCS 115A, Material Number 59880253
Bayer Medical Care, Inc.
Quasar MD Plus, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device.
Quasar Bio-Tech, Inc.
Laparoscopy CDS
Medline Industries, Inc.
GE Vivid E9 ultrasound system Product Usage: GE Vivid E9 ultrasound system is a general purpose ultrasound system for use in cardiac imaging.…
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
Zen RC Toric-Gas permeable contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx)as follows: Zen RC TPC (Toric Peripheral Curve) Zen RC F…
Alden Optical
Baby Quasar Plus, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device.
Quasar Bio-Tech, Inc.
LASER CDS
Medline Industries, Inc.
GE LOGIQ 9 ultrasound system Product Usage: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdomin…
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830
DePuy Orthopaedics, Inc.
Bard Midstream Urine Collector with Rigid Funnel and Iodophor Prep Pads. Product Packaging: Three (3) PVP-I prep pads are packed into each urine col…
Bard Medical Division
WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523.
Biosense Webster, Inc.
GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems
GE Medical Systems China Co., Ltd.
AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01540S, for use on the cranium
Stryker Leibinger GmbH & Co. KG
QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01526S, for use on the cranium
Stryker Leibinger GmbH & Co. KG
QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01524S, for use on the cranium
Stryker Leibinger GmbH & Co. KG
SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER/CATHETER SET; T94C T94M T96M T98M
Medical Components, Inc dba MedComp
AXS PP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01541S, for use on the cranium
Stryker Leibinger GmbH & Co. KG
Medline 0.9 % Sodium Chloride Injection, USP 5 mL in 10 mL Syringe ZR Intended for flushing IV catheters and IV tubing only.
Medline Industries Inc
QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01521S The Stryker QuickFlap Sterile Procedure Pack is inten…
Stryker Leibinger GmbH & Co. KG
RAPIDLab 1265 Blood Gas Analyzer; 110321852, 10470366, 10491395 Device is point-of-care system for comprehensive lab-quality testing to patient's…
Siemens Healthcare Diagnostics, Inc.
RAPIDLab 1245 Blood Gas Analyzer; 10321844, 10337179, 10491393 Device is point-of-care system for comprehensive lab-quality testing to patient's …
Siemens Healthcare Diagnostics, Inc.
Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and identification of pathogenic enteric bacteria, viruses, and genetic virulence ma…
Luminex Corporation
Haemonetics OrthoPAT System-Integrated Set. Product Code: 1150H-00 OrthoPAT orthopedic perioperative autotransfusion system indicated for use to…
Haemonetics Corporation
AXS PP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01548S, for use on the cranium
Stryker Leibinger GmbH & Co. KG
QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01522S, for use on the cranium.
Stryker Leibinger GmbH & Co. KG
Duo-Flow XTP Straight Full Set; Hemodialysis catheter insertion kits, AAC02106 AAC02107 AAC02108
Medical Components, Inc dba MedComp
Duo-Flow Catheter Full Tray; MCDLT3500 MCDLT4000 MCDLT4400 MCDLT4424# Hemodialysis catheter insertion kits
Medical Components, Inc dba MedComp
Duo-Flow Double Lumen Catheter Only/Catheter Set; T114C T114M T116C T116M T116ME T118C T118M T118ME T119M
Medical Components, Inc dba MedComp
Roche cobas p 612 pre-analytical system (63x) Model: 07563116001 The cobas p 612 pre-analytical system is a computer controlled fully automatic …
Roche Diagnostics Corporation
AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01541S, for use on the cranium
Stryker Leibinger GmbH & Co. KG
SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER TRAY; T3500 T4000 T4400 T4424
Medical Components, Inc dba MedComp
AXS PP, 1X14MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01544S, for use on the cranium
Stryker Leibinger GmbH & Co. KG
QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01534S, for use on the cranium
Stryker Leibinger GmbH & Co. KG
QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01528S, for use on the cranium
Stryker Leibinger GmbH & Co. KG
Ceterix Disposable Knot Pusher / Suture Cutter; NovoCut Suture Manager. Model# CTX-C001. orthopedic arthroscopic accessory.
Ceterix Orthopedics, Inc.
AXS PP, 1X20MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01546S, for use on the cranium
Stryker Leibinger GmbH & Co. KG
QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01531S, for use on the cranium
Stryker Leibinger GmbH & Co. KG
Double Lumen CRRT/ABP Catheter Set; Hemodialysis catheter insertion kits, DL 11/15 DL 11/20 DL 9/15
Medical Components, Inc dba MedComp
FLOSEAL Special Applicator Tips in cartons labeled in part, "Floseal SPECIAL APPLICATOR TIPS***6 x Malleable Tip Trimmable Tip***Baxter***." The pou…
Baxter Healthcare Corporation
Cortisol Saliva Luminescence Immunoassay The IBL International Cortisol Saliva Luminescence immunoassay is intended for the in-vitro diagnostic q…
Tecan US, Inc.
Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems. Product Number/CFN: 186-0208 UDI-Device Identifier (GTIN/UPN): 108845211303…
Covidien LLC
RAPIDPoint 500 Blood Gas Analyzer; 10492730, 1069855, 10696857, 10697306 Device is point-of-care system for comprehensive lab-quality testing to …
Siemens Healthcare Diagnostics, Inc.
Duo-Flow IJ Full Tray; MCDLT114IJ MCDLT116IJ MCDLT118IJ
Medical Components, Inc dba MedComp
DUO FLOW DOUBLE LUMEN CATHETER, XTP114CT, XTP114MT, ; RAULERSON DUO FLOW IJ DOUBLE LUMEN CATHETER/CATHETER SET, XTP114IJC, XTP114IJS, XTP114IJSE, XT…
Medical Components, Inc dba MedComp
CIVCO Needle Guide, REF 676-150, QTY 24, STERILE EO
Civco Medical Instruments Co. Inc.
QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01520S The Stryker QuickFlap Sterile Procedure Pack is inte…
Stryker Leibinger GmbH & Co. KG
Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label for the HemoPoint H2 shows Manufactured by EKF-d…
Stanbio Laboratory, LP
CIVCO Needle Guide, REF 676-144, QTY 24, STERILE EO
Civco Medical Instruments Co. Inc.
Stryker Mako Vizadisc Knee Procedure Tracking Kit
Mako Surgical Corporation
Duo-Flow XTP Straight Full Set, RMS02105 RMS02108
Medical Components, Inc dba MedComp
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.