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
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 422 of 819
BIOPHEN UFH Control C1, REF 224101
Aniara Diagnostica LLC
Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Left, Product No. LJV190T
Integra LifeSciences Corp.
Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XC
Gyrus ACMI, Inc.
Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 2, Right, Part No. LJU202T
Integra LifeSciences Corp.
Lactate Gen.2, Catalog Nos. 03183700190, 05171881190, 11822837190, ***added as of 5/10/19*** 03183700190 Product Usage: An In vitro diagnosti…
Roche Diagnostics Corporation
14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061422
Medical Components, Inc dba MedComp
Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XS
Gyrus ACMI, Inc.
icumedical ChemoLock Closed Vial Spike w/Skirt, (a) REF CL-80S-4 (4 units) (b) REF CL-80S-5 (5 units). Used in IV administration sets. The…
ICU Medical, Inc.
Brilliance 16 Air, 728246 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer rec…
Philips Medical Systems (Cleveland) Inc
Biomerieux Vitek 2 Test kit VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification …
bioMerieux, Inc.
SetSource ChemoClave Vented Vial Spike, 20mm, REF Z7148. Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfer D…
ICU Medical, Inc.
Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Left, Product No. LJV192T
Integra LifeSciences Corp.
BIOPHEN LMWH Control C4, REF 224201
Aniara Diagnostica LLC
Tibial Total Ankle Prosthesis Tray, Size 2, Product No. LJU222T
Integra LifeSciences Corp.
syngo Lab Data Manager System - Product Usage: syngo Lab Data Manager is a clinical system that assists medical laboratory professions with pre-analy…
Siemens Healthcare Diagnostics, Inc.
Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 1, Left, Part No. LJU211T
Integra LifeSciences Corp.
Talar Dome Total Ankle Prosthesis, Flat Cut, Size 1, Left, Product No. LJU821T
Integra LifeSciences Corp.
icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-80S. Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfe…
ICU Medical, Inc.
Diego Elite Blades Monopolar, 4mm Straight, TIA Product Code:MB4000SS
Gyrus ACMI, Inc.
icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-70S . Used in IV administration sets. The ChemoClave is a needle-free Closed System Transf…
ICU Medical, Inc.
icumedical Oncology Kit w/12" (30cm) Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter; ChemoClave Vented Vial Spike, 20mm; ChemoClave Vented Vial…
ICU Medical, Inc.
Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Right, Product No. LJV182T
Integra LifeSciences Corp.
Abbott Alinity c Processing Module LN 03R67-01 - Product Usage: The Alinity c processing module is a fully automated chemistry analyzer allowing rand…
Abbott Gmbh & Co. KG
Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Right, Product No. LJV183T
Integra LifeSciences Corp.
Talar Dome Total Ankle Prosthesis , Flat Cut, Size 3, Left, Product No. LJU823T
Integra LifeSciences Corp.
Acusnare Polypectomy (Duck Bill Shaped) Snare Used with an electrosurgical unit for endoscopic polypectomy.
Wilson-Cook Medical Inc.
Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Left, Product No. LJU822T
Integra LifeSciences Corp.
IMAGEnet 6 v1.53- IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of dig…
Topcon Medical Systems, Inc.
Salto Talaris Tibial Ankle Prosthesis Tray, Talar Dome, Size 1, Right, Part No. LJU201T
Integra LifeSciences Corp.
Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Right, Product No. LJU812T
Integra LifeSciences Corp.
PDS II SUTURE 18"(45CM) 2-0 VIO Product Code:Z739D - PDS Sutures are intended for use in soft tissue approximation, including use in pediatric cardi…
Ethicon, Inc.
Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part Number: BB4000SS
Gyrus ACMI, Inc.
Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Right, Product No. LJV181T
Integra LifeSciences Corp.
Innova IGS 6, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vas…
GE Healthcare, LLC
BIOPHEN UFH Control C2, REF 223901
Aniara Diagnostica LLC
Foot Switches used with the following systems: 722001 Allura Xper FD 10 C 722002 Allura Xper FD10 F 722003 Allura Xper FD10 722005 Allura Xper…
Philips Medical Systems Nederlands
Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Left, Product No. LJV193T
Integra LifeSciences Corp.
Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Right, Product No. LJV180T
Integra LifeSciences Corp.
BIOVENTUS Bioactive Bone Graft Putty 15g Rx only/sterile. Filler device intended for use in bony voids or gaps that are not intrinsic to the stabilit…
Bioventus, LLC
Abbott Alinity i Processing Module LN 03R65-01 - Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing ra…
Abbott Gmbh & Co. KG
Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number:BB4040SS
Gyrus ACMI, Inc.
VICRYL PLUS Sutures: VICRYL PLUS SUTURE 18"(45CM) 3-0 VIO VICRYL PLUS SUTURE 18"(45CM) 0 UND VICRYL PLUS SUTURE 18"(45CM) 0 VIO VICRYL PLUS SUT…
Ethicon, Inc.
Tibial Total Ankle Prosthesis Tray, Size 1, Product No. LJU221T
Integra LifeSciences Corp.
Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040SC
Gyrus ACMI, Inc.
ProSun Onyx 32 Sli Intensive (12 minutes) tanning bed, Model 32/1. Labeled as the following: PROSUN ONYX 32 SLI INTENSIVE RED, PROSUN ONYX 32 SLI IN…
ProSun International, LLC
Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 3, Right, Part No. LJU203T
Integra LifeSciences Corp.
Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 2, Left, Part No. LJU212T
Integra LifeSciences Corp.
Diego Elite Malleable, 4mm Standard Monopolar Blades Product Code:MM4000SS
Gyrus ACMI, Inc.
Innova IGS 630, Angiographic X-Ray, s5i system option used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vas…
GE Healthcare, LLC
VICRYL Sutures VICRYL SUTURE 18"(45CM) 0 VIO VICRYL SUTURE 18"(45CM) 4-0 UND VICRYL SUTURE 18"(45CM) 2-0 VIO VICRYL SUTURE 18"(45CM) 0 VIO VICRY…
Ethicon, 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.