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 455 of 819
Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 460 mm, Item Number: 814413460
Zimmer Biomet, Inc.
Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 380 mm, Item Number: 814611380
Zimmer Biomet, Inc.
Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 460 mm, Item Number: 814509460
Zimmer Biomet, Inc.
Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 420 mm, Item Number: 814513420
Zimmer Biomet, Inc.
Edwards Lifesciences Aortic Perfusion Cannula, 24F x 30CM, resterilized.
SPS Sterilization, Inc
Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 260 mm, Item Number: 814513260
Zimmer Biomet, Inc.
Affixus¿ Hip Fracture Nail 130¿ 9 mm x 180 mm, Item Number: 814509180
Zimmer Biomet, Inc.
Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 400 mm, Item Number: 814509400
Zimmer Biomet, Inc.
Affixus¿ Hip Fracture Nail Right 130¿ 15 mm x 440 mm, Item Number: 814515440
Zimmer Biomet, Inc.
Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 300 mm, Item Number: 814513300
Zimmer Biomet, Inc.
Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 340 mm, Item Number: 814511340
Zimmer Biomet, Inc.
remel THIOGLYCOLLATE MEDIUM W/O IND. W/ DEXTROSE W/ HEMIN & VIT.K (a) 10ML, REF 07182 (b) 10ML, REF 07180 (c) 5ML, REF 064732 (d) 5ML, REF 064730…
Remel Inc
Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 360 mm, Item Number: 814511360
Zimmer Biomet, Inc.
Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 380 mm, Item Number: 814309380
Zimmer Biomet, Inc.
Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 260 mm, Item Number: 814611260
Zimmer Biomet, Inc.
Edwards Lifesciences Femoral Venous Cannula, 20F X 55CM, resterilized.
SPS Sterilization, Inc
Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 460 mm, Item Number: 814409460
Zimmer Biomet, Inc.
Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 340 mm, Item Number: 814411340
Zimmer Biomet, Inc.
Affixus¿ Hip Fracture Nail Left 130¿ 15 mm x 360 mm, Item Number: 814615360
Zimmer Biomet, Inc.
Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 300 mm, Item Number: 814509300
Zimmer Biomet, Inc.
Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 360 mm, Item Number: 814309360
Zimmer Biomet, Inc.
Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 300 mm, Item Number 814309300
Zimmer Biomet, Inc.
Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 420 mm, Item Number: 814409420
Zimmer Biomet, Inc.
Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 400 mm, Item Number: 814313400
Zimmer Biomet, Inc.
Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 320 mm, Item Number: 814409320
Zimmer Biomet, Inc.
Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 400 mm, Item Number: 814411400
Zimmer Biomet, Inc.
da Vinci X/Xi EndoWrist 8mm Monopolar Curved Scissors Model No. 470179-14 Product Usage: EndoWrist Instruments, including scissors, scalpels, for…
Intuitive Surgical, Inc.
GE Vivid E7 ultrasound system Product Usage: Vivid E7 is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intend…
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
GE Vivid E90 ultrasound system Product Usage: Vivid E80 / E90 / E95 ultrasound system is general-purpose ultrasound systems, specialized for use i…
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
VidiStar(TM) PACS & DICOM Viewer Software system
Hitachi Healthcare Americas Corp Informatics Division
Overhead Counterpoise Systems (OCS) OCS CONF an accessory device for use with Bayer injector systems as a support for an injector head. , SHORT CEIL…
Bayer Medical Care, Inc.
AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human immunoreactive trypsin(ogen) (IRT) i…
PerkinElmer Life and Analytical Sciences, Wallac, OY
Peg Fully Threaded, Locking, 2.5mm x 10mm, Item Number 131212610 Orthopedic device used for stabilization and fixation of small bone fragments In…
Zimmer Biomet, Inc.
Pure Rayz, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device.
Quasar Bio-Tech, Inc.
Zenlens Toric-Gas Permeable Contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx) as follows: Zenlens FT(Front Toric); Zenlens Toric-Zen…
Alden Optical
Art-Line Surgery Pack-LF, STERILE, 40 packs each per case.
Medline Industries, Inc.
Foundation Modular Femoral Stem, Part Number, 220-10-110. Knee prosthesis component. The Foundation Revision Knee is a total knee system indicat…
Encore Medical, Lp
Outer Package Label: Tapered Screw-Vent Implant System, 4.1mm X 10mm, 3.5mm, REF:TSVM4B10, Sterile:R, Rx Only; Inner Package Label: Implant, MTX, 3.7…
Zimmer Dental Inc
GE LOGIQ E9 ultrasound system Product Usage: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdomina…
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep Apnea, Inspire Part #900-003-020, Product Usage: The device is an …
Inspire Medical Systems Inc.
PICC Tray, STERILE, 12 packs each per case.
Medline Industries, Inc.
Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle replacements.
Exactech, Inc.
DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD)
Canon Medical System, USA, INC.
GE Vivid E95 ultrasound system Product The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal (incl…
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
GE Vivid 7 ultrasound system Product Usage: Vivid E7 is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intende…
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
McKesson Cardiology Hemo, Release SW version 13.0. Used for physiological monitoring, image and data processing. McKesson Cardiology Hemo is int…
McKesson Israel Ltd.
Cardiac Insulation Pad, OPEN HEART CDS
Medline Industries, Inc.
Overhead Counterpoise Systems (OCS), OCS, 580mm CEILING MOUNT, PORTEGRA2, Catalog # OCS CEIL 58, Material Number 84433765
Bayer Medical Care, Inc.
GE Vivid E80 ultrasound system Vivid E80 / E90 / E95 ultrasound system is general-purpose ultrasound systems, specialized for use in cardiac imagi…
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
AMSCO V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems The V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterili…
Steris Corporation
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.