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 · 2026-08-25
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 528 of 819
Dimension Vista Digoxin (DIGXN) Flex reagent cartridge
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Estradiol (E2) Flex reagent cartridge
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Ferritin (FERR) Flex reagent cartridge
Siemens Healthcare Diagnostics, Inc.
Dimension Troponin 1 (TNI) Flex reagent cartridge
Siemens Healthcare Diagnostics, Inc.
Human Chorionic Gonadotropin, 125 IU HCG, in 0.5 ml syringe, subcutaneous administration, Rx only, Complete Pharmacy & Medical Solutions, Miami Lake…
Complete Pharmacy and Medical Solutions LLC
NasalCrom (cromolyn sodium) Nasal Spray, USP, 5.2 mg per spray, 200 metered sprays, 0.88 FL OZ (26 mL) metered spray pump bottle, Distributed by: Med…
Bausch & Lomb, Inc.
FEM IM NAIL 14MMDX30CM LEFT, FEM IM NAIL 14MMDX30CM RIGHT FEM IM NAIL 13MMDX32CM LEFT FEM IM NAIL 14MMDX32CM LEFT FEM IM NAIL 13MMDX32CM RIGHT FE…
Zimmer Biomet, Inc.
VITEK¿ 2 Gram Negative Susceptibility card (AST-N351), IVD, REF 421257, 20 cards per carton.
Biomerieux Inc
Video Cytoscopes
Pentax of America Inc
VITEK¿ 2 Gram Positive Susceptibility card (AST-P648), IVD, REF 420857, 20 cards per carton.
Biomerieux Inc
SCHRITTMACHER ANGIO X3; Item Number: 4045255423347
Medtronic
VITEK¿ 2 Gram Positive Susceptibility card (AST-P580), REF 22233, 20 cards per carton.
Biomerieux Inc
VITEK¿ 2 Gram Negative Susceptibility card (AST-GN80), REF 413437, 20 cards per carton.
Biomerieux Inc
VITEK¿ 2 Gram Negative Susceptibility card (AST-N268), REF 413868, 20 cards per carton.
Biomerieux Inc
Por fullct fem st 17x200mm, Sterile,
Zimmer Biomet, Inc.
VITEK¿ 2 Gram Negative Susceptibility card (AST-N300), IVD, REF 416241, 20 cards per carton.
Biomerieux Inc
Segmental fluted stem, 17x190mm str, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Imp…
Zimmer Biomet, Inc.
VITEK¿ 2 Gram Positive Susceptibility card (AST-P607), REF 22335, 20 cards per carton.
Biomerieux Inc
GE Healthcare Optima CT520 X-ray system
GE Healthcare, LLC
VITEK¿ 2 Gram Negative Susceptibility card (AST-N222), REF 413083, 20 cards per carton.
Biomerieux Inc
Philips DigitalDiagnost 3.1.x X-Ray System
Philips Electronics North America Corporation
VITEK¿ 2 Gram Negative Susceptibility card (AST-N214), REF 413064, 20 cards per carton.
Biomerieux Inc
VITEK¿ 2 Gram Negative Susceptibility card (AST-N362), IVD, REF 421585, 20 cards per carton.
Biomerieux Inc
Fem IM Nail 14mmdx48cm left, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Zimmer Biomet, Inc.
Clarke-Reich Laparoscopic Knot Pusher
Cook Inc.
Stamey Needle
Cook Inc.
Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004EPTMCA85400
Creganna Medical Devices
VITEK¿ 2 Gram Negative Susceptibility card (AST-N265), REF 413865, 20 cards per carton.
Biomerieux Inc
VITEK¿ 2 Gram Streptococcus Susceptibility card (AST-ST01), REF 410028, 20 cards per carton.
Biomerieux Inc
CUSTOM SUTURE PACK; Item Number: US1540 and US1614
Medtronic
Fem IM Nail 16mmdx38cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Zimmer Biomet, Inc.
Segmental malefemale taper, 220mm, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Impla…
Zimmer Biomet, Inc.
VITEK¿ 2 Gram Positive Susceptibility card (AST-P631), REF 414961, 20 cards per carton.
Biomerieux Inc
Arrow Pressure Injectable PICC Kit Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days The Arrow Pressure Injectable PICC is inten…
Arrow International Inc
VITEK¿ 2 Gram Negative Susceptibility card (AST-N359), IVD, REF 421573, 20 cards per carton.
Biomerieux Inc
VITEK¿ 2 Gram Positive Susceptibility card (AST-GP67), REF 22226, 20 cards per carton.
Biomerieux Inc
Xl por st 24.0x220mm, bowed, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Zimmer Biomet, Inc.
Segmental fluted stem, 18x190mm str, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Imp…
Zimmer Biomet, Inc.
VITEK 2 Bacillus identification card (BCL), IVD, REF 21345, 20 cards per carton.
Biomerieux Inc
VITEK¿ 2 Gram Negative Susceptibility card (AST-N212), REF 413061, 20 cards per carton.
Biomerieux Inc
VITEK¿ 2 Gram Fungal Susceptibility card (AST-YS05), REF 411945, 20 cards per carton.
Biomerieux Inc
VITEK¿ 2 Gram Positive Susceptibility card (AST-P600), REF 22313, 20 cards per carton.
Biomerieux Inc
Infant Warmer System (IWS)
GE Healthcare, LLC
VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H
Zimmer Biomet, Inc.
VITEK¿ 2 Gram Positive Susceptibility card (AST-P586), REF 22276, 20 cards per carton.
Biomerieux Inc
Endoscopic Introducer/Extractor
Cook Inc.
Segmental fluted stem, 19x190mm str, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Imp…
Zimmer Biomet, Inc.
VITEK¿ 2 Gram Negative Susceptibility card (AST-N195), REF412609, 20 cards per carton.
Biomerieux Inc
VITEK¿ 2 Gram Negative Susceptibility card (AST-N340), IVD, REF 419412, 20 cards per carton.
Biomerieux Inc
VITEK¿ 2 Gram Negative Susceptibility card (AST-GN76), REF 413433, 20 cards per carton.
Biomerieux 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.