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 467 of 819
Femoral Nail, A/R T2 Femur ¿10x340 mm, Product Number 18251034S
Stryker GmbH
Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D154VRC Prod…
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Femoral Nail, A/R T2 Femur ¿15x240 mm, Product Number 18251524S
Stryker GmbH
Femoral Nail, LEFT T2 GTN ¿10x360 mm, Product Number 18501036S
Stryker GmbH
Femoral Nail, A/R, R1500 T2 Femur ¿10x320 mm, Product Number 18281032S
Stryker GmbH
Femoral Nail, RIGHT T2 GTN ¿9x320 mm, Product Number 18510932S
Stryker GmbH
Coronary Sinus (CS) Uni-Directional Diagnostic Electrophysiology (EP) Catheter, catalog numbers D135303 and D135304. Product Usage: The Reprocess…
Stryker Sustainability Solutions
Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D154ATG Produ…
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Discovery IGS 740 Interventional Fluoroscopic X-ray Systems
GE Medical Systems, SCS
PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine PD-L1 levels for determination of patient treatment options.
Dako North America Inc.
Tibial Nail, Standard T2 Tibia ¿12x315 mm, Product Number 18221231S
Stryker GmbH
BioMerieux mini VIDAS System in combination with Quality Control VIDAS* (QCV*) Product Usage: the Quality Control VIDAS (QCV) is an automated tes…
bioMerieux, Inc.
Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D153VRC Prod…
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Femoral Nail, LEFT T2 GTN ¿12x360 mm, Product Number 18501236S
Stryker GmbH
Femoral Nail, A/R, R1500 T2 Femur ¿12x380 mm, Product Number 18281238S
Stryker GmbH
Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 Product Usage: A device designed to produce and deliver a proton beam for the treatment of patie…
Ion Beam Applications S.A.
LigaSure" Exact Dissector Nano Coated 20.6mm-21cm Product Usage: A bipolar electrosurgical instrument intended for use in open surgical procedure…
Covidien LLC
NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy Cassette, Cat. No. VPT1-CASS Product Usage: pregnancy test
Ekla Corporation
Percepta CRT-P MRI SureScan, REF W1TR04 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (…
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic EnTrust Escudo D144VRC (OUS distribution) Product Usage: The implantable cardioverter defibrillator is intended to provide ventricular a…
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Femoral Nail, A/R T2 Femur ¿12x360 mm, Product Number 18251236S
Stryker GmbH
Vacuum Regulator, Push-T-Set Intermittent Suction Unit (PTS-ISU) Product Usage: The vacuum regulator is intended to be used in a medical facilit…
Ohio Medical Corporation
Elecsys Vitamin D total II, Vitamin D Test System, Material number 07464215160 Product Usage: This assay is intended for the quantitative determi…
Roche Diagnostics Corporation
da Vinci Xi EndoWrist Stapler 45 Reload Blue, Model 48645B-03, 12 reloads/box.
Intuitive Surgical, Inc.
Elecsys Vitamin D total II, Vitamin D Test System, Material number 07028148190 Product Usage: This assay is intended for the quantitative determi…
Roche Diagnostics Corporation
AperFix AM Femoral Implant, Model numbers CM-2409 (9mm x 24 mm) and CM-2410 (10 mm x 24 mm). For orthopedic use in ligament reconstruction.
Cayenne Medical Inc.
FDI FORT DEFIANCE INDUSTRIES P2131 AUTOMATED FIELD STEAM STERILIZER, NSN: 6530-01-641-4641 Product Usage: The Fort Defiance Industries Automated …
Fort Defiance Industries, LLC
VPS Rhythm ECG Accessory Pack with Johans Adapter, REF RHY-100-ECGJ Product Usage: To provide real time tip location information of a central ven…
Arrow International Inc
Morphine Sulfate 1 mg/mL (preservative free; sulfite free) 2 mL fill 3 mL syringe, SCA Pharmaceuticals, LLC, Windsor, CT
SCA Pharmaceuticals, LLC
da Vinci X Surgical System, Model IS4200. Product Usage: The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System …
Intuitive Surgical, Inc.
GE Healthcare CARESCAPE Monitor B650
GE Healthcare Finland Oy
microTargeting" STar" Drive System (Manual), Product Number ST-DS-MA
FHC, Inc.
microTargeting" STar" Drive System (Manual), Product Number 70-ZD-MA
FHC, Inc.
Medtronic MiniMed Paradigm Veo Insulin Pump Product Catalog Number: MMT-554, MMT-754
Medtronic Inc.
Safety Sideport Knife 1.0mm 45¿, REF 378210 Product Usage: Indicated to make stab incisions during ophthalmic surgery
Beaver Visitec
Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 13.5; 00-7713-013-00
Zimmer Biomet, Inc.
LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-040
Howmedica Osteonics Corp.
microTargeting" Drive System, Product Number MT-DS
FHC, Inc.
REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60
Implant Direct Sybron Manufacturing, LLC
Zimmer¿ M/L Taper Hip Prosthesis With Kinectiv¿ Technology Cementless, Size 6; 00-7713-006-00
Zimmer Biomet, Inc.
LFIT Anatomic CoCr Femoral Heads, 6260-9-036
Howmedica Osteonics Corp.
LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-044
Howmedica Osteonics Corp.
Zimmer¿ M/L Taper Hip Prosthesis Plasma Sprayed, Size 4 Standard Offset; 00-7711-004-10
Zimmer Biomet, Inc.
Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 16.25; 00-7713-016-00
Zimmer Biomet, Inc.
ECOLAB MICROTEK Rolled Probe Cover, 2.6 cm x 20 cm (1 in x 8 in), Ref PC0906, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons/shipping cas…
ECOLAB INC
microTargeting" Drive System, Product Number 66-ZD-MD
FHC, Inc.
LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-336
Howmedica Osteonics Corp.
Ratcheting Cannulated Driver Handle, Catalog #: 210-00-004, Rx Only, Non Sterile
Trilliant Surgical Ltd.
Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 20; 00-7713-020-00
Zimmer Biomet, Inc.
Zimmer¿ M/L Taper Hip Prosthesis With Kinectiv¿ Technology Cementless, Size 5; 00-7713-005-00
Zimmer Biomet, 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.