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 · 2026-08-24
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 493 of 819
smith&nephew, LEGION HK FEMORAL WEDGE (WEDGE AND SCREW), 5 MM, SIZE 5, REF 71422159, QTY: (1), STERILE The Revision Knee System Components are in…
Smith & Nephew, Inc.
PEDIATRIC IV & IV START KIT
Centurion Medical Products Corporation
Cooper Surgical 2 MHZ Waterproof OB Probe Product The CooperSurgical 2 MHz Waterproof OB probe is for obstetrical use in the labor and department…
CooperSurgical, Inc.
Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features, a…
Arrow International Inc
Pressure Injectable Two- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter and Sharps Safety Features. Per…
Arrow International Inc
ST. CHRISTOPHER'S SECUREMENT SET
Centurion Medical Products Corporation
Iridex TruFocus LIO Premiere" Laser Indirect Ophthalmoscope ( LIO ) The LIO is a headmounted indirect ophthalmoscope which is used with a handh…
Iridex Corporation
Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter, Sharps Safety Features and Maxi…
Arrow International Inc
Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter and Sharps Safety Features. P…
Arrow International Inc
CIRCUMCISION TRAY
Centurion Medical Products Corporation
Pressure Injectable Multi- Lumen CVC Kit
Arrow International Inc
Ayurvedic Face Care Kit; Each kit contains: Coconut Cream Cleanser 0.5 fl oz jar Tulsi Facial Tonic HydroSoul 1 fl oz bottle Argan Intensive …
Plant Devas Inc
PORT-A-CATH II PS/Titan, Tray PAC II. Labeled as: a. VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO (1/EA); b. DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO …
Smiths Medical ASD Inc.
NovaKone Toric Daily Wear Soft contact; Catalog Number: AONKT54 Product Usage: The NOVAKONE TORIC lens is indicated for daily wear for persons re…
Alden Optical
CPT 12/14 COCR SIZE 0 STD prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
Zimmer Biomet, Inc.
VERSYS 6 INCH BEADED FC 13X160MM LM BODY EXT NECK & STD NECK Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Zimmer Biomet, Inc.
LPS PRECOAT FEM SIZE D-RT LPS PRECOAT FEM SIZE E-RT LPS POROUS FEM SIZE F-RT This device is indicated for patients with severe knee pain and dis…
Zimmer Biomet, Inc.
Coons Interventional Wire Guide
Cook Inc.
Movable Core Wire Guide
Cook Inc.
STA - Neoplastine¿ Cl Plus ¿ (ref. 00606) Product Usage: Manual or automated determination of the prothrombin time (PT).
Diagnostica Stago, Inc.
BD Vacutainer¿ K2 EDTA (K2E) 3.6mg Blood Collection Tube (13 x 75 mm x 2.0 mL). Catalog Number: 367841. Used for whole blood hematology determina…
Becton Dickinson & Company
MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays. Product Number: 8888222316.
Medtronic Minimally Invasive Therapies Group
ARROWg+ard BLUE PLUS Pressure Injectable Two- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) centr…
Arrow International Inc
Neoplastine¿ Cl Plus ¿ (ref. 00375) Product Usage: Manual or automated determination of the prothrombin time (PT).
Diagnostica Stago, Inc.
CR OPTION FEM COMP SIZE C/L CR OPTION FEM COMP SIZE C/R CR OPTION FEM COMP SIZE D/L CR OPTION FEM COMP SIZE D/R CR OPTION FEM COMP SIZE E/L CR O…
Zimmer Biomet, Inc.
Amplatz Extra Stiff Wire Guide
Cook Inc.
STA - Neoplastine¿ Cl ¿ (ref. 00605) Product Usage: Manual or automated determination of the prothrombin time (PT).
Diagnostica Stago, Inc.
ACE (TM) BRAND, DELUXE ANKLE BRACE, 207736, UPC 0 51131 20387 7
3M Company - Health Care Business
Amplatz Ultra Stiff Wire Guide
Cook Inc.
LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-R LPS-FLEX OPTION FEMORAL D-L LPS-FLEX OPTION FEMORAL D-R LPS-…
Zimmer Biomet, Inc.
Bentson Cerebral Wire Guide
Cook Inc.
ARROWg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central ve…
Arrow International Inc
Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Kit used when administering IV during emergency.
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
Femoral Artery Pressure Monitoring Set
Cook Inc.
Reuter Tip Deflecting Wire Guide
Cook Inc.
Pressure Injectable Multi- Lumen Central Venous Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology Product Usage: The Arrow¿ C…
Arrow International Inc
Neoplastine¿ Cl Plus @ (ref.00374) Product Usage: Manual or automated determination of the prothrombin time (PT).
Diagnostica Stago, Inc.
OneStep CPR Complete, Adult Multi Function Electrodes, Part Numbers: 8900 0214 01 (case of 8 single electrodes, UDI: 10847946016279) and 8900 0224 01…
ZOLL Medical Corporation
ExacTrac versions 6.5 through 6.5 intended to be used to place patients at an accurately defined point within the treatment beam of a medical acceler…
Brainlab AG
CR-FLEX POR HATCP FEM C-L CR-FLEX POR HATCP FEM C-R CR-FLEX POR HATCP FEM D-L CR-FLEX POR HATCP FEM D-R CR-FLEX POR HATCP FEM E-L CR-FLEX POR HA…
Zimmer Biomet, Inc.
Vanguard CR Porous Femoral 62.5mm (Left Femur) For use in total knee arthroplasty
Zimmer Biomet, Inc.
Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features Product Usage: The Arrow¿ CVC is indicate…
Arrow International Inc
Amplatz Stiff Wire Guide
Cook Inc.
Proteus 235, Pencil Beam Scanning, PTS-9.4.X, PTS-10.0.1.1 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is …
Ion Beam Applications S.A.
CMI (Collagen Meniscus Implant) device, Ivy Sports Medicine s collagen-based meniscus implant Product Usage: The CMI device, Ivy Sports Medicine …
Stryker Corporation
Double Flexible Tipped Wire Guide
Cook Inc.
LPS-FLEX GSF OPT SZ C-L¿ LPS-FLEX GSF OPT SZ C-R¿ LPS-FLEX GSF OPT SZ D-L¿ LPS-FLEX GSF OPT SZ D-R¿ LPS-FLEX GSF OPT SZ E-L¿ LPS-FLEX GSF OPT SZ…
Zimmer Biomet, Inc.
FEM PRC LT M/RT L SML FEM PRC RT M/LT L SML FEM PRC LT M/RT L SML+ FEM PRC RT M/LT L SML+ FEM PRC LT M/RT L REG…
Zimmer Biomet, Inc.
SYSTEM 26. Part Numbers: OS900035-NS; OS900036-NS; OS900037-NS; OS900038-NS; OS900040-NS; OS900041-NS; OS900042-NS; OS900043-NS; OS900047-NS…
ORTHO SOLUTIONS, LTD.
36MM COCR MODULAR HD -6MM
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.