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 · 2026-08-30
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 647 of 819
DRESSING CHANGE CUSTOMED 50/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture rem…
Customed, Inc
CESAREAN PACK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigat…
Customed, Inc
MAYO STAND COVER W/CSR WRAP 30/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture r…
Customed, Inc
C-SECTION SURGICAL PACK 2/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture r…
Customed, Inc
MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnostic.
Diagnostic Hybrids Inc
Mahurkar Elite Acute Triple Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12.5 Fr x 13 cm Item Code: 8888233413 Product Usag…
Covidien LLC
LAPAROTOMY BASIC PACK 10/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture remova…
Customed, Inc
EXTREMITY PACK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irr…
Customed, Inc
O.B. PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate …
Customed, Inc
Transonic Flow Probe, 6 mm, Catalog Number HQD6FMV -- Product Usage: to measure flow intra-operatively.
Transonic Systems Inc
ANGIOGRAPHY PACK CUSTOMED 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture r…
Customed, Inc
LAPAROSCOPY PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irriga…
Customed, Inc
KimVent* Closed Suction System for Adults, 14 F, D-Tip, T-Piece (Product Code 22059); KimVent* Closed Suction System for Adults, 14 F, T-Piece, Direc…
Halyard Health, Inc
FANFOLD DRAPE 44"X58 60/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture remo…
Customed, Inc
SHOULDER PACK (I) (2) 6/CS CUSTOMED Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, sut…
Customed, Inc
BASIC PACK W/OUT GOWN 11/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture remova…
Customed, Inc
Neuro Kinetics, Inc. (NKI) I-Portal¿ NOTC system with the OVAR research test; a rotary chair system used in vestibular and neuro-otologic diagnostic …
Neuro Kinetics, Inc.
CESAREAN PACK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigat…
Customed, Inc
MINOR LAPAROTOMY PK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, i…
Customed, Inc
URETHRAL CATHETER TRAY CUSTOMED 50/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, sutur…
Customed, Inc
ENDOVENOUS CUSTOM PACK 5/CS CUSTOMED Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, sutur…
Customed, Inc
Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Straight Extensions with IC* Safety Components, 13.5 Fr x 24 cm Item Code: 8888211424 …
Covidien LLC
UNIVERSAL PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irr…
Customed, Inc
CYSTO TUR PACK CUSTOMED 10/CS REV. C 10/13 NON STERILE Used by medical staff to perform surgical procedures and patient care procedures such as wou…
Customed, Inc
KimVent* Closed Suction System for Adults, 12 F, T-Piece,12 in Tracheostomy (Product Code 215135); KimVent* Closed Suction System for Adults, 12 F, …
Halyard Health, Inc
GOWN IMPERVIOUS EXTRA LONG 24/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture re…
Customed, Inc
NEURO SPINE PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, …
Customed, Inc
KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI (Product Code 2271418) A tracheobronchial suction catheter is a device that…
Halyard Health, Inc
FOLEY CATH KIT 16FR. W/FOLEY S SENSOR 20/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound heali…
Customed, Inc
7 Hole VL Gridlock Fibula Plate, Part # 300-60-001 NON-STERILE SINGLE USE ONLY; 9 Hole VL Gridlock Fibula Plate, Part # 300-60-002 NON-STERILE SINGLE…
Trilliant Surgical Ltd.
KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE (Product Code 227); KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 …
Halyard Health, Inc
Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician Engineered Products, Inc., Model SBL60
Physician Engineered Products, Inc.
Transonic Flow Probe, 3 mm, Catalog Number HQC3MP -- Product Usage: to measure flow intra-operatively.
Transonic Systems Inc
LAPAROSCOPY-GYN SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture remova…
Customed, Inc
GAUZE SPONGE 4"X4" 16 PLY SOFT 1280/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, sut…
Customed, Inc
MAHURKAR"* 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Curved Extensions, PASS Tray Item Code: 8888103003HP Product Usage: …
Covidien LLC
KimVent* Multi-Access Port Closed Suction System for Adults, Endotracheal, DSY, 14 F (Product Code 24014-5) A tracheobronchial suction catheter is a…
Halyard Health, Inc
ARTHROSCOPY PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals,…
Customed, Inc
IRRIGATION TRAY W/BULB SYRINGE CUSTOMED 50/CS Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrig…
Customed, Inc
TUMMY TUCK & BREAST PACK-RFMHI 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, su…
Customed, Inc
Neptune 2 Waste Management System Docking Station (120V and 230V), New and Refurbished Product Usage: The Stryker Docking Station (Docker) is a c…
Stryker Instruments Div. of Stryker Corporation
INCISION AND DRAINAGE TRAY 50/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture …
Customed, Inc
KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DSE, MDI (Product 8224); KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DSE (Pro…
Halyard Health, Inc
SHOULDER ARTHROSCOPY PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture remo…
Customed, Inc
GAUZE 2" X 2" PRODUCTION ONLY 1500PK/CS CUSTOMED Used by medical staff to perform surgical procedures and patient care procedures such as wound he…
Customed, Inc
KimVent* Multi-Access Port Replacement Catheter for Adults,Tracheostomy, 14 F (Product Code 2401453-5) A tracheobronchial suction catheter is a devi…
Halyard Health, Inc
SHOULDER ARTHROSCOPY PACK 2/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture re…
Customed, Inc
MediTrace Cadence Adult Multi-Function Defibrillation Electrodes Item Code:22550PC
Covidien LLC
Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Pre-Curved with IC* Safety Components, 13.5 Fr x 20 cm Item Code: 8888213420 Product Usa…
Covidien LLC
FEMORAL PACK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrig…
Customed, 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.