PlainRecalls

Product category · Updated Jul 29, 2026

Medical Devices recalls

Medical device recalls including implants, diagnostic equipment, and surgical tools

Total recalls
40,910
Top agency
FDA Devices
Years covered
2000–2026
Compiled from official public sources by the publisher.
Check a product → All categories

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 · 2026-08-23

Medical Devices recalls by year

2000–2026

0 1000 2000 3000 4000 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2576 3437 2649 3803 3003 3209 2356 2247 2606 3417 2982 1787

Source: FDA · CPSC · NHTSA As of Jul 29, 2026

Severity distribution

Graded records only

recalls
Source FDA / CPSC severity classification

Recalls by issuing agency

recalls
Source PlainRecalls index of federal feeds

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 471 of 819

FDA Devices Moderate Jun 20, 2018

MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1116P

Sun Med, LLC
FDA Devices Moderate Jun 20, 2018

IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865350

Philips Electronics North America Corporation
FDA Devices Moderate Jun 20, 2018

Brilliance 16 P with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728246. Computed Tomography X-ray system

Philips Medical Systems (Cleveland) Inc
FDA Devices Moderate Jun 20, 2018

MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, FILTER AND 7 FT. OXYGEN TUBING, REF CPRM1126F

Sun Med, LLC
FDA Devices Moderate Jun 20, 2018

MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR AND 7 FT. OXYGEN TUBING, REF CPRM1116

Sun Med, LLC
FDA Devices Moderate Jun 20, 2018

CAN 5F DUAL XCELA PICC, Catalog Number 60M701532

Angiodynamics Inc. (Navilyst Medical Inc.)
FDA Devices Moderate Jun 20, 2018

MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, PEEP VALVE, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1116PC

Sun Med, LLC
FDA Devices Moderate Jun 20, 2018

Dimension Vista Gentamicin Flex reagent cartridge, DV GENT, gentamicin enzyme immunoassay. Affected lots are 17135BC, 17150BF, 17159BD, 17178AC, 172…

Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Jun 20, 2018

RS TANDEM 5F DL XCELA PICC PASV, Catalog Number 60M181582

Angiodynamics Inc. (Navilyst Medical Inc.)
FDA Devices Moderate Jun 20, 2018

VIDAS TOXO IgG Avidity is an automated qualitative test for use on the VIDAS family instruments, for the determination of anti-toxoplasma IgG avidity…

BioMerieux SA
FDA Devices Moderate Jun 20, 2018

RS 5F DL BIOFLO PASV, Catalog Number 60M150373

Angiodynamics Inc. (Navilyst Medical Inc.)
FDA Devices Moderate Jun 20, 2018

Xcela 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number 75-003

Angiodynamics Inc. (Navilyst Medical Inc.)
FDA Devices Moderate Jun 20, 2018

Biomet Modular Primary Tibial Tray Implants; Modular Interlok Primary Tray (size 75 mm); Item No. 141215; UDI: (01) 00880304005310 (17) 280306 (10) 3…

Zimmer Biomet, Inc.
FDA Devices Moderate Jun 20, 2018

MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, FILTER AND 7 FT. OXYGEN TUBING, REF CPRM1116F

Sun Med, LLC
FDA Devices Moderate Jun 20, 2018

Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiographic x-ray system device intended to be used for the radiography in the h…

Shimadzu Medical Systems
FDA Devices Moderate Jun 20, 2018

Aortic Arterial Cannula 22 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part Number 701002246, Article Number A22-7107. For use in cardio…

Maquet Cardiopulmonary Ag
FDA Devices Moderate Jun 20, 2018

CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products: CellaVision DM96, DM1200, DM9600 and DI-60 Product Usage: Th…

Cellavision AB
FDA Devices Moderate Jun 20, 2018

Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved PG, Catalog Number 45-872

Angiodynamics Inc. (Navilyst Medical Inc.)
FDA Devices Moderate Jun 20, 2018

Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035R01 Product Usage: The Maquet Cardiopulmonary Bypass…

Datascope Corporation
FDA Devices Moderate Jun 20, 2018

Aortic Arterial Cannula 20 Fr (O.D.); 23 cm (L); with 3/8-inch wide connector, Part Number 701002206, Article Number A20-0101. For use in cardiopulm…

Maquet Cardiopulmonary Ag
FDA Devices Moderate Jun 20, 2018

MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR AND 7 FT. OXYGEN TUBING, REF CPRM1126

Sun Med, LLC
FDA Devices Moderate Jun 20, 2018

Cell Observer SD, DirectFRAP, Laser TIRF 1, Laser TIRF 2, Laser TIRF3, LightSheet, Elyra, and multiple Laser Scanning Microscopes. Laser scanning…

Zeiss, Carl Inc
FDA Devices Moderate Jun 20, 2018

MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK 5, BAG RESERVOIR, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1116PD5

Sun Med, LLC
FDA Devices Moderate Jun 20, 2018

RS 5F DL BIOFLO PASV, Catalog Number 60M181578

Angiodynamics Inc. (Navilyst Medical Inc.)
FDA Devices Moderate Jun 20, 2018

RS 5F DL BIOFLO PICC, Catalog Number 60M071831

Angiodynamics Inc. (Navilyst Medical Inc.)
FDA Devices Moderate Jun 20, 2018

BioFlo Midline 5F DL-20cm Max Sterile Barrier Drape Kit w/ Two Nitinol Guidewire PG, Catalog Number 46-490

Angiodynamics Inc. (Navilyst Medical Inc.)
FDA Devices Moderate Jun 20, 2018

DermaPro Waterproof Silicone Tape, SNS57232

Safe N Simple, LLC
FDA Devices Moderate Jun 20, 2018

smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)

Smith & Nephew, Inc.
FDA Devices Moderate Jun 20, 2018

Accu-Chek Performa Test Strip, Blood glucose monitoring system, Catalog no. 07299702001 Product Usage: The Accu-Chek Performa test strips are for…

Roche Diabetes Care, Inc.
FDA Devices Moderate Jun 20, 2018

The VITEK 2 Gram-Positive identification card (GP) is intended for use with the VITEK 2 Systems for the automated identification of most significant …

BioMerieux SA
FDA Devices Moderate Jun 20, 2018

Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, Catalog Number 45-871

Angiodynamics Inc. (Navilyst Medical Inc.)
FDA Devices Moderate Jun 20, 2018

XCELA PASV 5F SL 55CM IR-145 Nitinol Wire KIT PG, Catalog Number 25-124

Angiodynamics Inc. (Navilyst Medical Inc.)
FDA Devices Moderate Jun 20, 2018

Bio-Stable 5F SL-55CM IR-145 Kit Valved with Nitinol GW PG, Catalog Number 45-882

Angiodynamics Inc. (Navilyst Medical Inc.)
FDA Devices Moderate Jun 20, 2018

Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-887

Angiodynamics Inc. (Navilyst Medical Inc.)
FDA Devices Moderate Jun 20, 2018

RS 5F DL XPP KIT, Catalog Number 60M183104

Angiodynamics Inc. (Navilyst Medical Inc.)
FDA Devices Moderate Jun 20, 2018

Accu-Chek Aviva Plus Test Strip, Blood glucose monitoring system, Catalog nos. 06908217001, 06908268001, 06908349001,06908217001 Product Usage: T…

Roche Diabetes Care, Inc.
FDA Devices Moderate Jun 20, 2018

Accu-Chek Inform II Test Strip, Whole blood glucose test system, Catalog no. 05942861001 Product Usage: The Accu-Chek Inform II test strips are f…

Roche Diabetes Care, Inc.
FDA Devices Moderate Jun 20, 2018

12C

Ion Beam Applications S.A.
FDA Devices Low Jun 20, 2018

lmmunalysis EDDP Urine Control Set 1 The EDDP Urine Controls (High 125 ng/ml and Low 75 ng/ml) are used as control materials in the ammonolysis ED…

Alere San Diego Inc. DBA Immunalysis Corporation
FDA Devices Moderate Jun 20, 2018

The VITEK 2 Neisseria-Haemophilus identification card (NH) is intended for use with the VITEK 2 Systems for the automated identification of most clin…

BioMerieux SA
FDA Devices Moderate Jun 20, 2018

Bio-Stable 5F SL-55CM MST-70 Kit Valved with Nitinol Guidewire PG, Catalog Number 45-892

Angiodynamics Inc. (Navilyst Medical Inc.)
FDA Devices Moderate Jun 20, 2018

Proteus 235 The PTS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and ot…

Ion Beam Applications S.A.
FDA Devices Moderate Jun 20, 2018

The VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine …

BioMerieux SA
FDA Devices Moderate Jun 20, 2018

Oxidase Reagent (ref: 55635): This test is used to detect the production of the enzyme cytochrome oxidase by bacteria. This enzyme is characteristic …

BioMerieux SA
FDA Devices Moderate Jun 20, 2018

CAN 5F DL BIOFLO PASV PICC NURSING TRAY, Catalog Number 60M700936

Angiodynamics Inc. (Navilyst Medical Inc.)
FDA Devices Moderate Jun 20, 2018

Brilliance 64 with DEPMED HARDENING KIT 12NC: 459800191351, Model Number 728231. Computed Tomography X-ray system

Philips Medical Systems (Cleveland) Inc
FDA Devices Moderate Jun 20, 2018

RS 5F DL BIOFLO PASV, Catalog Number 60M183481

Angiodynamics Inc. (Navilyst Medical Inc.)
FDA Devices Moderate Jun 20, 2018

RS - TANDEM 5F DL BIOFLO MIDLINE, Catalog Number 60M035472

Angiodynamics Inc. (Navilyst Medical Inc.)
FDA Devices Moderate Jun 20, 2018

RS TANDEM 5F DL BIOFLO PASV, Catalog Number 60M232242

Angiodynamics Inc. (Navilyst Medical Inc.)
FDA Devices Moderate Jun 20, 2018

Bio-Stable 5F SL-55CM IR-145 Kit Valved PG, Catalog Number 45-818

Angiodynamics Inc. (Navilyst Medical 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.

Food

25,473 recalls →

Drugs & Medications

14,437 recalls →

Vehicles

8,940 recalls →

Children & Baby Products

4,007 recalls →

Household Products

3,567 recalls →

Dietary Supplements

2,016 recalls →

Data sources

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.