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 editorial process.
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

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 377 of 819

FDA Devices Moderate Dec 4, 2019

Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-1…

Zimmer Biomet, Inc.
FDA Devices Moderate Dec 4, 2019

Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 8cm UPN: M00536660

Boston Scientific Corporation
FDA Devices Moderate Dec 4, 2019

2.0MM BALL NOSE GUIDE WIRE, Item Nos. 281017006 - Product Usage: These instruments and delivery systems are used to facilitate implantation of orthop…

Zimmer Biomet, Inc.
FDA Devices Moderate Dec 4, 2019

PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter

Bard Peripheral Vascular Inc
FDA Devices Moderate Dec 4, 2019

Site~Rite 8 Ultrasound Systems-intended for diagnostic ultrasound imaging of the human body. Site~Rite 8 Ultrasound System, Catalog No.9770500 Refu…

Becton Dickinson & Company
FDA Devices Moderate Dec 4, 2019

Comprehensive HHR Tess Cleat, Item Nos. 110260 110261 110262 110263 Product Usage: N/A

Zimmer Biomet, Inc.
FDA Devices Moderate Dec 4, 2019

FoundationOne CDx test report

Foundation Medicine, Inc.
FDA Devices Moderate Dec 4, 2019

Behind-the-Ear hearing aids, Model Numbers: Q962-DRW, T561-DRW, T562-DRW, T762-DRW, T777-DW, AMZ964-DRW, ET588-DWH, ET598-DW, ET788-DWH, ET798-DW, E…

GN Hearing A/S
FDA Devices Low Dec 4, 2019

Platelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studies, Contains: 2X1 mL ADP Reagent containing adenosine diphosphate, 2X 1 …

Helena Laboratories, Corp.
FDA Devices Moderate Dec 4, 2019

Dart Fire HEADED SCREW 4.0X 32MM, Part Number D1S40032S

Wright Medical Technology, Inc.
FDA Devices Low Dec 4, 2019

Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation studies, Contains: Collagen (equine tendon) For In-Vitro Diagnostic Use,

Helena Laboratories, Corp.
FDA Devices Moderate Dec 4, 2019

ORTHOLOC 3DI PLT SYS STERILE, LOCKING SCREW, 3.5 x 38mm Sterile, Part Number 58S03538

Wright Medical Technology, Inc.
FDA Devices Moderate Dec 4, 2019

GUIDE WIRE 2.2MM X 28IN, Aim/Art Guide wire, Item No. 809222028 - Product Usage: These instruments and delivery systems are used to facilitate implan…

Zimmer Biomet, Inc.
FDA Devices Moderate Dec 4, 2019

Rebel Monorail PtCr Coronary Stent System, REF / Catalog No. H7493927324300, Rebel MR OUS 3.0mm x 24mm. The Rebel Monorail (MR) Stent System is a b…

Boston Scientific Corporation
FDA Devices Moderate Dec 4, 2019

Stryker X-Change Medial Wall Mesh Small (6-Petal)-Intended to be implanted to replace a hip joint REF 0942-8-025

Howmedica Osteonics Corp.
FDA Devices Moderate Dec 4, 2019

Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493919308200 EMERG…

Boston Scientific Corporation
FDA Devices Low Dec 4, 2019

Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures

SPINEART SA
FDA Devices Moderate Dec 4, 2019

Accessory kit, Alinity c containing Alinity ci Level Sensor, Bulk Solution

Abbott Gmbh & Co. KG
FDA Devices Moderate Dec 4, 2019

SWANSON FINGER JOINT #2, Part Number 4700002

Wright Medical Technology, Inc.
FDA Devices Moderate Nov 27, 2019

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in gi…

Cook Inc.
FDA Devices Moderate Nov 27, 2019

BIOFLO 8F SINGLE TITANIUM NON- FILLED; VALVED, UPN H965440250, Cat. No. 44-025 - Product Usage: Long-term access to the central venous system for adm…

Angiodynamics Inc. (Navilyst Medical Inc.)
FDA Devices Moderate Nov 27, 2019

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in gi…

Cook Inc.
FDA Devices Moderate Nov 27, 2019

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in gi…

Cook Inc.
FDA Devices Moderate Nov 27, 2019

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in gi…

Cook Inc.
FDA Devices Moderate Nov 27, 2019

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in gi…

Cook Inc.
FDA Devices Moderate Nov 27, 2019

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in gi…

Cook Inc.
FDA Devices Moderate Nov 27, 2019

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in gi…

Cook Inc.
FDA Devices Moderate Nov 27, 2019

NOSEBLEED TRAY Kit Code: MNS3885

Centurion Medical Products Corporation
FDA Devices Moderate Nov 27, 2019

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in gi…

Cook Inc.
FDA Devices Moderate Nov 27, 2019

CoolBlue Hyper-Hypothermia System- body hypothermia system Model: Innercool - Product Usage: The system is composed of a heater, a compressor, a cir…

Cincinnati Sub-Zero Products LLC, a Gentherm Company
FDA Devices Moderate Nov 27, 2019

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in gi…

Cook Inc.
FDA Devices Moderate Nov 27, 2019

Randox Liquid Cardiac Controls Catalogue Numbers CQ5053.

Randox Laboratories, Limited
FDA Devices Moderate Nov 27, 2019

Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embryos into the uterine cavity.

Cook Inc.
FDA Devices Moderate Nov 27, 2019

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in gi…

Cook Inc.
FDA Devices Moderate Nov 27, 2019

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in gi…

Cook Inc.
FDA Devices Moderate Nov 27, 2019

Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature management Model 233 - Product Usage: The system is composed of a heat…

Cincinnati Sub-Zero Products LLC, a Gentherm Company
FDA Devices Moderate Nov 27, 2019

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in gi…

Cook Inc.
FDA Devices Moderate Nov 27, 2019

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in gi…

Cook Inc.
FDA Devices Moderate Nov 27, 2019

BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306575 (Canada only)

Becton Dickinson & Company
FDA Devices Moderate Nov 27, 2019

BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306547

Becton Dickinson & Company
FDA Devices Moderate Nov 27, 2019

EPISTAXIS TRAY Kit Code: MNS10165

Centurion Medical Products Corporation
FDA Devices Moderate Nov 27, 2019

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in gi…

Cook Inc.
FDA Devices Moderate Nov 27, 2019

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in gi…

Cook Inc.
FDA Devices Moderate Nov 27, 2019

HeartStart XL+ Defibrillator/Monitor, Model 861290

Philips North America, LLC
FDA Devices Moderate Nov 27, 2019

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in gi…

Cook Inc.
FDA Devices Moderate Nov 27, 2019

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in gi…

Cook Inc.
FDA Devices Moderate Nov 27, 2019

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in gi…

Cook Inc.
FDA Devices Moderate Nov 27, 2019

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in gi…

Cook Inc.
FDA Devices Moderate Nov 27, 2019

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in gi…

Cook Inc.
FDA Devices Moderate Nov 27, 2019

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in gi…

Cook 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.