PlainRecalls

Product category · Updated Aug 19, 2026

Medical Devices recalls

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

Total recalls
41,070
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 (41,070 notices, 39.3% of the archive); 9% of graded records are high-severity.

The FDA, CPSC, USDA FSIS and NHTSA have published 41,070 medical devices recalls between 2000 and 2026 - roughly 39.3% of the 104,423-record archive. Among 12 product categories, that is #1 of 12. Of the 41,070 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.

  • 41,070 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 41,070 recalls, about 39.3% of the 104,423-record federal archive, with 3,653 graded high-severity, most issued by FDA Devices.

41,070
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

41,070 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 · USDA FSIS · NHTSA federal recall filings · 2026-09-02

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 1947

Source: FDA · CPSC · USDA FSIS · NHTSA As of Aug 19, 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 723 of 822

FDA Devices Moderate Jun 18, 2014

Alere Triage¿ D-Dimer Test PN 98100, Lot W53884B. The Alere Triage¿ D-Dimer Test is a fluorescence immunoassay to be used with the Alere Triage¿ Me…

Alere San Diego, Inc.
FDA Devices Moderate Jun 18, 2014

Stryker 2.0mm Tapered Round Elite Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neur…

Stryker Instruments Div. of Stryker Corporation
FDA Devices Moderate Jun 18, 2014

Stryker 3.0mm x 3.8mm Precision Neuro Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue durin…

Stryker Instruments Div. of Stryker Corporation
FDA Devices Moderate Jun 18, 2014

Stryker 5.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during …

Stryker Instruments Div. of Stryker Corporation
FDA Devices Moderate Jun 18, 2014

VITROS 5,1 FS Chemistry System and VITROS 5,1 FS Refurbished, Product Codes/Catalog Numbers 6801375, 6801890 for in vitro diagnostic use.

Ortho-Clinical Diagnostics
FDA Devices Moderate Jun 18, 2014

Stryker 1.5mm Wire Pass Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery…

Stryker Instruments Div. of Stryker Corporation
FDA Devices Low Jun 18, 2014

Beekley Spots Light Image O-Spots for Mammography Catalog Number: 252 Product Usage: To identify raised moles in Mammography

Beekley Corporation
FDA Devices Moderate Jun 18, 2014

bluephase style Light probe Pin-point 6>2 mm black REF # 636 241. The accessory is a pin point light probe, an accessory to a dental curing light …

Ivoclar Vivadent, Inc.
FDA Devices Moderate Jun 18, 2014

Stryker 3.0mm x 3.8mm Neuro Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosur…

Stryker Instruments Div. of Stryker Corporation
FDA Devices Moderate Jun 18, 2014

Stryker 3.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during …

Stryker Instruments Div. of Stryker Corporation
FDA Devices Moderate Jun 18, 2014

BioDerm Liberty Pouch Clean & Dry External Male Catheter Specialty Type with integral collection chamber (Component: SKIN-PREP Protective wipes). …

BioDerm, Inc.
FDA Devices Moderate Jun 18, 2014

enGen Laboratory Automation Systems (enGen) with TCAutomation -- For in vitro quantitative measurement of a variety of analytes of clinical interes…

Ortho-Clinical Diagnostics
FDA Devices Moderate Jun 18, 2014

Stryker 4.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery…

Stryker Instruments Div. of Stryker Corporation
FDA Devices Moderate Jun 18, 2014

Ultrasonic Transducer Kits For use with the Access Family of Immunoassay Systems*. *The Access Family of Immunoassay Systems includes the Access …

Beckman Coulter Inc.
FDA Devices Moderate Jun 18, 2014

RUSCH Easy Cath Coude Kit, 10 FR, Rx Only, Sterile, Distributed by: Teleflex Medical, Research Triangle Park, NC 27708. A tubular device that is i…

Teleflex Medical
FDA Devices Moderate Jun 18, 2014

Stryker 6.0mm Egg Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, includ…

Stryker Instruments Div. of Stryker Corporation
FDA Devices Moderate Jun 18, 2014

Stryker 5.5mm Round Fluted Bur Soft Touch Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during …

Stryker Instruments Div. of Stryker Corporation
FDA Devices Moderate Jun 18, 2014

VITROS 5600 Integrated System, Product Code/Catalog Number 6802413 for in vitro diagnostic use.

Ortho-Clinical Diagnostics
FDA Devices Moderate Jun 18, 2014

IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (PIIC iX); 865350, 865351, 865352

Philips Medical Systems, Inc.
FDA Devices Moderate Jun 18, 2014

Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use.

Cordis Corporation
FDA Devices Moderate Jun 18, 2014

Stryker 1.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurge…

Stryker Instruments Div. of Stryker Corporation
FDA Devices Moderate Jun 18, 2014

Stryker 2.5mm x 3.6mm Neuro Drill Soft Touch Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue duri…

Stryker Instruments Div. of Stryker Corporation
FDA Devices Moderate Jun 18, 2014

VITROS 4600 Chemistry System, Product Code/Catalog Number 6802445 for in vitro diagnostic use.

Ortho-Clinical Diagnostics
FDA Devices Moderate Jun 18, 2014

Stryker 3.5mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during…

Stryker Instruments Div. of Stryker Corporation
FDA Devices Moderate Jun 18, 2014

Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized using ethylene oxide, UPN M00552010 and M00552000, Manufactured by NeoMet…

NEO METRICS, INC.
FDA Devices Moderate Jun 18, 2014

Siemens Healthcare Diagnostics Vista Air Compressor. Vista AirCompressor replacement part: SMN 10706557 SKIT Air Compressor Assy, used on the Di…

Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Jun 18, 2014

Stryker 6.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during …

Stryker Instruments Div. of Stryker Corporation
FDA Devices Moderate Jun 18, 2014

Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography. Model Number: 61-2005

CooperSurgical, Inc.
FDA Devices Critical Jun 18, 2014

Portex Low Dead Space Connector with Sideport, 3.5mm Product Usage: The connector is used to attach the endotracheal tube to the patient breathin…

Smiths Medical ASD, Inc.
FDA Devices Moderate Jun 18, 2014

Horizon Medical Imaging Horizon Medical Imaging is a medical image and information management application that is intended to receive transmit, st…

Mckesson Medical Immaging
FDA Devices Moderate Jun 18, 2014

enGen (TM) Laboratory Automation System Configured with TCAutomation" Software v3.5 -- For in vitro quantitative measurement of a variety of analytes…

Ortho-Clinical Diagnostics
FDA Devices Moderate Jun 18, 2014

BioDerm Safe n' Dry 21006 (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin for applying skin protectant to the …

BioDerm, Inc.
FDA Devices Moderate Jun 18, 2014

Stryker 2.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurg…

Stryker Instruments Div. of Stryker Corporation
FDA Devices Moderate Jun 18, 2014

Stryker 4.0mm x 5.1mm Neuro Drill Soft Touch Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue duri…

Stryker Instruments Div. of Stryker Corporation
FDA Devices Moderate Jun 18, 2014

Armstrong Grommet with wire Otological Ventilation Tube Catalog #: VT-0507-01, Sterilized by Ethylene Oxide, Rx Only. Intended to provide ventil…

Summit Medical, Inc.
FDA Devices Moderate Jun 18, 2014

Tissue-Tek PARAFORM PROC/EMB/MEDIUM, FORMULA 3 - 8x1Kg. for diagnostic chemistry use. Sakura Finetek USA, Inc.

Sakura Finetek USA Inc
FDA Devices Moderate Jun 18, 2014

Stryker 4.5mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during …

Stryker Instruments Div. of Stryker Corporation
FDA Devices Moderate Jun 18, 2014

Maquet PowerLED 700. Product Usage; To provide illumination to the surgical area or the patient.

Maquet Medical Systems USA
FDA Devices Moderate Jun 18, 2014

Philips IntellVue Info Center iX 866023; PIIC iX Upgrade 866024; IntellVue Server iX Upgrade 866026; PIIC Classic Upgrade 866117 Patient Physiologic…

Philips Healthcare Inc.
FDA Devices Moderate Jun 18, 2014

Stryker 6.0mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during…

Stryker Instruments Div. of Stryker Corporation
FDA Devices Moderate Jun 18, 2014

Stryker 2.0mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during…

Stryker Instruments Div. of Stryker Corporation
FDA Devices Moderate Jun 18, 2014

Taut Operative Cholangiogram Catheter, 4.5FR (1.5mm) x 76cm To facilitate the introduction of contrast media into the biliary ducts to obtain a ch…

Teleflex Medical
FDA Devices Moderate Jun 18, 2014

Stryker 3.0mm x 3.8mm Neuro Drill Less Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue…

Stryker Instruments Div. of Stryker Corporation
FDA Devices Moderate Jun 18, 2014

Stryker 5.0mm Barrel Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, inc…

Stryker Instruments Div. of Stryker Corporation
FDA Devices Moderate Jun 18, 2014

Stryker 6.0mm Acorn Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, incl…

Stryker Instruments Div. of Stryker Corporation
FDA Devices Moderate Jun 18, 2014

Synthes Matrix Mandible Short Cut Plate Cutter Synthes Matrix Mandible Short Cut Plate Cutter is intended for oral, maxillofacial surgery.

Synthes, Inc.
FDA Devices Moderate Jun 18, 2014

Stryker 0.5mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery…

Stryker Instruments Div. of Stryker Corporation
FDA Devices Moderate Jun 18, 2014

Leica Ceiling Mount MSF-1 for use with M841 and M501 operating microscopes. Article Number 10446781 utilizes a supply voltage of 230 V. Article Numb…

Leica Microsystems, Inc.
FDA Devices Moderate Jun 18, 2014

Stryker 5.5mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during …

Stryker Instruments Div. of Stryker Corporation
FDA Devices Moderate Jun 18, 2014

BioDerm Liberty 3.0 External Male Catheter Specialty Type with integral collection chamber (Component: SKIN-PREP Protective wipes). The recalled …

BioDerm, 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

25,513 recalls →

Drugs & Medications

14,473 recalls →

Vehicles

8,938 recalls →

Children & Baby Products

4,017 recalls →

Household Products

3,574 recalls →

Dietary Supplements

2,018 recalls →

Data sources

Category data as of Aug 19, 2026.

Every figure on PlainRecalls is rendered directly from official FDA, CPSC, USDA FSIS 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 Aug 19, 2026.