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
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 718 of 822

FDA Devices Moderate Jul 16, 2014

The Hospira MedNet Medication Management Suite (MMS). Product Usage: The Hospira MedNet Medication Management Suite (MMS) is intended to facilita…

Hospira Inc.

FDA Devices Moderate Jul 16, 2014

Aquatec Fixed Backrest - accessory for Mobile Shower and Toilet commode Aquatec Ocean, Ocean VIP and Ocean E-VIP family.

Invacare Corporation

FDA Devices Moderate Jul 16, 2014

STOPCOCK EXT. SET W/ 3-WAY STOPCOCK WITH INJ. SITE AND SPINLOCK CONNECTOR, 22 inches and 37 inches

B. Braun Medical, Inc.

FDA Devices Moderate Jul 16, 2014

3M Attest Auto-reader. Model numbers 390, 390G,and 490. These devices incubate the biological indicators (BIs) to determine a positive or ne…

3M Company - Health Care Business

FDA Devices Moderate Jul 16, 2014

Aquapak 340 SW, 340, mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.

Teleflex Medical

FDA Devices Moderate Jul 16, 2014

Patient Side Cart Battery Box used in conjunction with the da Vinci A surgical system. Intuitive Surgical Inc. Sunnyvale, CA 94086

Intuitive Surgical, Inc.

FDA Devices Moderate Jul 16, 2014

Aquapak 640 SW, 650 mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.

Teleflex Medical

FDA Devices Low Jul 16, 2014

Reliance 1227 Cart and Utensil Washer/Disinfector Product Usage: Usage: The Reliance 1227 Cart and Utensil Washer/Disinfector is intended for us…

Steris Corporation

FDA Devices Moderate Jul 16, 2014

Aquapak 101 SW, 190, mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas humidifier adaptor

Teleflex Medical

FDA Devices Moderate Jul 16, 2014

Terumo¿ Advanced Perfusion System 1 220/240V AC, Advanced Perfusion System Platform (APS)

Terumo Cardiovascular Systems Corporation

FDA Devices Moderate Jul 16, 2014

07-150-07 MIZUHO, MAL DISP DOPPLER PROBE BX 4, REF 138200 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of bl…

Vascular Technology, Inc.

FDA Devices Moderate Jul 16, 2014

Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology, HIP JOINT PROSTHESIS¿, Sizes:4, 5, 6, 7.5, 9, 10, 11 & 12.5. The femoral stem compo…

Zimmer, Inc.

FDA Devices Moderate Jul 16, 2014

Dafilon Suture Black 10/0 (0.2) 15 cm DRM4 NS, non-sterile, non-absorbable polyamide Surgical Suture, additional label affixed on the box states the…

Aesculap, Inc.

FDA Devices Moderate Jul 16, 2014

Aquapak 640 SW, 650 mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas humidifier adaptor.

Teleflex Medical

FDA Devices Moderate Jul 16, 2014

07-150-10 MIZUHO, DOPPLER PROBE, SLIM, BX 4, REF 138660 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of bloo…

Vascular Technology, Inc.

FDA Devices Moderate Jul 16, 2014

Adaptor, 040 Hum, International, Teleflex Medical, respiratory gas humidifier adaptor.

Teleflex Medical

FDA Devices Moderate Jul 16, 2014

Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures.

RGI Medical Manufacturing, Inc.

FDA Devices Moderate Jul 16, 2014

Humidifier Adaptor 040, Teleflex Medical, respiratory gas humidifier adaptor.

Teleflex Medical

FDA Devices Moderate Jul 16, 2014

Aqua 540 SW, 540 w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.

Teleflex Medical

FDA Devices Moderate Jul 16, 2014

ColorSafe IV lines Catalog No.(Model No.) CS3000-R (76.7806), CS400-R (76.7800), CS408N-R (76.8000), CS3000-B (76.7807), B314 (25.7406), …

Codan Us Corporation

FDA Devices Moderate Jul 16, 2014

Aquapak 340 SW, 340, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas humidifier adaptor .

Teleflex Medical

FDA Devices Moderate Jul 16, 2014

Aquapak 340 SW, 340, mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas humidifier adaptor.

Teleflex Medical

FDA Devices Moderate Jul 16, 2014

07-150-12 MIZUHO, MINI, SLIM, STERILE, BOX OF 4, REF 138665 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of …

Vascular Technology, Inc.

FDA Devices Moderate Jul 16, 2014

The STERIS 4085 General Surgical Table Product Usage: is an electro-hydraulically operated surgical table designed to support all general surgica…

Steris Corporation

FDA Devices Moderate Jul 16, 2014

Zimmer EDI PERIARTICULAR PLATING SYSTEM CANCELLOUS BONE SCREW, FULLY THREADED, HEX HEAD 4MM DIAMETER, 14 MM LENGTH, and EDI 4.0 MM CANCELLOUS SCRE…

Zimmer Manufacturing B.V.

FDA Devices Moderate Jul 16, 2014

Aquapak SW/EAU Sterile, 650 mL w/Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.

Teleflex Medical

FDA Devices Moderate Jul 16, 2014

SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 10061661A 14035457 14035485 14046894 14035458

CareFusion 303, Inc.

FDA Devices Moderate Jul 16, 2014

Amerigel Wound Dressing 55 gallons/drum

Kova Laboratories, Inc.

FDA Devices Moderate Jul 16, 2014

Essential NEO, Audio/Visual Integration Unit An audio/visual integration unit.

Karl Storz Endoscopy

FDA Devices Moderate Jul 16, 2014

Terumo¿ Advanced Perfusion System 1 100/120V AC, Advanced Perfusion System Platform (APS)

Terumo Cardiovascular Systems Corporation

FDA Devices Moderate Jul 16, 2014

HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer.

Cenorin, LLC

FDA Devices Moderate Jul 16, 2014

Devon Supine, Lithotomy and Trendelenburg Positioning Kit; Product Code: 31151090 Product Usage: The device is intended to provide padding under …

Covidien LLC

FDA Devices Moderate Jul 16, 2014

Zimmer M/L Taper Hip Stem Standard & Extended Offset, HIP JOINT PROSTHESIS, Sizes: 5.0, 7.5, 9.0, 10.0, 11.0, 12.5, 13.5, 15.0, 11.25, 17.25, 20.0 &…

Zimmer, Inc.

FDA Devices Moderate Jul 16, 2014

Aquapak 640 SW, 650 mL w/040 Adaptor, French, Teleflex Medical, respiratory gas humidifier adaptor.

Teleflex Medical

FDA Devices Moderate Jul 16, 2014

Aquapak SW/EAU, Sterile, 340 mL, w/Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.

Teleflex Medical

FDA Devices Moderate Jul 16, 2014

Zimmer M/L Taper Reduced Neck Standard & Extended Offset, HIP JOINT PROSTHESIS, Sizes:4, 5, 6, 7.5, 9, 10, 11 & 12.5. The femoral stem compo…

Zimmer, Inc.

FDA Devices Moderate Jul 16, 2014

Intuitive Surgical Inc. Large Clip Applier instruments used in conjunction with da Vinci S and da Vinci SI Surgical Systems Intuitive Surgical Inc…

Intuitive Surgical, Inc.

FDA Devices Moderate Jul 16, 2014

VTI BAYONET DOPPLER, 20MHz DOPPLER PROBE, SLIM, BX 4, REF 108660 The Doppler probe is intended for the intraoperative and transcutaneous evaluatio…

Vascular Technology, Inc.

FDA Devices Moderate Jul 16, 2014

GEMINI TF PET/CT16: 882470, GEMINI TF PET/CT 64: 882471, GEMINI TF Big Bore: 882476. A diagnostic imaging system for fixed or mobile installations…

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Jul 16, 2014

Aquapak 340 SW, 340, mL w/040 Adaptor, French, Teleflex Medical, respiratory gas humidifier adaptor.

Teleflex Medical

FDA Devices Critical Jul 9, 2014

Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Catalog No. 46914. Intended to allow drainage and measurement o…

Medtronic Neurosurgery

FDA Devices Moderate Jul 9, 2014

Stryker Orthopaedics Triathlon Tritanium Patella Inserter, . NON-STERILE Product Usage: The Triathlon Tritanium Patella Inserter is part of the T…

Stryker Howmedica Osteonics Corp.

FDA Devices Moderate Jul 9, 2014

GE Healthcare, Revolution XR/d. Revolution XR/d Intended Use: The Revolution XR/d Digital Radiographic imaging system is indicated for use in gen…

GE Healthcare, LLC

FDA Devices Moderate Jul 9, 2014

NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 1. Part of the NexGen systems of …

Zimmer, Inc.

FDA Devices Moderate Jul 9, 2014

NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 3. Part of the NexGen systems of …

Zimmer, Inc.

FDA Devices Moderate Jul 9, 2014

NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 5. Part of the NexGen systems of …

Zimmer, Inc.

FDA Devices Moderate Jul 9, 2014

GE Healthcare, Proteus XR/a. Proteus XR/a Intended Use: Is intended for use in generating radiographic images of human anatomy in all general purp…

GE Healthcare, LLC

FDA Devices Moderate Jul 9, 2014

The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging receptor and stationary grid. It contains signaling electronics to…

Claymount Assembli

FDA Devices Moderate Jul 9, 2014

IRK QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System and Si-e. Intuitive Surgical Endoscopic Instrument C…

Intuitive Surgical, Inc.

FDA Devices Moderate Jul 9, 2014

Stride Femoral Component Size 2, PFSI-00053, Right Lateral /Left Medial. Unicondylar Knee prosthesis.

Blue Belt Technologies MN

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

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.