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 · 2026-08-21

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 441 of 819

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-COTTON TIP APPLICATORS, 10'S (6") Product Number:R1112B

Custom Healthcare Systems, Inc.
FDA Devices Moderate Oct 31, 2018

Surgical Handpiece, Model: SGA-E Order Code: H083, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage …

Nakanishi Inc.
FDA Devices Moderate Oct 31, 2018

STREAMLAB CORE UNIT / LYNX WITH IOM

Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-SUTURE REMOVAL KIT #1 Product Number: -ZZ-0664

Custom Healthcare Systems, Inc.
FDA Devices Moderate Oct 31, 2018

O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027R SYS PRODUCT RWK, Model Number Bl70000027R Product Usage: The O-arm Imaging System is…

Medtronic Navigation, Inc.-Littleton
FDA Devices Critical Oct 31, 2018

CyPass System 241-S, CYPASS MICRO-STENT, CYPASS LOADED, CYPASS APPLIER, REF CATALOG #: 8065754003 For ophthalmic use.

Alcon Research, LTD.
FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit- PENROSE DRAIN (.75" X 18") Product Number:D8-9425B

Custom Healthcare Systems, Inc.
FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-WEBSTER NEEDLE HOLDER Product Number:01-375C

Custom Healthcare Systems, Inc.
FDA Devices Moderate Oct 31, 2018

BACT/ALERT VIRTUO system, B Unit, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated micro…

bioMerieux, Inc.
FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-TOOTHBRUSH, 46 TUFT Product Number:R1635

Custom Healthcare Systems, Inc.
FDA Devices Moderate Oct 31, 2018

APTIO INPUT/OUTPUT MODULE

Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Oct 31, 2018

Micro Surgery Handpiece SGS, Model: SGS-E2S, Order Code: H266, Manufactured by: Nakanishi Inc The SGS/SGA Surgical Handpieces are intended for su…

Nakanishi Inc.
FDA Devices Moderate Oct 31, 2018

Boston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14, Model Numbers: M00440000, M0044000D0, M0044000H0,M0044000R0, M0044000Z…

Boston Scientific Corporation
FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit- LITTLE SNIPPER CIRCUMCISION TRAY Part Number: YMCIR-400

Custom Healthcare Systems, Inc.
FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-FENESTRATED DRAPE 40 X 62P Part Number: 1222-2112

Custom Healthcare Systems, Inc.
FDA Devices Moderate Oct 31, 2018

BACT/ALERT VIRTUO system, A Unit China, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated…

bioMerieux, Inc.
FDA Devices Moderate Oct 31, 2018

Micro Surgery Handpiece SGA, Model SGA-ES, Order Code:H263, Manufactured by: Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for …

Nakanishi Inc.
FDA Devices Moderate Oct 31, 2018

STREAMLAB - REFRIGERATED STORAGE MODULE 9000

Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience (1) 1231-150L GOWN, RAGLAN, LG, NONREINF (2) 1231-150XL GOWN, RAGLAN, XL, NONREINF (3) 1231-140XL GOWN, SPECIALTY XL, XLO…

Custom Healthcare Systems, Inc.
FDA Devices Moderate Oct 31, 2018

O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GERR SYS PRODUCT REFURB, Model Number Bl70000027GERR Product Usage: The O-arm Imaging …

Medtronic Navigation, Inc.-Littleton
FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-SUTURE REMOVAL KIT (W.ADSON SERR)Product Number:UNC-9481B

Custom Healthcare Systems, Inc.
FDA Devices Moderate Oct 31, 2018

IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software product that can receive information from a hospital computer system (als…

Data Innovations, LLC
FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-GENERAL UTILITY TRAY Product Number:S1528-02

Custom Healthcare Systems, Inc.
FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit- COBAN¿, LF (1"X5 YDS) Product Number:D5-14591

Custom Healthcare Systems, Inc.
FDA Devices Moderate Oct 31, 2018

O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230R SYSTEM 230V RWK, Model Number Bl70000027230R Product Usage: The O-arm Imaging Sys…

Medtronic Navigation, Inc.-Littleton
FDA Devices Critical Oct 31, 2018

CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754001. For ophthalmic use.

Alcon Research, LTD.
FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-MOSQUITO FORCEPS 5 STR Product Number:B9-18914

Custom Healthcare Systems, Inc.
FDA Devices Moderate Oct 31, 2018

O-arm 1000 2nd Edition Imaging System, BASE BASE OARM Bl70000027120R SYSTEM 120V RWK, Model Number Bl70000027120R Product Usage: The O-arm Imagin…

Medtronic Navigation, Inc.-Littleton
FDA Devices Moderate Oct 31, 2018

STREAMLAB - REFRIGERATED STORAGE MODULE 15000

Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Oct 31, 2018

Medacta International MiniMAX CEMENTLESS ANATOMICAL STEM, 12/14: for cementless use in total or partial hip arthroplasty in primary or revision surge…

Medacta Usa Inc
FDA Devices Moderate Oct 31, 2018

J-Plasma Precise 360, single use, disposable. The Bovie J-Plasma Precise 360 Handpiece is used for the delivery of helium gas plasma for cutting,…

Bovie Medical Corporation
FDA Devices Moderate Oct 31, 2018

APTIO RACK OUTPUT MODULE

Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Oct 31, 2018

TRINIAS Digital Angiographic System intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiogr…

Shimadzu Medical Systems Usa Com
FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-ROCHESTER PEAN, CURVED (8") Product Number:D36-16669

Custom Healthcare Systems, Inc.
FDA Devices Moderate Oct 31, 2018

Micro Surgery Handpiece SGS, Model: SGS-ES, Order Code: H264, Manufactured by: Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for su…

Nakanishi Inc.
FDA Devices Moderate Oct 31, 2018

O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027120 SYSTEM 120V, Model Number Bl70000027120 Product Usage: The O-arm Imaging System is…

Medtronic Navigation, Inc.-Littleton
FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-SPECIALIST¿ CAST PADDING 3" X 4 YDS) Product Number:D4-324SCP

Custom Healthcare Systems, Inc.
FDA Devices Moderate Oct 31, 2018

Tritanium TL Steerable Inserter, Cat. No. 48930000, UDI 07613327381900 Product Usage: The TL Steerable Inserter is a Class 1 instrument which is …

Howmedica Osteonics Corp.
FDA Devices Moderate Oct 31, 2018

NucliSENS¿ Magnetic Extraction Reagents

BioMerieux SA
FDA Devices Moderate Oct 31, 2018

Instrument Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si R…

Ecolab Inc
FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-LP NEEDLE, 22G X 1 Product Number:NC401000

Custom Healthcare Systems, Inc.
FDA Devices Moderate Oct 31, 2018

Camera Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robot…

Ecolab Inc
FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit- (1) DT SCATPAD, DBL. TAPE, 12.5 X 16.5 Product Number: SEPA 402 (2) SCATPAD, 11 X 34 Product Number: SPA502

Custom Healthcare Systems, Inc.
FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-TOENAIL REMOVAL TRAY Product Number: (1) ZZ-0956; (2) ZZ-0685

Custom Healthcare Systems, Inc.
FDA Devices Moderate Oct 31, 2018

Mitek Screw and Washer Depth Gauge, Product Code 219024

DePuy Mitek, Inc., a Johnson & Johnson Co.
FDA Devices Moderate Oct 31, 2018

Disposable Accessory Kit, 3-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da …

Ecolab Inc
FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-INJECTION TRAY Product Number: B9-17201

Custom Healthcare Systems, Inc.
FDA Devices Critical Oct 31, 2018

CyPass ULTRA SYSTEM, CYPASS MICRO-STENT, CYPASS APPLIER, REF CATALOG #: 8065754007. For ophthalmic use.

Alcon Research, LTD.
FDA Devices Moderate Oct 31, 2018

O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100R SYSTEM lOOV RWK, Model Number Bl70000027100R Product Usage: The O-arm Imaging Sys…

Medtronic Navigation, Inc.-Littleton
FDA Devices Moderate Oct 31, 2018

MyLab Gamma, Model 7410

ESAOTE S.P.A.

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.