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 · 2026-09-03

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 791 of 822

FDA Devices Moderate Jan 30, 2013

ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - SHARP, Disposable Hyfrecator(R) Tips, REF/Catalog No. 7-100-8CS, Sterile, Rx ONLY -- CONMED CORPORATION Ele…

ConMed Corporation

FDA Devices Moderate Jan 30, 2013

TUR/Endoscopic Cable, 10 feet (3.05 mm), REF/Catalog No. 135171, Disposable, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coag…

ConMed Corporation

FDA Devices Moderate Jan 30, 2013

DePuy Spine VIPER POLY SCREW 5.5 9 X100MM Tl Product Code: 1867-15-999 Spinal Implant Component.

DePuy Spine, Inc.

FDA Devices Moderate Jan 30, 2013

Becton, Dickinson and Company, BBL Crystal Enteric/Nonfermenter ID Kit, Catalog # 24500, cartons of 20 kits, In-vitro diagnostic reagents for microbi…

Becton Dickinson & Co.

FDA Devices Moderate Jan 30, 2013

CONMED(R) ELECTROSURGICAL SAFETY HOLSTER, Disposable Safety Holster, REF/Catalog No. 137668, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, …

ConMed Corporation

FDA Devices Moderate Jan 30, 2013

DePuy Spine VIPER POLY SCREW 5.5 9 X70MM Tl Product Code: 1867-15-970 Spinal Implant Component.

DePuy Spine, Inc.

FDA Devices Moderate Jan 30, 2013

DePuy Spine VIPER POLY SCREW 5.5 10 X 70MM Tl Product Code: 1867-15-170 Spinal Implant Component.

DePuy Spine, Inc.

FDA Devices Moderate Jan 30, 2013

UltraClean(R) Accessory Electrode 6 inch Coated Blade, REF/Catalog No. 139107, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION, Electrosurgical,…

ConMed Corporation

FDA Devices Moderate Jan 23, 2013

Sarns high-flow aortic arch cannula, 5.2 mm (16 Fr) OD with 3/8in connector, 7.5in (19 cm) long The Sarns&…

Terumo Cardiovascular Systems Corporation

FDA Devices Moderate Jan 23, 2013

Sarns flexible arterial cannula, 8.0 mm (24 Fr) with 3/8in connector, suture ring, 9.5in (24 cm) long The Sarns&am…

Terumo Cardiovascular Systems Corporation

FDA Devices Moderate Jan 23, 2013

NEONATAL TOTAL GALACTOSE KIT Product Numbers: 3029-0010, 3029-001B. This kit is intended for the quantitati…

Perkinelmer

FDA Devices Low Jan 23, 2013

Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2.5 Ca 1Mg .16.5GAL Catalog Number: OFD3251-3B Product Usage: …

Fresenius Medical Care Holdings, Inc.

FDA Devices Low Jan 23, 2013

Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2,0 Ca 1.0Mg .16.5GAL Catalog Number: OFD3201-3B Product Usage…

Fresenius Medical Care Holdings, Inc.

FDA Devices Critical Jan 23, 2013

Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device***STERILE*** Product Usage: The Vycor Viewsite Brain Access System (VBAS) has …

Vycor Medical, Inc.

FDA Devices Moderate Jan 23, 2013

Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, 11in (28 cm) long The Sarns&a…

Terumo Cardiovascular Systems Corporation

FDA Devices Low Jan 23, 2013

Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2,5 Ca 0.75Mg .16.5GAL Catalog Number: OFD2223-3B Product Usag…

Fresenius Medical Care Holdings, Inc.

FDA Devices Moderate Jan 23, 2013

25-Hydroxy Vitamin D EIA, Catalog #AC-57F1. Product Usage: The IDS 25-Hydroxy Vitamin D EIA kit is an enzymeimmunoassay intended for the quantita…

IDS (Immunodiagnostic Systems Ltd.)

FDA Devices Moderate Jan 23, 2013

Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Scanning Systems: Brilliance 64 - Model #728231; and Ingenuity CT - Model # 728326, Distrib…

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Jan 23, 2013

Hoffman LRF Wire Bolt, Catalog number 4933-1-001 through -003.

Stryker Howmedica Osteonics Corp.

FDA Devices Moderate Jan 23, 2013

Sarns flexible arterial cannula, 7.3 mm (22 Fr) OD with 3/8in connector, suture ring, 9.5in (24 cm) long The Sarns&amp…

Terumo Cardiovascular Systems Corporation

FDA Devices Moderate Jan 23, 2013

DBS MICROPLATE, TRUNCATED V-BOTTOMED Product Number: 3033-0010

Perkinelmer

FDA Devices Low Jan 23, 2013

Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.0 Ca 1Mg .16.5GAL Catalog Number: OFD2201-3B Product Usage: …

Fresenius Medical Care Holdings, Inc.

FDA Devices Moderate Jan 23, 2013

Eterna Giovinezza System, Powered Laser Surgical Instrument. Permanent hair reduction; Photocoagulation of dermatological vascular lesions; Photot…

Quanta System, S.p.A.

FDA Devices Moderate Jan 23, 2013

Spacelabs Smart Disclosure System, Model 92810, is an integrated component of the Intesys Clinical Suite (ICS) G2, Version 4.03. The Smart Disclos…

Spacelabs Healthcare, Llc

FDA Devices Moderate Jan 23, 2013

Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser Surgical Instrument. Nd:YAG 1064 nm: Coagulation and hemostasis of benign vascular lesions…

Quanta System, S.p.A.

FDA Devices Moderate Jan 23, 2013

DePuy Spine EXPEDIUM Offset Torque Wrench Product Code 2797-29-510 The device is intended for use during the final tightening of an Expedium Offs…

DePuy Spine, Inc.

FDA Devices Low Jan 23, 2013

Fresenius GranuFlo Dry Acid Concentrate For Bicarbonate Dialysis 2.0 K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B Product Usage: GranuFlo i…

Fresenius Medical Care Holdings, Inc.

FDA Devices Moderate Jan 23, 2013

Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, 11in (28 cm) long, with X coating surface The Sarns&a…

Terumo Cardiovascular Systems Corporation

FDA Devices Low Jan 23, 2013

Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2,5 Ca 0.75Mg .16.5GAL Catalog Number: OFD2325-3B Product Usag…

Fresenius Medical Care Holdings, Inc.

FDA Devices Moderate Jan 23, 2013

NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT Product Number: 3026-0030. This kit is intended for the measurement and eva…

Perkinelmer

FDA Devices Low Jan 23, 2013

Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2,5 Ca 0.75 Mg .16.5GAL Catalog Number: OFD2225-3B Product Us…

Fresenius Medical Care Holdings, Inc.

FDA Devices Moderate Jan 23, 2013

Microplate, truncated V-bottomed lots included in the above listed products Product Number: 1380 5465. DBS Microplate is a general purpo…

Perkinelmer

FDA Devices Moderate Jan 23, 2013

NEOBASE NON-DERIVATIZED MSMS KIT Product Number: 3040-001U. This tandem mass spectrometry (MSMS) reagent kit is…

Perkinelmer

FDA Devices Moderate Jan 23, 2013

Sarns flexible arterial cannula, 6.7 mm (20Fr) OD with 3/8 in. connector, suture ring, 9.5 in (24 cm) long The Sarns&a…

Terumo Cardiovascular Systems Corporation

FDA Devices Low Jan 23, 2013

Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.25 Ca 1Mg .16.5GAL Catalog Number: OFD2231-3B Product Usage:…

Fresenius Medical Care Holdings, Inc.

FDA Devices Moderate Jan 23, 2013

Q-Plus T Powered Laser Surgical Instrument Nd:YAG 1064 nm and 532 nm: Treatment of vascular lesions and pigmented lesions; Hair and tattoo removal…

Quanta System, S.p.A.

FDA Devices Low Jan 23, 2013

Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 1.0K 2.0 Ca 1Mg .16.5GAL Catalog Number: OFD1201-3B Product Usage: …

Fresenius Medical Care Holdings, Inc.

FDA Devices Moderate Jan 23, 2013

Computed Tomography X-Ray System Brilliance Workspace Portal, Model #728269 Philips Medical Systems, Highland Heights, OH. The Brilliance Workspac…

Philips Medical Systems (Cleveland) Inc

FDA Devices Critical Jan 23, 2013

Bausch and Lomb 27G sterile cannula packed in the Bausch and Lomb Amvisc 1.2% Sodium Hyaluronate ( Model 59051, 59081, 59051L, 59081L) and Amvisc Plu…

Bausch and Lomb, Incorporated

CPSC No agency class Jan 17, 2013

American Signature Recalls Hayward Push Back Chairs Due to Fall Hazard; Sold Exclusively at Value City Furniture and American Signature Furniture Sto…

FDA Devices Low Jan 16, 2013

Immunoradiometric assay. Device is an immunoradiometric assay designed for the quantitative measurement of thyroid stimulating hormone (thyrotropi…

Siemens Healthcare Diagnostics

FDA Devices Moderate Jan 16, 2013

PT113950 PT HYBRID Glenoid Post Regenerex porous titanium construct Sterile R Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Biomet, Inc.

FDA Devices Moderate Jan 16, 2013

(l) Visum Halogen Surgical Light, (2) Visum LED Surgical Light, (3) Stryker Flat Panel and Navigation Arm The Spring Arm Circlip is part of the S…

Stryker Communications, Inc.

FDA Devices Moderate Jan 16, 2013

CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and deflate intra-aortic balloons. It provide temporary support t…

Maquet Cardiovascular, LLC

FDA Devices Moderate Jan 16, 2013

Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA; and Laerdal branded FR…

Philips Medical Systems North America Co. Phillips

FDA Devices Moderate Jan 16, 2013

Merit Medical's Custom Procedural Tray or Kits K12T-03162B & K12T-02641F.Custom Procedural Tray or Kits is a combination of legally marketed…

Merit Medical Systems, Inc.

FDA Devices Moderate Jan 16, 2013

Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #3.5, Howmedica Osteonics Corp…

Stryker Howmedica Osteonics Corp.

FDA Devices Moderate Jan 16, 2013

Sterile Rigid Tip Suction Wand The Suction Wands are indicated for use to remove excess fluid from the surgical field.

California Medical Laboratories Inc

FDA Devices Low Jan 16, 2013

Immunoradiometric assay.

Siemens Healthcare Diagnostics

FDA Devices Moderate Jan 16, 2013

UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 5cc Product Code: RT53005 Donated Human Tissue All…

Surgical Tissue Network, 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.

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.