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 407 of 819

FDA Devices Moderate Jul 10, 2019

VITROS 250 Chemistry System Refurbished, Product Code 6801759, (UDI # 10758750001330) Product Usage: Performs discrete clinical tests on serum, …

Ortho-Clinical Diagnostics
FDA Devices Moderate Jul 10, 2019

SOMATOM go.Now (Model #11061620), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is inte…

Siemens Medical Solutions USA, Inc
FDA Devices Moderate Jul 10, 2019

Siemens Artis Q biplane---Interventional Fluoroscopic X-Ray System Model Number: 10848282

Siemens Medical Solutions USA, Inc
FDA Devices Moderate Jul 10, 2019

SOMATOM go.Up, Model No. 11061628 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is i…

Siemens Medical Solutions USA, Inc
FDA Devices Low Jul 10, 2019

cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic sample storage and retrieval.

Roche Diagnostics Corporation
FDA Devices Moderate Jul 10, 2019

Disposable 25GA Vitrectomy Cutter, REF NGP0025, RX Only, Abbott Medical Optics Inc., The product provides the item necessary to perform one vitr…

Johnson & Johnson Surgical Vision Inc
FDA Devices Moderate Jul 10, 2019

VITROS 250AT Chemistry System, Product Code 1758143, (UDI # 10758750000036) Product Usage: Performs discrete clinical tests on serum, urine, and…

Ortho-Clinical Diagnostics
FDA Devices Moderate Jul 10, 2019

REVACLEAR 300 Dialyzer, Product Code 114745L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal fai…

Baxter Healthcare Corporation
FDA Devices Moderate Jul 10, 2019

Siemens Artis Q.zen floor----Interventional Fluoroscopic X-Ray System Model Number: 10848353

Siemens Medical Solutions USA, Inc
FDA Devices Moderate Jul 10, 2019

First Step Draco Pad, Product Number EP-4D

Madison Polymeric Engineering
FDA Devices Moderate Jul 10, 2019

Atellica CH Creatine Kinase (CK_L) Reagent, Product Code 11097640, UDI Number: 00630414006642 - Product Usage: The ADVIA¿ Chemistry Creatine Kinase (…

Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Jul 10, 2019

Siemens Artis pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000

Siemens Medical Solutions USA, Inc
FDA Devices Moderate Jul 10, 2019

Centricity PACS Foundation Centricity PACS software product is intended for the storage, reading, diagnostic review, analysis, annotation, distrib…

GE Healthcare, LLC
FDA Devices Low Jul 10, 2019

cobas p 701 post-analytical units, Part Number 05349966001. For diagnostic sample storage and retrieval.

Roche Diagnostics Corporation
FDA Devices Moderate Jul 10, 2019

Siemens Artis Q.zen biplane-Interventional Fluoroscopic X-Ray System Model Number: 10848355

Siemens Medical Solutions USA, Inc
FDA Devices Moderate Jul 10, 2019

Draco Enzymatic Deep-Cleaning Pad with Ready-to-Use Enzymatic Detergent, Product Number HY0305Z

Madison Polymeric Engineering
FDA Devices Moderate Jul 10, 2019

SOMATOM go.All, Model No. 11061638 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is …

Siemens Medical Solutions USA, Inc
FDA Devices Moderate Jul 10, 2019

CLEO Patient Monitor /Tranquility VS Patient Monitor

Infinium Medical, Inc
FDA Devices Moderate Jul 10, 2019

Siemens Artis zeego--Interventional Fluoroscopic X-Ray System Model Number: 10280959

Siemens Medical Solutions USA, Inc
CPSC No agency class Jul 10, 2019

Winco Fireworks Recalls Black Cat "Cat Mobiles" Due to Explosion, Burn and Projectile Hazards

Winco Fireworks International, of Grandview, Mo.
FDA Drug Moderate Jul 3, 2019

Droperidol Injectable Sterile Solution, 0.625mg/mL, 1mL in a 3mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Wee…

Premier Pharmacy Labs Inc
FDA Drug Moderate Jul 3, 2019

Neostigmine Methylsulfate, 5mg/5mL (1mg/mL), 5mL Single Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, ND…

Premier Pharmacy Labs Inc
FDA Drug Moderate Jul 3, 2019

SUCCINYLcholine Chloride, 100mg/5mL (20mg/mL), 5mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL …

Premier Pharmacy Labs Inc
FDA Drug Moderate Jul 3, 2019

SUCCINYLcholine Chloride, 200mg/10mL (20mg/mL), 10mL Sterile Single Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, …

Premier Pharmacy Labs Inc
FDA Drug Moderate Jul 3, 2019

Atropine Sulfate PF INJ, 0.8 mg/2 mL (0.4 mg/mL), 2mL Single Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 3461…

Premier Pharmacy Labs Inc
FDA Drug Moderate Jul 3, 2019

Dexamethasone Sodium Phosphate Preservative Free Sterile Solution for INJ, 24mg/mL, 1mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy Labs, 8…

Premier Pharmacy Labs Inc
FDA Drug Moderate Jul 3, 2019

Orphenadrine Citrate Sterile Injectable Solution *Contains Sulfites*, 30mg/mL, 1mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy Labs, 8265 C…

Premier Pharmacy Labs Inc
FDA Drug Moderate Jul 3, 2019

Phenylephrine HCL PF INJ in 0.9% Sodium Chloride, 1000mcg/10mL (100mgc/mL), *Contains Sulfites*, 10mL Single-Dose Syringe, Rx only, Premier Pharmacy …

Premier Pharmacy Labs Inc
FDA Devices Moderate Jul 3, 2019

Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 45cm Shaft PRODUCT CODE: NSLX145C

Ethicon Endo-Surgery Inc
FDA Devices Moderate Jul 3, 2019

Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229037A Model: VST66DF

Maquet Cardiovascular Us Sales, Llc
FDA Devices Moderate Jul 3, 2019

TASE 400 Imaging systems

COLLINS AEROSPACE
FDA Devices Low Jul 3, 2019

Leadwire sets with snap ends: REF/Catalog Number Description 2106381-001 ECG Leadwire set, 5-lead, snap, AHA, 74 cm/ 29 in 2106381-002 ECG Leadwir…

GE Healthcare, LLC
FDA Devices Moderate Jul 3, 2019

Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.

Medtronic Inc
FDA Devices Moderate Jul 3, 2019

Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 37cm Shaft PRODUCT CODE: NSLX137C

Ethicon Endo-Surgery Inc
FDA Devices Critical Jul 3, 2019

SmartSite Syringe Administration Set-Product Package Size 50, Catalog Number: 10798696

Becton Dickinson & Company
FDA Devices Moderate Jul 3, 2019

Thermo Scientific General Purpose Dynamic Bath Precision 10L GP Bath Model Number: TSGP10

Thermo Fisher Scientific (Asheville) LLC
FDA Devices Low Jul 3, 2019

Replacement leadwires with grabber ends: REF/Catalog Number Description 2106388-005 Replacement ECG Leadwire, grabber, BRN V, AHA, 74 cm/ 29 in 21…

GE Healthcare, LLC
FDA Devices Moderate Jul 3, 2019

Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229003A Model: VST66DF AIM

Maquet Cardiovascular Us Sales, Llc
FDA Devices Moderate Jul 3, 2019

Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 20L GP Bath Model Number: FSGPD20

Thermo Fisher Scientific (Asheville) LLC
FDA Devices Moderate Jul 3, 2019

Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 25cm Shaft PRODUCT CODE: NSLX125C

Ethicon Endo-Surgery Inc
FDA Devices Moderate Jul 3, 2019

Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229000A Model: VST60SF AIM

Maquet Cardiovascular Us Sales, Llc
FDA Devices Moderate Jul 3, 2019

Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568812910 Model: VLT400SF STP

Maquet Cardiovascular Us Sales, Llc
FDA Devices Moderate Jul 3, 2019

Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229001A Model: VST60DF AIM

Maquet Cardiovascular Us Sales, Llc
FDA Devices Moderate Jul 3, 2019

Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 10L GP Bath Model Number: FSGPD10

Thermo Fisher Scientific (Asheville) LLC
FDA Devices Low Jul 3, 2019

ECG Trunk Cables: REF/Catalog Number Description 2106305-001 ECG Trunk Cable, 3/5-lead, AHA, 3.6 m/12 ft. 2106305-002 ECG Trunk Cable, 3/5-lead, …

GE Healthcare, LLC
FDA Devices Moderate Jul 3, 2019

Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811961 Model: VLT600DF AIM STP

Maquet Cardiovascular Us Sales, Llc
FDA Devices Moderate Jul 3, 2019

Centricity PACS-IW with Universal Viewer version 5.0, Model Number 2068177-001 Product Usage: Centricity Universal Viewer is a device that displa…

GE Healthcare, LLC
FDA Devices Moderate Jul 3, 2019

Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229002A Model: VST66SF AIM

Maquet Cardiovascular Us Sales, Llc
FDA Devices Moderate Jul 3, 2019

Mosaic 310 Bioprosthesis, Mitral, REF 310C31 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.

Medtronic Inc
FDA Devices Moderate Jul 3, 2019

Freedom EVO 200 - Product Usage: It is intended for routine laboratory tasks, such as general purpose pipetting and general purpose liquid handling a…

Tecan US, 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.