PlainRecalls

Product category · Updated Jul 2, 2026

Medical Devices recalls

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

Total recalls
40,372
Top agency
FDA Devices
Years covered
2000–2026
Check a product → All categories

Medical Devices accounts for 40,372 recalls, about 39.7% of the federal recall archive, of which 9% of graded records are high-severity.

The FDA, CPSC and NHTSA have published 40,372 medical devices recalls between 2000 and 2026 - roughly 39.7% of the 101,704-record archive. Of the 40,372 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.

  • 40,372 total recalls
  • 39.7% of the archive
  • 9% graded high-severity
  • FDA Devices top agency

Category snapshot

Medical Devices accounts for 40,372 recalls, about 39.7% of the 101,704-record federal archive, with 3,538 graded high-severity, most issued by FDA Devices.

40,372
total recalls
9%
graded high-severity
FDA Devices
top issuing agency
2000–2026
years covered

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 1248

Source: FDA · CPSC · NHTSA As of Jul 2, 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 109 of 808

FDA Devices Moderate Sep 4, 2024

Medline procedure packs containing Shenli syringes, labeled as follows: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281J ; 2) ANGIOGRAPHY DRAPE PAC…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 4, 2024

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001048;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001373;

Beaver Visitec International, Inc.

FDA Devices Critical Sep 4, 2024

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Co…

Smiths Medical ASD Inc.

FDA Devices Moderate Sep 4, 2024

Medline procedural kits labeled as: 1) TYMPANOPLASTY , Pack Number CDS980203S; 2) MAJOR EAR , Pack Number CDS982016T; 3) MAJOR EAR PACK, Pack …

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 4, 2024

Centurion procedure kits, labeled as: 1) 6" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C; 2) ARTERIAL LINE TRAY-NO CATHETER, Pack Number …

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 4, 2024

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001157;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001818;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001825;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001774;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584712;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000477;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001025;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973; 2) 2259988; 3) 2266999; 4) 2373519; 5) 2379827; …

GE Healthcare (China) Co., Ltd.

FDA Devices Moderate Sep 4, 2024

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001212;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001526;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001423;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001176;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000455;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001693;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

Medline procedural kits labeled as: NEURO TRAY, Pack Number DYNJ55909B

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 4, 2024

Medline procedural kits labeled as: 1) ALL DOC EYE PACK, Pack Number DYNJ51654A ; 2) ASC CATARACT PACK , Pack Number DYNJ0855117O ; 3) BAI , Pack…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 4, 2024

Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAM TRAY, Pack Number MNS11965A; 2) CIRCUMCISION TRAY, Pack Number …

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 4, 2024

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002000;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000757;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001314;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

BrainFeedback Pro 2 Device - is intended as an instrument that provides a visual and auditory signal corresponding to the status of a patients physi…

RONAN MEDICAL LLC

FDA Devices Critical Sep 4, 2024

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N030; b) NEONATAL TRACH TUB…

Smiths Medical ASD Inc.

FDA Devices Moderate Sep 4, 2024

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584742;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

Medline procedural kits labeled as: 1) AFCH ANTERIOR SEGMENT PK, Pack Number DYNJ63330B ; 2) ANTERIOR HIP PACK , Pack Number DYNJ82317; 3) ART…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 4, 2024

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001691;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

Centurion procedure kits labeled as: 1) BIOPSY KIT, Pack Number DYNDA1466A; 2) BIOPSY SKIN/LACERATION TRAY, Pack Number SUT20455; 3) CHEST TUB…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 4, 2024

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001999;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

Medline procedural kits labeled as: 1) CIRCUMCISION TRAY, Pack Number CIT6715; 2) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 3) P…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 4, 2024

Medline procedural kits labeled as: 1) CIRCUMCISION TRAY, Pack Number CIT6715; 2) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 3) …

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Critical Sep 4, 2024

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Co…

Smiths Medical ASD Inc.

FDA Devices Moderate Sep 4, 2024

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001375;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001395;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002063;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001305;

Beaver Visitec International, Inc.

FDA Devices Critical Sep 4, 2024

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N025; b) TTS NEONATAL…

Smiths Medical ASD Inc.

FDA Devices Moderate Sep 4, 2024

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001123;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001795;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

McKesson Syringe 60CC, Luer Lock Tip, Sterile, ITEM NO 102-S60C. Model No. 102-S60C - SYRINGE, LL 60CC (25/BX 4BX/CS)

Cypress Medical Products LLC

FDA Devices Moderate Sep 4, 2024

Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.

Abbott Diagnostics Technologies AS

FDA Devices Moderate Sep 4, 2024

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001649;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000479;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001838;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

See RES description

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 4, 2024

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000921;

Beaver Visitec International, 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 Jul 2, 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 2, 2026.