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 111 of 808

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: 58001174;

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: 58001970;

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: 58001554;

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: 58002074;

Beaver Visitec International, Inc.

FDA Devices Critical Sep 4, 2024

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: TTS NEONATAL TRACHY TUBE 4.0MMTIGHT TO SHAFT CUFF , Product Code/List Number/Item Code 67N040

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: 58001608;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

Medline procedure packs containing Shenli syringes, labeled as follows: 1) CVC DOUBLE LUMEN 16CM, Pack Number ECVC8105; 2) VANTEX 7FR 3L 20CM CV…

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: 58001380;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

Medline procedural kits labeled as: 1) BIOPSY PACK, Pack Number DYNJ63370A; 2) CIRCUMCISION TRAY, Pack Number CIT7210; 3) CIRCUMCISION TRAY, P…

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: 58001933;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System

ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL

FDA Devices Moderate Sep 4, 2024

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584625;

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: 58001568;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

Medline procedural kits labeled as: 1) FETAL SURGERY-LF, Pack Number CDS840214Q; 2) FETAL SURGERY CDS-LF, Pack Number CMPJ26754O

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: 58000813;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

Centurion procedure packs, containing Caina syringes, labeled as: SHAVE KIT, Pack Number MNS8250

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: 58001809;

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: 584727;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

Medline procedural kits labeled as: 1) BOTOX KIT - CHRONIC MIGRAINE, Pack Number DYKM2000; 2) BREAST, Pack Number DYNJ902703K; 3) ENT TYMPANOP…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 4, 2024

Medline procedural kits labeled as: 1) PERIPHERAL ULTRASOUND CATHETER INSERTION, Pack Number MNS9865; 2) CIRCUMCISION TRAY, Pack Number CIT6715;…

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: 58000126;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570

Schiller, Ag

FDA Devices Moderate Sep 4, 2024

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000120;

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: 58001967;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

Stryker iBur 3.0mm Precision Round, Distal Bend- Intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting…

Stryker Corporation

FDA Devices Critical Sep 4, 2024

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED , Product Code/List Number/Item Code 60P025; b) …

Smiths Medical ASD Inc.

FDA Devices Moderate Sep 4, 2024

Centurion procedure kits labeled as: UMBILICAL VESSEL TRAY, Pack Number UVT1100

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: 58002080;

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: 584545;

Beaver Visitec International, Inc.

FDA Devices Critical Sep 4, 2024

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

Smiths Medical ASD Inc.

FDA Devices Moderate Sep 4, 2024

Medline procedural kits labeled as: 1) GLMI ARTHROGRAM KIT:PCL, Pack Number SPEC0300B; 2) MERCY MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; …

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: 58001836;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

Medline procedural kits labeled as: CIRCUMCISION TRAY, Pack Number DYNDA2271

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 4, 2024

DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.

Beckman Coulter, Inc.

FDA Devices Moderate Sep 4, 2024

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000867;

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: 58000709;

Beaver Visitec International, Inc.

FDA Devices Critical Sep 4, 2024

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 67017…

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: 58000162;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

Medline procedural kits labeled as: 1) INFANT DELIVERY KIT , Pack Number DYKM1426; 2) SR OB DELIVERY , Pack Number DYNJ908583; 3) SR OB DELIVE…

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: 58001721;

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: 58001658;

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: 58001374;

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: 58001695;

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: 58001331;

Beaver Visitec International, Inc.

FDA Devices Critical Sep 4, 2024

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 6.0MM FLEXTEND PEDIATRIC PLUS VEE TRACH TUBE , Product Code/List Number/Item Code 60PFP60

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: 58000501;

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: 58000985;

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: 58000195;

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: 58001545;

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.