PlainRecalls

Product category · Updated Jun 3, 2026

Medical Devices recalls

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

Total recalls
40,478
Top agency
FDA Devices
Years covered
2000–2026
Check a product → All categories

Medical Devices accounts for 40,478 recalls — about 40.4% of the federal recall archive, of which 9% of graded records are high-severity.

The FDA, CPSC and NHTSA have published 40,478 medical devices recalls between 2000 and 2026 — roughly 40.4% of the 100,165-record archive. Of the 40,478 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.

  • 40,478 total recalls
  • 40.4% of the archive
  • 9% graded high-severity
  • FDA Devices top agency

Category snapshot

Medical Devices accounts for 40,478 recalls — about 40.4% of the 100,165-record federal archive, with 3,549 graded high-severity, most issued by FDA Devices.

40,478
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 2567 3385 2655 3821 3004 3208 2360 2254 2607 3417 2992 1243

Source: FDA · CPSC · NHTSA As of Jun 3, 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 34 of 810

FDA Devices Moderate Nov 26, 2025

REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with a Honeywell Vuquest or Jadk FM-5 barcode reader …

Cellavision AB

FDA Devices Moderate Nov 26, 2025

MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S; 2) MINOR EYE TRAY #81, REF DYNJ27466T.

Medline Industries, LP

FDA Devices Moderate Nov 26, 2025

SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 ¿L; Prepared with Sodium Heparin Model/Catalog Number: 06 0009 Product Description: A clear, …

ASP Global, LLC. dba Anatomy Supply Partners, LLC.

FDA Devices Moderate Nov 26, 2025

MEDLINE convenience kits labeled as: 1) CENTRAL LINE PACK, REF DYNJ00281P; 2) FREE FLAP PACK, REF DYNJ68213C.

Medline Industries, LP

FDA Devices Moderate Nov 26, 2025

MEDLINE convenience kits labeled as: GP-LEEP PACK-LF, REF PHS396969004F

Medline Industries, LP

FDA Devices Critical Nov 26, 2025

BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY ONE PIECE BEZEL 8100, REF: 49000270. Used with …

CareFusion 303, Inc.

FDA Devices Moderate Nov 26, 2025

Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog Number: 106531US, HeartMate 3 Controller, US; 106531INT, Hear…

Thoratec LLC

FDA Devices Moderate Nov 26, 2025

SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 ¿L; Prepared with Balanced Heparin, Model/Catalog Number: 06 0187 Product Description: A cle…

ASP Global, LLC. dba Anatomy Supply Partners, LLC.

FDA Devices Moderate Nov 26, 2025

Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Product Descript…

Exactech, Inc.

FDA Devices Moderate Nov 26, 2025

SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Sodium Fluoride; Gray Model/Catalog Number: 07 7340 Product Description: The…

ASP Global, LLC. dba Anatomy Supply Partners, LLC.

FDA Devices Moderate Nov 26, 2025

Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay

Meridian Bioscience Inc

FDA Devices Moderate Nov 26, 2025

SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Lithium Heparin and Plasma Separator Gel; Green Model/Catalog Number: 07 7221 …

ASP Global, LLC. dba Anatomy Supply Partners, LLC.

FDA Devices Moderate Nov 26, 2025

Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03

Medtronic Perfusion Systems

FDA Devices Low Nov 26, 2025

OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor FOBT (Fecal Occult Blood Test)

POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC

FDA Devices Moderate Nov 26, 2025

Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephrostomy Balloon Catheter Model…

Olympus Corporation of the Americas

FDA Devices Moderate Nov 26, 2025

MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 2) GYN LAPAROSCOPY CDS-LF, REF CDS983764J; 3) ROBOTIC, REF…

Medline Industries, LP

FDA Devices Moderate Nov 26, 2025

SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Prepared with Sodium Heparin Model/Catalog Number: 06 0007 Product Description: A clear, p…

ASP Global, LLC. dba Anatomy Supply Partners, LLC.

FDA Devices Moderate Nov 26, 2025

Mixing Fleas for SAFE-T-FILL Blood Gas Capillaries, Model 07 9503

ASP Global, LLC. dba Anatomy Supply Partners, LLC.

FDA Devices Moderate Nov 26, 2025

SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 7251 Product Description: Th…

ASP Global, LLC. dba Anatomy Supply Partners, LLC.

FDA Devices Moderate Nov 26, 2025

MEDLINE convenience kits labeled as: 1) MAJOR VAGINAL HARPER PACK-LF, REF DYNJ0161768G; 2) ACH MAJOR VAGINAL PACK, REF DYNJ67757B.

Medline Industries, LP

FDA Devices Moderate Nov 26, 2025

Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test Assay

Meridian Bioscience Inc

FDA Devices Moderate Nov 26, 2025

MC3 VitalFlow Console, REF 58100; Blood pump of ecmo

Medtronic Perfusion Systems

FDA Devices Moderate Nov 26, 2025

SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Untreated. Model 06 0199 Product Description: A clear, plastic capillary blood colle…

ASP Global, LLC. dba Anatomy Supply Partners, LLC.

FDA Devices Moderate Nov 26, 2025

Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product Description: Greiner VACUETTE Blo…

Greiner Bio-One North America, Inc.

FDA Devices Critical Nov 26, 2025

TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only

TMJ Solutions Inc

FDA Devices Moderate Nov 26, 2025

Brand Name: HeartMate Product Name: HeartMate II¿ Controller (standalone) Model/Catalog Number: 106017, HeartMate II¿ Pocket Controller, US; 106762…

Thoratec LLC

FDA Devices Moderate Nov 26, 2025

SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Clot Activator; Red Model/Catalog Number: 07 7151 Product Description: The S…

ASP Global, LLC. dba Anatomy Supply Partners, LLC.

FDA Devices Moderate Nov 26, 2025

MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075W; 2) C-SECTION, REF CDS984261J; 3) C-SECTION CDS, REF CDS985282F; …

Medline Industries, LP

FDA Devices Moderate Nov 26, 2025

SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L; Plastic, Ammonium Heparinized, Red Marking Model/Catalog Number: 06 0507 Product Description:…

ASP Global, LLC. dba Anatomy Supply Partners, LLC.

FDA Devices Moderate Nov 26, 2025

Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant Assay Model/Catalog Number: 01-190 Software Version: N/A …

Quest International, Inc.

FDA Devices Moderate Nov 26, 2025

MEDLINE convenience kits labeled as: CATH LAB PACEMAKER PACK, REF DYNJ59818A

Medline Industries, LP

FDA Devices Moderate Nov 26, 2025

BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;

Becton Dickinson & Company

FDA Devices Moderate Nov 26, 2025

SAFE-T-FILL Magnetic Rings for SAFE-T-FILL Blood Gas Capillaries, Model 07 9502

ASP Global, LLC. dba Anatomy Supply Partners, LLC.

FDA Devices Moderate Nov 26, 2025

SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator; Amber Microtube, Red Model/Catalog Number: 07 7450 Product D…

ASP Global, LLC. dba Anatomy Supply Partners, LLC.

FDA Devices Moderate Nov 26, 2025

Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630 Tribio" Implant is indicated for use in bony voi…

Berkeley Advanced Biomaterials, LLC

FDA Devices Moderate Nov 26, 2025

DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for use as an in vitro diagnostic d…

Beckman Coulter Inc.

FDA Devices Moderate Nov 26, 2025

Brand Name: HeartMate Product Name: HeartMate II¿ LVAS Implant Kit Model/Catalog Number: 106015, HeartMate II¿ LVAS Kit, with Pocket Controller, Se…

Thoratec LLC

FDA Devices Moderate Nov 26, 2025

Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Product Name: CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8F…

Sterilmed, Inc.

FDA Devices Moderate Nov 26, 2025

MEDLINE convenience kits labeled as LOCAL BASIC, REF DYNJ34418M

Medline Industries, LP

FDA Devices Moderate Nov 26, 2025

MEDLINE convenience kits labeled as: 1) MAJOR LAPAROTOMY CDS, REF CDS860015W; 2) MAJOR LAPAROTOMY CDS, REF CDS860015X; 3) MINOR LAPAROTOMY CDS…

Medline Industries, LP

FDA Devices Moderate Nov 26, 2025

SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Clot Activator and Serum Separator Gel; Red Model/Catalog Number: 07 7121 Pr…

ASP Global, LLC. dba Anatomy Supply Partners, LLC.

FDA Devices Moderate Nov 26, 2025

SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 ¿L; Prepared with Balanced Heparin Model/Catalog Number: 06 0185 Product Description: A clear,…

ASP Global, LLC. dba Anatomy Supply Partners, LLC.

FDA Devices Moderate Nov 26, 2025

MEDLINE convenience kits labeled as: 1) GENERAL AAA #11-RF, REF CDS840261AB; 2) CAROTID ENDARTERECTOMY CDS-LF, REF CDS983637I; 3) PERIPHERAL V…

Medline Industries, LP

FDA Devices Moderate Nov 26, 2025

MEDLINE convenience kits labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V; 2) BASIC BACK CDS, REF CDS780147N; 3) INSTRUMENTED BACK C…

Medline Industries, LP

FDA Devices Moderate Nov 26, 2025

MONARCH Bronchoscope. Model Number: MBR-000211-B

Auris Health, Inc

FDA Devices Moderate Nov 26, 2025

Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US, HeartMate 3 LVAS KIT, US; 10652…

Thoratec LLC

FDA Devices Moderate Nov 26, 2025

SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 ¿L; Prepared with Sodium Heparin Model/Catalog Number: 06 0005 Product Description: A clear, …

ASP Global, LLC. dba Anatomy Supply Partners, LLC.

FDA Devices Moderate Nov 26, 2025

Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Version: N/A Product Descripti…

Exactech, Inc.

FDA Devices Moderate Nov 26, 2025

MEDLINE convenience kits labeled as: 1) GENERAL LAPAROSCOPY, REF CDS930027W; 2) GENERAL MAJOR CDS, REF CDS980245X; 3) BASIC GENERAL CDS, REF C…

Medline Industries, LP

FDA Devices Moderate Nov 26, 2025

MOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.2.3.0 Software Version and UDI Codes: 3.1.3.0 (01)07340201500026(10)…

ELEKTA SOLUTIONS AB

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 Jun 3, 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 Jun 3, 2026.