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 72 of 810

FDA Devices Moderate Mar 26, 2025

Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.1.1, 12.2, 12.3, 12.3.1, 12.3.2, 12.3.3, 12.4, 12.4.1, 12.4.2; Merge Car…

Merge Healthcare, Inc.

FDA Devices Moderate Mar 26, 2025

DR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

LABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-02

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.

American Contract Systems Inc

FDA Devices Critical Mar 26, 2025

smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4172-…

Smiths Medical ASD, Inc.

FDA Devices Moderate Mar 26, 2025

VERICIS, Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.0.1, 12.0.2; The VERICIS is an integrated cardiovascular information …

Merge Healthcare, Inc.

FDA Devices Moderate Mar 26, 2025

Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens, Positive Controls, & Immunodiffusion (ID) plates for use in t…

Immuno-Mycologics, Inc

FDA Devices Critical Mar 26, 2025

smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.6Fr Introd…

Smiths Medical ASD, Inc.

FDA Devices Moderate Mar 26, 2025

Microstream Instructions for Use and Part Number used with - Product Description, REF: OmniVentLine Set, 012808 - OmniVentLine Set Adult-Pedi…

Oridion Medical 1987 Ltd.

FDA Devices Moderate Mar 26, 2025

Proxima Drape labeled as UNIVERSAL DAVINCI ROBOTIC P. Sterile surgical drape.

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Mar 26, 2025

Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11

Waldemar Link GmbH & Co. KG (Mfg Site)

FDA Devices Moderate Mar 26, 2025

VEIN TRAY, Model No UTVT21C UTVT21C02 UTVT21C-03

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Luer Intubated Adult Pediatric, PT00156355 - …

Oridion Medical 1987 Ltd.

FDA Devices Moderate Mar 26, 2025

Proxima Drape labeled as HEAD AND NECK OSIS, WILLIS SHOULDER PACK, EXTREMITY PACK-LF, TOTAL HIP PACK-LF, SHOULDER W/POUCH-LF, VEIN PACK. Sterile surg…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Mar 26, 2025

Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0…

Microbiologics Inc

FDA Devices Critical Mar 26, 2025

smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9 Fr Introducer, REF 21-4151-24

Smiths Medical ASD, Inc.

FDA Devices Moderate Mar 26, 2025

CYSTO PACK , Model N. HKCY31A

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 11…

ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY

FDA Devices Moderate Mar 26, 2025

BORN ON ARRIVAL KIT , Model No LLBN11B

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100

Smiths Medical ASD, Inc.

FDA Devices Moderate Mar 26, 2025

URO ROBOTIC PACK , Model No LVUR44C LVUR44C-03

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 13 mm, Product Code: 880-601/13

Waldemar Link GmbH & Co. KG (Mfg Site)

FDA Devices Moderate Mar 26, 2025

GENERAL ANGIO PACK , Model Nos LLAP75G LLAP75G-01 LLAP75G-02 LLAP75G-03

American Contract Systems Inc

FDA Devices Critical Mar 26, 2025

smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24

Smiths Medical ASD, Inc.

FDA Devices Moderate Mar 26, 2025

C-SECTION PPS , Model No LLCI66M LLCI66M-02 LLCI66M-03 LLCI66M-04

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1

Brainlab AG

FDA Devices Critical Mar 26, 2025

smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9Fr Introducer, REF 21-4187-24

Smiths Medical ASD, Inc.

FDA Devices Moderate Mar 26, 2025

CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214

Smiths Medical ASD, Inc.

FDA Devices Moderate Mar 26, 2025

AV FISTULA , Model No UTAV77T

American Contract Systems Inc

FDA Devices Critical Mar 26, 2025

smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. (5.8 Fr) x 1.0mm I.D., REF 21-4152-24

Smiths Medical ASD, Inc.

FDA Devices Moderate Mar 26, 2025

Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Infant Intubated, PT00134354 - Micros…

Oridion Medical 1987 Ltd.

FDA Devices Moderate Mar 26, 2025

Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Adult-Pediatric Intubated, PT00134333 - …

Oridion Medical 1987 Ltd.

FDA Devices Moderate Mar 26, 2025

Proxima Drape labeled as MINOR PACK and LAPAROSCOPY. Sterile surgical drape.

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Mar 26, 2025

THORACIC PACK , Model No UTTC82Y UTTC82AA-01

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278

Beckman Coulter, Inc.

FDA Devices Moderate Mar 26, 2025

BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedStation ES Tower, REF: 352, CII Safe ES, REF: 1116-00, CII Safe ES Deskt…

CareFusion 303, Inc.

FDA Devices Moderate Mar 26, 2025

Access 2 Immunoassay Analyzer, Catalog Number 81600N

Beckman Coulter, Inc.

FDA Devices Moderate Mar 26, 2025

Proxima Drape labeled as ENT-PLASTICS PACK. Sterile surgical drape.

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Mar 26, 2025

OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

Synapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4.010, 7.4.100, 7.4.110, 7.4.200.

FUJIFILM Healthcare Americas Corporation

FDA Devices Moderate Mar 26, 2025

Medline procedure kits labeled as: 1) EYE PACK, Pack Number VAL038BSCLC

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Mar 26, 2025

CV BASIC PUMP PACK , Model No WECV23D

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ909098

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Mar 26, 2025

IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;

Angiodynamics, Inc.

FDA Devices Moderate Mar 26, 2025

Proxima Drape labeled as DRAPE C-SECTION W/ WINDOW; SHEET, DRAPE, SPLIT, ST,10/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS; DRAPE,LAPROSCOPY,CHOLE,W/…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Mar 26, 2025

Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 12 mm, Product Code: 880-601/12

Waldemar Link GmbH & Co. KG (Mfg Site)

FDA Devices Moderate Mar 26, 2025

Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter.

B Braun Medical Inc

FDA Devices Moderate Mar 26, 2025

MAJOR DIEP, Model Nos. CCMJ73G-01 CCMJ73H

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

SPINE LUMBAR PACK , Model No UTSL72AA UTSL72AB

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

NEURO IR TRAY , Model No WENI56J

American Contract Systems 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 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.