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 49 of 810

FDA Devices Moderate Sep 10, 2025

Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Sheet Dressing with Leptospermum Model/Catalog Number: 31612, 31622, 31644 Product Description…

Integra LifeSciences Corp. (NeuroSciences)

FDA Devices Critical Sep 10, 2025

Novum IQ Syringe Pump, Product Code 40700BAX, infusion pump

Baxter Healthcare Corporation

FDA Devices Moderate Sep 10, 2025

TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.

PREMIA SPINE LTD

FDA Devices Moderate Sep 10, 2025

Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Model/Catalog Number: 31620, 31640 Product Description: MEDIHONEY¿ Non-Adhesive Hydrogel …

Integra LifeSciences Corp. (NeuroSciences)

FDA Devices Critical Sep 10, 2025

WATCHMAN TruSteer Access System, US, Material Number (UPN) M635TU90050;intended to provide vascular and transseptal access for the family of WATCHMAN…

Boston Scientific Corporation

FDA Devices Critical Sep 10, 2025

IDM-ARLITE-R. Electrical wheelchair component.

mo-Vis BVBA

FDA Devices Moderate Sep 10, 2025

Brand Name: MediHoney ¿ Product Name: MediHoney ¿ Tube Model/Catalog Number: 31515 and 31535 Product Description: MediHoney¿ Paste with Active Lep…

Integra LifeSciences Corp. (NeuroSciences)

FDA Devices Critical Sep 10, 2025

Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App Model/Catalog Number: SW12300 Software Version: ver…

Dexcom, Inc.

FDA Devices Critical Sep 10, 2025

All-round Joystick R-net Light. Electrical wheelchair component.

mo-Vis BVBA

FDA Devices Critical Sep 10, 2025

IDM-MULTI-R. Electrical wheelchair component.

mo-Vis BVBA

FDA Devices Moderate Sep 10, 2025

Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Surgical Adhesive Sheet Model/Catalog Number: 31738 Product Description: MEDIHONEY¿ HCS SURGIC…

Integra LifeSciences Corp. (NeuroSciences)

FDA Devices Moderate Sep 10, 2025

Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Adhesive Sheet Model/Catalog Number: 31722, 31744 Product Description: MEDIHONEY¿ HCS ADH…

Integra LifeSciences Corp. (NeuroSciences)

FDA Devices Critical Sep 10, 2025

WATCHMAN TruSeal Access System SGL, OUS, Material Number (UPN) M635TS70010; intended to provide vascular and transseptal access for all WATCHMAN Left…

Boston Scientific Corporation

FDA Devices Critical Sep 10, 2025

WATCHMAN FXD Curve Access System Sgl, US, Material Number (UPN) M635TU80010; intended to provide vascular and transseptal access for the family of W…

Boston Scientific Corporation

FDA Devices Critical Sep 10, 2025

WATCHMAN TruSeal Access System ANT, US, Material Number (UPN) M635TU70040; intended to provide vascular and transseptal access for all WATCHMAN Left …

Boston Scientific Corporation

FDA Devices Moderate Sep 10, 2025

Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029

O&M HALYARD INC

FDA Devices Critical Sep 10, 2025

Multi Joystick R-net. Electrical wheelchair component.

mo-Vis BVBA

FDA Devices Moderate Sep 10, 2025

Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the following with corresponding model numbers: 1. Allura Xper F…

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA Devices Critical Sep 10, 2025

WATCHMAN TruSeal Access System ANT, OUS, Material Number (UPN) M635TS70040; intended to provide vascular and transseptal access for all WATCHMAN Left…

Boston Scientific Corporation

FDA Devices Moderate Sep 10, 2025

Smiths Medical CADD" Yellow Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included 100mL, Product Code 21-…

ICU Medical Inc.

FDA Devices Critical Sep 10, 2025

DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113

Medtronic Perfusion Systems

FDA Devices Moderate Sep 10, 2025

RayStation with the following product descriptions: 1. RayStation 7, Software Version: 7.0.0.19. 2. RayStation 8A, Software Version: 8.0.0.61.…

RAYSEARCH LABORATORIES AB

FDA Devices Moderate Sep 10, 2025

RayStation with the following product descriptions: 1. RayStation 2023B, Software Version: 14.0.0.3338. 2. RayStation 2024A, Software Version:…

RAYSEARCH LABORATORIES AB

CPSC Moderate Sep 4, 2025

StopBox USA Recalls AR-15 Chamber Lock Pros Due to Risk of Serious Injury and Death

StopBox USA, of Spokane Valley, Washington

FDA Devices Low Sep 3, 2025

TRANSDUCER L12-5 Transducer Probe

Philips Ultrasound, Inc

FDA Devices Moderate Sep 3, 2025

AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, MODEL/ITEM NUMBER AMAH40N; 2)TOTAL KNEE DAN MYER, …

American Contract Systems Inc

FDA Devices Moderate Sep 3, 2025

Orascoptic Superior Visualization Dragonfly Essentials Kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver)

Orascoptic Surgical Acuity

FDA Devices Moderate Sep 3, 2025

Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: CDS984076J GYN ROBOTIC DYNJG001004A LAVH MINOR DYNJG901001B CRANIOTO…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Low Sep 3, 2025

C6-2 Transducer Probe

Philips Ultrasound, Inc

FDA Devices Low Sep 3, 2025

L12-5 38mm Transducer Probe

Philips Ultrasound, Inc

FDA Devices Low Sep 3, 2025

C8-4v Transducer Probe

Philips Ultrasound, Inc

FDA Devices Moderate Sep 3, 2025

Corin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4) 770001B2, (5) 770001F0, (6) 770001F2; All Software Versions.

MAQUET GMBH

FDA Devices Low Sep 3, 2025

L9-3 Transducer Probe

Philips Ultrasound, Inc

FDA Devices Moderate Sep 3, 2025

The Medline General Surgery Tray is customized to meet requirements of the hospitals and health care professionals utilizing them. The kit is provide…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Low Sep 3, 2025

X7-2 Transducer Probe

Philips Ultrasound, Inc

FDA Devices Moderate Sep 3, 2025

GE HealthCare OEC 9900 Elite C-arm Systems.

GE Medical Systems, LLC

FDA Devices Moderate Sep 3, 2025

Brand Name: HOMEDICS Product Name: Air Compression Leg Massager Model/Catalog Number: SR-160HJ Product Description: Powered Inflatable Tube Massag…

Zhejiang Luyao Electronics Technology Co., Ltd.

FDA Devices Critical Sep 3, 2025

Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacement, Refurbished, REF: 1003808;…

Tandem Diabetes Care, Inc.

FDA Devices Low Sep 3, 2025

S9-2 Transducer Probe

Philips Ultrasound, Inc

FDA Devices Critical Sep 3, 2025

Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models 401150RH, 401206RH, 401207RH, 401210R…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Low Sep 3, 2025

C8-5 Transducer Probe

Philips Ultrasound, Inc

FDA Devices Moderate Sep 3, 2025

AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON ARRIVAL KIT, Model/Item Number LLBN11C; 2) LABOR & DELIVERY P…

American Contract Systems Inc

FDA Devices Low Sep 3, 2025

mC7-2 Transducer Probe

Philips Ultrasound, Inc

FDA Devices Low Sep 3, 2025

C5-2 Lumify Transducer Probe

Philips Ultrasound, Inc

FDA Devices Moderate Sep 3, 2025

Spectrum IQ Infusion Pump, Product Code 3570009

Baxter Healthcare Corporation

FDA Devices Moderate Sep 3, 2025

GE HealthCare OEC 9800.

GE Medical Systems, LLC

FDA Devices Low Sep 3, 2025

X6-1 Transducer Probe

Philips Ultrasound, Inc

FDA Devices Low Sep 3, 2025

C9-3v Transducer Probe

Philips Ultrasound, Inc

FDA Devices Low Sep 3, 2025

L12-4 Transducer Probe

Philips Ultrasound, Inc

FDA Devices Low Sep 3, 2025

BP10-5ec Transducer Probe

Philips Ultrasound, 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.