Product category · Updated Jun 3, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
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
Severity distribution
Graded records only
- High severity 3,549
High severity
3,549 recalls
- Moderate
Moderate
35,871 recalls
- Lower severity 1,058
Lower severity
1,058 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,096 recalls
- FDA Drug 882
FDA Drug
882 recalls
- CPSC 441
CPSC
441 recalls
- FDA Food 59
FDA Food
59 recalls
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
Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Sheet Dressing with Leptospermum Model/Catalog Number: 31612, 31622, 31644 Product Description…
Integra LifeSciences Corp. (NeuroSciences)
Novum IQ Syringe Pump, Product Code 40700BAX, infusion pump
Baxter Healthcare Corporation
TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.
PREMIA SPINE LTD
Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Model/Catalog Number: 31620, 31640 Product Description: MEDIHONEY¿ Non-Adhesive Hydrogel …
Integra LifeSciences Corp. (NeuroSciences)
WATCHMAN TruSteer Access System, US, Material Number (UPN) M635TU90050;intended to provide vascular and transseptal access for the family of WATCHMAN…
Boston Scientific Corporation
IDM-ARLITE-R. Electrical wheelchair component.
mo-Vis BVBA
Brand Name: MediHoney ¿ Product Name: MediHoney ¿ Tube Model/Catalog Number: 31515 and 31535 Product Description: MediHoney¿ Paste with Active Lep…
Integra LifeSciences Corp. (NeuroSciences)
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App Model/Catalog Number: SW12300 Software Version: ver…
Dexcom, Inc.
All-round Joystick R-net Light. Electrical wheelchair component.
mo-Vis BVBA
IDM-MULTI-R. Electrical wheelchair component.
mo-Vis BVBA
Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Surgical Adhesive Sheet Model/Catalog Number: 31738 Product Description: MEDIHONEY¿ HCS SURGIC…
Integra LifeSciences Corp. (NeuroSciences)
Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Adhesive Sheet Model/Catalog Number: 31722, 31744 Product Description: MEDIHONEY¿ HCS ADH…
Integra LifeSciences Corp. (NeuroSciences)
WATCHMAN TruSeal Access System SGL, OUS, Material Number (UPN) M635TS70010; intended to provide vascular and transseptal access for all WATCHMAN Left…
Boston Scientific Corporation
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
WATCHMAN TruSeal Access System ANT, US, Material Number (UPN) M635TU70040; intended to provide vascular and transseptal access for all WATCHMAN Left …
Boston Scientific Corporation
Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029
O&M HALYARD INC
Multi Joystick R-net. Electrical wheelchair component.
mo-Vis BVBA
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.
WATCHMAN TruSeal Access System ANT, OUS, Material Number (UPN) M635TS70040; intended to provide vascular and transseptal access for all WATCHMAN Left…
Boston Scientific Corporation
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.
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113
Medtronic Perfusion Systems
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
RayStation with the following product descriptions: 1. RayStation 2023B, Software Version: 14.0.0.3338. 2. RayStation 2024A, Software Version:…
RAYSEARCH LABORATORIES AB
StopBox USA Recalls AR-15 Chamber Lock Pros Due to Risk of Serious Injury and Death
StopBox USA, of Spokane Valley, Washington
TRANSDUCER L12-5 Transducer Probe
Philips Ultrasound, Inc
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
Orascoptic Superior Visualization Dragonfly Essentials Kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver)
Orascoptic Surgical Acuity
Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: CDS984076J GYN ROBOTIC DYNJG001004A LAVH MINOR DYNJG901001B CRANIOTO…
MEDLINE INDUSTRIES, LP - Northfield
C6-2 Transducer Probe
Philips Ultrasound, Inc
L12-5 38mm Transducer Probe
Philips Ultrasound, Inc
C8-4v Transducer Probe
Philips Ultrasound, Inc
Corin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4) 770001B2, (5) 770001F0, (6) 770001F2; All Software Versions.
MAQUET GMBH
L9-3 Transducer Probe
Philips Ultrasound, Inc
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
X7-2 Transducer Probe
Philips Ultrasound, Inc
GE HealthCare OEC 9900 Elite C-arm Systems.
GE Medical Systems, LLC
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.
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.
S9-2 Transducer Probe
Philips Ultrasound, Inc
Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models 401150RH, 401206RH, 401207RH, 401210R…
MEDLINE INDUSTRIES, LP - Northfield
C8-5 Transducer Probe
Philips Ultrasound, Inc
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
mC7-2 Transducer Probe
Philips Ultrasound, Inc
C5-2 Lumify Transducer Probe
Philips Ultrasound, Inc
Spectrum IQ Infusion Pump, Product Code 3570009
Baxter Healthcare Corporation
GE HealthCare OEC 9800.
GE Medical Systems, LLC
X6-1 Transducer Probe
Philips Ultrasound, Inc
C9-3v Transducer Probe
Philips Ultrasound, Inc
L12-4 Transducer Probe
Philips Ultrasound, Inc
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
- Source: FDA — openFDA Enforcement API (food, drug, and device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls
- Source: NHTSA — National Highway Traffic Safety Administration Recalls (vehicles & equipment)
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.