Medline Industries, LP recalls Reprocessed Livewire Steerable Electrophysiology Catheter Item Numbers 401575RH 401582RH 401600RH 401603RH 401606RH 401652RH 401653RH…
Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk…
Read the official notice →- Date
- 2025-10-08
- Country
- United States
- Brand
- Medline Industries
- Product
- Reprocessed Livewire Steerable Electrophysiology Catheter Item Numbers 401575RH 401582RH 401600RH 401603RH 401606RH 401652RH 401653RH…
- Classification
- Class I
- Units
- Domestic US distribution nationwide. International distribution pending. No…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Medline Industries recalls
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- US
Medline Industries, LP recalls Medline Adult Anesthesia Set, REF DYNJ39985G
Specific items and lots of Medline Kits may contain Clearlink IV Sets which Baxter recalled due to customer reports of leaking.
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Medline Industries, LP recalls Medline Kits: 1) VALVE PACK-LF, Model Number: DYNJ0415366P; 2) VALVE PACK-LF, Model Number: DYNJ0415366Q
The kits contain certain lots of cannula products where the catheter may not retain its shape.
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Medline Industries, LP recalls Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B
Convenience kits labeled as sterile have not gone through the sterilization process.
- 2025-10-01
- US
- 2024-05-30
- US
Medline Industries Recalls 1.5 Million Adult Portable Bed Rails Due to Serious Entrapment and Asphyxia Hazards; Two Deaths Reported
When the recalled bed rails are attached to an adult's bed, users can become entrapped within the bed rail or between the bed rail and the side of the mattress. This poses a serious entrapment hazard and risk of death…
Other drugs & medical recalls in the United States
- 2025-10-08
- US
Bard Peripheral Vascular Inc recalls Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Venclose EVSRF…
Software version 3.35 of the Venclose digiRF Generator incorporates a catheter verification feature specifically designed to detect internal wiring anomalies in Venclose EVSRF Ablation Catheters prior to clinical use.…
FDA · DeviceBard Peripheral Vascular IncWorldwide - US Nationwide distribution including in the states of NJ, NY, FL,…Official notice → - US
North American Rescue LLC. recalls JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside kits: KIT, TCCC Training- Complete (Modules 1-3), REF:…
Device used for unilateral or bilateral occlusion of blood flow to the lower limbs has a potential manufacturing defect that may compromise the structural integrity of the device and device performance during use.
FDA · DeviceNorth American Rescue LLC.Worldwide - US Nationwide distribution in the states of SC, OK, ID, KY, VA,…Official notice → - US
Draeger, Inc. recalls Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Product Description: The Atlan…
The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
FDA · DeviceDraeger, Inc.Devices were imported from Draegerwerk Ag and Co. KGaA and distributed in the…Official notice → - US
Medline Industries, LP recalls Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B
Convenience kits labeled as sterile have not gone through the sterilization process.
- US
W L Gore & Associates, Inc. recalls GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W,…
Reports of vascular graft delamination, which may lead to reduced access flow; cannulation difficulties; bleeding or bruising; and harms related to reintervention procedures, so Instructions for Use will be updated to…
FDA · DeviceW L Gore & Associates, Inc.US: OR, AL, OH, MD, VA, CA, FL, NC, OK, MA, MO, AZ, TX, IL, GA, PA, NH, HI,…Official notice → - US
LeMaitre Vascular, Inc. recalls Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 715, (7) AG 730, (8)…
The bovine carotid arteries used to produce the impacted grafts from affected lots were sourced using raw material from a supplier that had not been reviewed and approved by the appropriate regulatory authority.
FDA · DeviceLeMaitre Vascular, Inc.US Nationwide distribution in the states of CA, CT, FL, GA, IL, MA, MS, NC,…Official notice →