Medtronic Neurosurgery recalls Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; DUREPAIR DURA SUBSTITUTE 3 X 3, 61105; DUREPAIR DURA SUBSTITUTE…
Dura regeneration matrix may have out-of-specification endotoxin levels due to issues with in-process and finished goods endotoxin testing, which may present clinically with signs and symptoms of an acute inflammatory…
Read the official notice →- Date
- 2023-07-26
- Country
- United States
- Brand
- Medtronic Neurosurgery
- Product
- Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; DUREPAIR DURA SUBSTITUTE 3 X 3, 61105; DUREPAIR DURA SUBSTITUTE…
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution including in the states of PR, TX, WA,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
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- Check the product name, strength and lot number against the official notice.
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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 Medtronic Neurosurgery recalls
- 2026-07-29
USMedtronic Neurosurgery recalls Ventriculostomy Kit, REF: 46154
Ventriculostomy devices, used during ventriculostomy procedures to gain access to the ventricular system, may exhibit endotoxin levels that exceed the acceptable limit for devices that come into contact with…
FDA · DeviceMedtronic NeurosurgeryWorldwide - US Nationwide distribution in the states of UT, AL, CA, NC, GA,…Official notice →- 2024-12-25
- US
Medtronic Neurosurgery recalls Exacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA W/EDM VCATH 35CM 27636 EDM 27636 EXACTA W/BRAIDED CORD LOCK 27666…
Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).
FDA · DeviceMedtronic NeurosurgeryWorldwide distribution. US nationwide including Puerto Rico; Algeria,…Official notice → - 2024-03-06
- US
Medtronic Neurosurgery recalls Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, REF 46913, Sterile EO, Rx Only. Used to drain…
Potential for catheter disconnection from the patient line stopcock connectors.
FDA · DeviceMedtronic NeurosurgeryWorldwide Distribution: US (nationwide): AL, AR, AZ, CA, CO, CT, DC, DE, FL,…Official notice → - 2023-08-23
- US
Medtronic Neurosurgery recalls Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular Catheter, STERILE EO, Rx Only
Product labeling contains incorrect expiration date
FDA · DeviceMedtronic NeurosurgeryUS Nationwide distribution in the states of NJ, FL, CA, IL.Official notice →
Other drugs & medical recalls in the United States
- 2023-07-26
- US
Ascensia Diabetes Care US, Inc. recalls Contour¿ next GEN Blood Glucose Monitoring System
Ascensia Diabetes Care has determined through customer complaints that 580 of 2900 meters from lot number DM01T033P are reconfigured from mg/dL to mmol/L. Among them, 579 meters distributed in the United States were…
FDA · DeviceAscensia Diabetes Care US, Inc.Domestic: CA, CO, FL, IN, MO, NJ, NY, OH, RI, SC, TN, TX, & VA.Official notice → - US
Cytocell Ltd. recalls RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA…
DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.
FDA · DeviceCytocell Ltd.US Nationwide distribution in the states of CA, FL, OH, & SC.Official notice → - US
Baxter Healthcare Corporation recalls GEM FLOW COUPLER Monitor, PN 5156-00000-011
An issue was identified where the LCD monitor display may not indicate the correct active channel. The issue occurs when the monitor is turned on using battery power, and channel B was selected as the last active…
- US
MEDLINE INDUSTRIES, LP - Northfield recalls Medline O.R. Scissors, S/B, Sterile, 5.5, Model #DYND04000
The scissors were manufactured without a tip protector resulting in the scissors breaking through the semi-rigid plastic tray compromising sterility.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldUS Nationwide distribution. There was government distribution but no military…Official notice → - US
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CVC PACK, Model Number DYNJ46967F;…
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldWorldwide Distribution: US (Nationwide) and OUS (foreign) United Arab…Official notice → - US
DiaSorin Molecular LLC recalls Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 box containing 3 Direct…
There is a potential for the direct amplification disc to malfunction which may result in spillage of liquid from the disc.
FDA · DeviceDiaSorin Molecular LLCWorldwide - US Nationwide distribution including in the states of AL, AR, AZ,…Official notice →