Wilson-Cook Medical Inc. recalls Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF G21049; b) HEMO-10-EU, REF G21346
There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, which can result in adhesion of the endoscope to tissue and consequent difficulty or inability to maneuver/remove the…
Read the official notice →- Date
- 2023-06-28
- Country
- United States
- Brand
- Wilson-Cook Medical
- Product
- Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF G21049; b) HEMO-10-EU, REF G21346
- Classification
- Class II
- Units
- US Nationwide - Worldwide Distribution
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Wilson-Cook Medical recalls
- 2026-02-25
USWilson-Cook Medical Inc. recalls Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 REF: TESLA-B2535-450 Model…
Due to product that may contain a void in the material that separates the wire guide and cutting wire lumens, which may cause an inappropriate path of current during cutting.
FDA · DeviceWilson-Cook Medical Inc.U.S. Distribution to states of: CA, CO, IN, and NC.Official notice →- 2026-02-11
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Wilson-Cook Medical Inc. recalls Product Name: Nasal Jejunal Feeding Tube REF: NJFT-10
Nasal feeding tube packaged without the nasal transfer tube component.
FDA · DeviceWilson-Cook Medical Inc.International distribution to the country of Australia.Official notice → - 2024-12-11
- US
Wilson-Cook Medical Inc. recalls Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.
Specific lots of product have been manufactured with nonconforming raw materials resulting in the red activation knob cracking or breaking at the activation knob internal threading while the device is activated.
FDA · DeviceWilson-Cook Medical Inc.Distribution was OUS only to Argentina, Brazil, and Israel.Official notice → - 2024-10-23
- US
Wilson-Cook Medical Inc. recalls Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile; and Hemo-10 Hemospray Endoscopic Hemostat, REF G21049,…
Specific lots of product have been manufactured with nonconforming raw materials.
FDA · DeviceWilson-Cook Medical Inc.Distribution was nationwide. There was government and military distribution.…Official notice → - 2023-12-13
- US
Wilson-Cook Medical Inc. recalls QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used to dilate strictures of the biliary tree
Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object,…
- 2023-08-09
- US
Wilson-Cook Medical Inc. recalls Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-3X6 G48278; Fusion Lithotripsy Extraction Baskets are intended to be used for…
Non-conforming product may appear in the field as inability to advance or retract the basket, or the drive wire breaking or separating from handle (with or without mechanical lithotripsy).
Other drugs & medical recalls in the United States
- 2023-06-28
- US
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b) REF MNK0015 wound gel
Medline issued a recall on TheraHoney Wound Gel due to the manufacturer notifying Medline of a sterilization dose audit failure on the wound gel and not augmenting the dose after failure per ISO 11137.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldWorldwide distribution - US Nationwide and the countries of SINGAPORE,…Official notice → - US
Karl Storz Endoscopy recalls KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, 39317A
Plastic sterilization trays used to encase and protect medical devices during sterilization have a new 510(k) with instructions for use that is for the first time specific to the tray models, that also includes…
FDA · DeviceKarl Storz EndoscopyWorldwide - US Nationwide distribution including in the states of AK, AR, AZ,…Official notice → - US
SenTec AG recalls V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).
The sensors may experience an out-of-box failure because after recalibration, the sensors stayed in the software mode "production" and were not reset to "released" mode.
FDA · DeviceSenTec AGUS Nationwide distribution in the states of CA, FL, IL, MA, MS, MT, NV, and TX.Official notice → - US
Illumina, Inc. recalls MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.
Cybersecurity vulnerability concerning the software used for sequencing instruments.
FDA · DeviceIllumina, Inc.Worldwide distribution - US Nationwide and the countries of Algeria, AU…Official notice → - US
Helena Laboratories, Corp. recalls Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicators. used in…
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FDA · DeviceHelena Laboratories, Corp.Distribution to US states of PA, NE, MI, FL, AR, NY, TX, and CA, and to…Official notice → - US
ARROW INTERNATIONAL Inc. recalls ARROW Endurance Extended Dwell Peripheral Catheter System
Potential for catheter separation or leakage
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