Cook Incorporated recalls Williams Cystoscopic Injection Needles, used for cystoscopic injection into the urethra, bladder neck, and bladder wall, Reference Part…
The female Luer lock adapter component in the affected device lots may not have been correctly seated due to misalignment and inadequate torquing during manufacturing. Potential events that may occur as a result of…
Read the official notice →- Date
- 2026-10-21
- Country
- United States
- Brand
- Cook
- Product
- Williams Cystoscopic Injection Needles, used for cystoscopic injection into the urethra, bladder neck, and bladder wall, Reference Part…
- Classification
- Class II
- Units
- US States: FL, IL, NM, TX, WA. Canada, France, Germany, Italy, Spain,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Cook recalls
- 2026-05-13
Cook Incorporated recalls Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures are available in a…
Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a…
FDA · DeviceCook IncorporatedUS distribution nationwide. OUS distribution to Brunei, Brazil, Canda, China,…Official notice →- 2026-04-15
Cook Incorporated recalls COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference Part Number…
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- 2025-12-31
Cook Incorporated recalls Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0-18/38-45-RB-ANL0-HC; 2) KCFW-9.0-18/38-45-RB-ANL1-HC; 3)…
Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not…
- 2025-06-25
Cook Incorporated recalls Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures. Catheters are available in…
Cook Medical identified that catheters supplied in the affected device lots may experience tip separation.
- 2025-05-28
Cook Incorporated recalls Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08686,
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
FDA · DeviceCook IncorporatedWorldwide distribution - US Nationwide and the countries of Belgium, Germany,…Official notice →- 2025-05-21
Cook Incorporated recalls Tornado Embolization Microcoil, intended for embolization of selective vessel supply to arteriovenous malformations and other vascular…
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil.
Other drugs & medical recalls in the United States
- 2026-10-21
Medline Industries, LP recalls Convenience Kits containing CONMED AirSeal Access Ports ADVANCE LAPAROSCOPIC DYNJ911135A CHN GYN ONCOLOGY DYNJ906731M
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FDA · DeviceMedline Industries, LPUS Nationwide distribution in the states of AZ, CA, IN, MD, MO, NJ, OH, and WI.Official notice →Medline Industries, LP recalls Medline surgical convenience kits labeled as: 1) OPEN HEART PACK A & B, Medline Product number/SKU DYNJ04584L; 2) OPEN HEART ACCESSORY…
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Howmedica Osteonics Corp. recalls TS Universal Baseplate Finishing Tray, Triathlon. Catalog Number: 6543-6-506.
Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may lead to a small amount of residual…
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In kit sub-lot 2530M-01 the date of expiration printed on the outer labeling may indicate the wrong expiration date of July 22, 2026 while the correct expiration date is July 13, 2026. If used the system will display…
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The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage; however, the check valve replacement was excluded from the annual…
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FDA · DeviceMicrogenics CorporationWorldwide - US Nationwide distribution in the states of UT, MI, OK, NY, TX,…Official notice →