Cope Mandril Wire Guide Guidewires Recalled for Packaging Seal Breach
Cook Incorporated is recalling Cope Mandril Wire Guide stainless steel guidewires because the packaging chevron seal may be completely breached, compromising device sterility. Affected lots total 2,748 units in the US and 302 internationally.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with a packaging defect (chevron seal breach) that compromises the sterile barrier. Although no illnesses or injuries have been reported, the potential for contamination in sterile medical devices used in invasive procedures represents a significant risk of harm. Per the rubric, a theoretical hazard without reported illness in a risk-of-harm product scores at most 3.
Plain-English summary
Cook Incorporated is recalling certain lots of Cope Mandril Wire Guide stainless steel guidewires (reference part numbers PMG-18SP-60-COPE, PMG-18SP-100-COPE, and PMG-18SP-125-COPE). These are sterile medical devices used in medical procedures.
The packaging for affected devices has a complete breach of the chevron seal. The chevron seal is critical for maintaining the sterile barrier of the device. When this seal is breached, the sterility of the affected devices may be compromised.
This recall affects approximately 2,748 units distributed in the United States and 302 units distributed internationally. Multiple lot numbers and expiration dates are affected, ranging from June 2027 through July 2027. Detailed lot and UDI information is available from Cook Incorporated.
Healthcare facilities and practitioners who have received devices from the affected lots should not use them. Contact Cook Incorporated for instructions on replacement, return, or disposal of affected units.
The recalled product
- Product
- Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire Reference Part Number/GPN PMG-18SP-60-COPE G05183 PMG-18SP-100-COPE G05822 PMG-18SP-125-COPE G10077
- Manufacturer
- Cook Incorporated
- Category
- Medical Device — Guidewire
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 24 recalled by Cook Incorporated under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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