Peel-Away Introducer medical devices recalled for low packaging seal strength
Cook Incorporated is recalling 55 Peel-Away Introducers due to packaging with low seal strength that may compromise device sterility.
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: This is an FDA Class II medical device recall involving a potential for device sterility compromise. No illnesses, injuries, or deaths are reported in the source material. Per the severity rubric, risk-of-harm products where injury has not yet been reported merit a High (3) classification.
Plain-English summary
Cook Incorporated is recalling Peel-Away Introducer medical devices intended for percutaneous introduction of catheters into blood vessels and nonvascular use.
The packaging may have low seal strength and may not meet peel strength specifications. This defect could compromise the device's sterility.
Approximately 55 units were distributed worldwide, including throughout the United States and to Austria, Australia, Brazil, Canada, Switzerland, Germany, Spain, the United Kingdom, Hong Kong, Ireland, Israel, India, Italy, New Zealand, and Singapore.
The recalled product
- Product
- Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end catheters into central and peripheral vasculature, and for nonvascular use. REFERENCE PART NUMBER (RPN)/ ORDER NUMBER (GPN): 1)PLVW-7.0-35 G00925…
- Manufacturer
- Cook Incorporated
- Affected units
- 55
Distribution
Part of a larger recall action
This product is one of 8 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.
See all 8 products in this recall →Related recalls
Same manufacturer · Cook Incorporated
See all →- ModerateCook Williams Cystoscopic Injection Needles Recalled for Manufacturing Defect
FDA (Devices) · 2026-10-21
- CriticalAurous Centimeter Sizing Catheter Recalled for Marker Band Cracking Risk
FDA (Devices) · 2026-05-13
- SevereBeacon Tip Centimeter Sizing Catheter recalled for cracking marker bands
FDA (Devices) · 2026-05-13
- CriticalCook Centimeter Sizing Catheter recall due to marker band cracking
FDA (Devices) · 2026-05-13
- HighCook Medical CTO-18 wire guides labeled with overstated expiration dates
FDA (Devices) · 2026-04-15
Same hazard · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- CriticalCook Inc. Recalls Flexor Check-Flo Introducer Sheaths Due to Separation Risk
FDA (Devices) · 2020-12-30
- HighCook Inc. Recalls Check-Flo Performer Introducer Sets Due to Blood Loss Risk
FDA (Devices) · 2017-03-08
- HighCook Inc. Recalls Check-Flo Performer Introducers Due to Blood Loss Reports
FDA (Devices) · 2017-03-08
- SevereCook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk
FDA (Devices) · 2020-12-30
- HighIntroducer Kit-Tearaway MicroSlide Medical Device Recall
FDA (Devices) · 2025-05-14
- HighCook Inc. Recalls Check-Flo Introducer Devices Due to Blood Loss Reports
FDA (Devices) · 2017-03-08