Cook Inc. Recalls Double Flexible Tipped Wire Guides Due to Labeling Error
Cook Inc. is recalling 10,367 Double Flexible Tipped Wire Guides because the labels fail to state that the product is heparin-coated.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a temporary or medically reversible adverse health consequence. The specific hazard is a labeling omission regarding heparin coating, which fits the criteria for moderate severity involving labeling errors without reported serious injury.
Plain-English summary
Cook Inc. is voluntarily recalling 10,367 units of the Double Flexible Tipped Wire Guide. The recall was initiated because the product labels do not state that the device is heparin-coated.
The affected products are distributed nationally. The recall includes items with Catalog # DTDW-/-BW and specific lot numbers ranging from F3749839 to F4916737 and NS4980257 to NS6098990.
Healthcare providers and consumers should check their inventory for these specific lot numbers. If the product is found, it should be removed from use and returned to the manufacturer or distributor according to standard recall procedures.
The recalled product
- Product
- Double Flexible Tipped Wire Guide
- Manufacturer
- Cook Inc.
- Hazard
- Affected units
- 10,367
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 20 recalled by Cook Inc. 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 20 products in this recall →Related recalls
Same manufacturer · Cook Inc.
See all →- HighSkinny Needle with Chiba Tip recalled for debris contamination
FDA (Devices) · 2021-12-29
- HighCook Flexor Check-Flo Introducer recalled for size mislabeling
FDA (Devices) · 2021-12-22
- ModerateFlexor Check-Flo Introducer Recalled for Mislabeled Caliber Size
FDA (Devices) · 2021-12-22
- HighTransseptal Needles Recalled Due to Rust Contamination Risk
FDA (Devices) · 2021-11-24
- HighTransseptal Needle with Catheter Recalled Due to Rust Contamination Risk
FDA (Devices) · 2021-11-24
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- HighCook Inc. Recalls Wire Guide Due to Incorrect Loading Risk
FDA (Devices) · 2020-02-12
- HighCook Medical Wire Guide Devices Recalled for Packaging Breach
FDA (Devices) · 2022-10-05
- HighCook Inc. Recalls Heavy Duty PTFE Wire Guides Due to Loading Error
FDA (Devices) · 2020-02-12
- HighCook Inc. Recalls Fixed Core Straight Safety Wire Guide
FDA (Devices) · 2020-02-12
- HighCook Inc. Recalls PTFE Wire Guides Due to Loading Error Risk
FDA (Devices) · 2020-02-12
- HighCook Incorporated Recalls Guidewire Due to Packaging Seal Breach
FDA (Devices) · 2022-10-05