FDAFDA recall Z-0147-2027 · Oct 21, 2026
INTEGRATED MEDCRAFT LLC: FORWARD Gunshot Wound Kit recall
Recall found
Product
FORWARD Gunshot Wound Kit; Model: AFT-GSW;
Reason for recall
Subrecall of a kitted device from SafeGuard Medical due to internal testing identified an issue affecting the device's sterile pad, potentially causing the sterile pad to degrade over time. The degradation may cause remnants of the nonwoven pad material to dislodge on the wound or in close proximity to the wound.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Model: ATF-GSW; UDI-DI: 00850056748063; Lot Numbers: IMC-00000024, IMC-00000034, IMC-00000053, IMC-00000056, IMC-00000076, IMC-00000081, IMC-00000082, IMC-00000083, IMC-00000084, IMC-00000085, IMC-00000094, IMC-00000148, IMC-00000149, IMC-00000152, IMC-00000153, IMC-00000154, IMC-00000173, IMC-00000174, IMC-00000179, IMC-00000186, IMC-00000187;
- Quantity
- 1033
- Distribution
- US Nationwide distribution in the states of GA, VA.
- Recalling firm
- INTEGRATED MEDCRAFT LLC, East Hampton, CT
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-09-25
Source: openFDA enforcement record Z-0147-2027 · search recall number Z-0147-2027 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 26, 2026, 8:14 PM EDT. The agency notice is the final word.