East Hampton, CT, United States
INTEGRATED MEDCRAFT LLC recalls
2 recalls recorded since 2018, most recently on 25 September 2026. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 25 September 2026
- Reason
- 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.
- Distribution
- US Nationwide distribution in the states of GA, VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0147-2027
- FORWARD Gunshot Wound Kit; Model: AFT-GSW;
Ongoing Class II Medical devices
- Recall started
- 7 July 2026
- Reason
- Devices could potentially contain an occluded or partially occluded Guedel Airway tip.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2836-2026, Z-2837-2026
- FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011-40002. Containing the affected One-piece Guedel airway components: 1. Size 00, ISO 5.0, blue. Product Code: 1100050. 2. Size 000, IS
- Kingfisher Compact Individual First Aid Kit. REF Number: 76656. Containing the affected One-piece Guedel airway components: 1. Size 00, ISO 5.0, blue. Product Code: 1100050. 2. Size 000, ISO 3.5, light green.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.