Agency classClass IIOur severity:Severe FDA (Devices)·Z-0081-2027·Announced 2026-10-14

Safeguard US Operating LLC Recalls Compression Bandages Due to Degradation

Safeguard US Operating LLC is recalling 46,881 units of compression bandages and trauma kits because the bandages may be degraded, posing a risk of introducing foreign material into wounds.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this as a Class II recall, indicating a reasonable probability of serious adverse health consequences such as infection or scar tissue formation. The source text does not report any specific illnesses, injuries, or deaths associated with this recall.

Plain-English summary

Safeguard US Operating LLC is recalling 46,881 units of various medical devices, including Battle Bandages, IFAK Bags, and trauma kits, due to a potential quality issue. The recall covers products distributed nationwide in the United States and in several international markets, including Brazil, Belgium, Singapore, and Australia.

The recall was initiated because the compression bandages may be degraded. This degradation may cause unwanted foreign material to be introduced inside a wound. Such exposure may lead to wound exploration and irrigation, the formation of scar tissue, and infection.

Consumers and healthcare providers should stop using the affected products and contact Safeguard US Operating LLC for instructions on how to return or dispose of them. The affected products include specific reference numbers and lot codes listed in the official FDA recall notice Z-0081-2027.

The recalled product

Product: Battle Bandage, REF: 32-700; Patrol IFAK Bag, Black - Advanced, REF: 81-125-BL; Patrol IFAK Bag, Multicam - Advanced, REF: 81-125-MC; Patrol IFAK II, Olive Drab, Stocked (Option 1), 81-129-OD; IFAK Bag, Intermediate, Black - Stocked, 81-133-BL; IFAK Bag, Intermediate…
Manufacturer: Safeguard US Operating LLC
Category: Medical Device — Trauma & First Aid
Hazard: foreign-material
infection
scar-tissue
Affected units: 46,881

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

REF/UDI-DI/Lot(Expiration): 32-700/M68932700070/PBO0005447(10/31/2029)
PBO0006353(2/12/2030)
PBO0004168(9/12/2029)
PBO0006219(10/22/2029)
PBO0005499(12/27/2028)
PBO0005960(11/29/2029)
PBO0004076(9/12/2029)
PBO0004497(10/31/2029)
PBO0004261(9/12/2029)
PBO0004301(10/17/2029)
PBO0005856(11/29/2029)
PBO0005599(2/12/2030)
PBO0006434(12/25/2029)
PBO0009032(8/14/2031)
PBO0008804(9/13/2030)
PBO0010083(12/4/2031)
PBO0010114(1/14/2032)
PBO0007376(6/20/2030)
PBO0005601(1/18/2030)
PBO0007651(10/31/2029)

Distribution

Distributed nationwide across the United States.

The notice also names 45 states specifically:

Same manufacturer · Safeguard US Operating LLC

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Same hazard · foreign material