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U.S. FDA openFDA (510(k) clearances and device enforcement reports). Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0081-2027%22

Class II recall Z-0081-2027: Safeguard US Operating LLC

Q: How to monitor Class II recall Z-0081-2027: Safeguard US Operating LLC and peer other records

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Class II recall Z-0081-2027: Safeguard US Operating LLC (North Carolina): Safeguard US Operating LLC. Dated 21 days ago, it is in the active follow-up window. Score 62/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).

Data as of 2026-11-03 · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

Free preview: all 14 published fields of this record are shown below. Locked: 8 related NC FDAPulse records and the 5-column CSV export.

Field	Value
Record	Device recall
Recall number	Z-0081-2027
Recalling firm	Safeguard US Operating LLC
Classification	Class II
Status	Ongoing
Voluntary / mandated	Voluntary: Firm initiated
Specialty	Other
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, Coyote Brown - Stocked, 81-133-CB; IFAK Bag, Intermediate, Multicam - Stocked, 81-133-MC; IFAK Bag, Advanced, Black - Stocked, 81-135-BL; IFAK Bag, Advanced, Multicam - Stocked, 81-135-MC; LEO Patrol Kit, 81-139; IFAK Refill, 81-301; IFAK Resupply, 81-303-01; IFAK Resupply - CS/30, 81-303-30; K9 Trauma Kit, 81-605;
Reason	Compression bandage may be degraded, which may cause unwanted foreign material to be introduced inside the wound, which may lead to wound exploration and irrigation, formation of scar tissue, and infection.
Quantity	46,881
Distribution	Worldwide - US Nationwide distribution including in the states of FL, OK, CA, WA, GA, TX, PA, IL, MD, NC, OR, DE, NJ, MI, RI, AR, WI, AZ, CO, IN, MO, OH, MA, NY, VA, KY, UT, NM, SC, TN, LA, AL, MN, MT, AK, WV, KS, NE, WY, MS, HI, NH, IA, DC, CT and the countries of BRA, BEL, SGP, AUS.
Recall initiated	2026-09-02
Reported	2026-10-14
Firm location	Huntersville, NC, United States
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Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Record date: 2026-10-14
Data refreshed: 2026-11-03
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT

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Peer benchmark and outreach value: Class II recall Z-0081-2027: Safeguard US Operating LLC and 9 North Carolina peers

Your role Typical deal size (USD) Assumed reply-to-deal rate (%)

North Carolina FDAPulse records like this one: 9
Timing: Medium: dated in the last 30 days
Estimated pipeline if you contact every North Carolina peer: $1,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

62 / 100 Predicate Speed & CAPA Advisory Opportunity Score

Class II recall: usually triggers CAPA and quality-system remediation work.
Recall is still ongoing.
Posted 21 days ago.

What is the FDAPulse record for Class II recall Z-0081-2027: Safeguard US Operating LLC in North Carolina?

Class II device recall Z-0081-2027 by Safeguard US Operating LLC: Compression bandage may be degraded, which may cause unwanted foreign material to be introduced inside the wound, which

How does Class II recall Z-0081-2027: Safeguard US Operating LLC compare to other North Carolina FDAPulse records?

It is 21 days old, still within a typical 45-day follow-up window.

Class II recall Z-0081-2027 vs. top 3 peers

Organization	Location	Record date
Class II recall Z-0081-2027	NC	2026-10-14
Class II recall Z-3155-2026	MA	2026-10-07
Class II recall Z-0232-2027		2026-10-28
Class II recall Z-0243-2027		2026-10-28

Compare Class II recall Z-0081-2027 vs Class II recall Z-0200-2027 →

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