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Class II recall Z-0081-2027: Safeguard US Operating LLC vs Class II recall Z-0200-2027: Greiner Bio-One North America, Inc.: FDAPulse comparison
Class II recall Z-0081-2027: Safeguard US Operating LLC (2026-10-14) and Class II recall Z-0200-2027: Greiner Bio-One North America, Inc. (2026-10-28) are peer FDAPulse records in North Carolina.
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Both records plus every comparable record, with all columns and source links · Card, Apple Pay, Google Pay or Link via Stripe
How does Class II recall Z-0081-2027: Safeguard US Operating LLC compare to Class II recall Z-0200-2027: Greiner Bio-One North America, Inc.?
| Field | Class II recall Z-0081-2027: Safeguard US Operating LLC | Class II recall Z-0200-2027: Greiner Bio-One North America, Inc. |
|---|---|---|
| Record | Device recall | Device recall |
| Recall number | Z-0081-2027 | Z-0200-2027 |
| Recalling firm | Safeguard US Operating LLC | Greiner Bio-One North America, Inc. |
| Classification | Class II | Class II |
| Status | Ongoing | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated | Voluntary: Firm initiated |
| Specialty | Other | 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; | Brand Name: VACUETTE Product Name: LH Lithium Heparin Separator Model/Catalog Number: 454008P Product Description: Greiner VACUETTE Blood Collection Tube with Lithium Heparin and Gel Separator (13 x 75 mm, 3.5ml) |
| 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. | Lot B26043FM may include EDTA contamination which introduces potassium while chelating calcium in patient samples, leading to falsely elevated potassium (K+) and falsely decreased calcium (Ca++) results which have the potential to cause hyperkalemia. |
| Quantity | 46,881 | 860450 |
| 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. | U.S. Nationwide distribution in the states of CO, FL, IL, MO, NE, NY, OH, PA, and VA. |
| Recall initiated | 2026-09-02 | 2026-07-29 |
| Reported | 2026-10-14 | 2026-10-28 |
| Firm location | Huntersville, NC, United States | Monroe, NC, United States |
| Predicate Speed & CAPA Advisory Opportunity Score | 62/100 | 68/100 |
| Peer rank and all 500 records (CSV) | 🔒 Click to unlock → | |
| Official source URLs for every peer record | 🔒 Click to unlock → | |
Official records: Class II recall Z-0081-2027: Safeguard US Operating LLC · Class II recall Z-0200-2027: Greiner Bio-One North America, Inc.
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