FDAClass II · Medical device · Recall Z-2532-2026 · Recalled July 1, 2026

Acumed Hexalob Screw various sizes recall — Acumed LLC

Agency report date: July 1, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: Acumed Hexalob Screw various sizes
Company / brand: Acumed
Lot / serial / date codes: 3070-27008/Lots: 668261/UDI: 10806378125997; 3070-27009/Lots: 680797/UDI: 10806378126000; 3070-27010/Lots: 667231, 682194/UDI: 10806378126017; 3070-27011/Lots: 680621, 680737/UDI: 10806378126024; 3070-27012/Lots: 667233, 668266, 668704, 682195/UDI: 10806378126031; 3070-27013/Lots:668706, 680400/UDI: 10806378126048; 3070-27014/Lots: 667236, 668705, 680935/UDI: 10806378126055; 3070-27015/Lots: 667237, 680936/UDI: 10806378126062; 3070-27016/Lots: 668269, 682390/UDI: 10806378126079; 3070-27017/Lot: 681575/UDI: 10806378126086; 3070-27018/Lot: 667169, 668260, 682482/UDI: 10806378126093; 3076-30010/Lots: 667202, 668271/UDI: 10806378126109; 3076-30012/Lots: 667242, 668273/UDI: 10806378126116; 3076-30014/Lots: 667205, 668272/UDI: 10806378126123
Distribution: US Nationwide distribution in the states of AR, CA, CO, CT, FL, GA, IL, KS, KY, LA, MA, MS, NC, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, WA, WI.

Agency product description and boundaries

Acumed Hexalob Screw various sizes: REF Numbers: : 3070-27008 2.7mm x 8mm NL Hexalobe Screw; 3070-27009 2.7mm x 9mm NL Hexalobe Screw; 3070-27010 2.7mm x 10mm NL Hexalobe Screw; 3070-27011 2.7mm x 11mm NL Hexalobe Screw; 3070-27012 2.7mm x 12mm NL Hexalobe Screw; 3070-27013 2.7mm x 13mm NL Hexalobe Screw; 3070-27014 2.7mm x 14mm NL Hexalobe Screw; 3070-27015 2.7mm x 15mm NL Hexalobe Screw; 3070-27016 2.7mm x 16mm NL Hexalobe Screw; 3070-27017 2.7mm x 17mm NL Hexalobe Screw; 3070-27018 2.7mm x 18mm NL Hexalobe Screw; 3076-30010 3.0mm x 10mm NL Hexalobe Screw; 3076-30012 3.0mm x 12mm NL Hexalobe Screw; 3076-30014 3.0mm x 14mm NL Hexalobe Screw

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: Acumed Hexalob Screw various sizes recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2532-2026
Brand: All Acumed recalls
Classification: Class II
Units affected: 5,272 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

Acumed Hexalob Screw various sizes recall status

Companies & origin

Recalling firm location: Hillsboro, OR, United States
Firm address: 5885 NW Cornelius Pass Rd, N/A, 97124-9370

Identifying details (verbatim from the notice)

Product codes / lots: 3070-27008/Lots: 668261/UDI: 10806378125997; 3070-27009/Lots: 680797/UDI: 10806378126000; 3070-27010/Lots: 667231, 682194/UDI: 10806378126017; 3070-27011/Lots: 680621, 680737/UDI: 10806378126024; 3070-27012/Lots: 667233, 668266, 668704, 682195/UDI: 10806378126031; 3070-27013/Lots:668706, 680400/UDI: 10806378126048; 3070-27014/Lots: 667236, 668705, 680935/UDI: 10806378126055; 3070-27015/Lots: 667237, 680936/UDI: 10806378126062; 3070-27016/Lots: 668269, 682390/UDI: 10806378126079; 3070-27017/Lot: 681575/UDI: 10806378126086; 3070-27018/Lot: 667169, 668260, 682482/UDI: 10806378126093; 3076-30010/Lots: 667202, 668271/UDI: 10806378126109; 3076-30012/Lots: 667242, 668273/UDI: 10806378126116; 3076-30014/Lots: 667205, 668272/UDI: 10806378126123
Distribution: US Nationwide distribution in the states of AR, CA, CO, CT, FL, GA, IL, KS, KY, LA, MA, MS, NC, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, WA, WI.
Firm notified the public via: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
FDA event ID: 99123
Recall initiated: May 28, 2026
FDA classified: June 23, 2026
FDA report date: July 1, 2026

Other medical device recalls from around the same time

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Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Pro recall — Abiomed, Inc.FDA · July 1, 2026
Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP recall — Abiomed, Inc.FDA · July 1, 2026

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved September 29, 2026 at 6:00 PM UTC.

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