FDAClass II · Medical device · Recall Z-2864-2026 · Recalled August 12, 2026

STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING recall — Stryker Corporation

Agency report date: August 12, 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: STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING
Company / brand: Stryker
Lot / serial / date codes: GTIN 07613327061475, Batch Number: 24284FG2, 24289FG2, 24313FG2, 24322FG2, 24338FG2, 24344FG2, 24351FG2, 25009FG2, 25036FG2, 25062FG2, 25091FG2, 25129FG2, 25161FG2.
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Brazil, Canada, Chile, France, Germany, Indonesia, Italy, Mexico, Netherlands, New Zealand, Philippines, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom.

Agency product description and boundaries

STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING, Catalog Number 0250070640

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: There has been an increased amount in reported complaints consistently describing leaking from the handpiece 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: STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2864-2026
Brand: Stryker
Classification: Class II
Units affected: 2,739 of units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING

Companies & origin

Recalling firm location: San Jose, CA, United States
Firm address: 5900 Optical Ct, 95138-1400

Identifying details (verbatim from the notice)

Product codes / lots: GTIN 07613327061475, Batch Number: 24284FG2, 24289FG2, 24313FG2, 24322FG2, 24338FG2, 24344FG2, 24351FG2, 25009FG2, 25036FG2, 25062FG2, 25091FG2, 25129FG2, 25161FG2.
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Brazil, Canada, Chile, France, Germany, Indonesia, Italy, Mexico, Netherlands, New Zealand, Philippines, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom.
Firm notified the public via: Letter
FDA event ID: 99340
Recall initiated: June 8, 2026
FDA classified: August 3, 2026
FDA report date: August 12, 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 September 7, 2026 at 6:00 AM UTC. Record retrieved September 7, 2026 at 6:00 AM UTC.

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