FDAClass II · Medical device · Recall Z-2626-2026 · Recalled July 8, 2026

CRE Pro Wireguided 6-8mm 240cm recall — Boston Scientific Corporation

Agency report date: July 8, 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: CRE Pro Wireguided 6-8mm 240cm
Company / brand: Boston Scientific
Lot / serial / date codes: UPN: M00558660; GTIN: 8714729797548; Lot No. 38031492, 38031493, 38031494, 38075351, 38078758, 38078759, 38130599, 38131540, 38131541, 38162878, 38187284, 38187285, 38204694, 38204695, 38204696, 38380212, 38380333, 38408115, 38408116, 38408117, 38408118, 38608097, 38622221, 38642730, 38678313, 38693569, 38770151, 38770152, 38864607, 38864608, 38906029, 38933949, 38960096; Exp. November 23, 2028 March 29, 2029.
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Bangladesh, Belgium, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Estonia, Finland, France, Germany, Great Britain, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Mongolia, Netherlands, New Zealand, Norway, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tobago, Trinidad, Tunisia, T¿rkiye, United Arab Emirates, Uruguay.

Agency product description and boundaries

CRE Pro Wireguided 6-8mm 240cm

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: Potential sterile breach of the pouches in which devices are packaged.

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: CRE Pro Wireguided 6-8mm 240cm recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2626-2026
Brand: All Boston Scientific recalls
Classification: Class II
Units affected: 81,543 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

CRE Pro Wireguided 6-8mm 240cm recall status

Companies & origin

Recalling firm location: Marlborough, MA, United States
Firm address: 100 Boston Scientific Way, N/A, 01752-1234

Identifying details (verbatim from the notice)

Product codes / lots: UPN: M00558660; GTIN: 8714729797548; Lot No. 38031492, 38031493, 38031494, 38075351, 38078758, 38078759, 38130599, 38131540, 38131541, 38162878, 38187284, 38187285, 38204694, 38204695, 38204696, 38380212, 38380333, 38408115, 38408116, 38408117, 38408118, 38608097, 38622221, 38642730, 38678313, 38693569, 38770151, 38770152, 38864607, 38864608, 38906029, 38933949, 38960096; Exp. November 23, 2028 March 29, 2029.
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Bangladesh, Belgium, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Estonia, Finland, France, Germany, Great Britain, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Mongolia, Netherlands, New Zealand, Norway, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tobago, Trinidad, Tunisia, T¿rkiye, United Arab Emirates, Uruguay.
Firm notified the public via: Letter
FDA event ID: 99067
Recall initiated: May 21, 2026
FDA classified: July 1, 2026
FDA report date: July 8, 2026

More Boston Scientific recalls

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Boston Scientific ENROUTE Transcarotid Neuroprotection System recall — Boston Scientific CorporationFDA · August 26, 2026
Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as recall — Boston Scientific CorporationFDA · May 6, 2026
Boston Scientific Pacemaker recall — Boston Scientific CorporationFDA · May 6, 2026

Other medical device recalls from around the same time

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Medtronic Harmony Delivery Catheter System recall — Medtronic Heart Valves DivisionFDA · July 8, 2026
A M S recall — Windstone Medical Packaging, Inc.FDA · July 8, 2026
A M S recall — Windstone Medical Packaging, Inc.FDA · July 8, 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 October 6, 2026 at 6:00 PM UTC.

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