CLASS II ONGOING Device recall · Reported 8 Jul 2026 · FDA Enforcement Report
CRE Wireguided recalled by Boston Scientific
Boston Scientific is recalling CRE Wireguided 10, distributed nationwide in the US. The recall was initiated on 21 May 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2634-2026
- FDA event ID
- 99067
- Recalling firm
- Boston Scientific, Marlborough, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 May 2026
- FDA classified
- 1 Jul 2026
- Reported
- 8 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 21 May 2026 | Recall initiated by company | |
| 1 Jul 2026 | Classified by FDA | +41 days |
| 8 Jul 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential sterile breach of the pouches in which devices are packaged.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
CRE Wireguided 10-12mm 240cm
Where it was distributed
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.
Questions about this recall
Why was it recalled?
Potential sterile breach of the pouches in which devices are packaged.
Which lots are affected?
UPN: M00558470; GTIN: 8714729339403; Lot No. 38099718, 38165001, 38165002, 38196568, 38196569, 38196570, 38204511, 38204512, 38204513, 38285933, 38397792, 38398767, 38398768, 38507308, 38552115, 38596881, 38596882, 38612829, 38612830, 38680058, 38683384, 38683385, 38689434, 38690171, 38707829, 38707830, 38710480, 38769697, 38800182, 38800183, 38871161, 38871162, 38871163, 38937571 ; Exp. November 2, 2028 February 23, 2029 .
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
11 other products · FDA event 99067This product is part of a recall event; the main page for the event is CRE Pro Wireguided recalled by Boston Scientific.
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