Boston Scientific CRE Wireguided Recall Issued
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Boston Scientific Corporation is recalling 81,543 units of CRE Wireguided 10-12mm 240cm devices worldwide due to potential sterile breach of packaging pouches.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 8, 2026 and geographically references Worldwide. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Boston Scientific Corporation initiated a voluntary recall of certain CRE Wireguided devices after identifying a potential sterile breach of the pouches in which the devices are packaged. The recall is classified as Class II by the FDA.
Which Products Are Affected
The affected product is CRE Wireguided 10-12mm 240cm (UPN: M00558470; GTIN: 8714729339403). It involves 81,543 units distributed worldwide, including 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, Türkiye, United Arab Emirates, and Uruguay. Affected lot numbers include 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. Expiration dates range from November 2, 2028 to February 23, 2029. Recall number: Z-2634-2026.
What You Should Do
Consumers and healthcare providers should contact Boston Scientific Corporation regarding the recalled devices. The recalling firm is located at 100 Boston Scientific Way, Marlborough, MA 01752-1234.
Why This Matters
The recall affects over 81,000 units distributed globally and addresses a potential compromise in device sterility.
Source
FDA recall number Z-2634-2026 (report date 20260708).
Original source: FDA Official Notice ↗
Related FDA Recalls
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Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (2,012 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 8, 2026.
Frequently Asked Questions
Common questions about this FDA recall.