Boston Scientific Recalls CRE Pro Wireguided Devices
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Boston Scientific Corporation is recalling 81,543 units of CRE Pro Wireguided 18-20mm 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 United States. 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 CRE Pro Wireguided devices due to potential sterile breach of the pouches in which devices are packaged. The recall is classified as Class II and remains ongoing.
Which Products Are Affected
The affected product is CRE Pro Wireguided 18-20mm 240cm (UPN: M00558710; GTIN: 8714729797593). A total of 81,543 units are involved, 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 38031485 through 38964093 with expiration dates of November 23, 2028 to March 29, 2029. Recall number is Z-2631-2026.
What You Should Do
The recalling firm notified customers via letter. Consumers and healthcare providers should follow instructions provided in the notification for the affected devices.
Why This Matters
The recall involves a large quantity of devices distributed globally, addressing a potential compromise in sterility for these medical devices.
Source
FDA Recall Z-2631-2026 - Boston Scientific Corporation, Marlborough, MA
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
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 (1,735 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.