Boston Scientific CRE Wireguided Recall
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Boston Scientific Corporation is recalling 81,543 units of CRE Wireguided 18-20mm 240cm devices 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 7, 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, MedicalDevices.
What Happened
Boston Scientific Corporation initiated a recall due to potential sterile breach of the pouches in which devices are packaged.
Which Products Are Affected
The affected product is CRE Wireguided 18-20mm 240cm (UPN: M00558500; GTIN: 8714729339434). Affected lot numbers include 38033572, 38063250, 38063251, 38063252, 38211783, 38211784, 38215261, 38215262, 38215263, 38222236, 38222237, 38222238, 38222239, 38241879, 38242360, 38242361, 38334062, 38334063, 38347338, 38468864, 38472364, 38472365, 38479755, 38596733, 38596734, 38596735, 38596736, 38596883, 38596884, 38692526, 38707831, 38709738, 38709739, 38748244, 38808896, 38874312, 38874313, 38874314, 38886248, 38886249 with expiration dates of October 24, 2028 through February 17, 2029. A total of 81,543 units are affected under recall number Z-2637-2026. Distribution was 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.
What You Should Do
Check product lot numbers against the listed affected lots. Contact Boston Scientific Corporation for further instructions regarding the recall.
Why This Matters
This Class II recall involves a potential compromise in device sterility for a widely distributed medical product.
Source
FDA recall number Z-2637-2026, report date 20260708.
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 (1,928 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 7, 2026.
Frequently Asked Questions
Common questions about this FDA recall.