Boston Scientific Recalls CRE Wireguided Devices
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Boston Scientific Corporation is recalling 81,543 units of CRE Wireguided 6-8mm 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, Devices.
What Happened
Boston Scientific Corporation initiated a voluntary recall due to potential sterile breach of the pouches in which devices are packaged.
Which Products Are Affected
The recall affects CRE Wireguided 6-8mm 240cm devices with UPN M00558450 and GTIN 8714729339380. Affected lot numbers are 38064056, 38064057, 38200574, 38200575, 38204501, 38204504, 38204506, 38204508, 38628161, 38640993, 38767490, 38904960, 38904961, 38946757, 38946758, and 38946759, with expiration dates of October 27, 2028 and February 24, 2029. A total of 81,543 units are involved in worldwide distribution, including US Nationwide and numerous other countries.
What You Should Do
Consumers and healthcare providers should follow instructions provided in the firm's notification letter regarding the affected devices.
Why This Matters
This Class II recall addresses a potential compromise in device sterility that could lead to temporary or reversible adverse health consequences.
Source
FDA recall number Z-2632-2026, initiated May 21, 2026.
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 (1,047 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.