Boston Scientific CRE Pro Wireguided Recall
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 Pro Wireguided 15-18mm 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 voluntary recall of certain CRE Pro 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 and remains ongoing.
Which Products Are Affected
The affected product is CRE Pro Wireguided 15-18mm 240cm with UPN M00558700 and GTIN 8714729797586. A total of 81,543 units are involved, distributed worldwide including US Nationwide and numerous other countries. Specific lot numbers include 38043116, 38192116, 38192117, 38192118, 38192119, 38192960, 38192961, 38214896, 38214897, 38222153, 38222496, 38222497, 38222498, 38222499, 38222660, 38222661, 38222662, 38222663, 38222664, 38222665, 38238864, 38239084, 38239085, 38239086, 38239087, 38239088, 38239089, 38241874, 38241875, 38241876, 38242679, 38242820, 38242821, 38242822, 38242824, 38269134, 38269135, 38274558, 38274559, 38282412, 38324631, 38324632, 38324633, 38324634, 38324636, 38324637, 38324638, 38347325, 38347326, 38347327, 38347328, 38364300, 38381887, 38421906, 38421907, 38421908, 38421909, 38421910, 38421911, 38421912, 38421913, 38421914, 38441933, 38441934, 38441935, 38441936, 38450077, 38450078, 38450079, 38450260, 38450261, 38450262, 38450263, 38462131, 38462132, 38462133, 38468755, 38468756, 38472371, 38472372, 38472373, 38479757, 38479758, 38503030, 38507563, 38507564, 38507565, 38507566, 38507567, 38507568, 38507569, 38568778, 38568779, 38568860, 38585010, 38585011, 38585012, 38585013, 38621957, 38621958, 38642724, 38642725, 38642726, 38642727, 38665032, 38665033, 38665034, 38665035, 38665036, 38665038, 38678315, 38688161, 38726662, 38726663, 38726664, 38734730, 38734731, 38745591, 38748249, 38748250, 38748251, 38748253, 38762224, 38762225, 38762226, 38762227, 38762228, 38769690, 38769691, 38769692, 38800533, 38800534, 38800535, 38800536, 38831782, 38831783, 38831784, 38831785, 38831786, 38831787, 38831788, 38877007, 38877008, 38877009, 38878807, 38878808, 38878809, 38878810, 38878811, 38878812, 38886257, 38886258, 38886259, 38916782, 38916783, 38916784, 38916785, 38933957, 38933958, 38933959, 38935360, 38945672 with expiration dates of November 24, 2028 or March 26, 2029. Recall number is Z-2630-2026.
What You Should Do
Consumers and healthcare providers should contact Boston Scientific Corporation at 100 Boston Scientific Way, Marlborough, MA 01752-1234 for additional information regarding the recall.
Why This Matters
A Class II recall indicates the device may cause temporary or medically reversible adverse health consequences, with the potential for serious injury being remote.
Source
FDA recall Z-2630-2026
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 (2,691 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.