Z-2635-2026Class II

CRE Wireguided 12-15mm 240cm

Name: Z-2635-2026 CRE Wireguided 12-15mm 240cm
Creator: Boston Scientific Corporation
Published: 2026-05-21
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2026-05-21 / Open, Classified / root cause: packaging

FDA source

Boston Scientific Corporation began a recall of CRE Wireguided 12-15mm 240cm on 2026-05-21. FDA classified it as Class II and gives the reason as "Potential sterile breach of the pouches in which devices are packaged". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2635-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-21
Posted: 2026-07-01
Recalling firm: Boston Scientific Corporation
Product: CRE Wireguided 12-15mm 240cm
Product code: FDT Duodenoscope And Accessories, Flexible/Rigid
Reason for recall: Potential sterile breach of the pouches in which devices are packaged.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: An Urgent Medical Device Removal - Immediate Action Required notification was mailed to consignees on 5/21/26. This notification informed consignees that Boston Scientific was conducting a removal of affected devices due to a potential sterile breach of product packaging (pouches). Consignees are instructed to immediately stop further use or distribution of product and quarantine them. Consignees are to complete and return the provided Reply Verification Tracking Form and return the product to Boston Scientific per the provided instructions. Consignees are to share the recall notification with any healthcare provider that uses the affected devices and with organizations to which product was further distributed. Consignees with any questions are to contact their Boston Scientific representative.
Quantity in commerce: 81,543 units
Distribution: Worldwide distribution - 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, T¿rkiye, United Arab Emirates, Uruguay.
Product codes and lots: UPN: M00558480; GTIN: 8714729339410; Lot No. 38033567, 38056239, 38056940, 38056941, 38215260, 38266854, 38266855, 38293330, 38391881, 38413876, 38413877, 38413878, 38413879, 38414080, 38422547, 38446204, 38466097, 38468862, 38468863, 38529518, 38529519, 38585004, 38622477, 38622478, 38640994, 38670501, 38670502, 38670504, 38686282, 38686283, 38693725, 38726666, 38726667, 38748254, 38767487, 38789996, 38800181, 38879160, 38879163, 38879164, 38911928, 38911929, 38911930, 38944841; Exp. October 24, 2028 February 24, 2029.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2635-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2626-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-01
Z-2627-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-01
Z-2628-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-01
Z-2629-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-01
Z-2630-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-01
Z-2631-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-01
Z-2632-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-01
Z-2633-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-01
Z-2634-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-01
Z-2635-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-01
Z-2636-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-01
Z-2637-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-01

Product code FDT

K110833Class IICre Balloon Dilatation CatheterBoston Scientific Corporation / cleared 2011-04-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)