Device recall: CRE Pro Wireguided 6-8mm 240cm
Class II FDA enforcement event 99067. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Potential sterile breach of the pouches in which devices are packaged.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Boston Scientific Corporation started this device recall on 21 May 2026. The firm address in the FDA record is in Marlborough, MA. FDA put the recall in Class II. FDA event 99067 has 12 product records. The first FDA enforcement report date is 8 Jul 2026. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Bangladesh, Belgium, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Dominican…
Recalling firm
Boston Scientific Corporation, Marlborough, MA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
12 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2626-2026 | CRE Pro Wireguided 6-8mm 240cm | 81,543 units | Class II | Ongoing | 8 Jul 2026 |
| Z-2627-2026 | CRE Pro Wireguided 8-10mm 240cm | 81,543 units | Class II | Ongoing | 8 Jul 2026 |
| Z-2628-2026 | CRE Pro Wireguided 10-12mm 240cm | 81,543 units | Class II | Ongoing | 8 Jul 2026 |
| Z-2629-2026 | CRE Pro Wireguided 12-15mm 240cm | 81,543 units | Class II | Ongoing | 8 Jul 2026 |
| Z-2630-2026 | CRE Pro Wireguided 15-18mm 240cm | 81,543 units | Class II | Ongoing | 8 Jul 2026 |
| Z-2631-2026 | CRE Pro Wireguided 18-20mm 240cm | 81,543 units | Class II | Ongoing | 8 Jul 2026 |
| Z-2632-2026 | CRE Wireguided 6-8mm 240cm | 81,543 units | Class II | Ongoing | 8 Jul 2026 |
| Z-2633-2026 | CRE Wireguided 8-10mm 240cm | 81,543 units | Class II | Ongoing | 8 Jul 2026 |
| Z-2634-2026 | CRE Wireguided 10-12mm 240cm | 81,543 units | Class II | Ongoing | 8 Jul 2026 |
| Z-2635-2026 | CRE Wireguided 12-15mm 240cm | 81,543 units | Class II | Ongoing | 8 Jul 2026 |
| Z-2636-2026 | CRE Wireguided 15-18mm 240cm | 81,543 units | Class II | Ongoing | 8 Jul 2026 |
| Z-2637-2026 | CRE Wireguided 18-20mm 240cm | 81,543 units | Class II | Ongoing | 8 Jul 2026 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2026
- 572
- Share of these events in Class II
- 87%
- Product records in this event
- 12Median of the firm: 2
- Events of the firm on the register
- 162
Other events of the firm
Official channels
- FDA enforcement report Z-2626-2026The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 99067. https://recallregister.com/fda/ii/99067/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this 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…
- What quantity of product is in FDA event 99067?
- The event has 12 product records. The first record gives this quantity:
81,543 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2026 have the same class?
- 87% of the 572 device events that started in 2026 are in Class II.