Z-1551-2026Class II

EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN)...

Name: Z-1551-2026 EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN)...
Creator: Boston Scientific Corporation
Published: 2026-02-10
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2026-02-10 / Open, Classified / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000 on 2026-02-10. FDA classified it as Class II and gives the reason as "Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile swabstick packaging, which could result in loss of sterility or drying of the antiseptic solution. This...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1551-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-02-10
Posted: 2026-03-11
Recalling firm: Boston Scientific Corporation
Product: EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000;
Product code: PIF Gastrointestinal Tubes With Enteral Specific Connectors
Reason for recall: Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile swabstick packaging, which could result in loss of sterility or drying of the antiseptic solution. This component is placed outside of the sterile barrier of the tray manufactured by Boston Scientific, which contains the majority of the kit components. As such, inclusion of the affected ChloraPrep Triple Swabsticks does not degrade the integrity of the other components within the PEG kit.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On February 10, 2026 Urgent Medical Device Removal - Immediate Action Required letters were sent to customers. Actions to be taken: " Do NOT use affected product (Attachment 1), remove affected product from your facility s inventory, and segregate the units in a secure place until they can be returned to Boston Scientific. " Immediately post this information in a visible location near the affected products to ensure this information is readily accessible to all handlers and users of the device. " Forward this notice to any healthcare professional from your organization for awareness and to any organization where affected devices have been transferred. " Complete and return the enclosed Reply Verification Tracking Form per the enclosed instructions. " Return affected product. This removal affects only the products and lots affected. No other material numbers or lots are impacted by this removal. If you are a facility that has sent products to another hospital or a facility within your network, ensure this notification is forwarded to them.
Quantity in commerce: 806 units
Distribution: US Nationwide distribution.
Product codes and lots: Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000; Outer Box UDI: 08714729880394; Inner Box UDI: 08714729880387; Outer Box Lot#s: 37435463, 37522541, 37528545, 37546847, 37546850, 37546849, 37550500, 37592036, 37732292; Inner Box Lot#s: 37435462, 37514809, 37525231, 37536563, 37536564, 37536562, 37546840, 37583642, 37731897;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1551-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1551-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-18	2026-03-11

Product code PIF

K150679Class IIEndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit ConnectorBoston Scientific Corp / cleared 2015-05-29

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)