EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 3 — Class II medical device recall Z-1527-2018
Terminated recall by Covidien LLC, reported 2018-05-02, distributed nationwide. There is a potential for improper welding of the yellow staple guide to the instrument. Use of a device with a
| Recall number | Z-1527-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien LLC, North Haven, CT, United States |
| Recall initiated | 2018-04-09 |
| Classified | 2018-04-26 |
| Reported by FDA | 2018-05-02 |
| Terminated | 2020-05-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BG, CA, CH, CZ, DE, DK, EE, ES, FI, FR, GB, ID, IT, KR, MY, NL, PL, PT, RU, SA, SE, SG, SK, TR, TW, VN, ZA |
| Quantity | 5,547 |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 10884521047518, 20884521047515 |
| Lot numbers | N7J1145MX, N7K0092MX, N7K0692MX, N7K0693MX, N7L0380MX, N7L0457MX, N7L0594MX, N7L0676MX, N7L0762MX, N7L0868MX, N7L0940MX, N7L1076MX, N7L1077MX, N7M0144MX, N7M0185MX, N7M0732MX, N7M0733MX, N7M0835MX, N8A0144MX, N8A0166MX |
Product
EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 3.5MM, Product Number HEM3335, GTIN Number 1 - 10884521047518, GTIN Number 2 - 20884521047515 Product Usage: The EEA Hemorrhoid and prolapse stapler set with DST Series Technology (instrument) is designed for use as a stapler instrument for control of rectal prolapse and hemorrhoid disease. The instrument places a circular, double-staggered row of titanium DST staples and removes a circular tissue specimen. The instrument is offered in a 33mm diameter size with either 3.5mm or 4.8mm staples. The accompanying accessories comprised of an access port, anoscope, and dilator. The access port aids the insertion and removal of the anoscope and the stapler device by dilating the anal sphincter throughout the procedure. The anoscope is designed to facilitate pursestring suture application above the dentate line. It is designed with a guide and markings to assist in creating a circumferential pursestring suture at a consistent placement within the rectum. The dilator is designed to aid the initial insertion of the anoscope and port by retracting the rectal tissue. Both the anoscope and port are transparent to facilitate visualization of the anal canal. The EEA Hemorrhoid and prolapse stapler set with DST Series Technology has application throughout the anal canal to perform surgical treatment of hemorrhoidal disease. The EEA Hemorrhoid and prolapse stapler also has application in the distal alimentary tract for the creation of end-to-end and end-to-side anastomoses.
Reason for recall
There is a potential for improper welding of the yellow staple guide to the instrument. Use of a device with an improperly welded staple guide may result in improper staple formation potentially leading to bleeding or anastomotic leak.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1527-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.