Medical Device Exchange — Class II medical device recall Z-2219-2015
Terminated recall by EXP Pharmaceutical Services Corp, reported 2015-08-05, distributed in AR, CA, CO, DC, FL, TX. EXP did not register as a medical device establishment, list the devices being recalled, or establish its own
| Recall number | Z-2219-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | EXP Pharmaceutical Services Corp, Fremont, CA, United States |
| Recall initiated | 2015-02-11 |
| Classified | 2015-07-24 |
| Reported by FDA | 2015-08-05 |
| Terminated | 2015-12-30 |
| Distributed | AR, CA, CO, DC, FL, TX |
| Quantity | 3 |
| Model numbers | TA6035L |
Product
Medical Device Exchange - Loading Unit w/ DST Series Technology 60mm - 3.5mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number TA6035L; EXP (repackager), Covidien (OEM) Implantable Staple
Reason for recall
EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
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-2219-2015. 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.