Puritan absorbent foam tipped applicator — Class II medical device recall Z-1278-2015
Terminated recall by Puritan Medical Products Co., LLC, reported 2015-03-25, distributed in GA, ME, MS, NC. Shaft breaks so that adequate patient specimen sample cannot be obtained.
| Recall number | Z-1278-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Puritan Medical Products Co., LLC, Guilford, ME, United States |
| Recall initiated | 2014-12-22 |
| Classified | 2015-03-13 |
| Reported by FDA | 2015-03-25 |
| Terminated | 2015-03-18 |
| Distributed | GA, ME, MS, NC |
| Lot numbers | 2016/04, 3111 |
| Model numbers | 25-1406 |
Product
Puritan absorbent foam tipped applicator; Catalog Number 25-1406 1 PF BT. Sterile absorbent foam tipped applicator used to apply medication or to obtain specimens from a patient.
Reason for recall
Shaft breaks so that adequate patient specimen sample cannot be obtained.
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-1278-2015. 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.