5 x 93 US Probe Cover CMS-6049 — Class II medical device recall Z-0974-2014
Terminated recall by Custom Medical Specialties, Inc., reported 2014-02-19, distributed in CT, FL, IL, NJ, NY, PA, TN, VA…. No endotoxin (LAL) testing to proper level.
| Recall number | Z-0974-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Custom Medical Specialties, Inc., Pine Level, NC, United States |
| Recall initiated | 2013-07-12 |
| Classified | 2014-02-12 |
| Reported by FDA | 2014-02-19 |
| Terminated | 2014-04-08 |
| Distributed | CT, FL, IL, NJ, NY, PA, TN, VA, WI |
| Quantity | 2,610 |
| Reason classes | sterility |
| Lot numbers | 15831-0906, 17181-0910, 17926-1001, 18672-1003, 19067-104, 19683-1005, 19771-1006, 19931-1006, 21886-1010, 23233-1103, 24926-1108, 25201-1109, 26150-1112, 26502-1201, 27522-1204, 28161-1206, 28999-1208, 29153-1208, 31811-1304, 32056-1305, 32391-1306, D100891, D101981, D102461, D103081, D103081A, D103331, D110871, D111021, D113551, D121521, D91821, D92081, D92301, D93411 |
| Expiration dates | 2012-01, 2012-06, 2013-01, 2013-03, 2013-04, 2013-05, 2013-06, 2013-10, 2014-03, 2014-08, 2014-09, 2014-12, 2015-01, 2015-04, 2015-06, 2015-08, 2016-04, 2016-05, 2016-06 |
Product
5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use. Custom Medical Specialties, Inc., Pine Level, NC, Federal (USA) law restricts this device to the sale by or on the order of a physician. Probe cover
Reason for recall
No endotoxin (LAL) testing to proper level.
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-0974-2014. 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.