MICROTEK — Class II medical device recall Z-0945-2014
Terminated recall by Ecolab Inc, reported 2014-02-19, distributed nationwide. Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.
| Recall number | Z-0945-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ecolab Inc, Saint Paul, MN, United States |
| Recall initiated | 2013-07-02 |
| Classified | 2014-02-10 |
| Reported by FDA | 2014-02-19 |
| Terminated | 2014-05-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CA, CH, DE, ES, FI, FR, GB, HU, IE, JO, LV, MT, NL, NO, PL, PT, SA |
| Quantity | 12,546 individual |
| Reason classes | sterility |
| Lot numbers | 126429V, 126602V, 126611V, 126612V, 126613V, 126614V, 127176V, 127182V, 127331V, 127382V, 137533V, 137666V, 137787V, 137817V, 137826V, 137967V |
| Model numbers | PC3688EU |
Product
MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER W/ GEL, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688EU, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702
Reason for recall
Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.
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-0945-2014. 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.