Blue Belt Technologies — Class II medical device recall Z-1995-2013
Terminated recall by Blue Belt Technologies MN, reported 2013-08-28, distributed nationwide. Blue Belt Technologies is recalling sterile Monitor Drapes used with their Navio PFS system during orthopedic
| Recall number | Z-1995-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Blue Belt Technologies MN, Plymouth, MN, United States |
| Recall initiated | 2013-07-19 |
| Classified | 2013-08-21 |
| Reported by FDA | 2013-08-28 |
| Terminated | 2013-11-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | GB |
| Reason classes | sterility |
| Lot numbers | D130432 |
| Model numbers | PFSD-V0001 |
| Expiration dates | 2018-02-20 |
Product
Blue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile EO. Product Usage: The intended use of this device is t protect equipment from contamination during a variety of procedures throughout the clinical setting.
Reason for recall
Blue Belt Technologies is recalling sterile Monitor Drapes used with their Navio PFS system during orthopedic knee surgery. The drapes are used to cover the Navio PFS system computer monitor and arm assembly and provide a sterile barrier in the surgical suite. The defect is evident when the computer monitor is being draped. The front section of the drape separates from the rest of the drape at
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-1995-2013. 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.