Instrumentation Industries BE183-SU and BE 183 SU-12 Manual Jet… — Class II medical device recall Z-1125-2013
Terminated recall by Instrumentation Industries Inc, reported 2013-04-24, distributed in AK, AL, AZ, CA, CO, CT, DC, FL…. Firm initiated an update to Directions for Use necessitating replacement of previously distributed Directions
| Recall number | Z-1125-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Instrumentation Industries Inc, Bethel Park, PA, United States |
| Recall initiated | 2012-09-07 |
| Classified | 2013-04-16 |
| Reported by FDA | 2013-04-24 |
| Terminated | 2013-07-05 |
| Distributed | AK, AL, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV |
| Countries outside the US | CA, HK, IE, NL, NZ, TH |
| Quantity | 2,998 |
| Lot numbers | 183, 183-R, BE183-SU, P0102809, P0103312, P0104510, P0106212, P0107712, P0108110, P0108808, P0109811, P0111111, P0111410, P0112208, P0112408, P0114112, P0115009, P0117112, P0118212, P0200709, P0203008, P0203009, P0203109, P0203508, P0205608, P0207611, P0207712, P0208109, P0208208, P0208308, P0208608, P0208711, P0208711R11, P0209411, P0210810, P0211112, P0211311, P0211312, P0211712, P0212510 and 162 more |
Product
Instrumentation Industries BE183-SU and BE 183 SU-12 Manual Jet Ventilators; BE 183-SUR and BE 183 SUR-12 Manual Jet Ventilators with Regulator and Gauge; BE 183-2 4 ft. Small Bore Tubing Assembly w/Inline Filter; and BE 183-R Regulator The BE 183-SUR and BE 183-SU Manual Jet Ventilators are designed to provide transtracheal ventilation in specific emergency situations of upper airway obstructions.
Reason for recall
Firm initiated an update to Directions for Use necessitating replacement of previously distributed Directions for Use.
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-1125-2013. 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.