FDA Device recall Z-1846-2012
Covidien ROTICULATOR 30-3.5 Single Use Stapler REF# 017615 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecolo…
- FDA Device
- Class II
- terminated
- Published 2012-06-27
On 2012-06-27 the FDA classified a Class II recall of Covidien ROTICULATOR 30-3.5 Single Use Stapler REF# 017615 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecolo… by Covidien, citing potential for the sterility barrier to be compromised.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1846-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-05-09 |
| Published | 2012-06-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Covidien |
| Distribution | US |
Product
Covidien ROTICULATOR 30-3.5 Single Use Stapler REF# 017615 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
Reason
Potential for the sterility barrier to be compromised.
Identifiers
| code_info | LOT #'s BEGINNING WITH THE FOLLOWING LETTER/NUMBER COMBINATIONS P7E P8B P8L P9H POE PIB PIL P7F P8C P8M P9J POF PIC…LOT #'s BEGINNING WITH THE FOLLOWING LETTER/NUMBER COMBINATIONS P7E P8B P8L P9H POE PIB PIL P7F P8C P8M P9J POF PIC PlM P7G P8D P9A P9K POG PlD P2A P7H P8E P9B P9L POH PIE P2B0153X P7J P8F P9C P9M POJ PlF P7K P8G P9D POA POK PlG P7L P8H P9E POB POL PlH P7M P8J P9F POC POM PlJ P8A P8K P9G POD PIA PlK Also Best Practice Kits Ref#'s: OOZ0800, OOZ0976, OOZ1401, OOZ1407, OOB0117, OOBOI22 NOTE: THE SPECIFIC LOT NUMBERS LISTED BELOW AND LOT NUMBERS ENDING IN ""RMX" and "RRMX" ARE NOT AFFECTED BY THIS RECALL AND ARE ACCEPT ABLE FOR USE. P2A0194XR, P2B0488XR, P2B0153XR |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1846-2012%22
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