CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for… — Class III medical device recall Z-0105-2016
Terminated recall by CooperSurgical, Inc., reported 2015-10-14, distributed in AL, AZ, CA, GA, IA, IL, KS, LA…. Kit Label incorrect :Labeled with Lidocaine HCI drug cartridges Lidocaine HCl (2%) but contains vials Lidocain
| Recall number | Z-0105-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CooperSurgical, Inc., Trumbull, CT, United States |
| Recall initiated | 2015-09-01 |
| Classified | 2015-10-06 |
| Reported by FDA | 2015-10-14 |
| Terminated | 2016-01-29 |
| Distributed | AL, AZ, CA, GA, IA, IL, KS, LA, MA, MD, MN, MO, MS, NY, OH, PA, TN, TX, VA, VT |
| Quantity | 305 units |
| Reason classes | labeling |
| Lot numbers | 187889 |
Product
CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure P/N 6061
Reason for recall
Kit Label incorrect :Labeled with Lidocaine HCI drug cartridges Lidocaine HCl (2%) but contains vials Lidocaine HCl (1%)
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-0105-2016. 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.