LEEP REDIKIT Product No — Class II medical device recall Z-1053-2013
Terminated recall by Cooper Surgical, Inc., reported 2013-04-10, distributed nationwide. LEEP RediKit Products (for use in Loop Electrosurgical Excision Procedures) have Xylocaine (Lidocaine) HCL (2%
| Recall number | Z-1053-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cooper Surgical, Inc., Trumbull, CT, United States |
| Recall initiated | 2013-02-26 |
| Classified | 2013-04-03 |
| Reported by FDA | 2013-04-10 |
| Terminated | 2014-06-12 |
| Distributed | Nationwide (US) |
| Quantity | 4,395 kits |
| Reason classes | labeling |
| Lot numbers | 116657, 116658, 116659, 120716 |
| Expiration dates | 2013-05-31, 2013-06-30, 2013-07-31, 2013-08-31 |
Product
LEEP REDIKIT Product No. 6060 In a Loop Electrosurgical Excision Procedure, a thin, low-voltage electrified wire loop is used to cut out abnormal cervical tissue. The cartridges of Polocaine and Xylocaine with Epinephrine contained in the LEEP RediKit are local anaesthetic which the physician may choose from during the procedure.
Reason for recall
LEEP RediKit Products (for use in Loop Electrosurgical Excision Procedures) have Xylocaine (Lidocaine) HCL (2%) listed on the tray lid label but this is not included in the contents of the kit, which contained Polocaine (Mepivacaine) HCL (3%) instead (which was not listed on the tray label).
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-1053-2013. 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.