CLASS II Device recall · Reported 10 Apr 2013 · FDA Enforcement Report

Leep Redikit Product No. a Loop Electrosurgical Excision recalled

Cooper Surgical is recalling Leep Redikit Product No. a Loop Electrosurgical Excision Procedure, a thin, low-voltage, distributed nationwide in the US. The recall was initiated on 26 Feb 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 120716, exp 8-31-13; Lot 116657 exp. 6-30-13; Lot 116658 exp. 5-31-13; Lot 116659 exp. 7-31-13

Quantity recalled4395 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1053-2013
FDA event ID: 64528
Recalling firm: Cooper Surgical, Trumbull, CT
Classification: Class II
Status: Terminated
Recall initiated: 26 Feb 2013
FDA classified: 3 Apr 2013
Reported: 10 Apr 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

26 Feb 2013	Recall initiated by company
3 Apr 2013	Classified by FDA	+36 days
10 Apr 2013	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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).

Product as listed by the FDA

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.

Where it was distributed

Nationwide Distribution including Puerto Rico

Nationwide Puerto Rico

Questions about this recall

Is Leep Redikit Product No. a Loop Electrosurgical Excision Procedure, a thin, low-voltage recalled?

Yes. Cooper Surgical recalled Leep Redikit Product No. a Loop Electrosurgical Excision Procedure, a thin, low-voltage on 26 Feb 2013. The recall is Class II and its status is Terminated. Recall number Z-1053-2013.

Why was it recalled?

Which lots are affected?

Lot 120716, exp 8-31-13; Lot 116657 exp. 6-30-13; Lot 116658 exp. 5-31-13; Lot 116659 exp. 7-31-13

Where was it sold?

Nationwide Distribution including Puerto Rico

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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