CLASS II Device recall · Reported 1 Jul 2015 · FDA Enforcement Report

McKesson Medi-Pak Vaginal Speculum recalled by CooperSurgical

CooperSurgical is recalling McKesson Medi-Pak Vaginal Speculum, distributed nationwide in the US. The recall was initiated on 13 Apr 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesWork Order:164290

Quantity recalled9400 units

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-1824-2015
FDA event ID: 71313
Recalling firm: CooperSurgical, Trumbull, CT
Classification: Class II
Status: Terminated
Recall initiated: 13 Apr 2015
FDA classified: 22 Jun 2015
Reported: 1 Jul 2015
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

13 Apr 2015	Recall initiated by company
22 Jun 2015	Classified by FDA	+70 days
1 Jul 2015	Published in enforcement report	+9 days

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

Reason for recall

Small sized specula were incorrectly packaged in printed bags for the medium sized speculum

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

McKesson Medi-Pak Vaginal Speculum, 10/bag Reorder No. 11-8309 Used to expose interior of the vagina to facilitate visualization during gynecological and obstetrical procedures

Where it was distributed

Nationwide Distribution including IL, FL, GA, MA, MO, TX, and WA.

Nationwide Florida Georgia Illinois Massachusetts Missouri Texas Washington

Questions about this recall

Why was it recalled?

Small sized specula were incorrectly packaged in printed bags for the medium sized speculum

Which lots are affected?

Work Order:164290

Where was it sold?

Nationwide Distribution including IL, FL, GA, MA, MO, TX, and WA.

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 26 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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