CLASS II Device recall · Reported 29 May 2019 · FDA Enforcement Report

Icsi Micropipette CooperSurgical recalled

CooperSurgical is recalling Icsi Micropipette CooperSurgical. The recall was initiated on 27 Mar 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 1557

Quantity recalled480 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-1367-2019
FDA event ID: 82663
Recalling firm: CooperSurgical, Trumbull, CT
Classification: Class II
Status: Terminated
Recall initiated: 27 Mar 2019
FDA classified: 17 May 2019
Reported: 29 May 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

27 Mar 2019	Recall initiated by company
17 May 2019	Classified by FDA	+51 days
29 May 2019	Published in enforcement report	+12 days

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

Reason for recall

ICSI CUSTOM MICROPIPETTES the thirty-degree bend is absent

Product as listed by the FDA

ICSI MICROPIPETTE CooperSurgical part number: MICC001-30-B1.0

Where it was distributed

Foreign: Denmark, Italy, Sweden

Questions about this recall

Is Icsi Micropipette CooperSurgical recalled?

Yes. CooperSurgical recalled Icsi Micropipette CooperSurgical on 27 Mar 2019. The recall is Class II and its status is Terminated. Recall number Z-1367-2019.

Why was it recalled?

ICSI CUSTOM MICROPIPETTES the thirty-degree bend is absent

Which lots are affected?

Lot 1557

Where was it sold?

Foreign: Denmark, Italy, Sweden

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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