Z-1367-2019Class II

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

Name: Z-1367-2019 ICSI MICROPIPETTE CooperSurgical part number: MICC001-30-B1.0
Creator: CooperSurgical, Inc.
Published: 2019-03-27
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2019-03-27 / Terminated

FDA source

CooperSurgical, Inc. began a recall of ICSI MICROPIPETTE CooperSurgical part number: MICC001-30-B1.0 on 2019-03-27. FDA classified it as Class II and gives the reason as "ICSI CUSTOM MICROPIPETTES the thirty-degree bend is absent". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1367-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-27
Posted: 2019-05-17
Terminated: 2020-05-01
Recalling firm: CooperSurgical, Inc.
Product: ICSI MICROPIPETTE CooperSurgical part number: MICC001-30-B1.0
Product code: MQH Microtools, Assisted Reproduction (Pipettes)
Reason for recall: ICSI CUSTOM MICROPIPETTES the thirty-degree bend is absent
FDA root cause: Under Investigation by firm
Action: CooperSurgical issued recall letter dated March 27, 2019 identified problem and action to take: discontinue use of this discrepant product, quarantine the product, and complete the Acknowledgement and Receipt Form to arrange for either a product replacement or credit to your account through CooperSurgical. Contact: 203-601-5200 ext. 3300.
Quantity in commerce: 480 units
Distribution: Foreign: Denmark, Italy, Sweden
Product codes and lots: Lot 1557

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1367-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1367-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-29	2019-05-17

Product code MQH

K990847Class IIIntracytoplasmic Sperm Injection Micropipets (Icsi) Spermatid Icsi Micropipets, Holding Micropipets, Assisted Hatching MHumagen Fertility Diagnostics, Inc. / cleared 1999-07-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)