Flexipet G18674Recalls & reported problems

Cook Incorporated · Flexipet, Adjustable Handle Set · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports: 3
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002186743), received between Aug 11, 2017 and Sep 15, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Device Contaminated During Manufacture or Shipping2
Device Contamination with Chemical or Other Material1
Insufficient Device Problem Information1

Patient problems

No Clinical Signs, Symptoms or Conditions2
No Patient Involvement1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 15, 2026Device Contaminated During Manufacture or Shipping
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50777531 ↗
MalfunctionJan 6, 2026Device Contaminated During Manufacture or Shipping
ADDITIONAL INFORMATION WAS RECEIVED ON 16JAN2026. THE HANDLE WAS NOT PREVIOUSLY USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23975122 ↗
MalfunctionAug 11, 2017Device Contamination with Chemical or Other Material; Insufficient Device Problem Information; Device Contamination with Chemical or Other Material; Insufficient Device Problem Information
THE USER FACILITY REPORTED AFTER RECEIVING THE FLEXI-PET ADJUSTABLE HANDLE SET, IT WAS OBSERVED TO HAVE THE SAME FLAWS THAT WERE FOUND IN THE PREVIOUS ONE THAT THIS PRODUCT WAS A REPLACEMENT FOR. AS REPORTED, THERE IS ALSO "OIL" IN THE FRONT PART OF THIS PRODUCT. THESE ISSUES WERE DISCOVERED PRIOR TO PATIENT CONTACT. THERE WAS NO PATIENT INVOLVEMENT WITH THIS ISSUE.
Patient problems: No Patient Involvement
MAUDE report 6787479 ↗

Device details

UDI-DI	`00827002186743`
Brand	Flexipet
Model	G18674
Catalog no.	K-MPH-1000
Company	Cook Incorporated
Product code	MQJ · Micromanipulators and microinjectors, assisted reproduction
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jun 25, 2019

Device type (GMDN): Mechanical pipette

A manually-operated device typically used in the laboratory to withdraw, transfer, and inject discrete volumes of fluid materials. The device is typically hand-held and operates through an internal mechanism powered by the fingers; it can have a single channel or multichannel piston/cylinder pick-up assembly. The device transfers consistent volumes of liquid into one or several receptacles simultaneously (e.g., the wells of a microtitre plate). A pipette may be factory pre-set to deliver a given volume, or may have user-selectable volumes within a useful volume range. The delivered volume may be mechanically indicated.

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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