CLASS II Device recall · Reported 23 May 2018 · FDA Enforcement Report

Fischer Cone Biopsy Excisor, Medium (5/Box) recalled by CooperSurgical

CooperSurgical is recalling Fischer Cone Biopsy Excisor, Medium (5/Box), distributed in 8 states. The recall was initiated on 12 Mar 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot number: 212074

Quantity recalled500

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-1879-2018
FDA event ID: 79828
Recalling firm: CooperSurgical, Trumbull, CT
Classification: Class II
Status: Terminated
Recall initiated: 12 Mar 2018
FDA classified: 15 May 2018
Reported: 23 May 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

12 Mar 2018	Recall initiated by company
15 May 2018	Classified by FDA	+64 days
23 May 2018	Published in enforcement report	+8 days

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

Reason for recall

Products have been packaged with an incorrect product size.

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

Fischer Cone Biopsy Excisor, Medium (5/Box); Model Number: 900-151

Where it was distributed

CA, SC, WI, MI, NH, MD, OH, NJ, Australia, France, Spain

California Maryland Michigan New Hampshire New Jersey Ohio South Carolina Wisconsin

Questions about this recall

Why was it recalled?

Products have been packaged with an incorrect product size.

Which lots are affected?

Lot number: 212074

Where was it sold?

CA, SC, WI, MI, NH, MD, OH, NJ, Australia, France, Spain

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.

More recalls from CooperSurgical

All 84

Reported	Class	Recall	Company	Reason	Where
30 Jul 2025Device	CLASS II	HSG Procedure Tray recalled by CooperSurgical	CooperSurgical	Sterility	Nationwide
30 Jul 2025Device	CLASS II	Endosee System Convenience Kit recalled by CooperSurgical	CooperSurgical	Sterility	Nationwide
30 Jul 2025Device	CLASS II	Endosee System Convenience Kit with IV Tube recalled by CooperSurgical	CooperSurgical	Sterility	Nationwide
25 Dec 2024Device	CLASS II	K-Systems R65 Trolley recalled by CooperSurgical	CooperSurgical	Temperature Abuse	14 states
25 Dec 2024Device	CLASS II	K-Systems T47 Warming Plate recalled by CooperSurgical	CooperSurgical	Temperature Abuse	14 states

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide