Z-0986-2013Class II

Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 60 Count/100 Capacity; Sterile; Removable Numbered...

Name: Z-0986-2013 Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 60 Count/100 Capacity; Sterile; Removable Numbered...
Creator: Cardinal Health
Published: 2012-12-18
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2012-12-18 / Terminated / root cause: packaging

FDA source

Cardinal Health began a recall of Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 60 Count/100 Capacity; Sterile; Removable Numbered Foam Block; Double Numbered Magnets (Cat. No... on 2012-12-18. FDA classified it as Class II and gives the reason as "Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0986-2013
Classification: Class II
Status: Terminated
Initiated: 2012-12-18
Posted: 2013-03-28
Terminated: 2016-08-01
Recalling firm: Medtronic, Inc.
Product: Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 60 Count/100 Capacity; Sterile; Removable Numbered Foam Block; Double Numbered Magnets (Cat. No. 4FM100SSA) Product Usage: Disposal system for counting of used surgical blades and needles.
Product code: FSM Tray, Surgical, Instrument
Reason for recall: Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: Cardinal Health sent an Urgent Product Recall letter dated December 18, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immedaitely stop using affected product and discard any product that may be on hand, return the enclosed acknowledgement form, notify any customers to whom you may have distributed product affected by this recall, and contact the appropriate Customer Service group to arrange for credit of any affected product discarded. For questions contact Cardinal Health Professional Services at 800-292-9332.
Quantity in commerce: Cat. No. 4FM100SSA: 4,464
Distribution: Worldwide Distribution - USA (Nationwide) and the countried of Australia, Canada and Japan.
Product codes and lots: Catalog Number: 4FM100SSA Lot Numbers: all lot numbers less than or equal to 847028

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0986-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0978-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-03	2013-03-28
Z-0979-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-03	2013-03-28
Z-0980-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-03	2013-03-28
Z-0981-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-03	2013-03-28
Z-0982-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-03	2013-03-28
Z-0983-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-03	2013-03-28
Z-0984-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-03	2013-03-28
Z-0985-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-03	2013-03-28
Z-0986-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-03	2013-03-28

Product code FSM

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)