Device recall: Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area…

Class II FDA enforcement event 63951. Recall start date: 18 Dec 2012. Status in the FDA record: Terminated. Termination date: 1 Aug 2016.

Reason for recall, in the words of FDA

Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Cardinal Health started this device recall on 18 Dec 2012. The firm address in the FDA record is in Mc Gaw Park, IL. FDA put the recall in Class II. FDA event 63951 has 9 product records. The first FDA enforcement report date is 3 Apr 2013. The record gives the status Terminated, with the termination date 1 Aug 2016.

FDA enforcement report The 9 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Worldwide Distribution - USA (Nationwide) and the countried of Australia, Canada and Japan.

Recalling firm

Cardinal Health, Mc Gaw Park, IL.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

9 product records in the event.

FDA event 63951: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0978-2013	Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 3FA40SSA) Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 3FM40SSA) Product Usage: Disposal system for counting of…	Cat. No. 3FA40SSA: 23,952; Cat. No. 3FM40SSA: 140,736	Class II	Terminated	3 Apr 2013
Z-0979-2013	Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 4FA40SSA) Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 4FM40SSA) Product…	Cat. No. 4FA40SSA: 96; Cat. No. 4FM40SSA: 32,592	Class II	Terminated	3 Apr 2013
Z-0980-2013	Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 4FS30SSA) Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacity; Sterile; Removable Numbered Foam Block; Double Foam Strips (Cat. No. 4FS31SSA)…	Cat. No. 4FS30SSA: 7488; Cat. No. 4FS31SSA: 48; Cat. No. 4MM30SSA: 6336	Class II	Terminated	3 Apr 2013
Z-0981-2013	Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Foam Strip; Magnetic Area (Cat. No. 3FS60SSA) Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Double Foam Strips; (Cat. No. 3FS61SSA) Needle Counters; Sterile; Foam Strip; 12.2 x 10.5…	Cat. No. 3FS60SSA: 7,560; Cat. No. 3FS61SSA: 14,184; Cat. No. 3MM60SSA: 12,384	Class II	Terminated	3 Apr 2013
Z-0982-2013	Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Foam Strip; Magnetic Area (Cat. No. 4FS60SSA) Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Double Foam Strips (Cat. No. 4FS61SSA) Needle Counters with Blade Disarmer; 12.2 x 10.5 x…	Cat. No. 4FS60SSA: 576; Cat. No. 4FS61SSA: 14,760; Cat. No. 4MM60SSA: 5,184	Class II	Terminated	3 Apr 2013
Z-0983-2013	Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 3FA70SSA) Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area; (Cat. No. 3FM70SSA) Product Usage: Disposal system for counting of…	Cat. No. 3FA70SSA: 23,808; Cat. No. 3FM70SSA: 54,912	Class II	Terminated	3 Apr 2013
Z-0984-2013	Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/80 Capacity; Sterile; Double Removable Numbered Foam Blocks (Cat. No. 3FF80SSA) Product Usage: Disposal system for counting of used surgical blades and needles.	Cat. No. 3FF80SSA: 16224	Class II	Terminated	3 Apr 2013
Z-0985-2013	Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 4FA70SSA) Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 4FM70SSA) Product…	Cat. No. 4FA70SSA: 1,248; Cat. No. 4FM70SSA: 43,920	Class II	Terminated	3 Apr 2013
Z-0986-2013	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.	Cat. No. 4FM100SSA: 4,464	Class II	Terminated	3 Apr 2013

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2012: 823
Share of these events in Class II: 88%
Product records in this event: 9Median of the firm: 1
Events of the firm on the register: 12

Other events of the firm

Other FDA enforcement events of Cardinal Health
Initiated	Product (first record)	Type	Class	Records
1 Nov 2022	Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 ml) 5ml Catheter Product Code: 2480 Intended for urinary dr	Device	Class II	6
2 Nov 2021	SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-line SKU: 32474	Device	Class II	11
4 Aug 2021	Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product Code 8881570121 The proposed device is indicat	Device	Class I	3
11 Jan 2020	AAMI 3 FABRIC REINFORCEDGown 2XL NS, Item Code 9571NA	Device	Class II	39
20 Jul 2016	BLUE IMPERVIOUS GOWN WITH THUMBHOOKS, X-LARGE. Non-Sterile, Single Use Only, Plastic Non-Surgical Isolation Gown Non-Ste	Device	Class II	1
27 Jun 2016	The 9025TRU Arterial Blood Gas (ABG) Kit is used to obtain arterial blood sampling for pH, Blood Gas, Electrolyte and Me	Device	Class II	1
29 Feb 2016	Gomco Style Circumcision Clamp Trays is an instrument used to compress the foreskin of the penis during circumcision of	Device	Class II	1
25 Aug 2015	Ambitex NMD400 Nitrile Exam Gloves size medium. General Hospital and Personal use. Intended to be worn on the hand for m	Device	Class II	1
23 Dec 2014	Lubricated Intubating Stylet 6FR that is inserted into an endotracheal tube to facilitate intubation. This product is us	Device	Class II	1
2 Oct 2013	Potassium Chloride, microencapsulated extended-release tablets, 20 mEq, blister card of 30/10 cards in a corrugated ship	Drug	Class III	1

Cardinal Health: all 12 events

Official channels

FDA enforcement report Z-0978-2013The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 63951. https://recallregister.com/fda/ii/63951/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide Distribution - USA (Nationwide) and the countried of Australia, Canada and Japan.
What quantity of product is in FDA event 63951?: The event has 9 product records. The first record gives this quantity: Cat. No. 3FA40SSA: 23,952; Cat. No. 3FM40SSA: 140,736
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2012 have the same class?: 88% of the 823 device events that started in 2012 are in Class II.