Cardinal Health: Medical Device Recall in 2013 - (Recall #: Z-0982-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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 1.7 cm; 30 Count/60 Capacity; Sterile; Double Numbered Magnets (Cat. No. 4MM60SSA) Product Usage: Disposal system for counting of used surgical blades and needles.

Product Classification:

Class II

Date Initiated: December 18, 2012

Date Posted: April 3, 2013

Recall Number: Z-0982-2013

Event ID: 63951

Reason for Recall:

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

Status: Terminated

Product Quantity: Cat. No. 4FS60SSA: 576; Cat. No. 4FS61SSA: 14,760; Cat. No. 4MM60SSA: 5,184

Code Information:

Catalog Number: 4FS60SSA Lot Numbers: all lot numbers less than or equal to 752068 Catalog Number: 4FS61SSA Lot Numbers: all lot numbers less than or equal to 802581 Catalog Number: 4MM60SSA Lot Numbers: all lot numbers less than or equal to 898715

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated