FDA Medical Device Recalls (openFDA)
Cardinal Health: 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.
- Recall number
- Z-0982-2013
- Recalling firm
- Cardinal Health
- Product
- 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.
- Status
- Terminated
- Initiated
- 2012-12-18
- Posted
- 2013-03-28
- Terminated
- 2016-08-01
- Reason
- Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
- 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
- Cat. No. 4FS60SSA: 576; Cat. No. 4FS61SSA: 14,760; Cat. No. 4MM60SSA: 5,184
- Distribution
- Worldwide Distribution - USA (Nationwide) and the countried of Australia, Canada and Japan.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FSM
- Firm FEI
- 3001236905
- Firm city
- Park
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28