Cardinal Health Recalls Sterile Needle Counters Due to Packaging Defects
Cardinal Health is recalling sterile needle counters because small holes in the packaging may compromise sterility. The recall covers units distributed in the US, Australia, Canada, and Japan.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterile medical device) where the defect (packaging holes) potentially compromises sterility, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Cardinal Health is recalling specific lots of sterile needle counters, including catalog numbers 3FS60SSA, 3FS61SSA, and 3MM60SSA. These products are disposal systems used for counting used surgical blades and needles. The recall was initiated because small holes, approximately 1 mm or less, were found in the device unit-level packaging. These defects potentially compromise the sterility of the products.
The affected units were distributed worldwide, specifically in the United States (nationwide), Australia, Canada, and Japan. The recall includes specific lot numbers for each catalog number: all lot numbers less than or equal to 898712 for 3FS60SSA, less than or equal to 898714 for 3FS61SSA, and less than or equal to 931754 for 3MM60SSA. The total quantity involved is 7,560 units of 3FS60SSA, 14,184 units of 3FS61SSA, and 12,384 units of 3MM60SSA.
Healthcare facilities and consumers should check their inventory for these specific catalog and lot numbers. If the products are found, they should be removed from use and returned to Cardinal Health or the distributor in accordance with the recall instructions.
The recalled product
- Product
- 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
- Manufacturer
- Cardinal Health
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Cardinal Health under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 9 products in this recall →Related recalls
Same manufacturer · Cardinal Health
See all →- HighDover Closed Urethral Tray Recalled for Potential Drainage Blockage Risk
FDA (Devices) · 2022-12-14
- HighDover Urethral Catheter Drainage System Recall for Potential Port Blockage
FDA (Devices) · 2022-12-14
- HighDover Urinary Catheter Drainage Tray Recall Due to Blockage Risk
FDA (Devices) · 2022-12-14
- HighDover Closed Urethral Tray Recalled Due to Drainage Port Blockage Risk
FDA (Devices) · 2022-12-14
- HighDover urinary catheter drainage bag occlusion defect nationwide recall
FDA (Devices) · 2022-12-14
Same hazard · sterility compromise
See all →- SevereSpectra Medical Devices Recalls Sodium Chloride Injection Ampules Due to Sterility Concerns
FDA (Devices) · 2026-08-19
- HighStryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assemblies Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12