Chiba Biopsy Needles Recalled for Potential Sterility Compromise
Cook Incorporated is recalling Chiba Biopsy Needles due to packaging that may have low seal strength, potentially compromising device sterility. The recall affects 6,178 units distributed worldwide.
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: This is an FDA Class II recall of a medical device used for invasive procedures. The packaging defect directly compromises device sterility, creating a risk of infection for patients undergoing biopsy procedures. However, no illnesses or injuries have been reported in the source material.
Plain-English summary
Cook Incorporated is recalling Chiba Biopsy Needles, used for aspiration biopsy procedures, due to a packaging defect. The packaging on affected units may have low seal strength and not meet peel strength specifications, which could compromise the sterility of the device.
Affected products include nine part numbers of the Chiba Biopsy Needle with specific reference part numbers and order numbers. A total of 6,178 units were affected by this recall.
The affected devices were distributed worldwide, including nationwide distribution in the United States and distribution to Austria, Australia, Brazil, Canada, Switzerland, Germany, Spain, Great Britain, Hong Kong, Ireland, Israel, India, Italy, New Zealand, and Singapore. Specific lot numbers and UDI codes for all affected part numbers have been identified.
Patients and healthcare providers who have these devices should not use them if they have not yet been used. Contact Cook Incorporated or the healthcare facility if you have questions about whether you have been affected by this recall.
The recalled product
- Product
- Chiba Biopsy Needle - Used for aspiration biopsy. REFERENCE PART NUMBER (RPN) ORDER NUMBER (GPN): 1) DCHN-18-10.0 G01559 2) DCHN-18-10.0-U G05040 3) DCHN-18-15.0 G00850 4) DCHN-22-10.0 G00852 5) DCHN-22-10.0-U G03978 6) DCHN-22-15.0 G00012 7) DCHN-22-15.0-U G03314 8)
- Manufacturer
- Cook Incorporated
- Hazard
- sterility-compromise
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- RPN/UDI/Lot Numbers 1) DCHN-18-10.0 (01)00827002015593(17) 15787141
- 15787142
- 15787693
- 15794668
- 15794669
- 15794728
- 15797998 2) DCHN-18-10.0-U (01)00827002050402(17) NS15781793
- NS15781794
- NS15783895 NS15783896
- NS15783899
- NS15783900
- NS15784336
- NS1580853
- 5 NS15808536
- 15785990
- 15791249 15794719 7) DCHN-22-15.0-U (01)00827002033146(17)15784638
- 15784722
- 15784724
- 15795935
- 15797991
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03