CLASS II ONGOING Device recall · Reported 24 Apr 2024 · FDA Enforcement Report
Chiba Biopsy Needle - Used for aspiration biopsy recalled
Cook is recalling Chiba Biopsy Needle - Used for aspiration biopsy, distributed nationwide in the US. The recall was initiated on 1 Mar 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1525-2024
- FDA event ID
- 94196
- Recalling firm
- Cook, Bloomington, IN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Mar 2024
- FDA classified
- 12 Apr 2024
- Reported
- 24 Apr 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Syringes & Needles
Timeline
| 1 Mar 2024 | Recall initiated by company | |
| 12 Apr 2024 | Classified by FDA | +42 days |
| 24 Apr 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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) DCHN-22-20.0 G00013 9) DCHN-22-20.0-U G04338
Where it was distributed
Worldwide distribution - US Nationwide and the countries of AT, AU, BR, CA, CH, DE, ES, GB, HK, IE, IL, IN, IT, NZ, SG.
Questions about this recall
Why was it recalled?
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Which lots are affected?
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, NS15808537 3) DCHN-18-15.0 (01)00827002008502(17) 15595244 4) DCHN-22-10.0 (01)00827002008526(17) 15628472 5) DCHN-22-10.0-U (01)00827002039780(17) 15614507 6) DCHN-22-15.0 (01)00827002000124(17) 15628470, 15785990,15791249 15794719 7) DCHN-22-15.0-U (01)00827002033146(17)15784638, 15784722,15784724, 15795935, 15797991, 15797992 8) DCHN-22-20.0 (01)00827002000131(17) 15629865 9) DCHN-22-20.0-U (01)00827002043381(17) NS15808547
Where was it sold?
Worldwide distribution - US Nationwide and the countries of AT, AU, BR, CA, CH, DE, ES, GB, HK, IE, IL, IN, IT, NZ, SG.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
7 other products · FDA event 94196This product is part of a recall event; the main page for the event is Peel-Away Introducer - Intended recalled by Cook Incorporated.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Peel-Away Introducer - Intended recalled by Cook Incorporated | Cook | Sterility | Nationwide | |
| CLASS II | Dilator - Intended to be used recalled by Cook Incorporated | Cook | Sterility | Nationwide | |
| CLASS II | Entuit Secure Adjustable Gastrointestinal Suture Anchor Set recalled | Cook | Sterility | Nationwide | |
| CLASS II | Yueh Centesis Disposable Catheter Needle - Intended recalled | Cook | Sterility | Nationwide | |
| CLASS II | Trocar Needle - Used for dilating puncture sites recalled | Cook | Sterility | Nationwide | |
| CLASS II | Dilator - Coons Taper - Used recalled by Cook Incorporated | Cook | Sterility | Nationwide | |
| CLASS II | Dilator With AQ Hydrophilic Coating recalled by Cook Incorporated | Cook | Sterility | Nationwide |
More recalls from Cook
All 349| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Beacon Tip Centimeter Sizing Catheter RPN/GPN recalled | Cook | Device Malfunction | Nationwide |
| Device | CLASS I | Aurous Centimeter Sizing Catheter RPN recalled by Cook Incorporated | Cook | Device Malfunction | Nationwide |
| Device | CLASS I | Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-Pig-csc recalled | Cook | Device Malfunction | Nationwide |
| Device | CLASS II | Medical Cook Staged Extubation Set: Reference recalled | Cook | Other | IN |
| Device | CLASS II | Medical Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference recalled | Cook | Other | IN |
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|---|---|---|---|---|---|
| Device | CLASS I | BD Needle Kit for Powered Driver recalled by Bard Access Systems | Bard Access Systems | Other | 32 states |
| Device | CLASS II | Boston Scientific Enhance Transcarotid/Peripheral Access Kit recalled | Galt Medical | Other | Nationwide |
| Device | CLASS II | Geneva Brachytherapy Applicator recalled by Elekta | Elekta | Other | Nationwide |
| Device | CLASS II | Brachytherapy Applicator Advanced Gynecological Applicator recalled | Elekta | Other | Nationwide |
| Device | CLASS II | Medline 111 Gravity Set W/3 Needle Free Y-Sites recalled | BD Switzerland Sarl | Other | IL |