Custom Assemblies Inc Surgical Kits Recall: Loose Needles May Cause Injuries
Custom Assemblies Inc recalls surgical kits with BD SafetyGlide needles that may release polypropylene particles during injection. Affected kits include biopsy trays with specific lot numbers. Contact for remedy.
Lower-risk recall
The firm manufactured and distributed custom surgical kits which contained BD SafetyGlide" 22GA 1¿ inch Needles. BD subsequently recalled these needles because, " Loose polypropylene particulate in the fluid path could be expelled out of the needle during injection.
Contact the company
What happened, in plain English
Custom Assemblies Inc recalled several surgical kits that contain BD SafetyGlide needles. These needles may release small plastic particles during injection, which could cause injury if injected into the body. Read more at govinfonow.com/recall/73842-custom-assemblies-inc-surgical-kits-recall-loose-needles-may-cause.
Source Summary by GovInfoNow · govinfonow.com/recall/73842-custom-assemblies-inc-surgical-kits-recall-loose-needles-may-cause · Updated September 23, 2026 · FDA enforcement record: FDA #Z-3059-2017
Cite this page
“Custom Assemblies Inc Surgical Kits Recall: Loose Needles May Cause Injuries.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/73842-custom-assemblies-inc-surgical-kits-recall-loose-needles-may-cause. Based on FDA recall #Z-3059-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3059-2017%22&limit=1).
Why it’s dangerous
The BD SafetyGlide needles contain loose polypropylene particles in their fluid path. During injection, these particles can be expelled from the needle and enter the body, potentially causing injury.
Who’s affected
Medical professionals using the recalled surgical kits are most at risk. Patients receiving injections with these needles could potentially be injured by the plastic particles.
How to tell if you have this one
Check for surgical kits with model numbers CMS-4153-R2, CMS-5832-R1, CMS-4108, CMS-3144-R6, CMS-2891-R1, CMS-5798-R1, or CMS-2357-R2. Look for specific lot numbers listed in the recall notice.
- Brand
Custom Assemblies Inc- Category
Medical device
What to do — step by step
Check Kit Model
Identify the model number of your surgical kit to see if it matches the recalled items listed in the notice.
Contact Manufacturer
Reach out to Custom Assemblies Inc for further instructions on the recall and potential remedies.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 6 states.
FDA distribution: “Nationwide Distribution to NJ, TN, NY, KS, OH, CA,” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Kansas, New Jersey, New York, Ohio, Tennessee.
Recall timeline
FDA terminated this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- FDA terminated the recall
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
What lot numbers are affected?
Affected lot numbers include 42754-1603, 42798-1603, 43030-1604, 42696-1602, 43200-1604, 433322-1605, 43056-1604, 42836-1603, 43182-1604, 42794-1603, 42912-1603, 43416-1606, and 43414-1606.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-3059-2017 (June 15, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3059-2017 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.