DePuy Mitek Gravity Tube Set Recall: Leakage at Bulb and Tube Connection
DePuy Mitek recalls 1113 Gravity Tube Set Pk/24 -SH due to leakage at bulb and tube connection. Affected units have specific lot codes. Contact for remedy.
Lower-risk recall
Leakage of FMS gravity tub sets (281113) at the bulb and tube connection
Contact the company
What happened, in plain English
DePuy Mitek is recalling gravity tube sets that can leak at the bulb and tube connection. This could lead to irrigation fluid leaking during surgery, potentially causing complications. Read more at govinfonow.com/recall/73093-depuy-mitek-gravity-tube-set-recall-leakage-at-bulb-and.
Source Summary by GovInfoNow · govinfonow.com/recall/73093-depuy-mitek-gravity-tube-set-recall-leakage-at-bulb-and · Updated September 18, 2026 · FDA enforcement record: FDA #Z-0695-2018
Cite this page
“DePuy Mitek Gravity Tube Set Recall: Leakage at Bulb and Tube Connection.” GovInfoNow, updated September 18, 2026. https://govinfonow.com/recall/73093-depuy-mitek-gravity-tube-set-recall-leakage-at-bulb-and. Based on FDA recall #Z-0695-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0695-2018%22&limit=1).
Why it’s dangerous
The gravity tube sets can leak at the bulb and tube connection, causing irrigation fluid to leak during surgery. This may lead to complications such as fluid accumulation or infection in the surgical site.
Who’s affected
Surgical teams using the gravity tube sets for arthroscopic procedures. Patients undergoing surgery with this product are at risk of irrigation fluid leakage.
How to tell if you have this one
Check for lot codes 138, 194, 633, 1067, 1741, 2576, 2608, and 2645 on the packaging. The product is a gravity tube set used in arthroscopic procedures.
- Brand
DePuy Mitek- Category
Medical device
What to do — step by step
Check Lot Codes
Look for lot codes 138, 194, 633, 1067, 1741, 2576, 2608, and 2645 on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 19 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0695-2018 (August 31, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0695-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 18, 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.