ADRIA Herniatome 17G x 15cm Recall: Sterilization Process Not Followed
ADRIA recalls specific Herniatome models due to sterilization process not being followed by contract sterilizers. Affected units have model number 5091745 and lot numbers ZV0994 AD0314/2:20 AD0316/20.
Lower-risk recall
The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed.
Contact the company
What happened, in plain English
ADRIA is recalling certain Herniatome surgical tools because contract sterilizers did not follow proper sterilization cycles. This could lead to improper sterilization and potential infection risks if the tools are used without proper cleaning. Read more at govinfonow.com/recall/62533-adria-herniatome-17g-x-15cm-recall-sterilization-process-not-followed.
Source Summary by GovInfoNow · govinfonow.com/recall/62533-adria-herniatome-17g-x-15cm-recall-sterilization-process-not-followed · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0145-2022
Cite this page
“ADRIA Herniatome 17G x 15cm Recall: Sterilization Process Not Followed.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/62533-adria-herniatome-17g-x-15cm-recall-sterilization-process-not-followed. Based on FDA recall #Z-0145-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0145-2022%22&limit=1).
Why it’s dangerous
The sterilization process was not followed by contract sterilizers, which means the tools might not be properly disinfected. This could lead to infection if the tools are used without adequate cleaning.
Who’s affected
Surgical professionals using the specific model number 5091745 Herniatome tools are affected. Those who have the lot numbers ZV0994 AD0314/20 or AD0316/20 are most at risk.
How to tell if you have this one
Check for model number 5091745 and lot numbers ZV0994 AD0314/20 or AD0316/20 on the product packaging or label.
- Brand
ADRIA- Category
Medical device
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
The products were distributed to the following US states: NJ and NY.
| Recall number | Product, codes & lots |
|---|---|
| Z-0144-2022 | Herniatome, 17G x 15cm, Lumbar Type with with 20ga-30cm Introducer, Model Number 5091715; Lot Number: AD0316/20 |
| Z-0145-2022 | Herniatome, 17G x 15cm, Lumbar Type, Model Number 5091745; Lot Number: ZV0994 AD0314/20 AD0316/20 |
| Z-0146-2022 | Herniatome, 17G x 9cm, Cervical Type, Model Number 5091749; Lot Number: AD0063/20 AD0313/20 AD0302/20 |
What to do — step by step
Check Product Details
Look for model number 5091745 and lot numbers ZV0994 AD0314/20 or AD0316/20 on the product.
Where it went and when
Where it was distributed
Distributed in New Jersey and New York.
FDA distribution: “The products were distributed to the following US states: NJ and NY.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: New Jersey, New York.
Recall timeline
FDA terminated this recall 2.5 years 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-0145-2022 (May 17, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0145-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 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.