Northgate Probe Recall: Biocompatibility Test Failure Risk
Northgate Technologies recalls Probe (NTI Catalog 9-900-54) due to failed biocompatibility testing. Affected units may pose health risks from improper material use in medical procedures.
Recall notice
As part of an investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
Contact the company
What happened, in plain English
Northgate Technologies is recalling a medical probe model 9-900-54 because it failed biocompatibility testing. This means the probe could cause health issues if used in medical procedures involving urinary or renal systems. Read more at govinfonow.com/recall/65670-northgate-probe-recall-biocompatibility-test-failure-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/65670-northgate-probe-recall-biocompatibility-test-failure-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1883-2020
Cite this page
“Northgate Probe Recall: Biocompatibility Test Failure Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65670-northgate-probe-recall-biocompatibility-test-failure-risk. Based on FDA recall #Z-1883-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1883-2020%22&limit=1).
Why it’s dangerous
The probe failed biocompatibility testing, meaning it may not be safe for medical use. This could lead to health issues if the probe comes into contact with bodily tissues during procedures.
Who’s affected
Medical professionals who use this probe for urinary/renal or biliary procedures are likely affected. Patients receiving these procedures with the recalled probe are at risk.
How to tell if you have this one
Check for the NTI Catalog Number 9-900-54 on the probe. This product is used for fragmenting urinary/renal and biliary calculi in medical procedures.
- Brand
Northgate Technologies- 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
US Nationwide distribution. No governmental.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1883-2020 | Probe, 9 FR AUTOLITH; NTI Catalog Number 9-900-54 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.; NTI Catalog Number 9-900-54. | 298 boxes. 3 units per box |
| Z-1884-2020 | AUTOLITH URO-TCH 9FR PROBE 54CM; NTI Catalog Number 9-203-0543 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.; NTI Catalog Number 9-203-0543. | 198 boxes. 3 units per box. |
| Z-1885-2020 | ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies, America (OSTA); NTI Catalog Number 72-00198-0 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.; NTI Catalog Number 72-00198-0. | 1238 boxes. 3 units per box. |
What to do — step by step
Check Product Details
Look for the NTI Catalog Number 9-900-54 on the probe to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution. No governmental.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 11 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-1883-2020 (March 10, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1883-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.