CLASS II Device recall · Reported 13 May 2020 · FDA Enforcement Report

Acmi Probe (e4-9f) recalled by Northgate Technologies

Northgate Technologies is recalling Acmi Probe (e4-9f), distributed nationwide in the US. The recall was initiated on 10 Mar 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesNTI Catalog Number 72-00198-0.
Quantity recalled1238 boxes. 3 units per box.

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-1885-2020
FDA event ID
85204
Recalling firm
Northgate Technologies, Elgin, IL
Classification
Class II
Status
Terminated
Recall initiated
10 Mar 2020
FDA classified
4 May 2020
Reported
13 May 2020
Type
Voluntary: Firm initiated
Customers notified by
E-Mail
Reason category
Other Reasons

Timeline

10 Mar 2020Recall initiated by company
4 May 2020Classified by FDA+55 days
13 May 2020Published in enforcement report+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.

Product as listed by the FDA

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.

Where it was distributed

US Nationwide distribution. No governmental.

Nationwide

Questions about this recall

Is Acmi Probe (e4-9f) recalled?

Yes. Northgate Technologies recalled Acmi Probe (e4-9f) on 10 Mar 2020. The recall is Class II and its status is Terminated. Recall number Z-1885-2020.

Why was it recalled?

Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.

Which lots are affected?

NTI Catalog Number 72-00198-0.

Where was it sold?

US Nationwide distribution. No governmental.

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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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