CLASS II Device recall · Reported 10 Jul 2024 · FDA Enforcement Report
AMT Initial Placement Dilator Set recalled by Applied Medical Technology
Applied Medical Technology is recalling AMT Initial Placement Dilator Set, distributed nationwide in the US. The recall was initiated on 14 May 2024 and the FDA has classified it as Class II.
Check your package
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-2238-2024
- FDA event ID
- 94702
- Recalling firm
- Applied Medical Technology, Brecksville, OH
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 14 May 2024
- FDA classified
- 28 Jun 2024
- Reported
- 10 Jul 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 14 May 2024 | Recall initiated by company | |
| 28 Jun 2024 | Classified by FDA | +45 days |
| 10 Jul 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Devices were labelled with the incorrect guidewire labelling.
Product as listed by the FDA
AMT Initial Placement Dilator Set. Used to place gastrostomy devices.
Where it was distributed
US Nationwide distribution in the states of GA, IL, IN, LA, NC, NE, SC, TN, TX, UT, VA, WA, & WV.
Nationwide GeorgiaIllinoisIndianaLouisianaNorth CarolinaNebraskaSouth CarolinaTennesseeTexasUtahVirginiaWashingtonWest Virginia
Questions about this recall
Why was it recalled?
Devices were labelled with the incorrect guidewire labelling.
Which lots are affected?
Model No: IP-DIL; UDI-DI: 00842071131876; Lot number: 231218-242; Exp. Date: 2026-11-01.
Where was it sold?
US Nationwide distribution in the states of GA, IL, IN, LA, NC, NE, SC, TN, TX, UT, VA, WA, & WV.
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 26 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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