CLASS III Device recall · Reported 30 Dec 2020 · FDA Enforcement Report
AMT Male ENFit-to-Stepped Male (Christmas Tree) Adapter recalled
Applied Medical Technology is recalling AMT Male ENFit-to-Stepped Male (Christmas Tree) Adapter, distributed nationwide in the US. The recall was initiated on 10 Nov 2020 and the FDA has classified it as Class III.
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-0698-2021
- FDA event ID
- 86828
- Recalling firm
- Applied Medical Technology, Brecksville, OH
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 10 Nov 2020
- FDA classified
- 23 Dec 2020
- Reported
- 30 Dec 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Masks, Gloves & PPE
Timeline
| 10 Nov 2020 | Recall initiated by company | |
| 23 Dec 2020 | Classified by FDA | +43 days |
| 30 Dec 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The products subject to this recall may contain obvious, incorrect pouch labels while the outer box has the correct label.
Product as listed by the FDA
AMT Male ENFit-to-Stepped Male (Christmas Tree) Adapter, Model Number ETRN102. Box PN TRN102, Box UDI (01)00842071109066(17)230901(10)200918-103, Pouch PN ETRN102, Pouch UDI (01)00842071108007(17)230901(10)200902-075
Where it was distributed
US Nationwide distribution in the states of CA, GA, IL, MA, MO, PA, TX, VA. No foreign distribution.
Nationwide CaliforniaGeorgiaIllinoisMassachusettsMissouriPennsylvaniaTexasVirginia
Questions about this recall
Why was it recalled?
The products subject to this recall may contain obvious, incorrect pouch labels while the outer box has the correct label.
Which lots are affected?
Box Lot Number 200918-103; Pouch Lot Number 200902-075
Where was it sold?
US Nationwide distribution in the states of CA, GA, IL, MA, MO, PA, TX, VA. No foreign distribution.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
More recalls from Applied Medical Technology
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|---|---|---|---|---|---|
| Device | CLASS II | NutraGlide, 5 f - 6F x 55 Nasal Feeding Tube with Stylet and ENfit recalled | Applied Medical Technology | Other | Nationwide |
| Device | CLASS II | NutraGlide, 5 F- 6 F x 55 Nasal Feeding Tube with Stylet and ENfit recalled | Applied Medical Technology | Other | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | P28 Phanton Intramedullary Nail System recalled by Paragon 28 | Paragon 28 | Sterility | Nationwide |
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| Device | CLASS II | Adapter for Head Positioning recalled by Baxter Healthcare | Baxter Healthcare | Other | Nationwide |
| Device | CLASS II | Cyberknife Treatment Deliver System equipped recalled | Accuray | Device Malfunction | Nationwide |
| Device | CLASS II | Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference recalled | O&M Halyard | Other | Nationwide |