CLASS II Device recall · Reported 2 May 2018 · FDA Enforcement Report
Double Blade Shoe F/Unigraft Knife 1.5 Thick recalled
Ace Surgical Supply is recalling Double Blade Shoe F/Unigraft Knife 1.5 Thick, distributed in California, Michigan, Oklahoma. The recall was initiated on 28 Mar 2018 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-1464-2018
- FDA event ID
- 79798
- Recalling firm
- Ace Surgical Supply, Brockton, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Mar 2018
- FDA classified
- 20 Apr 2018
- Reported
- 2 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 28 Mar 2018 | Recall initiated by company | |
| 20 Apr 2018 | Classified by FDA | +23 days |
| 2 May 2018 | 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
The product inside the package is incorrect. A single blade shoe was mistakenly packaged instead of a double blade.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used to achieve epithelial graft in the oral cavity.
Where it was distributed
US Distribution to the states of : MI, CA, OK, and Internationally to China, Canada,
Questions about this recall
Why was it recalled?
The product inside the package is incorrect. A single blade shoe was mistakenly packaged instead of a double blade.
Which lots are affected?
Lot # M050225
Where was it sold?
US Distribution to the states of : MI, CA, OK, and Internationally to China, Canada,
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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