CLASS II Device recall · Reported 14 Oct 2020 · FDA Enforcement Report
Microflex Diamond Grip Examination Gloves, MF recalled
Ansell Healthcare Products is recalling Microflex Diamond Grip Examination Gloves, MF-300, distributed nationwide in the US. The recall was initiated on 19 Aug 2020 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-0051-2021
- FDA event ID
- 86352
- Recalling firm
- Ansell Healthcare Products, Reno, NV
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Aug 2020
- FDA classified
- 2 Oct 2020
- Reported
- 14 Oct 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Masks, Gloves & PPE
Timeline
| 19 Aug 2020 | Recall initiated by company | |
| 2 Oct 2020 | Classified by FDA | +44 days |
| 14 Oct 2020 | 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
Examination gloves were shipped inadvertently, without to verify barrier integrity.
Product as listed by the FDA
MICROFLEX Diamond Grip Examination Gloves, MF-300 - Product Usage: A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner s hand or finger to prevent contamination between patient and examiner.
Where it was distributed
U.S. Nationwide distribution including in the states of IL, OK, WI, PA, TX, OH, MI, IN, VA, AR, KS, MO, NV, OR, FL, QC, NJ, NE, KY, AL, TN, LA, NY, SC, MS, MD, CA, GA, SD.
Nationwide AlabamaArkansasCaliforniaFloridaGeorgiaIllinoisIndianaKansasKentuckyLouisianaMarylandMichiganMissouriMississippiNebraskaNew JerseyNevadaNew YorkOhioOklahoma
Questions about this recall
Why was it recalled?
Examination gloves were shipped inadvertently, without to verify barrier integrity.
Which lots are affected?
Lot: 2003LG, Batch: 20035314LG
Where was it sold?
U.S. Nationwide distribution including in the states of IL, OK, WI, PA, TX, OH, MI, IN, VA, AR, KS, MO, NV, OR, FL, QC, NJ, NE, KY, AL, TN, LA, NY, SC, MS, MD, CA, GA, SD.
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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