Device recall: MICROFLEX Diamond Grip Examination Gloves, MF-300 - Product Usage: A patient examination glove is a disposable device…
Class II FDA enforcement event 86352. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Examination gloves were shipped inadvertently, without to verify barrier integrity.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Ansell Healthcare Products LLC started this device recall on 19 Aug 2020. The firm address in the FDA record is in Reno, NV. FDA put the recall in Class II. FDA event 86352 has 1 product record. The first FDA enforcement report date is 14 Oct 2020. The record gives the status Terminated, with the termination date 3 Nov 2021.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
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.
Recalling firm
Ansell Healthcare Products LLC, Reno, NV.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0051-2021 | 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. | 1312 Cases | Class II | Terminated | 14 Oct 2020 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2020
- 916
- Share of these events in Class II
- 93%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 6
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 3 Aug 2023 | GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290 | Device | Class II | 2 |
| 19 Feb 2022 | Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2 | Device | Class II | 1 |
| 24 Oct 2016 | Gammex Non-Latex Sensitive Neoprene Surgical Gloves Ansell Lanka (pvt) Ltd. Biyagama Export Processing Zone, Biyagama, S | Device | Class II | 1 |
| 14 Jan 2013 | LifeStyles ZERO 10 uber-thin lubricated latex condoms. Mfd. for Ansell Healthcare Products LLC, Dothan, AL 96303. A shea | Device | Class II | 1 |
| 5 Nov 2012 | Lifestyles Pleasure Collection 30 Premium Lubricated Condoms Assortment of Ultra Sensitive, Flavors and Colors, Skyn, Th | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-0051-2021The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 86352. https://recallregister.com/fda/ii/86352/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
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 quantity of product is in FDA event 86352?
- The FDA record gives this quantity:
1312 Cases
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2020 have the same class?
- 93% of the 916 device events that started in 2020 are in Class II.