FDA Medical Device Recalls (openFDA)
Ansell Healthcare Products LLC: 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.
- Recall number
- Z-0051-2021
- Recalling firm
- Ansell Healthcare Products LLC
- Product
- 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.
- Status
- Terminated
- Initiated
- 2020-08-19
- Posted
- not on file
- Terminated
- 2021-11-03
- Reason
- Examination gloves were shipped inadvertently, without to verify barrier integrity.
- Root cause
- Under Investigation by firm
- Action
- On 08/19/2020, recall notices were emailed to customers who were asked to do the following: If you believe you may have received affected product, please visit: http://www.novasyte.com/ansell/capa-206-2020 to complete the necessary acknowledgement form. Upon completion of the acknowledgement form, Ansell will partner with you to arrange for a return of the product, provide a credit, and offer you the option of a reship. For any assistance regarding the acknowledgement form, please contact Novasyte at 855-863-7288 or ansell-capa-206-2020@novasyte.com Novasyte emailed E-Mail/ Letter for Distributors to Send End-User Customers, Dated 08/18/20, to distributors informing them to send this letter to the end users. End users were asked to return affected products to distributors. On 08/21/2020, the firm followed up with customers via phone.
- Quantity
- 1312 Cases
- 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.
- Lot, serial or model codes
- Lot: 2003LG, Batch: 20035314LG
- 510(k) numbers
- K974424
- PMA numbers
- not on file
- Product code
- LYY
- Firm FEI
- 3011209798
- Firm city
- Reno
- Firm state
- NV
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28