Food, drugs, devices › Cypress Medical Products LLC
Device recall: Powder Free Vinyl Exam Gloves, Item Nos. 14-116, 14-118 Product Usage: Medical exam glove for use by professional health
Cypress Medical Products LLC (Richmond, VA) initiated this device recall on 2 Jul 2018; FDA lists 1 product record under event 80669, classified Class II.
FDA defines Class II as 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. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 7 Apr 2023. Initiation: voluntary: firm initiated. Cypress Medical Products LLC has 9 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Cypress Medical Products LLC, Richmond, VA.
Reason for recall
"The firm is recalling one lot of McKesson Powder Free Vinyl Exam Gloves because a sample of product from that lot did not meet certain release specifications. It is possible that certain gloves from this lot may not be of medical exam quality and, therefore, may not provide an effective barrier to infectious material."
Distribution
"US Nationwide Distribution in the states of in AL, AR, IA, LA, OK, TX, UT, and VA."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2828-2018 | Powder Free Vinyl Exam Gloves, Item Nos. 14-116, 14-118 Product Usage: Medical exam glove for use by professional healthcare workers and/or consumers. | 66 cases | Class II | Terminated | 22 Aug 2018 |
Context
Other enforcement events for Cypress Medical Products LLC
All 9 events for Cypress Medical Products LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The firm is recalling one lot of McKesson Powder Free Vinyl Exam Gloves because a sample of product from that lot did not meet certain release specifications. It is possible that certain gloves from this lot may not be of medical exam quality and, therefore, may not provide an effective barrier to infectious material."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is 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.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide Distribution in the states of in AL, AR, IA, LA, OK, TX, UT, and VA."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 7 Apr 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.