Severity
Moderate
FDA Devices recall · Reported May 24, 2023
Some of the tubes may be incorrectly labeled.
Greiner Bio-One North America, Inc. recalled greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24… - a moderate-severity action.
greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24… was recalled by Greiner Bio-One North America, Inc. in May 24, 2023. Reason: Some of the tubes may be incorrectly labeled.. Check the official notice for the remedy. Verify recall #Z-1583-2023 with the FDA Devices before acting.
The recall
Greiner Bio-One North America, Inc. issued this moderate-severity FDA Devices recall-Some of the tubes may be incorrectly labeled..
Sourced from official FDA Devices enforcement records. Verify recall #Z-1583-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-1583-2023) was formally reported on May 24, 2023, with the manufacturer initiating the action on March 31, 2023. It is classified under Moderate severity (Class II), with a current status of Completed. Greiner Bio-One North America, Inc. is listed as the recalling firm, operating out of Monroe, NC. Federal records list the affected scope as 36,000 pieces (30 full cases).
The documented reason for this recall is: Some of the tubes may be incorrectly labeled. Distribution data in the federal record shows the product reached: US Nationwide distribution in the states of WI and GA.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
36,000 pieces (30 full cases)
Related Recalls
6
3 from same agency
greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24 racks of 50 pcs., 1200 pcs in total, Item #456003
Some of the tubes may be incorrectly labeled.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Completed |
| Recall number | Z-1583-2023 |
| Date reported | May 24, 2023 |
| Date initiated | March 31, 2023 |
| Recalling firm | Greiner Bio-One North America, Inc. |
| Firm location | Monroe, NC |
| Affected scope | 36,000 pieces (30 full cases) |
| Distribution | US Nationwide distribution in the states of WI and GA. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported May 24, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.