Severity
Moderate
FDA Devices recall · Reported January 26, 2022
Some of the blood collection tubes show clotting due to variation of Lithium Heparin.
Greiner Bio-One North America, Inc. recalled greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-yellow ring,… - a moderate-severity action.
greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-yellow ring,… was recalled by Greiner Bio-One North America, Inc. in January 26, 2022. Reason: Some of the blood collection tubes show clotting due to variation of Lithium Heparin.. Check the official notice for the remedy. Verify recall #Z-0502-2022 with the FDA Devices before acting.
The recall
Greiner Bio-One North America, Inc. issued this moderate-severity FDA Devices recall-Some of the blood collection tubes show clotting due to variation of Lithium Heparin..
Sourced from official FDA Devices enforcement records. Verify recall #Z-0502-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-0502-2022) was formally reported on January 26, 2022, with the manufacturer initiating the action on December 9, 2021. It is classified under Moderate severity (Class II), with a current status of Terminated. Greiner Bio-One North America, Inc. is listed as the recalling firm, operating out of Monroe, NC. Federal records list the affected scope as 889,200 pcs..
The documented reason for this recall is: Some of the blood collection tubes show clotting due to variation of Lithium Heparin. Distribution data in the federal record shows the product reached: Distribution was made to FL, IL, MO, NC, NM, NY, PA, TN, TX, and VA. There was no foreign/military/government distribution.. 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
889,200 pcs.
Related Recalls
6
3 from same agency
greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-yellow ring, non-ridged, 24 racks of 50 pcs., 1200 pcs. in total, REF 456087P
Some of the blood collection tubes show clotting due to variation of Lithium Heparin.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0502-2022 |
| Date reported | January 26, 2022 |
| Date initiated | December 9, 2021 |
| Recalling firm | Greiner Bio-One North America, Inc. |
| Firm location | Monroe, NC |
| Affected scope | 889,200 pcs. |
| Distribution | Distribution was made to FL, IL, MO, NC, NM, NY, PA, TN, TX, and VA. There was no foreign/military/government distribution. |
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 January 26, 2022. 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.