PlainRecalls
ModerateClass IICompleted

FDA Devices recall · Reported May 24, 2023

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.

Recall #
Z-1583-2023
Affected scope
36,000 pieces (30 full cases)
Initiated
March 31, 2023
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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..

Moderate
severity level
Class II
classification
May 24, 2023
reported

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.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 6 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.

Medical Devices recalls over time

Where this recall sits in its category - 41,021 medical devices recalls on record

01,0002,0003,0004,000 20052008201120142017202020232026 1,947
Severity1906864652High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.

Product description

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

Reason for recall

Some of the tubes may be incorrectly labeled.

Recall Profile

Structured summary of the FDA Devices recall record
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.

  • Check the recall number (Z-1583-2023) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Devices before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

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.

Frequently Asked Questions

What product was recalled?
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. Recalled by Greiner Bio-One North America, Inc.. Units affected: 36,000 pieces (30 full cases).
Why was this product recalled?
Some of the tubes may be incorrectly labeled.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 24, 2023. Severity: Moderate. Recall number: Z-1583-2023.
Where was the recalled product distributed?
Distribution: US Nationwide distribution in the states of WI and GA..
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar Medical Devices · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

Compare this recall with GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VS… → · All Medical Devices recalls

This recall: FDA Devices, reported May 24, 2023. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026