PlainRecalls
ModerateClass IITerminated

FDA Devices recall · Reported April 21, 2021

MedSchenker Smart Transport Medium (STM) System: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL - MULTIPURPOSE CULTURE MEDIUM - Product Usage: intended for the collection and transport of clinical specimens containing viruses, from the collection site to the testing laboratory. I

Discoloration and turbidity were present in the specified lots of STMs because of Longer Monsoon season at the South Korean Manufacturing Facility.

Recall #
Z-1417-2021
Affected scope
130,000 devices
Initiated
February 16, 2021
Verify with FDA Devices →
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Vectornate USA Inc recalled MedSchenker Smart Transport Medium (STM) System: CULTURE MEDIA, NON-SELECTIVE AND NON-DIF… - a moderate-severity action.

MedSchenker Smart Transport Medium (STM) System: CULTURE MEDIA, NON-SELECTIVE AND NON-DIF… was recalled by Vectornate USA Inc in April 21, 2021. Reason: Discoloration and turbidity were present in the specified lots of STMs because of Longer Monsoon season at th…. Check the official notice for the remedy. Verify recall #Z-1417-2021 with the FDA Devices before acting.

The recall

Vectornate USA Inc issued this moderate-severity FDA Devices recall-Discoloration and turbidity were present in the specified lots of STMs because of Longer Monsoon season at th….

Moderate
severity level
130K units
affected scope
Class II
classification
April 21, 2021
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1417-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope (see the Recall Profile below) is large enough to require multi-state distribution tracking. 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

MedSchenker Smart Transport Medium (STM) System: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL - MULTIPURPOSE CULTURE MEDIUM - Product Usage: intended for the collection and transport of clinical specimens containing viruses, from the collection site to the testing laboratory. I

Reason for recall

Discoloration and turbidity were present in the specified lots of STMs because of Longer Monsoon season at the South Korean Manufacturing Facility.

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 Terminated
Recall number Z-1417-2021
Date reported April 21, 2021
Date initiated February 16, 2021
Recalling firm Vectornate USA Inc
Firm location Mahwah, NJ
Affected scope 130,000 devices
Distribution US Nationwide distribution in the state of NJ.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

130,000 devices units affected - multi-state distribution scale.

Regional (<10K units) -
Multi-state (10K – 100K units) -
Large-scale (100K – 1M units) ✓ This recall
Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (Z-1417-2021) 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? ▼
MedSchenker Smart Transport Medium (STM) System: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL - MULTIPURPOSE CULTURE MEDIUM - Product Usage: intended for the collection and transport of clinical specimens containing viruses, from the collection site to the testing laboratory. I. Recalled by Vectornate USA Inc. Units affected: 130,000 devices.
Why was this product recalled? ▼
Discoloration and turbidity were present in the specified lots of STMs because of Longer Monsoon season at the South Korean Manufacturing Facility.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 21, 2021. Severity: Moderate. Recall number: Z-1417-2021.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution in the state of NJ..
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.

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

This recall: FDA Devices, reported April 21, 2021. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026