Medicina Reusable Oral syringe 5ml Code: OTH05

Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification

Recall #: Z-0113-2023
Affected scope: 26 boxes (2600 syringes)
Initiated: July 4, 2022

Compiled from official public sources by the publisher. · Updated September 2026

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Medicina Uk Ltd recalled Medicina Reusable Oral syringe 5ml Code: OTH05 - a moderate-severity action.

Medicina Reusable Oral syringe 5ml Code: OTH05 was recalled by Medicina Uk Ltd in October 26, 2022. Reason: Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does…. Check the official notice for the remedy. Verify recall #Z-0113-2023 with the FDA Devices before acting.

The recall

Medicina Uk Ltd issued this moderate-severity FDA Devices recall-Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does….

Moderate
severity level: Class II
classification: October 26, 2022
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0113-2023 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.

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

Medicina Reusable Oral syringe 5ml Code: OTH05

Reason for recall

Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification

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	Ongoing
Recall number	Z-0113-2023
Date reported	October 26, 2022
Date initiated	July 4, 2022
Recalling firm	Medicina Uk Ltd
Firm location	Bolton, N/A
Affected scope	26 boxes (2600 syringes)
Distribution	Nationwide

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-0113-2023) 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? ▼

Medicina Reusable Oral syringe 5ml Code: OTH05. Recalled by Medicina Uk Ltd. Units affected: 26 boxes (2600 syringes).

Why was this product recalled? ▼

Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on October 26, 2022. Severity: Moderate. Recall number: Z-0113-2023.

Where was the recalled product distributed? ▼

Distribution: Nationwide.

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 severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

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This recall: FDA Devices, reported October 26, 2022. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026