Severity
Moderate
FDA Devices recall · Reported January 13, 2016
Product mislabeled as latex free. Actual Catalog number 1581, lot 2020-10AN. contains latex. This could pose a health risk to users with sensitivity or allergic reaction to late…
3M Company - Health Care Business recalled 3M Coban Self-Adherent Wrap Shipper carton label identified the product as 3M Coban LF La… - a moderate-severity action.
3M Coban Self-Adherent Wrap Shipper carton label identified the product as 3M Coban LF La… was recalled by 3M Company - Health Care Business in January 13, 2016. Reason: Product mislabeled as latex free. Actual Catalog number 1581, lot 2020-10AN. contains latex. This could pose…. Check the official notice for the remedy. Verify recall #Z-0601-2016 with the FDA Devices before acting.
The recall
3M Company - Health Care Business issued this moderate-severity FDA Devices recall-Product mislabeled as latex free. Actual Catalog number 1581, lot 2020-10AN. contains latex. This could pose….
Sourced from official FDA Devices enforcement records. Verify recall #Z-0601-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-0601-2016) was formally reported on January 13, 2016, with the manufacturer initiating the action on December 1, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. 3M Company - Health Care Business is listed as the recalling firm, operating out of Saint Paul, MN. Federal records list the affected scope as 167 cases (30 rolls/case).
The documented reason for this recall is: Product mislabeled as latex free. Actual Catalog number 1581, lot 2020-10AN. contains latex. This could pose a health risk to users with sensitivity or allergic reaction to latex, which could range from mild to severe. Distribution data in the federal record shows the product reached: US nationwide 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
167 cases (30 rolls/case)
Related Recalls
6
3 from same agency
3M Coban Self-Adherent Wrap Shipper carton label identified the product as 3M Coban LF Latex Free Catalog #2081, lot number 2018-10AM.
Product mislabeled as latex free. Actual Catalog number 1581, lot 2020-10AN. contains latex. This could pose a health risk to users with sensitivity or allergic reaction to latex, which could range from mild to severe.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0601-2016 |
| Date reported | January 13, 2016 |
| Date initiated | December 1, 2015 |
| Recalling firm | 3M Company - Health Care Business |
| Firm location | Saint Paul, MN |
| Affected scope | 167 cases (30 rolls/case) |
| Distribution | US nationwide 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 13, 2016. 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.