Severity
Moderate
FDA Devices recall · Reported September 14, 2016
Ecolab is recalling 2 models of Angiography Drapes with Radiation Shields because the sterile packaging may contain small holes in the film of the pouch.
Ecolab Inc recalled Microtek Franz Angiography Drape with Radiation Shield, Item # RBA202, and Microtek Angio… - a moderate-severity action.
Microtek Franz Angiography Drape with Radiation Shield, Item # RBA202, and Microtek Angio… was recalled by Ecolab Inc in September 14, 2016. Reason: Ecolab is recalling 2 models of Angiography Drapes with Radiation Shields because the sterile packaging may c…. Check the official notice for the remedy. Verify recall #Z-2744-2016 with the FDA Devices before acting.
The recall
Ecolab Inc issued this moderate-severity FDA Devices recall-Ecolab is recalling 2 models of Angiography Drapes with Radiation Shields because the sterile packaging may c….
Sourced from official FDA Devices enforcement records. Verify recall #Z-2744-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-2744-2016) was formally reported on September 14, 2016, with the manufacturer initiating the action on July 14, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Ecolab Inc is listed as the recalling firm, operating out of Saint Paul, MN. Federal records list the affected scope as 6750 eaches (675 cases).
The documented reason for this recall is: Ecolab is recalling 2 models of Angiography Drapes with Radiation Shields because the sterile packaging may contain small holes in the film of the pouch. Distribution data in the federal record shows the product reached: US: OH, NY, CA, MN.. 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
6750 eaches (675 cases)
Related Recalls
6
3 from same agency
Microtek Franz Angiography Drape with Radiation Shield, Item # RBA202, and Microtek Angiography Drape with Radiation Shield and Pouches, Item # RBA203. Sterile EO. Microtek Medical, Inc., Columbus, MS 39702.
Ecolab is recalling 2 models of Angiography Drapes with Radiation Shields because the sterile packaging may contain small holes in the film of the pouch.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2744-2016 |
| Date reported | September 14, 2016 |
| Date initiated | July 14, 2016 |
| Recalling firm | Ecolab Inc |
| Firm location | Saint Paul, MN |
| Affected scope | 6750 eaches (675 cases) |
| Distribution | US: OH, NY, CA, MN. |
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 September 14, 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.