Ecolab Recalls Microtek Angiography Drapes Due to Packaging Defects
Ecolab is recalling specific Microtek angiography drapes because their sterile packaging may contain small holes in the film, potentially compromising sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a potential breach of sterility due to packaging defects, which fits the criteria for a moderate risk where harm is possible but not reported.
Plain-English summary
Ecolab Inc is recalling two models of Microtek angiography drapes with radiation shields: the Franz Angiography Drape (Item # RBA202) and the Angiography Drape with Radiation Shield and Pouches (Item # RBA203). The recall involves 6,750 units (675 cases) distributed to facilities in Ohio, New York, California, and Minnesota.
The recall was initiated because the sterile packaging for these medical devices may contain small holes in the film of the pouch. This defect could potentially compromise the sterile environment of the device. The affected lot numbers for Item # RBA202 include D111574, D111654, D111724, D111864, D112024, D112094, D112224, D120164, D120454, D120544, D121144, D121314, D121674, D121944, D122204, D122554, D122854, D123324, D130354, D130454, D130914, D131704, D131994, D132464, D132974, D140834, D141204, D141774, D142244, D150404, D151334, D151464, D152304, D152364, D152454, D153084, D153204, D153494, and D160544. The affected lot numbers for Item # RBA203 are D122194 and D122354.
Healthcare facilities and consumers should check their inventory for these specific item numbers and lot codes. If the product is found, it should be removed from use and returned to the distributor or manufacturer for credit or replacement, in accordance with standard recall procedures.
The recalled product
- Product
- 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.
- Manufacturer
- Ecolab Inc
- Category
- Medical Device — Surgical Drapes
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- RBA202 Lot numbers: D111574
- D111654
- D111724
- D111864
- D112024
- D112094
- D112224
- D120164
- D120454
- D120544
- D121144
- D121314
- D121674
- D121944
- D122204
- D122554
- D122854
- D123324
- D130354
- D130454
Distribution
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