Probe Cover recall
Probe Cover, PU and Elastic Blue Bands - 6" x 48", with hole Item ID: SH17
Why was Probe Cover recalled?
No 510k for the product to be used in a natural or surgical opening to the body
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: 1909E197 1910E296 1911E050 2002E180 2004E028
- Product
- Probe Cover, PU and Elastic Blue Bands - 6" x 48", with hole Item ID: SH17
- Recalling firm
- Exact Medical Manufacturing, Inc.
- Quantity
- 78000 units
- Distribution
- US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico
- Recall date
- June 30, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)