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Sterilmed, Inc. FDA Recalls
2 recalls on file across devices, 0 of them Class I and 2 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Product Name: CATHETER ACClass IIOct 8, 2025Affected catheters were reprocessed beyond validated cycles. |
| Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR Class IIOct 8, 2025Affected catheters were reprocessed beyond validated cycles. |