Devicor recalls HydroMARK Breast Biopsy Marker Model 4010-05-08-T4 due to patient labels incorrectly identifying the product as a different model. This mismatch could lead to confusion during medical procedures.
Small patient labels do not match the primary device label. The primary device label accurately identifies the product as 4010-05-08-T4, while the smaller patient label incorrectly identifies the product as 4010-05-08-T3.
Devicor is recalling HydroMARK Breast Biopsy Markers with model number 4010-05-08-T4 because the smaller patient labels incorrectly identify the product as model 4010-05-08-T3. This mismatch could cause confusion during medical procedures if healthcare providers use the wrong model.
The patient labels for this device incorrectly state the model number as 4010-05-08-T3 instead of the correct 4010-05-08-T4. This mismatch could lead to confusion if healthcare providers use the wrong model during procedures, potentially causing errors in treatment.
Healthcare providers using the HydroMARK Breast Biopsy Marker model 4010-05-08-T4 are most at risk if they rely on patient labels for identification during procedures.
Check for the model number 4010-05-08-T4 on the primary device label. The patient labels may incorrectly show model number 4010-05-08-T3.
Verify the primary device label shows model number 4010-05-08-T4 and patient labels show 4010-05-08-T3.
The patient labels incorrectly identify the product as model 4010-05-08-T3 instead of the correct model 4010-05-08-T4.
Check the device labels to confirm the model number. If the patient labels show 4010-05-08-T3, contact Devicor for clarification.
The recall record does not mention a remedy or fix.
We’ve drafted a message you can send Devicor Medical Products to request your refund or repair — edit it as you like.
Subject: Recall Z-1124-2022 — Devicor Medical Products Devicor Medical Products Hello, I own a Devicor Medical Products that is covered by recall Z-1124-2022 from Devicor Medical Products. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
