Pacific Medical recalls Toco Transducers (M1355A) sold between Oct 2014 and Apr 2019 that were distributed without required U.S. regulatory clearance for fetal monitoring.
Fetal transducers distributed in advance of receiving 510(k) and international clearances.
Pacific Medical is recalling Toco Transducers (model M1355A) that were distributed before receiving U.S. regulatory approval. These devices could be used without proper clearance, potentially affecting fetal monitoring safety.
The transducers were distributed without U.S. regulatory clearance (510(k) approval) before being sold. This means they may not meet safety standards for fetal monitoring, potentially leading to inadequate monitoring of the fetus.
Pregnant women using this transducer for fetal monitoring during pregnancy are most at risk. The affected devices were sold between October 2014 and April 2019.
Check for the model number M1355A on the transducer. The devices were sold between October 2014 and April 2019 with serial numbers that match the recall range.
Look for the model number M1355A on the transducer to confirm it is affected.
The transducers were distributed without U.S. regulatory clearance (510(k) approval) before being sold.
These transducers were sold between October 2014 and April 2019.
The recall record does not specify a remedy, so no action is required beyond checking if your device is affected.
We’ve drafted a message you can send Pacific Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0984-2020 — Pacific Medical Pacific Medical Hello, I own a Pacific Medical that is covered by recall Z-0984-2020 from Pacific Medical. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
