Pro-Dex recalls surgical battery packs with visual particulates in Tyvek pouches. These sterile batteries risk contamination during surgery. Affected units include PDBP-001-2 and PDB:040-2 models from specific lots.
Visual particulates within a battery Tyvek pouch. The battery is provided sterile for use with surgical drivers.
Pro-Dex is recalling surgical battery packs that may contain visual particulates in their Tyvek pouches. This poses a contamination risk during surgery since the batteries are sterile and used with surgical drivers.
The battery pouches may contain visible particles that could contaminate the surgical field. Since these batteries are sterile and used in surgery, any particulates might compromise the sterile environment. However, the hazard is described as visual particulates, not active contamination.
Surgical professionals using Pro-Dex PDSD-5000 surgical drivers with the recalled battery packs. The risk is low as the particulates are visual and not confirmed to cause injury.
Check for the model numbers PDBP-001-2 (single pouch) or PDBP-040-2 (40 pouches) with lot numbers K098N (61900) or K0B3F (62625).
Identify if your battery has model PDBP-001-2 or PDBP-040-2 with lot numbers K098N or K0B3F.
Visual particulates within the Tyvek pouch may contaminate the surgical field during use, though the hazard is described as visual and not confirmed to cause injury.
The recall does not specify a stop-use instruction; the hazard is low risk and visual particulates only.
PDBP-001-2 (single pouch) and PDBP-040-2 (40 pouches) with lot numbers K098N (61900) or K0B3F (62625).
We’ve drafted a message you can send Pro-Dex to request your refund or repair — edit it as you like.
Subject: Recall Z-2340-2019 — Pro-Dex Pro-Dex Hello, I own a Pro-Dex that is covered by recall Z-2340-2019 from Pro-Dex. 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.
