Stryker recalls ComfortGel model 2850 for home use without healthcare professional guidance, risking improper pressure injury treatment.
Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals
Stryker is recalling ComfortGel medical gel for pressure injury treatment. Home users may not be aware of proper healthcare use instructions, which could lead to ineffective treatment or complications.
The product is designed for healthcare facilities but was distributed to residential customers. Home users may not understand the specific instructions intended for healthcare professionals, potentially leading to improper use.
Home users who purchased ComfortGel model 2850 for pressure injury care are at risk. Healthcare professionals are not affected as the product is intended for facility use.
Check for model number 2850 and serial numbers starting with 20170928500311838. The product was sold with UDI codes 07613327277852 and 07613327277937.
Look for model number 2850 and serial numbers starting with 20170928500311838.
The product is intended for healthcare facilities, but home users may not be aware of proper instructions for pressure injury treatment.
The official recall does not specify a remedy, so contact Stryker directly for guidance.
Check for model number 2850 and serial numbers starting with 20170928500311838.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-2212-2021 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-2212-2021 from Stryker. 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.
