FDA (Devices) recall action 98197
The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.
Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Medline is recalling 12 units of procedure convenience kits containing Stryker Strykeflow 2 Suction Irrigators, which can leak or emit vaporized saline during use.
Medline is recalling 41,432 laparoscopy convenience kits containing Stryker Strykeflow 2 Suction Irrigators, which can leak or emit vaporized saline during use.
Medline is recalling 1457 units of procedure convenience kits containing Stryker Strykeflow 2 Suction Irrigators, which can leak or emit vaporized saline during use.
Medline is recalling 96 units of procedure convenience kits containing Stryker Strykeflow 2 Suction Irrigators, which can leak or emit vaporized saline during use.
Medline is recalling 12,584 procedure convenience kits containing Stryker Strykeflow 2 Suction Irrigators, which can leak or emit vaporized saline during use.
Heraeus Medical is recalling PALACOS MV pro 40 and PALACOS MV pro 80 bone cement because an unfortunate combination of factors can leave ampoules unbroken, so no appropriate cement dough is formed.