FDA (Devices) recall action 66323
The FDA (Devices) publishes a recall like this one as 4 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 4 pages.
The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic Drill System, including the motor hand-piece, Auto Lube foot control, without a pressure relief valve (PRV) due to the hand piece's outer hose can rupture without warning if the air flow is blocked 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.
The Anspach Effort, Inc. is voluntarily removing the microMax Pneumatic Drill System because the outer hose may rupture without warning if airflow is blocked.
The Anspach Effort, Inc. is voluntarily removing Pneumatic Drill Systems because the outer hose can rupture without warning if airflow is blocked.
The Anspach Effort, Inc. is voluntarily removing Pneumatic Drill Systems from the market because the outer hose on the motor hand-piece can rupture without warning if air flow is blocked.
The Anspach Effort, Inc. is voluntarily removing Pneumatic Drill Systems because the handpiece hose can rupture without warning if airflow is blocked.