FDA (Devices) recall action 76059
The FDA (Devices) publishes a recall like this one as 103 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 103 pages.
Supplied Directions for Use (DFU) did not contain a recommended service interval.
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 recalling 17 Autolube-III pneumatic systems because the supplied directions for use did not include a recommended service interval.
The Anspach Effort, Inc. is recalling 11.0cm Long Attachments for pneumatic systems because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 51 units of the Autolube-III with Irrigation pneumatic system because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 8.0cm Medium Pneumatic System Attachments because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling five IMRI Short HD Pneumatic Attachments because the supplied directions for use did not include a recommended service interval.
The Anspach Effort, Inc. is recalling 7.5cm Angle Attachments because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 618 Minimal Access Attachment pneumatic systems because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 13.5CM Angle Attachments because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling Adult Craniotome Pneumatic Systems because the supplied Directions for Use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 130 units of 6.5cm Adult Cranial Thin Foot Plates because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 128 Compact Speed Reducer units because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 119 Otologic Curved Micro pneumatic systems because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 247 pneumatic system attachments because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 16 Oscillating MICRO-SAW pneumatic systems because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 16 Small Attachment, J-Latch units because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 17 AL-III pneumatic hose units because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling Large Craniotome pneumatic systems because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 45 degree Contra Angle Attachments because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 8.0CM Heavy Duty Medium Pneumatic Attachments because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling three IMRI Air Control pneumatic systems because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling foot control irrigation systems because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 8CM Angle Attachments because the supplied directions for use did not include a recommended service interval.
The Anspach Effort, Inc. is recalling 209 Electronic Foot Controls with Direction Switches because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 50 units of the SMALL ATTACHMENT, JACOBS CHUCK because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 568 Bearing Sleeves because the supplied directions for use did not contain a recommended service interval.