FDA (Devices) recall action 71212
The FDA (Devices) publishes a recall like this one as 34 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 34 pages.
G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater.
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 142 G1 dissection tools because the labeled shaft exposure may not be consistent with all listed attachments, potentially resulting in greater exposure.
The Anspach Effort, Inc. is recalling 70 G1 dissection tools because the labeled shaft exposure may be inconsistent with actual use, potentially resulting in greater exposure than specified.
The Anspach Effort, Inc. is recalling 178 units of 3mm Fluted Ball dissection tools because the specified shaft exposure may be inconsistent with the product labeling.
The Anspach Effort, Inc. is recalling 189 Anspach 7MM Fluted Acorn dissection tools because the specified shaft exposure on the label may not be consistent with all listed attachments.
The Anspach Effort, Inc. is recalling 246 units of the 4mm Diamond Ball dissection tool because the shaft exposure may be greater than labeled when used with certain attachments.
The Anspach Effort, Inc. is recalling 78 G1 dissection tools because the specified shaft exposure may be greater than labeled when used with certain attachments.
The Anspach Effort, Inc. is recalling 353 Fluted Ball dissection tools because the labeled shaft exposure may be inconsistent with actual usage.
The Anspach Effort, Inc. is recalling 103 G1 dissection tools because the specified shaft exposure may be greater than labeled when used with certain attachments.
The Anspach Effort, Inc. is recalling 178 G1 dissection tools because the specified shaft exposure may be inconsistent with attachments, potentially resulting in greater exposure than labeled.