Severity 1 of 5
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Severity 1 (Low) recalls are typically cosmetic defects, documentation issues, packaging-only problems, and Class III administrative corrections. The product itself is unlikely to cause adverse health consequences. The manufacturer is correcting the issue to comply with FDA or USDA rules, not because anyone is at risk. You can almost always continue using a Severity-1 product without concern.
The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.
BMW is recalling 2017 X5 M and X6 M vehicles because the tire information label lists the wrong tire size, failing to meet federal safety standards.
Teva Pharmaceuticals USA is recalling specific lots of Prednisolone Oral Solution because they failed stability specifications.
Akorn, Inc. is recalling 1,292 kits of IC-Green (indocyanine green for injection) due to low pH values. The product was distributed nationwide.
Mentor Texas, LP. is recalling 28 units of Mentor Smooth Round SPECTRUM Post-Operatively Adjustable Saline Breast Implants because the Dome Pack accessory is missing.
Sun Pharmaceutical Industries is recalling Olanzapine Tablets, 10 mg, because they failed impurity specifications. The recall covers 38,316 bottles distributed nationwide and in Puerto Rico.
Sanofi-Aventis is recalling 2,133 vials of Mozobil (plerixafor) nationwide because the package insert is incorrect or missing.
The Anspach Effort, Inc. is recalling 293 eMax2 Hybrid Hand Controls because the supplied directions for use did not contain a recommended service interval.
Fagron, Inc. is recalling Zinc Oxide Paste 25% because of an incorrect strength value in the Drug Facts Panel.
The Anspach Effort, Inc. is recalling 25 BLACKMAX-NEURO LOW PRESSURE pneumatic systems 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 13.5CM Angle Attachments 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.
Zimmer Trabecular Metal Technology, Inc. is recalling the TM Ardis Interbody System due to a procedural error in the approval of literature, resulting in the unauthorized release of certain content.
The Anspach Effort, Inc. is recalling two Black Max contra angle attachments because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling three IMRI Motor pneumatic systems because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 13 units of the 10.5cm Angle Attachment, Black Max, because the supplied directions for use did not include a recommended service interval.
The Anspach Effort, Inc. is recalling 10 IMRI CRANI-A pneumatic attachments because the supplied directions for use did not include a recommended service interval.
The Anspach Effort, Inc. is recalling 10 units of the 90 Degree Right Angle Attach, Black Max, because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 375 units of 7.5cm QD Angle Attachments because the supplied directions for use did not contain a recommended service interval.
The Harvard Drug Group is recalling Aripiprazole Tablets, 2 mg, due to out-of-specification assay results. The recall covers 36,990 tablets distributed nationwide and in Puerto Rico.
The Anspach Effort, Inc. is recalling 5,757 units of the 5.0cm Short Attachment because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 821 Electronic Foot Controls because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 16 Autolube-III pneumatic systems because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 6.8cm Controlled Depth Attachments because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 49 Rotating Adult Craniotomes because the supplied directions for use did not contain a recommended service interval.