Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

35201–35225 of 40449

ModerateFDA (Devices)·Z-2271-2014·2014-08-27
AMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Labeling
AMO Puerto Rico Manufacturing is recalling 77,055 TECNIS CL intraocular lenses because they may be labeled with the incorrect diopter power.
Product
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5 Product…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2283-2014·2014-08-27
AMO TECNIS CL Foldable Silicone IOLs Recalled for Incorrect Diopter Labeling
AMO Puerto Rico Manufacturing is recalling 77,055 TECNIS CL intraocular lenses because units may be labeled with the incorrect diopter power.
Product
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 21.5-22.5 Product Usage: AMO TECNIS CL monofocal foldable…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2276-2014·2014-08-27
AMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Power Labeling
AMO Puerto Rico Manufacturing is recalling 77,055 TECNIS CL intraocular lenses because units may be labeled with the incorrect diopter power.
Product
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 14.5, 15.0 Product Usage: AMO TECNIS CL monofocal foldable…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2268-2014·2014-08-27
Ansar ANX-3.0 Autonomic Monitor Blood Pressure Circuit Recall
Ansar Group is recalling 351 ANX-3.0 Autonomic Monitor systems because the blood pressure circuit may fail to inflate the cuff or activate, resulting in no blood pressure measurement.
Product
Blood pressure (BP) circuit of the ANSAR ANX-3.0 Autonomic Monitor system. The ANX 3.0 system is comprised of these components. 1. Patient Physiological Monitor, 2. Laptop Computer, 3. Stand w/wheels, 4. Patient cables, 5. Software components (Respiratory and Cardiac…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2280-2014·2014-08-27
AMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Labeling
AMO Puerto Rico Manufacturing is recalling 77,055 TECNIS CL intraocular lenses because they may be labeled with the incorrect diopter power.
Product
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 18.5-19.0 Product Usage: AMO TECNIS CL monofocal foldable…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2267-2014·2014-08-27
Intelerad IntelePACS Software Recall Due to Potential File Truncation Errors
Intelerad Medical Systems is recalling IntelePACS software versions 3-8-1 to 4-9-1 because partially truncated files may be incorrectly reported as complete.
Product
IntelePACS software versions 3-8-1 to 4-9-1, Product Usage: IntelePACS is a device that receives digital images and data from various sources (such as, CT scanners, MRI scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2285-2014·2014-08-27
AMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Power Labeling
AMO Puerto Rico Manufacturing is recalling 77,055 TECNIS CL intraocular lenses because they may be labeled with the incorrect diopter power.
Product
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 24.5, 25, 25.5 & 26. Product Usage: AMO TECNIS CL…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2242-2014·2014-08-27
Biomet Recalls Vanguard 360 Femoral Boss Reamers Due to Sizing Defect
Biomet is recalling 461 Vanguard 360 Femoral Boss Reamers because they were manufactured oversized and may not fit into mating components.
Product
Vanguard 360 Femoral Boss Reamer, Label: REF 32-488474 VANGUARD 360 1NSTRUMENT FEMORAL BOSS REAMER NON-STERILE, BIOMET ORTHOPEDICS 56 EAST BELL DRIVE P.O. BOX 587 WARSAW, IN 46581 USA
Category
Medical Device
Distribution
34 states
ModerateFDA (Devices)·Z-2279-2014·2014-08-27
AMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Labeling
AMO Puerto Rico Manufacturing is recalling 77,055 TECNIS CL intraocular lenses because they may be labeled with the incorrect diopter power.
Product
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 17.5, 18.0 Product Usage: AMO TECNIS CL monofocal foldable…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2274-2014·2014-08-27
AMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Labeling
AMO Puerto Rico Manufacturing is recalling 77,055 TECNIS CL intraocular lenses because units may be labeled with the incorrect diopter power.
Product
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 12.0 and 12.5 Product Usage: AMO TECNIS CL monofocal…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2249-2014·2014-08-27
Zimmer Recalls 6.5 mm Cancellous Screws Due to Leak Test Failures
Zimmer, Inc. is recalling 6.5 mm Cancellous Screws that failed leak tests due to inner cavity damage. The recall covers 47,682 units distributed nationally and internationally.
Product
6.5 mm Cancellous Screw Fully Threaded Sterile zimmer
Category
Medical Device
Distribution
45 states
ModerateFDA (Devices)·Z-2286-2014·2014-08-27
AMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Labeling
AMO Puerto Rico Manufacturing is recalling 77,055 intraocular lenses that may be labeled with the incorrect diopter power.
Product
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 26.5, 27, 27.5 & 28.5. Product Usage: AMO TECNIS CL…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2269-2014·2014-08-27
Gyrus ACMI Falope-Ring Dilator Recalled for Non-Sterile Stand-Alone Sales
Gyrus Medical is recalling 507 units of the ACMI Falope-Ring Dilator because the non-sterile component was sold as a stand-alone item.
Product
Gyrus ACMI Falope-Ring Dilator, item 000878-4. The Falope-Ring Dilator is a conical plastic device that is a component of the Falope-Ring Band Contraceptive Tubal Occlusion Device procedure pack (FRB-30). The Falope-Ring Band Contraceptive Tubal Occlusion Device (TOD) consists…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2282-2014·2014-08-27
AMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Power Labeling
AMO Puerto Rico Manufacturing is recalling 77,055 TECNIS CL intraocular lenses because they may be labeled with the incorrect diopter power.
Product
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 20.5-21 Product Usage: AMO TECNIS CL monofocal foldable…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2287-2014·2014-08-27
AMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Labeling
AMO Puerto Rico Manufacturing is recalling 77,055 TECNIS CL intraocular lenses because units may be labeled with the incorrect diopter power.
Product
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 29, 29.5 & 30. Product Usage: AMO TECNIS CL monofocal…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2263-2014·2014-08-27
Biolase Recalls WaterLase iPlus Dental Laser Systems Due to Software Error
Biolase Technology Inc is recalling 117 WaterLase iPlus Dental Laser Systems because a software error may cause the air setting to change to 1% and OFF during procedures.
Product
WaterLase iPlus Dental Laser System, Part No. 7200854-XX Software Upgrade Kit, Part No. 6201463.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2278-2014·2014-08-27
AMO Tecnis CL Intraocular Lenses Recalled for Incorrect Diopter Power Labeling
AMO Puerto Rico Manufacturing is recalling 77,055 Tecnis CL intraocular lenses because units may be labeled with the incorrect diopter power.
Product
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 16.5, 17.0 Product Usage: AMO TECNIS CL monofocal foldable…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2273-2014·2014-08-27
AMO Tecnis CL Intraocular Lenses Recalled for Incorrect Diopter Labeling
AMO Puerto Rico Manufacturing is recalling 77,055 Tecnis CL intraocular lenses because units may be labeled with the incorrect diopter power.
Product
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 11.0 and 11.5 Product Usage: AMO TECNIS CL monofocal…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2248-2014·2014-08-27
Zimmer Recalls 6.5 mm Cancellous Screws Due to Leak Test Failures
Zimmer, Inc. is recalling 47,682 units of 6.5 mm Cancellous Screws because they failed a leak test due to damage of the inner cavity.
Product
6.5 mm Cancellous Screw 32 mm Thread Length Sterile zimmer
Category
Medical Device
Distribution
45 states
ModerateFDA (Devices)·Z-2244-2014·2014-08-27
Zimmer Recalls Magna-Fx Cannulated Bone Screws Due to Leak Test Failures
Zimmer, Inc. is recalling 47,682 units of Magna-Fx Cannulated Bone Screws because they failed leak tests due to inner cavity damage.
Product
Magna-Fx Cannulated Screw Fixation System Bone Screw Fully Threaded Sterile zimmer
Category
Medical Device
Distribution
45 states
ModerateFDA (Devices)·Z-2275-2014·2014-08-27
AMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Labeling
AMO Puerto Rico Manufacturing is recalling 77,055 TECNIS CL intraocular lenses because they may be labeled with the incorrect diopter power.
Product
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 13.0, 13.5, 14.0 Product Usage: AMO TECNIS CL monofocal…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2272-2014·2014-08-27
AMO Tecnis CL Intraocular Lenses Recalled for Incorrect Diopter Labeling
AMO Puerto Rico Manufacturing is recalling 77,055 Tecnis CL intraocular lenses because units may be labeled with the incorrect diopter power.
Product
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 10.0 and 10.5 Product Usage: AMO TECNIS CL monofocal…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2281-2014·2014-08-27
AMO Tecnis CL Intraocular Lenses Recalled for Incorrect Diopter Power Labeling
AMO Puerto Rico Manufacturing is recalling 77,055 Tecnis CL intraocular lenses because they may be labeled with the incorrect diopter power.
Product
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 19.5-20 Product Usage: AMO TECNIS CL monofocal foldable…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2277-2014·2014-08-27
AMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Power Labeling
AMO Puerto Rico Manufacturing is recalling 77,055 TECNIS CL intraocular lenses because units may be labeled with the incorrect diopter power.
Product
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 15.5, 16.0 Product Usage: AMO TECNIS CL monofocal foldable…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2251-2014·2014-08-27
Zimmer Recalls 4.0 mm Cancellous Screws Due to Leak Test Failures
Zimmer, Inc. is recalling 47,682 units of 4.0 mm Cancellous Screws because they failed leak tests due to inner cavity damage.
Product
4.0 mm Cancellous Screw, Partially Threaded Sterile Zimmer
Category
Medical Device
Distribution
45 states

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35201–35225 of 40449