The Recall Desk

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.

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35101–35125 of 40325

  • HighFDA (Devices)·Z-2246-2014·2014-08-27

    Zimmer Recalls 6.5 mm Cancellous Screws for 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
  • HighFDA (Devices)·Z-2301-2014·2014-08-27

    Zimmer Recalls Persona Knee System Trial Components Due to Breakage

    Zimmer, Inc. is recalling Persona Knee System trial components after receiving complaints about breakage. The recall covers distribution events in the US and several international countries.

    Product
    Persona (TM) The Personalized Knee System CPS Tibial Articular Surface Provisional Top Nonsterile TASP MLC L 3-5 CD TOP TASP MLC L 6-9 CD TOP TASP MLC L 3-5 EF TOP TASP MLC L 6-9 EF TOP TASP MLC L 10-11 EF TOP TASP MLC L 6-9 GH TOP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2299-2014·2014-08-27

    Zimmer Recalls Persona Knee Trial Articular Surface Provisionals

    Zimmer, Inc. is recalling Persona Knee Trial Articular Surface Provisionals due to reported breakage. The recall covers corrective actions taken earlier this year.

    Product
    Persona (TM) The Personalized Knee System UC Tibial Articular Surface Provisional Top Nonsterile TASP UC L 3-7 CD TOP TASP UC L 4-11 EF TOP TASP UC L 7-12 GH TOP TASP UC L 9-12 J TOP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2257-2014·2014-08-27

    Ortho Development Recalls Knee Implants Due to Improperly Sealed Foil Pouches

    Ortho Development is recalling various knee implant components because improperly sealed foil pouches allow air to enter, increasing the risk of material degradation due to oxidation.

    Product
    Tibila Insert CK, Balanced Knee System Revision, REF563-1YYY Product Usage: UHMWPE component used in TKA and revision TKA procedures to serve as a tibial bearing surface for articulation with the femoral component where additional joint constraint is needed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2250-2014·2014-08-27

    Zimmer Recalls 4.5 mm Malleolar Screws Due to Leak Test Failures

    Zimmer, Inc. is recalling 47,682 units of 4.5 mm Malleolar Screws because they failed a leak test due to inner cavity damage.

    Product
    4.5 mm Malleolar Screw Sterile zimmer
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Devices)·Z-2266-2014·2014-08-27

    Vascutek Recalls Gelweave Vascular Prostheses Due to Cautery Shelf Life Labeling

    Vascutek is recalling Gelweave Vascular Prostheses because the included cautery has a shorter shelf life than the graft, creating a labeling discrepancy.

    Product
    Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a TERUMO company
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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