The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

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.

17126–17150 of 21645

  • ModerateFDA (Devices)·Z-0730-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Documentation Issues

    Stryker Endoscopy is recalling 180,573 units of laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.

    Product
    PKG, ASPIRATION NEEDLE, 33CM, P/N 0250080702 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0737-2015·2014-12-24

    Stryker Endoscopy Recalls Fenestrated Forceps Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 fenestrated forceps units because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 5MM, 45CM, INSERT, FENESTRATED FORCEPS, P/N 0250080732 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0792-2015·2014-12-24

    Stryker Endoscopy Recalls 180,573 Laparoscopic Graspers Due to Sterilization Labeling Error

    Stryker Endoscopy is recalling 180,573 laparoscopic atraumatic graspers because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 3MM INSERT, ATRAUMATIC GRASPER, DOUBLE ACTION, 20CM, P/N 0250282100 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0776-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Scissors Due to Sterilization Documentation Error

    Stryker Endoscopy is recalling 180,573 units of laparoscopic scissors because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 3MM INSERT, PERITONEAL SCISSORS, 29CM, P/N 0250282048 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0611-2015·2014-12-24

    Stryker Endoscopy Recalls Fixable Cone for 11mm Hasson Due to Sterilization Labeling

    Stryker Endoscopy is recalling 180,573 units of the Fixable Cone for 11mm Hasson because the instructions for use do not support specific sterilization methods.

    Product
    PKG, FIXABLE CONE FOR 11MM HASSON, P/N 0250080180. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0631-2015·2014-12-24

    Stryker Pennington Forceps Recalled Due to Sterilization Instructions Error

    Stryker Endoscopy is recalling 180,573 Pennington Forceps units because the instructions for use do not support specific sterilization methods.

    Product
    PKG, PENNINGTON FORCEPS, P/N 0250080242. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0798-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Instruments Due to Sterilization Labeling Errors

    Stryker Endoscopy is recalling 180,573 laparoscopic instruments because the instructions for use do not support specific sterilization methods.

    Product
    PKG, CANNULA 8MM AUTOMATIC VALVE STOP COCK, W/O TROCAR, P/N 0250080172 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0633-2015·2014-12-24

    Stryker Laparoscopic Claw Forceps Recalled Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 laparoscopic claw forceps units because the instructions for use do not support specific sterilization methods.

    Product
    PKG, CLAW FORCEPS, DOUBLE ACTION, P/N 0250080245. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0773-2015·2014-12-24

    Stryker Endoscopy Recalls 3mm PEEK Monopolar Handle Due to Sterilization Documentation Error

    Stryker Endoscopy is recalling 180,573 units of 3mm PEEK Monopolar Handles because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 3MM PEEK MONOPOLAR HANDLE, P/N 0250282045 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0616-2015·2014-12-24

    Stryker Laparoscopic Reducers Recalled for Sterilization Parameter Errors

    Stryker Endoscopy is recalling 180,573 laparoscopic reducers because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 12.5/11MM - 5.5 REDUCER, P/N 0250080204. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0300-2015·2014-12-24

    Mercaptopurine Tablets Recalled for Failed Dissolution Test Requirements

    American Health Packaging is recalling specific lots of Mercaptopurine Tablets, 50 mg, because they failed USP dissolution test requirements.

    Product
    Mercaptopurine Tablets, USP, 50 mg, 30 Tablets (3 x 10) unit dose blisters per carton, Rx only, Manufactured by Prometheus Laboratories Inc. 9410 Carroll Park Drive, San Diego, CA 92121, repackaged by American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217, NDC…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0747-2015·2014-12-24

    Stryker Endoscopy Recalls Allis Forceps Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 units of Allis Forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 5MM X 45CM INSERT, ALLIS FORCEPS, DOUBLE ROW TEETH, P/N 0250080754 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0605-2015·2014-12-24

    Stryker Laparoscopic Cannula Recall Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 laparoscopic cannulas because the instructions for use do not support specific sterilization methods.

    Product
    PKG, CANNULA 5.5MM AUTOMATIC VALVE STOP COCK W/O TROCAR, P/N 0250080171. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0823-2015·2014-12-24

    Biomet Sirius Cemented Hip Stem Recall Due to Packaging Mix-up

    Biomet is recalling eight Sirius Polish Cemented Hip Stems because parts were mixed up prior to packaging and shipment.

    Product
    Sirius Polish Cemented Stem 38C Catalog Number: 51-199335 Lot Number Identification: 141680, 180920 The Biomet's Sirius Femoral Hip Stem is a double-tapered, highly polished cemented hip stem, designed for either primary or revision surgery. A distal centralizer is provided…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0742-2015·2014-12-24

    Stryker Endoscopy Recalls Park Forceps Due to Sterilization Instructions

    Stryker Endoscopy is recalling specific Park Forceps instruments because the instructions for use do not support certain sterilization methods.

    Product
    PKG, 5MM INSERT, 45CM, PARK FORCEPS, P/N 0250080745 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0831-2015·2014-12-24

    Integra Licox Brain Tissue Oxygen Monitoring Catheters Recalled for Inaccurate Values

    Integra LifeSciences is recalling 2,506 Licox brain tissue oxygen monitoring catheters because they contain a smart card programmed with an inaccurate lkN2 value.

    Product
    Integra Licox Brain Tissue Oxygen Monitoring Integra Licox Recon Tissue Oxygen Monitoring 1) LICOX¿ Complete Brain Probe Kit (comprised of IP1, CC1.P1) 2) LICOX¿ Complete Brain Probe Kit (comprised of IP2, CC1.P1) 3) LICOX¿ Complete Brain Tunnelling Probe Kit (comprised of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0820-2015·2014-12-24

    Carestream DirectView CR Software Recalled for Reduced Mammographic Image Quality

    Carestream Health is recalling 59 units of DirectView CR Software due to reduced image quality when printing true size multi-format images.

    Product
    CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0606-2015·2014-12-24

    Stryker Maryland Forceps Recalled Due to Sterilization Instructions

    Stryker Endoscopy is recalling Maryland Forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, MARYLAND FORCEPS, CURVED, P/N 0250080009. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0796-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Labeling

    Stryker Endoscopy is recalling 180,573 laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 3MM X 29CM INSERT, RIGHT ANGLE DISSECTOR, LONG JAW, P/N 0250282105 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0654-2015·2014-12-24

    Stryker Endoscopy Recalls Tissue Grasper Forceps Due to Sterilization Labeling Error

    Stryker Endoscopy is recalling 180,573 units of tissue grasper forceps because the instructions for use do not support two specific sterilization methods.

    Product
    PKG, GRASPER FORCEPS, TISSUE, P/N 0250080284. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0600-2015·2014-12-24

    Stryker Myoma Drill Recall Due to Sterilization Instructions

    Stryker Endoscopy is recalling Myoma Drill instruments because the instructions for use do not support specific sterilization methods.

    Product
    PKG, MYOMA DRILL 5MM LENGTH 320MM, P/N 0250080133 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0740-2015·2014-12-24

    Stryker Dorsey Grasper Forceps Recalled Due to Sterilization Instructions

    Stryker Endoscopy is recalling Dorsey Grasper Forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 5MM, 45CM, INSERT, DORSEY GRASPER FORCEPS, P/N 0250080736 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0793-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Instruments Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 laparoscopic instruments because the provided instructions do not support specific sterilization methods.

    Product
    PKG, 3MM INSERT, ATRAUMATIC GRASPER, DOUBLE ACTION, 29CM, P/N 0250282101 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0613-2015·2014-12-24

    Stryker Metzenbaum Scissors Recalled Due to Sterilization Instructions

    Stryker Endoscopy is recalling Metzenbaum Scissors because the instructions for use do not support specific sterilization methods.

    Product
    PKG, METZENBAUM SCISSORS, CURVED, LONG, P/N 0250080025. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0698-2015·2014-12-24

    Stryker Laparoscopic Forceps Recalled for Sterilization Parameter Errors

    Stryker Endoscopy is recalling 180,573 laparoscopic forceps units because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 5MM INSULATED SHAFT 33CM, FOR BIPOLAR FORCEPS, P/N 0250080371. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio…
    Category
    Medical Device
    Distribution
    Distributed nationwide