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.

10851–10875 of 21617

  • ModerateFDA (Devices)·Z-1285-2018·2018-04-11

    Arrow Radial Artery Catheterization Kits Recalled for Shelf Life Labeling Error

    Arrow International is recalling 570 Radial Artery Catheterization Kits because the included povidone iodine prep pads are labeled with an incorrect 36-month shelf life.

    Product
    Radial Artery Catheterization Kit; Model: AK-04122
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1283-2018·2018-04-11

    Arrow Radial Artery Catheterization Kits Recalled for Shelf Life Labeling Error

    Arrow International is recalling Radial Artery Catheterization Kits because the included povidone iodine prep pads do not meet the 36-month shelf life requirement and must be labeled with a 24-month shelf life.

    Product
    Radial Artery Catheterization Kit; Model: AK-04020-C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1286-2018·2018-04-11

    Arrow Radial Artery Catheterization Kits Recalled for Shelf Life Labeling

    Arrow International is recalling Radial Artery Catheterization Kits because the included povidone iodine prep pads do not meet the 36-month shelf life requirement and should be labeled with a 24-month shelf life.

    Product
    Radial Artery Catheterization Kit; Model: AK-04220
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1302-2018·2018-04-11

    GE Healthcare Recalls Centricity PACS-IW Due to Image Data Loss Risk

    GE Healthcare is recalling 569 units of Centricity PACS-IW because a database error may cause image series to be missing from exams without user notification.

    Product
    GE Healthcare Centricity PACS-IW, Model Numbers: (a) 2052831-00X (b) 2049588-008 Product Usage: Centricity PACS-IW by GE Healthcare is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1290-2018·2018-04-11

    Aesculap DS Titanium Ligation Clips Recalled for Contraindication Update

    Aesculap Implant Systems LLC is recalling DS Titanium Ligation Clips to update instructions for use, adding a contraindication for living donor nephrectomies.

    Product
    DS Titanium Ligation Clip, used in laparoscopic surgery
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0995-2018·2018-04-11

    Pepsi Recalls Diet Pepsi Cans Due to Incorrect Sweetener Labeling

    Pepsi Beverage Co is recalling 1,972 cases of Diet Pepsi because the cans are labeled to contain Sucralose but actually contain Aspartame.

    Product
    diet Pepsi, 12 FL OZ, in aluminum cans packaged in 12 pk paper cartons
    Category
    Food
    Distribution
    4 states
  • ModerateUSDA FSIS·030-2018·2018-04-07

    J.T.M. Provisions Recalls Pulled Beef Products Due to Rubber Contamination

    J.T.M. Provisions is recalling approximately 14,525 pounds of pulled barbequed beef products that may contain rubber. The recall covers products shipped to Indiana, Kentucky, and Ohio.

    Product
    J.T.M. Provisions Company — J.T.M. Provisions Company Recalls Beef Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1198-2018·2018-04-04

    GE Healthcare Recalls 28 Datex-Ohmeda TEC 7 Anesthesia Vaporizers

    GE Healthcare is recalling 28 Datex-Ohmeda TEC 7 anesthesia vaporizers shipped from a service center without proper evaluation, potentially making them nonconforming.

    Product
    DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER Is designed for the metered delivery of specific inhalation anesthetic agents for use in continuous flow techniques of inhalation anesthesia.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1190-2018·2018-04-04

    Zimmer Dental Recalls Tapered Screw-Vent Implants Due to Mislabeled Lots

    Zimmer Dental Inc is recalling Tapered Screw-Vent MTX dental implants because two lots with different thread diameters were commingled and may be mislabeled.

    Product
    Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1270-2018·2018-04-04

    Roche cobas e 411 Analyzer Recall for Questionable Results

    Roche Diagnostics is recalling cobas e 411 Immunoassay Analyzers because using 13 mm sample tubes without adapters may cause questionable results.

    Product
    cobas e 411 Immunoassay Analyzer (Discrete Photometric Analyzer for Clinical use), Catalog Numbers: 04775201001 (rack system), 04775279001 (disk system), 04775201973 (rack system) & 04775279973 (disk system).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1199-2018·2018-04-04

    GE Healthcare Recalls Datex-Ohmeda Anesthetic Cassettes for Quality Control Issues

    GE Healthcare is recalling two Datex-Ohmeda AISYS CS2 Aladin2 cassettes because they were shipped without proper evaluation and may be nonconforming.

    Product
    DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used to deliver anesthetic agent.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1211-2018·2018-04-04

    Johnson & Johnson Recalls 1-DAY ACUVUE Moist for Astigmatism Contact Lenses

    Johnson & Johnson Vision Care is recalling 1-DAY ACUVUE Moist for Astigmatism contact lenses due to reports of foreign matter found between the blister package and foil.

    Product
    1-DAY ACUVUE Moist for ASTIGMATISM Brand Contact Lenses
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1272-2018·2018-04-04

    SIE AG Recalls FEMTO LDV Z8 Femtosecond Surgical Lasers

    SIE AG is recalling 125 FEMTO LDV Z8 femtosecond surgical lasers worldwide due to usability and performance improvements identified after a cataract procedure complication.

    Product
    The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser is an ophthalmic surgical laser intended for use in the creation of corneal incisions indicated for use in patients undergoing LASIK surgery, tunnel creation for implantation of rin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1273-2018·2018-04-04

    Mesa Laboratories Recalls ProSpore Biological Indicators Due to Concentration Defect

    Mesa Laboratories is recalling specific lots of ProSpore Biological Indicators because the concentration of bromocresol purple does not conform to specification.

    Product
    ProSpore Biological Indicator Part Numbers: PS-6-50, PS-5-50, PS-4-10, PS-4-50, 3471
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1173-2018·2018-04-04

    Biomet Recalls Orthopedic Implants Due to Screw Hole Mismatch

    Biomet is recalling 634 Zimmer Biomet Comprehensive Segmental Revision System implants because a screw hole mismatch may prevent proper assembly during surgery.

    Product
    Zimmer Biomet Comprehensive Segmental Revision System (SRS). Orthopedic implants for Proximal Humeral Reconstruction, Distal Humeral Reconstruction, and Total Humeral Reconstruction
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1209-2018·2018-04-04

    Johnson & Johnson Recalls ACUVUE OASYS Contact Lenses Due to Foreign Matter

    Johnson & Johnson Vision Care is recalling specific lots of ACUVUE OASYS contact lenses because foreign matter was found between the blister package and foil.

    Product
    ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1224-2018·2018-04-04

    Zimmer Biomet Recalls Persona Knee System Components Due to Missing Parts

    Zimmer Biomet is recalling 3 units of the Persona Knee System because the set screw and taper plug were missing from the packaging.

    Product
    PERSONA¿ THE PERSONALIZED KNEE SYSTEM "PSN TIB STM 5 DEG SZ D R" indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1261-2018·2018-04-04

    Siemens Syngo.via software recall due to data archiving configuration error

    Siemens is recalling 165 units of Syngo.via software because a software upgrade disabled a data cleanup function, causing incorrect archiving flags and reduced disk capacity.

    Product
    Syngo.via software is intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo based software options.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1204-2018·2018-04-04

    Johnson & Johnson Recalls Select First Aid Wraps Due to Latex Labeling Error

    Johnson & Johnson is voluntarily recalling select first aid wraps because the label incorrectly states they are not made with natural rubber latex.

    Product
    Johnson & Johnson BAND-AID¿ Brand First Aid Products SECURE-FLEX¿ Wrap (size: 3in)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1210-2018·2018-04-04

    Johnson & Johnson Recalls ACUVUE ADVANCE Contact Lenses Due to Foreign Matter

    Johnson & Johnson Vision Care is recalling specific lots of ACUVUE ADVANCE contact lenses because foreign matter was found between the blister package and foil.

    Product
    ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0980-2018·2018-04-04

    Dreyer's Vanilla Bean Ice Cream Recalled for Incorrect Butter Pecan Contents

    Nestle Dreyers is recalling 30 cases of Dreyer's Slow Churned Vanilla Bean Ice Cream in Colorado because the cartons contain Butter Pecan ice cream.

    Product
    Dreyer's Slow Churned Vanilla Bean Ice Cream; 1.5 qt, (48-fl oz.); Lid is for Dreyer's Slow Churned Butter Pecan Ice Cream UPC 41548 00386
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1239-2018·2018-04-04

    Zimmer Biomet Recalls Coonrad/Morrey Elbow Implant Humeral Assemblies

    Zimmer Biomet is recalling nine Coonrad/Morrey Elbow Implant humeral assemblies because they are missing required humeral bushing components.

    Product
    Coonrad/Morrey Elbow Implant System humeral assembly 4IN XSML, Item Number: 32-8105-027-04 (UDI: (01)0088902427 4006(17)220731(10)63694912)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1189-2018·2018-04-04

    Zimmer Dental Recalls Tapered Screw-Vent Implants Due to Labeling Error

    Zimmer Dental Inc is recalling Tapered Screw-Vent MTX dental implants because two lots were inadvertently commingled during manufacturing, potentially resulting in mislabeling.

    Product
    Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSVTB10.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1205-2018·2018-04-04

    Johnson & Johnson Recalls First Aid Wraps Due to Latex Labeling Error

    Johnson & Johnson is voluntarily recalling select first aid wraps because the 'not made with natural rubber latex' label is inaccurate.

    Product
    Johnson & Johnson BAND-AID¿ Brand First Aid Products HURT-FREE¿ Wrap (size: 1in)
    Category
    Medical Device
    Distribution
    0 states