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.

14051–14075 of 21617

  • ModerateFDA (Devices)·Z-2516-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i, LLC is recalling 1,648,273 dental implant cover screws because pouches may not have been sealed during packing.

    Product
    Certain Cover Screw Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2425-2016·2016-08-24

    Biomet 3i Recalls Dental Implant O-Ring Abutments Due to Sealing Defects

    Biomet 3i is recalling specific O-Ring Abutments for dental implants because pouches may not have been sealed during packing.

    Product
    O-Ring Abutment 4.1mm(D) x 4mm(H) Item: OSO40 Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2532-2016·2016-08-24

    Merge Healthcare Recalls iConnect Access Software Due to Patient Data Errors

    Merge Healthcare is recalling iConnect Access software because it may display incorrect patient demographics after edits, potentially affecting medical specialists.

    Product
    iConnect Access used with Ortho PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet) networks.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·073-2016·2016-08-24

    Green Bay Dressed Beef Recalls Beef Brains Due to Specified Risk Materials

    Green Bay Dressed Beef, LLC is recalling approximately 7,420 pounds of beef brain products that may be contaminated with specified risk materials (SRM). The products were shipped to a distributor in California.

    Product
    Green Bay Dressed Beef, LLC — Green Bay Dressed Beef Recalls Beef Products Due To Possible Specified Risk Materials Contamination
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2448-2016·2016-08-24

    Biomet 3i Recalls Temporary Hexed Cylinder Dental Implants

    Biomet 3i, LLC is recalling Temporary Hexed Cylinder Dental implants because pouches may not have been sealed during packing.

    Product
    Temporary Hexed Cylinder Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2576-2016·2016-08-24

    Medtronic Recalls Valleylab Laparoscopic Electrodes Due to Sterile Barrier Risk

    Medtronic is recalling 332 Valleylab Laparoscopic Flat L-Hook Electrodes because the packaging may be compromised, potentially breaching the sterile barrier.

    Product
    Valleylab Laparoscopic Flat L-Hook Electrode 28cm Item Code: E278428 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2411-2016·2016-08-24

    Biomet 3i Recalls Certain Gingihue Post Dental Implants

    Biomet 3i, LLC is recalling specific Gingihue Post dental implants because pouches may not have been sealed during packing.

    Product
    Certain Gingihue Post 5mm(D) x 5mm(P) x 2mm(H) Item: IWPP552G Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2432-2016·2016-08-24

    Biomet 3i Recalls Locator Replacement Housing Kits Due to Sealing Defects

    Biomet 3i is recalling Locator Replacement Housing Kits because pouches may not have been sealed during packing. The recall affects 1,648,273 units distributed worldwide.

    Product
    Locator Replacement Housing Kit Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2456-2016·2016-08-24

    Biomet 3i Recalls Conical Healing Caps Due to Unsealed Pouches

    Biomet 3i, LLC is recalling 1,648,273 Conical Healing Caps for dental implants because pouches may not have been sealed during packing.

    Product
    Conical Healing Cap Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2502-2016·2016-08-24

    Biomet 3i Recalls Twist Lock Dental Implants Due to Unsealed Pouches

    Biomet 3i is recalling Twist Lock Straight Transfer Coping Dental Implants because pouches may not have been sealed during packing.

    Product
    Certain Twist Lock TM Straight Transfer Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2439-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i, LLC is recalling Prep-Tite Post Dental implants because pouches may not have been sealed during packing.

    Product
    Prep-Tite Post Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2531-2016·2016-08-24

    Merge Healthcare Recalls iConnect Access Software for Patient Data Errors

    Merge Healthcare is recalling iConnect Access software because it may display incorrect patient demographics for studies originating on Merge PACS or Ortho PACS.

    Product
    iConnect Access used with Merge PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet) networks.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2514-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i, LLC is recalling 1,648,273 Conical 25 degree Angled Abutment Dental Implants because pouches may not have been sealed during packing.

    Product
    Certain Conical 25 degree Angled Abutment Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2507-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i, LLC is recalling Conical Abutment Gold Standard ZR Dental implants because pouches may not have been sealed during packing.

    Product
    Conical Abutment Gold Standard ZR TM Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2461-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i is recalling DAL-RO Threaded Female Dental implants because pouches may not have been sealed during packing.

    Product
    DAL-RO Threaded Female Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2504-2016·2016-08-24

    Biomet 3i Recalls Conical 17 Degree Angled Abutment Dental Implants

    Biomet 3i, LLC is recalling Conical 17 degree Angled Abutment dental implants because pouches may not have been sealed during packing.

    Product
    Conical 17 degree Angled Abutment Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2497-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i is recalling specific dental implants because their pouches may not have been sealed during packing, potentially compromising sterility.

    Product
    Certain Straight Pick Up Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2452-2016·2016-08-24

    Biomet 3i Recalls Conical EP Healing Caps Due to Sealing Defects

    Biomet 3i, LLC is recalling Conical EP Healing Caps for dental implants because pouches may not have been sealed during packing.

    Product
    Conical EP Healing Cap Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1459-2016·2016-08-24

    Venlafaxine Hydrochloride Extended-Release Capsules Recalled for Dissolution Failures

    Golden State Medical Supply Inc. is recalling 40,631 bottles of Venlafaxine Hydrochloride Extended-Release Capsules, 75 mg, due to out-of-specification dissolution results.

    Product
    Venlafaxine Hydrochloride Extended-Release Capsules, 75 mg, 90 capsules per bottle, Rx Only, GSMS, NDC # 60429-122-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2422-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Potential Unsealed Pouches

    Biomet 3i, LLC is recalling 1,648,273 LDA Screw SBL 3mm(D) dental implants because pouches may not have been sealed during packing.

    Product
    LDA Screw SBL 3mm(D) Item: SCRSBL1 Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide