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.

14101–14125 of 21617

  • ModerateFDA (Devices)·Z-2465-2016·2016-08-24

    Biomet 3i Recalls Gingihue Post Dental Implants Due to Sealing Defects

    Biomet 3i is recalling Gingihue Post Dental implants because pouches may not have been sealed during packing, potentially compromising sterility.

    Product
    Gingihue Post Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2420-2016·2016-08-24

    Biomet 3i Recalls Gold-Tite Hexed Retaining Screws Due to Sealing Defects

    Biomet 3i is recalling Gold-Tite Hexed Retaining Screws because pouches may not have been sealed during packing. The recall covers 1,648,273 units distributed worldwide.

    Product
    Gold-Tite Hexed Retaining Screw 3mm Item: GSH30 Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2428-2016·2016-08-24

    Biomet 3i Recalls Locator Extra Light Angled Dental Implant Components

    Biomet 3i is recalling Locator Extra Light Angled Replacement Males because pouches may not have been sealed during packing.

    Product
    Locator Extra Light Angled Replacement Males 4pk Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2520-2016·2016-08-24

    Biomet 3i Recalls Flat Implant Cover Screws Due to Sealing Defects

    Biomet 3i is recalling 1,648,273 Flat Implant Cover Screws because pouches may not have been sealed during packing.

    Product
    Certain Flat Implant Cover Screw Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2499-2016·2016-08-24

    Biomet 3i Recalls Temporary Dental Implants Due to Unsealed Pouches

    Biomet 3i is recalling 1,648,273 temporary dental implants because their packaging pouches may not have been sealed during packing.

    Product
    Certain Temporary Non-Hexed Cylinder Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2593-2016·2016-08-24

    Hospira Receptal Canisters Recalled Due to Incorrect Liner Size Usage

    Hospira is recalling Receptal canisters and liners because customers may use incorrect liner sizes, potentially causing the lid to not fit properly and reducing vacuum suction.

    Product
    Hospira RECEPTAL CANISTERS: 1L(1000mL), 1.5L(1500mL), 2L(2000mL) Canister, ATS, 2000, with Valve 1) List Numbers 43449-01 and 43449-11; LIST NO. 43449 RECEPTAL CANISTER; CANISTER FOR REUSE, THROW AWAY LINER ONLY; DO NOT FILL 900 ABOVE LINE 2) List Numbers 43423-01 and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2484-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Potential Unsealed Pouches

    Biomet 3i, LLC is recalling 1,648,273 Implant EP Twist Lock Coping Dental Implants because pouches may not have been sealed during packing.

    Product
    Certain Implant EP Twist Lock TM Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2508-2016·2016-08-24

    Biomet 3i Recalls Conical Abutment Pick-up Coping Dental Implants

    Biomet 3i, LLC is recalling Conical Abutment Pick-up Coping Dental implants because pouches may not have been sealed during packing.

    Product
    Conical Abutment Pick-up Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1457-2016·2016-08-24

    Actavis Recalls Glipizide 2.5 mg Extended-Release Tablets for Dissolution Failure

    Actavis Inc is recalling specific lots of Glipizide 2.5 mg Extended-Release tablets because they failed to meet dissolution specifications.

    Product
    Glipizide 2.5 mg Extended-release tablets, 30-count bottle, Rx Only, Manufactured By: Patheon Pharmaceuticals Inc Cincinnati, OH 45237, NDC 00591-0900-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2500-2016·2016-08-24

    Biomet 3i Recalls Titanium Dental Implants Due to Unsealed Pouches

    Biomet 3i is recalling 1,648,273 titanium dental implants because pouches may not have been sealed during packing.

    Product
    Certain Titanium Large Hexed Screw Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2409-2016·2016-08-24

    Biomet 3i Recalls Certain Gingihue Dental Implants Due to Sealing Defects

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

    Product
    Certain Gingihue TM 15 degree Angled Post 3.4mm(D) x 3.8mm(P) x 2mm(H) Item: IMPAP32G Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2481-2016·2016-08-24

    Biomet 3i Recalls Locator Abutment Impression Coping Dental Implants

    Biomet 3i, LLC is recalling Locator Abutment Impression Coping dental implants because pouches may not have been sealed during packing.

    Product
    Locator Abutment Impression Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2485-2016·2016-08-24

    Biomet 3i Recalls Dental Implant Cover Screws Due to Sealing Defect

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

    Product
    Certain Implant Straight Cover Screw Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2412-2016·2016-08-24

    Biomet 3i Recalls Certain Gingihue Post Dental Implants Due to Sealing Issues

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

    Product
    Certain Gingihue Post 3.4mm(D) x 3.8mm(P) x 2mm(H) Item: IMAP32G Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2418-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

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

    Product
    Certain Straight Pick-Up Coping 5.0mm(D) x 0mm(P) Item:IWIP50 Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2477-2016·2016-08-24

    Biomet 3i Recalls IOL Pick-Up Impression Coping Due to Sealing Issues

    Biomet 3i is recalling IOL Pick-Up Impression Coping dental implant devices because pouches may not have been sealed during packing.

    Product
    IOL Pick-Up Impression Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2454-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i, LLC is recalling Conical EP Pick-Up Coping dental implants because pouches may not have been sealed during packing.

    Product
    Conical EP Pick-Up Coping (Non-Hexed) Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2474-2016·2016-08-24

    Biomet 3i Recalls Dental Implant Abutments Due to Sealing Defects

    Biomet 3i is recalling IOL Abutment and Screw dental implants because pouches may not have been sealed during packing.

    Product
    IOL Abutment and Screw Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2468-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

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

    Product
    Healing Abutment Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2547-2016·2016-08-24

    Bard TruGuide Biopsy Needle Recall for Incorrect Stylet Configuration

    Bard Peripheral Vascular Inc is recalling 1,250 TruGuide Disposable Coaxial Biopsy Needles because some units may contain two trocar or two blunt tip stylets instead of one of each.

    Product
    Bard TruGuide Disposable Coaxial Biopsy Needle  Mixed Product Part Number C1816B The TruGuide Disposable Coaxial Biopsy Needles are intended for use as a guiding needle in obtaining core biopsy samples from soft tissue such as liver, kidney, spleen, lymph nodes and various…
    Category
    Medical Device
    Distribution
    Distributed nationwide