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.

14026–14050 of 21617

  • ModerateFDA (Devices)·Z-2594-2016·2016-08-24

    Hospira Recalls Receptal Liners Due to Potential Suction Failure

    Hospira is recalling Receptal liners because using incorrect sizes with canisters may prevent the lid from fitting properly, resulting in insufficient or inconsistent vacuum suction.

    Product
    Hospira RECEPTAL LINERS: 1L(1000mL), 1.5L (1500mL), 2L (2000mL) 1) List Number 43056-01; 2) List Number 43023-01; 3) List Number 43025-01; 4) List Number 43025-11; 5) List Number 43025-21; 6) List Number 43025-25; 7) List Number 43038-05; 8) List Number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2455-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i is recalling Conical EP Twist Lock TM Coping Dental implants because pouches may not have been sealed during packing.

    Product
    Conical EP Twist Lock TM Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2509-2016·2016-08-24

    Biomet 3i Recalls EP Healing Abutments Due to Unsealed Pouches

    Biomet 3i is recalling specific EP Healing Abutments because pouches may not have been sealed during packing, potentially compromising sterility.

    Product
    Certain EP Healing Abutment 4.1mm(D) x 5mm(P) x 2mm(H) Item: ITHA52 Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2545-2016·2016-08-24

    LeMaitre Vascular Recalls 1.5 mm HYDRO LeMaitre Valvulotome Devices

    LeMaitre Vascular is recalling 50 units of the 1.5 mm HYDRO LeMaitre Valvulotome because the wire may detach, rendering the device inoperable.

    Product
    1.5 mm HYDRO LeMaitre Valvulotome, 40 cm. Sterile REF # 1010-00 Product Usage: The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2501-2016·2016-08-24

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

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

    Product
    Certain Twist Lock TM Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2483-2016·2016-08-24

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

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

    Product
    Certain Implant Cover Screw Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2437-2016·2016-08-24

    Biomet 3i Recalls Preformance Temporary Cylinder Dental Implants

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

    Product
    Preformance Temporary Cylinder Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2431-2016·2016-08-24

    Biomet 3i Recalls Locator Replacement Housing Dental Implants

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

    Product
    Locator Replacement Housing Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2554-2016·2016-08-24

    Medtronic Recalls Valleylab Laparoscopic Argon Electrodes Due to Sterile Barrier Risk

    Medtronic is recalling Valleylab Laparoscopic Flexible Argon Electrodes because the packaging may be compromised, potentially breaching the sterile barrier.

    Product
    Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes Item Code: E253028 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2426-2016·2016-08-24

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

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

    Product
    O-Ring Abutment 4.1mm(D) x 6mm(H) Item: OSO60 Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2441-2016·2016-08-24

    Biomet 3i Dental Implants Recalled for Unsealed Pouches

    Biomet 3i is recalling 1.6 million dental implant protection caps because pouches may not have been sealed during packing.

    Product
    Provide Protection Cap Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2489-2016·2016-08-24

    Biomet 3i Recalls Non-Hexed Dental Implants Due to Sealing Defects

    Biomet 3i is recalling approximately 1.6 million non-hexed dental implants because pouches may not have been sealed during packing.

    Product
    Certain Non-Hexed Implant Pick-up Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2560-2016·2016-08-24

    Medtronic Recalls Valleylab Laparoscopic Electrodes Due to Sterile Barrier Risk

    Medtronic is recalling Valleylab Laparoscopic AP Argon Blunt Needle Electrodes because the package may be compromised, potentially breaching the sterile barrier.

    Product
    Valleylab Laparoscopic AP Argon Blunt Needle Electrode 28cm Item Code: E258328 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2562-2016·2016-08-24

    Medtronic Valleylab Laparoscopic Electrodes Recalled for Sterile Barrier Compromise

    Medtronic is recalling Valleylab Laparoscopic Curved Spatula Electrodes due to a potential sterile barrier breach that could compromise the package integrity.

    Product
    Valleylab Laparoscopic Curved Spatula Electrode 36CM Item Code: E277136 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-2495-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

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

    Product
    Certain Standard Abutment Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2472-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i, LLC is recalling Implant Twist Lock TM Coping Dental implants because pouches may not have been sealed during packing.

    Product
    Implant Twist Lock TM Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2543-2016·2016-08-24

    LeMaitre Vascular Recalls 1.5 mm HYDRO LeMaitre Valvulotome Devices

    LeMaitre Vascular is recalling 1,992 units of the 1.5 mm HYDRO LeMaitre Valvulotome because the wire may detach at the handle, rendering the device inoperable.

    Product
    1.5 mm HYDRO LeMaitre Valvulotome, 98 cm, Sterile REF # 1009-00 Product Usage: The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2435-2016·2016-08-24

    Biomet 3i Recalls Preformance Dental Implants Due to Unsealed Pouches

    Biomet 3i, LLC is recalling Preformance 15 degrees pre-angled post dental implants because pouches may not have been sealed during packing.

    Product
    Preformance 15 degrees pre-angled post Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2444-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

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

    Product
    Standard Abutment Pick -Up Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2464-2016·2016-08-24

    Biomet 3i Recalls Gingihue Dental Implants Due to Unsealed Pouches

    Biomet 3i is recalling Gingihue 15 Degree Pre-Angled Post Dental implants because pouches may not have been sealed during packing.

    Product
    Gingihue 15 Degree Pre-Angled Post Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2407-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Potential Unsealed Pouches

    Biomet 3i, LLC is recalling specific dental implant abutments because the packaging pouches may not have been sealed during packing.

    Product
    Certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 4mm(H) Item: IWTH54 Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide