The Recall Desk

Severity 1 of 5

Low recalls

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

What “low” means here

Severity 1 (Low) recalls are typically cosmetic defects, documentation issues, packaging-only problems, and Class III administrative corrections. The product itself is unlikely to cause adverse health consequences. The manufacturer is correcting the issue to comply with FDA or USDA rules, not because anyone is at risk. You can almost always continue using a Severity-1 product without concern.

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.

1451–1475 of 2769

  • LowFDA (Devices)·Z-0838-2017·2016-12-28

    Biomet 3i Low Profile Dental Abutments Recalled for Packaging Seal Defects

    Biomet 3i is recalling 123 units of Low Profile Dental Abutments because some product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0831-2017·2016-12-28

    Biomet 3i Low Profile Dental Abutments Recalled for Packaging Seal Defects

    Biomet 3i is recalling 735 low profile dental abutments because a limited number of product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0839-2017·2016-12-28

    Biomet 3i Low Profile One-Piece Abutment Recall for Packaging Seal Defects

    Biomet 3i is recalling 450 units of Low Profile One-Piece Abutments because a limited number of product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0850-2017·2016-12-28

    Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects

    Biomet 3i is recalling 204 dental implant abutments because some product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0846-2017·2016-12-28

    Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects

    Biomet 3i is recalling 246 dental implant abutments because a limited number of product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0828-2017·2016-12-28

    Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects

    Biomet 3i is recalling 127 dental implant abutments because some product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 3.4MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0879-2017·2016-12-28

    OrthoPediatrics PediNail Cortical Screw Recalled for Dimensional Discrepancy

    OrthoPediatrics is recalling 22 PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screws because they measure 50mm instead of the labeled 48mm.

    Product
    OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screw
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-0832-2017·2016-12-28

    Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects

    Biomet 3i is recalling specific low-profile dental implant abutments because a limited number of product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0855-2017·2016-12-28

    Biomet 3i Low Profile Abutment Healing Caps Recalled for Packaging Defects

    Biomet 3i is recalling 391 Low Profile Abutment Healing Caps because a limited number of product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i LOW PROFILE ABUTMENT HEALING CAP An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0830-2017·2016-12-28

    Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects

    Biomet 3i is recalling 27 specific dental implant abutments because some product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 5MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0881-2017·2016-12-28

    Amendia Recalls K-Wires Due to Unacceptable Packaging Seals

    Amendia, Inc. is recalling 5,833 units of K-Wires because the packaging seals are unacceptable, with some showing compromised integrity due to channels or voids.

    Product
    K-Wire 1.4mm x 12in Non-Threaded, Part Number 9080-12U; K-Wire Threaded 1.4mm x 18, Part Number 9080-18T; K-Wire Non-Threaded 1.4mm x 18, Part Number 9080-18U; 1.4mm x 24 Threaded Guide Wire, Part Number 9080-24T; K-Wire Non-Threaded 24, Part Number 9080-24U; Blunt K-Wire, 18 inc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0860-2017·2016-12-28

    Biomet 3i Low Profile Abutment Recall for Packaging Seal Defects

    Biomet 3i is recalling 108 low profile abutments because some pouches may not have been sealed during packaging.

    Product
    BIOMET 3i LOW PROFILE ABUTMENT HEXED TEMPORARY CYLINDER An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0853-2017·2016-12-28

    Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects

    Biomet 3i is recalling 191 dental implant abutments because some product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-0205-2017·2016-12-21

    Jubilant Cadista Recalls Methylprednisolone Tablets Due to Incorrect Expiration Date Labeling

    Jubilant Cadista Pharmaceuticals is recalling 1,512 bottles of Methylprednisolone Tablets, USP, 16 mg, because the expiration date is printed incorrectly as 02/0218 instead of 02/2018.

    Product
    Methylprednisolone Tablets, USP, 16 mg, 50-count bottles, Rx only, Manufactured by Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-003-14.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0606-2017·2016-12-14

    Safecor Vitamin B-1 Tablets Recalled for Incorrect Ingredient Labeling

    Safecor Health is recalling Vitamin B-1 tablets because the boxes are labeled with the wrong chemical form of thiamine.

    Product
    Safecor Vitamin B-1 (THIAMINE) 100 mg tablets NDC: 48433-0108-01 Distributed by: SAFECOR HEALTH, 317 NEW BOSTON STREET, WOBURN, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0170-2017·2016-12-14

    Teva Recalls Qnasl Nasal Aerosol Due to Content Uniformity Failure

    Teva Pharmaceuticals is recalling Qnasl nasal aerosol canisters because the product failed stability testing for spray content uniformity.

    Product
    Qnasl (beclomethasone dipropionate) Nasal Aerosol 40 Mcg, 60 Metered Sprays, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA 19044, By: 3M Drug Delivery Systems, Northridge, CA 91324, NDC 59310-206-06 and 59310-206-08 (Physician Samples).
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0722-2017·2016-12-14

    OraSure Barbiturate Micro-Plate EIA Recalled for Shipping Error

    OraSure Technologies is recalling four kits of Barbiturates Intercept Micro-Plate EIA because cocaine metabolite microplates were shipped instead.

    Product
    Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate) Product is intended for use by clinical laboratories in the qualitative determination of barbiturates in oral fluids.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Drugs)·D-0169-2017·2016-12-14

    Hospira Recalls Lidocaine and Dextrose Injection for Stability Failures

    Hospira Inc. is recalling specific lots of 5% Lidocaine HCL and 7.5% Dextrose Injection because they failed stability specifications for color and pH.

    Product
    5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Single-dose ampule, 5 count box, Rx Only, For Spinal Anesthesia Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4712-01
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-0171-2017·2016-12-14

    Teva Recalls Qnasl Nasal Aerosol Due to Content Uniformity Failure

    Teva Pharmaceuticals USA is recalling Qnasl nasal aerosol because stability testing showed the product failed content uniformity specifications.

    Product
    Qnasl (beclomethasone dipropionate) Nasal Aerosol 80 Mcg, 50 Metered Sprays, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA 19044, By: 3M Drug Delivery Systems, Northridge, CA 91324, NDC 59310-210-13.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0172-2017·2016-12-14

    West-Ward Recalls Sodium Ferric Gluconate Injection Due to Low Iron Content

    West-Ward Pharmaceuticals is recalling 5,142 shelf-packs of Sodium Ferric Gluconate Complex in Sucrose Injection because stability testing revealed the product had lower iron content than specified.

    Product
    SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE — SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE (SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0616-2017·2016-12-14

    Newly Weds Foods Recalls Ham Pump Seasoning for Wood Chips

    Newly Weds Foods Inc is recalling G72642 Ham Pump 35% seasoning bags distributed in Oregon due to potential wood chip contamination.

    Product
    G72642 Ham Pump 35%, 41.92 LB bag composed of one 39.67 LB bag of seasoning and one 2.25 LB bag of cure.
    Category
    Food
    Distribution
    1 state
  • LowUSDA FSIS·117-2016·2016-12-12

    King Meat Services Recalls Beef Products Due To Misbranding

    King Meat Services is recalling approximately 50,991 pounds of beef products due to misbranding. The recall covers items shipped to California distributors, retail, and food service locations.

    Product
    King Meat Service Inc. — King Meat Services, Inc. Recalls Beef Products Due To Misbranding
    Category
    Food
    Distribution
    1 state