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 2741

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-0837-2017·2016-12-28
Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects
Biomet 3i is recalling 64 dental implant abutments because some product pouches may not have been sealed during packaging.
Product
BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 4MM(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-0861-2017·2016-12-28
Biomet 3i Low Profile Abutment Recall for Unsealed Packaging
Biomet 3i is recalling 1,371 low profile abutments because a limited number of product pouches may not have been sealed during packaging.
Product
BIOMET 3i LOW PROFILE ABUTMENT NON-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-0851-2017·2016-12-28
Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects
Biomet 3i is recalling 137 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 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-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-0897-2017·2016-12-28
PerkinElmer Recalls EnLite Neonatal TREC Kits for Missing UDI Labels
PerkinElmer is recalling 73 EnLite Neonatal TREC Kits because the Unique Device Identifier (UDI) is missing from the outer box labels.
Product
EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the semi-quantitative determination of TREC (T-cell receptor excision circle) DNA in blood specimens dried on filter paper. The test is for use on the VICTOR" EnLite instrument. The test is indicated for use as…
Category
Medical Device
Distribution
2 states
LowFDA (Devices)·Z-0854-2017·2016-12-28
Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects
Biomet 3i is recalling 124 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 4MM(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-0834-2017·2016-12-28
Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects
Biomet 3i is recalling 228 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 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-0779-2017·2016-12-28
PerkinElmer Recalls DELFIA hFSH Kits Due to Stability Testing Failures
PerkinElmer Health Sciences is recalling 79 DELFIA hFSH kits because real-time stability testing showed decreased hFSH concentrations in control sera.
Product
DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum
Category
Medical Device
Distribution
4 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-0848-2017·2016-12-28
Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects
Biomet 3i is recalling 216 dental implant abutments because some product pouches may not have been sealed during packaging.
Product
BIOMET 3i LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 4MM(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-0842-2017·2016-12-28
Biomet 3i Dental Abutments Recalled for Potential Packaging Seal Defects
Biomet 3i is recalling 46 units of a specific dental implant abutment because some product pouches may not have been sealed during packaging.
Product
BIOMET 3i CERTAIN 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-0225-2017·2016-12-28
Tom's of Maine Antiperspirant Recalled for Incorrect Back Label
Les Emballages Knowlton Inc. is recalling Tom's of Maine Naturally Dry Natural Powder Antiperspirant Stick because an incorrect back label was applied to the product.
Product
Toms of Maine Naturally Dry Natural Powder Antiperspirant Stick, Distributed by: Tom's of Maine, Kennebunk, ME 04043, Made in Canada, Unit UPC: 077326831953 Case UPC: 10077326831950
Category
Consumer Product
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0835-2017·2016-12-28
Biomet 3i Low Profile Dental Implant Abutments Recalled for Packaging Defect
Biomet 3i is recalling 50 units of Low Profile Dental Implant Abutments because some product pouches may not have been sealed during packaging.
Product
BIOMET 3i CERTAIN LOW PROFILE 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-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…
Category
Medical Device
Distribution
Distributed nationwide
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 (Devices)·Z-0753-2017·2016-12-21
Ecolab Microtek Rolled Probe Cover Recalled for Incorrect Expiration Date Labeling
Ecolab Inc is recalling Microtek Rolled Probe Cover PC0907NB because the inner carton box displays an incorrect expiration date.
Product
Ecolab, Microtek Rolled Probe Cover PC0907NB, Rx Only.
Category
Medical Device
Distribution
7 states
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 (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-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 (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
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 (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 (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