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.

876–900 of 2769

LowFDA (Devices)·Z-0358-2019·2018-11-07
Beckman Coulter Sorting-Drive Software Recalled for Barcode Label Errors
Beckman Coulter is recalling Sorting-Drive software versions 4.2 and 4.2.1 because a manual barcode printing feature may generate incorrect tube label IDs.
Product
Sorting-Drive Product Part, Sorting-Drive Plus Kit (Sorting Drive Software v4.2.1), Part No. A89483, Beckman Coulter, Inc. The Sorting-Drive Plus Kit includes the Sorting-Drive 4.2.1 User Kit which includes the Sorting-Drive 4.2.1 Software DVD. . The Sorting-Drive software fa
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0359-2019·2018-11-07
Beckman Coulter Sorting-Drive Software Recall for Barcode Printing Errors
Beckman Coulter is recalling Sorting-Drive software versions 4.2 and 4.2.1 because a manual barcode printing feature may generate incorrect IDs for tube labels.
Product
Sorting-Drive Professional Part, Sorting-Drive Professional Kit, (Sorting Drive Software v4.2.1), Part No. A94144, Beckman Coulter, Inc. The Sorting-Drive Professional Kit (PN A94144) includes the Sorting-Drive 4.2.1 User Kit (PN B95347) which includes the Sorting-Drive 4.2
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0355-2019·2018-11-07
Beckman Coulter Recalls Sorting-Drive Software Due to Barcode Errors
Beckman Coulter is recalling Sorting-Drive software versions 4.2 and 4.2.1 because the manual barcode printing function may generate incorrect IDs for sample tubes.
Product
Software Package, Sorting-Drive 4.2.1 User Kit for Windows XP and Windows 10, Part No. B95347, Manufactured by: Beckman Coulter Biomedical GmbH The Sorting-Drive itself is an optional software to be used with the Automate 2500 Family of products. . The Sorting-Drive 4.2.1 Use
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0368-2019·2018-11-07
3M Fast Release Varnish Recalled for Unpleasant Flavor
3M is recalling 73 units of Fast Release Varnish due to a manufacturing error that introduced extraneous material, causing an unpleasant flavor.
Product
3M Fast Release Varnish, 5% Sodium Fluoride, Mint Flavor, Rx Only, single use. 200 pack, with each package containing 1 0.40 ml varnish and 1 applicator brush. Product is applied to tooth surfaces for sealing dentinal tubules and treatment of hypersensitive teeth.
Category
Medical Device
Distribution
8 states
LowFDA (Devices)·Z-0354-2019·2018-11-07
Beckman Coulter Sorting-Drive 4.2 Software Recalled for Barcode Errors
Beckman Coulter is recalling 25 units of Sorting-Drive 4.2 software due to a defect that may generate incorrect barcode IDs when printing consecutively numbered tube labels.
Product
Software Package, Sorting-Drive 4.2 User Kit, Part No. B73488, Manufactured by: Beckman Coulter Biomedical GmbH The Sorting-Drive itself is an optional software to be used with the Automate 2500 Family of products. The system automates the process of sorting, decapping, and
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0349-2019·2018-11-07
Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions
Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.
Product
Zilver 635 Biliary Stent 5mm x 60mm, Catalog Number: ZIB6-80-5.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0323-2019·2018-11-07
Cook Medical Recalls Zilver 518 Biliary Stent for Incorrect Instructions
Cook Medical is recalling 9,834 Zilver 518 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.
Product
Zilver 518 Biliary Stent 5mm x 80mm, Catalog Number: ZIB5-80-5.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0321-2019·2018-11-07
Cook Medical Recalls Zilver 518 Biliary Stent Due to Incorrect Instructions
Cook Medical is recalling 9,834 Zilver 518 Biliary Stents because the instructions for use contain incorrect details regarding the removal of the delivery system.
Product
Zilver 518 Biliary Stent 5mm x 40mm, Catalog Number: ZIB5-125-5.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0087-2019·2018-10-31
Lupin Recalls Testosterone Topical Solution Due to Defective Pump
Lupin Pharmaceuticals is recalling 6,752 bottles of Testosterone Topical Solution because the pump mechanism is not working.
Product
TESTOSTERONE — TESTOSTERONE (TESTOSTERONE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Food)·F-0060-2019·2018-10-31
Victoria Taylor's New Orleans Seasoning Recalled for Incorrect Labeling
Victoria Gourmet, Inc. is recalling 17 jars of Victoria Taylor's Seasonings - New Orleans due to incorrect product labeling. No illnesses or injuries have been reported.
Product
Victoria Taylor's Seasonings - New Orleans - 5.0 oz. UPC: 666227015090, packaged in a glass jar with lid
Category
Food
Distribution
17 states
LowFDA (Food)·F-0059-2019·2018-10-31
Victoria Taylor's Seasonings Blackening Rub Recalled for Incorrect Labeling
Victoria Gourmet, Inc. is recalling 21 jars of Victoria Taylor's Seasonings Blackening Rub because the product labeling is incorrect.
Product
Victoria Taylor's Seasonings - Blackening Rub, 6.4 oz., UPC: 666227015274, packaged in a glass jar with a lid
Category
Food
Distribution
17 states
LowFDA (Drugs)·D-0239-2019·2018-10-31
Promise Pharmacy Recalls Prednisolone and Gatifloxacin Ophthalmic Solution Due to Precipitate
Promise Pharmacy LLC is recalling Prednisolone and Gatifloxacin Ophthalmic Solution due to the presence of precipitate. The recall covers nationwide distribution.
Product
Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bottle, Rx Only, 31818 US Hwy 19N, Palm Harbor, FL 34684
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0270-2019·2018-10-31
Ameditech Recalls Accutest Drug Test Cups Missing Adulteration Strip
Ameditech Inc is recalling Accutest Drug Test Cup 5+3 units because they were released without the required adulteration strip.
Product
Accutest Drug Test Cup 5+3 Product Usage: The Accutest Drug Test Cup is an in vitro diagnostic test for the rapid detection of multiple drugs in human urine. The test is intended as the first step in a two-step process to provide consumers with information concerning the pres
Category
Medical Device
Distribution
1 state
LowUSDA FSIS·104-2018·2018-10-25
All Peoples Food Recalls Smoked Whole Chicken for Undeclared MSG
All Peoples Food is recalling approximately 3,904 pounds of smoked whole chicken products because they contain monosodium glutamate (MSG) that is not declared on the label.
Product
Recall Notification Report 104-2018 (Smoked Whole Chicken Products)
Category
Food
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0249-2019·2018-10-24
Amerigen Recalls Temozolomide Capsules Due to Dissolution Failures
Amerigen Pharmaceuticals is recalling Temozolomide capsules because stability testing revealed out-of-specification dissolution results.
Product
Temozolomide capsules, 20 mg, packaged in a) 5-count bottle(NCD 43975-253-05), b) 14-count bottle (NDC 43975-253-14), Rx only, Mfd. by: Stason Pharmaceuticals, Inc., Irvine, CA 92618, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ 07071.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0070-2019·2018-10-24
Cicatricure Scar Cream Recalled for Low Active Ingredient Levels
Product Quest Manufacturing LLC is recalling Cicatricure Scar Cream + Sunscreen SPF 30 because the octocrylene and avobenzone levels were found to be lower than required.
Product
Cicatricure, Scar Cream + Sunscreen SPF 30 (avobenzone 3%, octocrylene 10%, oxybenzone 6%), 0.7 oz. (19.8 g) tube, Distributed by: Genomma Lab USA Inc., Houston, TX 77027, UPC 6 50067 00018 7.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0025-2019·2018-10-24
Mylan Recalls Levonorgestrel and Ethinyl Estradiol Tablets Due to Labeling Errors
Mylan Pharmaceuticals is recalling specific lots of levonorgestrel and ethinyl estradiol tablets because the blister packs display incorrect NDC and product name information.
Product
Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg, Rx Only, 3 extended-cycle blister packs containing 91 tablets each, Made in India, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-7281-53.
Category
Drug
Distribution
0 states
LowFDA (Drugs)·D-0069-2019·2018-10-24
Well at Walgreens Scar Cream Recalled for Low Active Ingredient Levels
Product Quest Manufacturing LLC is recalling 6,516 tubes of Well at Walgreens Scar Cream with SPF 30 because the octocrylene and avobenzone levels were found to be lower than required.
Product
Well at Walgreens, Scar Cream with SPF 30, (Avobenzone 3%, Octocrylene 10%, Oxybenzone 6%), 0.7 OZ (19.8 g) tube, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, UPC 3 11917 18281 0.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0016-2019·2018-10-17
Xiromed Recalls Altavera Tablets Due to Generic Name Mislabeling
Xiromed LLC is recalling Altavera tablets because the generic name on the packaging may cause confusion. The FDA classifies this as a Class III recall.
Product
ALTAVERA — ALTAVERA (LEVONORGESTREL AND ETHINYL ESTRADIOL)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0081-2019·2018-10-17
BD FocalPoint Slide Profiler Recalled for Temperature Limit Labeling Error
Becton Dickinson is recalling BD FocalPoint Slide Profiler and GS Review Station units because they may not function below 15°C. The agency states this issue has no potential to cause harm.
Product
BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos. 490398, 490653, 491085, 491086, 491090, 490189 The BD FocalPoint GS Imaging System is intended to assist in cervical cancer screening of BD SurePath Liquid-based Pap Test slides to detect evidence
Category
Medical Device
Distribution
Distributed nationwide
LowNHTSA·18V711000·2018-10-11
Toyota Recalls 2018-2019 Tundra for Incorrect Load Capacity Label
Toyota is recalling 2018-2019 Tundra vehicles because the load carrying capacity label incorrectly overstates weight by 10 pounds, failing federal safety standards.
Product
TOYOTA — TOYOTA TUNDRA
Category
Vehicle
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0072-2019·2018-10-10
Smiths Medical Nasal Cannula Recalled for Incorrect Labeling
Smiths Medical ASD Inc. is recalling 2,550 adult nasal cannulas because the 'Manufactured' and 'Use By' labels are transposed, suggesting the product expired before it was manufactured.
Product
smiths medical portex First Breath Adult Nasal Cannula, REF 001285, Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0074-2019·2018-10-10
Smiths Medical Portex Nasal Oxygen Cannula Recall for Labeling Error
Smiths Medical ASD Inc. is recalling 13,750 Portex First Breath Nasal Oxygen Cannulas because the 'Manufactured' and 'Use By' labels are transposed, incorrectly suggesting the product expired before it was manufactured.
Product
smiths medical portex First Breath Nasal Oxygen Cannula, REF 001292, with Gas Monitoring Line, 305 cm (10ft.) & Male Luer Connector, 213 cm (7ft.) Tubing, & Oxygen Adapter. Product Usage: For the administration of nasal oxygen and humidity to patients.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0071-2019·2018-10-10
Smiths Medical Nasal Cannula Recalled for Transposed Date Labels
Smiths Medical ASD Inc. is recalling 12,000 First Breath Adult Nasal Cannulas because the 'Manufactured' and 'Use By' labels are transposed, incorrectly suggesting the product expired before it was manufactured.
Product
smiths medical portex First Breath Adult Nasal Cannula, REF 001283, Non-flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0075-2019·2018-10-10
Smiths Medical Portex Nasal Oxygen Cannula Recalled for Labeling Error
Smiths Medical ASD Inc. is recalling 850 Portex First Breath Nasal Oxygen Cannulas because the 'Manufactured' and 'Use By' dates are transposed, incorrectly suggesting the product expired before it was made.
Product
smiths medical portex First Breath Nasal Oxygen Cannula, REF 001293, with Gas Monitoring Line, 305 cm (10ft.) & Female Luer Connector, 213 cm (7ft.) Tubing, & Oxygen Adapter. Product Usage: For the administration of nasal oxygen and humidity to patients.
Category
Medical Device
Distribution
Distributed nationwide