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.

18076–18100 of 21645

ModerateFDA (Devices)·Z-2105-2014·2014-07-30
Terumo Recalls Sarns Soft-Flow Aortic Cannulae Due to Fiber Particulate
Terumo CVS is recalling Sarns Soft-Flow Aortic Cannulae because in-process inspections found loose fiber particulate exceeding specifications.
Product
Sarns Soft-Flow Aortic Cannulae 6.0mm, 7mm & 8mm angled and straight tip, suture bulb with or without Luer and/or Xcoating Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2102-2014·2014-07-30
Terumo Dual-stage Venous Return Cannulae Recalled for Loose Fiber Particulate
Terumo CVS is recalling specific lots of venous return cannulae used in heart surgery due to loose fiber particulate found during inspection.
Product
Terumo Dual-stage Venous Return Cannulae 28/38, 29/37, 32/40, 34/46, 36/46 & 36/51 Fr with 1/2" flare or connector Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-2218-2014·2014-07-30
Land O'Lakes Recalls American Cheese Due to Plastic Contamination
Land O'Lakes is recalling 5 lb blocks of Extra Melt American White cheese due to potential contamination with large pieces of plastic.
Product
Item: 4815 Land O'Lakes, Extra Melt American White, Pasteurized Process American Cheese, Net WT 5 lbs (2.26 KG)
Category
Food
Distribution
9 states
ModerateFDA (Food)·F-2217-2014·2014-07-30
Kraft Recalls Knudsen and Other Cottage Cheese Brands for Temperature Violations
Kraft Foods is voluntarily recalling multiple cottage cheese brands produced in California because ingredients were not stored at proper temperatures.
Product
Low fat cottage cheese, 1.5% milkfat, with pineapple sold under the Knudsen brand packaged in plastic containers with a net weight of 16 oz. (1 lb.) 453 g.
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Food)·F-2211-2014·2014-07-30
Kraft Recalls Knudsen, Breakstone's, and Other Cottage Cheese Brands
Kraft Foods is voluntarily recalling multiple cottage cheese brands due to ingredients not being stored at proper temperatures.
Product
Cottage Doubles - cottage cheese, 2% milkfat, with strawberry topping sold under the Knudsen brand and packaged in a plastic container with a net weight of 3.9 oz. (110 g).
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2104-2014·2014-07-30
Terumo Recalls Three-stage Venous Return Cannulae Due to Loose Fiber Particulate
Terumo Cardiovascular Systems is recalling specific lots of Three-stage Venous Return Cannulae because in-process inspections found loose fiber particulate exceeding specifications.
Product
Terumo Three-stage Venous Return Cannulae 28 Fr with 3/8" flare, 30 Fr with 3/8" connector and 30 Fr with 3/8" flare. Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2088-2014·2014-07-30
ITC-Nexus Dx Recalls Hemochron Jr. APTT Cuvettes Due to Test Errors
ITC-Nexus Dx is recalling Hemochron Jr. APTT cuvettes because they may produce erroneously elevated test results or out-of-range high error codes in non-heparinized blood samples.
Product
Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103.
Category
Medical Device
Distribution
3 states
ModerateFDA (Food)·F-2210-2014·2014-07-30
Kraft Recalls Knudsen, Breakstone's, and Other Cottage Cheese Brands
Kraft Foods is voluntarily recalling multiple cottage cheese brands due to ingredients not being stored at proper temperatures.
Product
Cottage Doubles - cottage cheese, 2% milkfat, with peach topping sold under the Knudsen brand and packaged in a plastic container with a net weight of 3.9 oz. (110 g).
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2083-2014·2014-07-30
DePuy Orthopaedics Recalls RECLAIM Distal Tapered Surgical Instruments
DePuy Orthopaedics is recalling RECLAIM Distal Tapered surgical instruments because they can be difficult to remove from the Distal Stem.
Product
RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
Category
Medical Device
Distribution
49 states
ModerateFDA (Food)·F-2207-2014·2014-07-30
Kraft Recalls Cottage Cheese Due to Temperature Storage Issues
Kraft Foods is voluntarily recalling Knudsen, Breakstone's, Simply Kraft, and Daily Chef cottage cheese because ingredients were not stored at proper temperatures.
Product
Fat free cottage cheese sold under the Knudsen or Kraft brand and packaged in a plastic container with a net weight of 16 oz. (1 lb.) 453 g, a plastic container with a net weight of 24 oz. (1.5 lb.) 680 g, or a plastic container with a net weight of 32 oz. (2 lb.) 907 g.
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2095-2014·2014-07-30
Terumo Recalls Sarns Aortic Arch Cannulas Due to Loose Fiber Particulate
Terumo CVS is recalling 120 units of Sarns Flexible Aortic Arch Cannulas because in-process inspections found loose fiber particulate exceeding specifications.
Product
Sarns Flexible Aortic Arch Cannula 8.0mm with luer, 3/8" connector Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-2213-2014·2014-07-30
Kraft Recalls Knudsen and Other Cottage Cheese Due to Storage Issues
Kraft Foods is voluntarily recalling multiple cottage cheese brands due to ingredients not being stored at proper temperatures.
Product
Cottage Doubles - cottage cheese, 2% milkfat, with blueberry topping sold under the Knudsen brand and packaged in a plastic container with a net weight of 3.9 oz. (110 g).
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2093-2014·2014-07-30
Salter Labs Recalls Oxygen Masks Due to Incorrect Labeling
Salter Labs is recalling 584 units of Model No. 8120-7 oxygen masks because the insert label incorrectly identifies the device as a non-rebreather instead of a partial rebreather.
Product
Oxygen Mask, Model No. 8120-7 Product Usage: Oxygen Mask, High Concentration partial rebreather, with 7 foot (2.1 m) supply tube, Elastic Strap Fixation, Single patient use.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-2212-2014·2014-07-30
Kraft Recalls Knudsen and Other Cottage Cheese Brands Due to Storage Issues
Kraft Foods is voluntarily recalling multiple cottage cheese brands produced in Tulare, CA, because ingredients were not stored at proper temperatures.
Product
Cottage Doubles - cottage cheese, 2% milkfat, with pineapple topping sold under the Knudsen brand and packaged in a plastic container with a net weight of 3.9 oz. (110 g).
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2101-2014·2014-07-30
Terumo Recalls Sarns Venoatrial Cannulae Due to Loose Fiber Particulate
Terumo CVS is recalling 3,040 Sarns Venoatrial Cannulae units because in-process inspections found loose fiber particulate exceeding specifications.
Product
Sarns Venoatrial Cannulae 36/46 Fr with 1/2" flare or connector Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. The Venous Return Cannula…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1450-2014·2014-07-30
Shamrock Recalls Mislabelled Sulfamethoxazole and Trimethoprim Tablets
Shamrock Medical Solutions Group LLC is recalling Sulfamethoxazole and Trimethoprim tablets due to a labeling error where 800 mg/160 mg tablets were labeled as 400 mg/80 mg.
Product
SULFAMETHOXAZOLE AND TRIMETHOPRIM — SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM)
Category
Drug
Distribution
5 states
ModerateFDA (Devices)·Z-2113-2014·2014-07-30
Biogenex InSite HER-2 Detection Kit Recalled for Lack of FDA Approval
Biogenex Laboratories is recalling four InSite HER-2 Detection Kits distributed in Brazil and Ecuador without FDA 510(k) approval.
Product
InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2103-2014·2014-07-30
Terumo TenderFlow Pediatric Venous Cannulae Recalled for Loose Fiber Particulate
Terumo CVS is recalling specific lots of TenderFlow Pediatric Venous Cannulae due to loose fiber particulate exceeding specifications found during inspection.
Product
Terumo TenderFlow Pediatric Venous Cannulae, 8, 10, 12, 14, 16, 18, 20, 22 & 24 Fr angled & straight tip, 1/4" & 3/8" flare, Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-2220-2014·2014-07-30
Land O'Lakes Recalls Yellow Process Cheese Due to Plastic Contamination
Land O'Lakes is recalling specific lots of yellow process cheese due to potential contamination with large pieces of plastic.
Product
Item: 48770 Land O'Lakes, Pasteurized Process Cheese Product, Yellow, NET WT 5 LBS (2.27 KG).
Category
Food
Distribution
9 states
ModerateFDA (Food)·F-2209-2014·2014-07-30
Kraft Recalls Cottage Cheese Due to Temperature Storage Violations
Kraft Foods is voluntarily recalling multiple brands of cottage cheese because ingredients were not stored at proper temperatures, creating a potential safety risk.
Product
Cottage cheese, 4% milkfat, sold under the Daily Chef, Knudsen, or Kraft brand and packaged in a plastic container with a net weight of 8 oz. (227 g), a plastic container with a net weight of 16 oz. (1 lb.) 453 g, a plastic container with a net weight of 24 oz. (1.5 lb.) 680 g…
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Food)·F-2208-2014·2014-07-30
Kraft Recalls Cottage Cheese Due to Improper Ingredient Storage
Kraft Foods is voluntarily recalling cottage cheese sold under Breakstone's, Daily Chef, Knudsen, and Kraft brands because ingredients were not stored at proper temperatures.
Product
Low fat cottage cheese, 2% milkfat, sold under the Breakstone's brand, Daily Chef brand, Knudsen brand, or Kraft brand packaged in a tray of 4 plastic containers each with a net weight of 4 oz. (113 g), a tray of 8 plastic containers each with a net weight of 4 oz. (113 g), a…
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Food)·F-2214-2014·2014-07-30
Kraft Recalls Knudsen and Other Cottage Cheese Due to Temperature Storage Issues
Kraft Foods is voluntarily recalling multiple cottage cheese brands produced in Tulare, CA, because ingredients were not stored at proper temperatures.
Product
Cottage Doubles - cottage cheese, 2% milkfat, with raspberry topping sold under the Knudsen brand and packaged in a plastic container with a net weight of 3.9 oz. (110 g).
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1451-2014·2014-07-30
Shamrock Medical Recalls Docusate Calcium Softgels Due to Labeling Error
Shamrock Medical Solutions is recalling Docusate Calcium Softgel Capsules because they were mislabeled as Docusate Sodium. The error involves a label mix-up for the specific active ingredient.
Product
Docusate Calcium Softgel Capsules, 240 mg, OTC, packaged and labeled to contain Docusate Sodium 240mg, Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfg: Major Pharmaceuticals, Livonia, MI NDC 00904-5779-60
Category
Drug
Distribution
5 states
ModerateFDA (Devices)·Z-2069-2014·2014-07-23
Axcentria Recalls Calcium Hydroxide Powder Due to Missing 510(k) Approval
Axcentria Pharmaceuticals is recalling one lot of Calcium Hydroxide Powder because it was distributed without FDA approval and lacks usage instructions.
Product
Calcium Hydroxide Powder, USP For use in root canal therapy by health care professional. Product Application or Usage: Provides bactericidal effect on carious dentine. Paste delivered to root apex provides pulp insulation. Protects the vital pulp from infections and further…
Category
Medical Device
Distribution
2 states
ModerateFDA (Food)·F-2193-2014·2014-07-23
Ducal Prepared Sauce Queso Recalled for pH Above 4.4
Industrias Alimenticias Kern's y Cia. S.C.A. is recalling Ducal Brand Prepared Sauce Queso/Cheese because lab analysis detected a pH greater than 4.4.
Product
Ducal Brand Prepared Sauce Queso/Cheese, UPC 088313-08328-6, Net Wt 4 oz, Product of Guatemala, C.A. Central American product made with quality by: Industrias Alimenticias Kern's Y/Cia, S.C.A., Km. 6 1/2 Carretera al Atlantico. Reg. D.G.R.V.C.S.D.R.C.A. B 658 The product was…
Category
Food
Distribution
5 states