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.

21526–21550 of 21633

ModerateFDA (Devices)·Z-1831-2012·2012-06-27
Spacelabs Healthcare Recalls Pathfinder SL Holter Analyzer Software
Spacelabs Healthcare is recalling Pathfinder SL software due to crashes and incorrect QTc values. The software is used to analyze Holter monitor data.
Product
The product is Pathfinder SL, version 1.6.0.3057 software used with the Spacelabs Healthcare Pathfinder SL Holter Analyzer, version 1.6.0. Product Usage: The Holter Analyzer analyzes information collected from ambulatory electrocardiogram recorders worn by patients and used…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1811-2012·2012-06-27
Tripath PrepStain Syringing Pipettes Recalled for Leaking Defect
Tripath Imaging is recalling PrepStain Syringing Pipettes 240 because they may leak and fail to dispense the minimum required sample volume.
Product
PrepStain Syringing Pipettes 240 (Catalog #490517)
Category
Medical Device
Distribution
0 states
ModerateFDA (Food)·F-1634-2012·2012-06-27
Shiitake-Ya Dried Mushroom Slices Recalled for Pesticide Residues
LA Link Corporation is recalling Shiitake-Ya Dried Shiitake mushroom slices because FDA testing found pesticide and polycyclic aromatic hydrocarbon residues with no established tolerances.
Product
Shiitake-Ya brand Dried Shiitake mushroom slices, 6 oz plastic jars, UPC 7 1452 22183 9. Product labeling reads in part: " Shiitake-Ya gourmet Shiitake SLICES***Antioxidants Amino Acids Omega 3+6***Immune-Boosting*** NET WEIGHT. 6 oz (170 g)***Natural Enzymes Fiber (80% Chitin)…
Category
Food
Distribution
3 states
ModerateFDA (Devices)·Z-1853-2012·2012-06-27
Accumetrics Recalls VerifyNow P2Y12 Assay for Field Correction
Accumetrics is recalling the VerifyNow P2Y12 Assay to implement a field correction that eliminates the reporting of BASE and % Inhibition results.
Product
VerifyNow P2Y12 Assay, Part Number: 85064, All reagent lots. Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. The VerifyNow Systems intended for…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1387-2012·2012-06-27
Kutol Hands Down Medicated Lotion Soap Recalled for Unapproved Dye
Kutol Products Co Inc is recalling Hands Down Medicated Lotion Soap because it contains Red Dye #15, an ingredient not approved for use in drugs.
Product
Hands Down Medicated Lotion Soap, 1 gallon bottle, 4 gallons per case, Distributed by PCS Industries, Crestwood, IL, 60446
Category
Drug
Distribution
1 state
ModerateFDA (Devices)·Z-1819-2012·2012-06-27
NIMS Recalls Exer-Rest Brochures for Unsubstantiated Claims
Non-Invasive Monitoring Systems is voluntarily recalling 3,665 Exer-Rest marketing brochures nationwide because they contain unsubstantiated health claims.
Product
US-001 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling indications for use, precautions and general operational information of the Exer-Rest device, Models AT3800 and AT4700. Ever-Rest US Brochure US-001 Rev A. Brochure…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1383-2012·2012-06-27
Linde Recalls 283 Oxygen Cylinders Due to Calibration Deviations
Linde Gas LLC is recalling 283 oxygen cylinders in Ohio because expired calibration equipment may have caused incorrect filling levels.
Product
LifeGas OXYGEN COMPRESSED UN1072 USP, Distributed by: Linde
Category
Drug
Distribution
1 state
ModerateFDA (Food)·F-1451-2012·2012-06-27
Reese Medium Smoked Oysters Recalled Due to Norovirus Risk
World Finer Foods is recalling Reese Medium Smoked Oysters due to inadequate sanitation controls that may have exposed the product to human fecal waste and norovirus.
Product
Reese Medium Smoked Oysters. Distributed by: World Finer Foods, Inc. Bloomfield, NJ 07003 USA. Product of Korea. UPC 70670-00600.
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1854-2012·2012-06-27
Accumetrics Recalls VerifyNow System for P2Y12 Test Result Changes
Accumetrics is recalling 1,167 VerifyNow Systems to correct the P2Y12 test results by removing the BASE and % Inhibition values.
Product
VerifyNow System, part #85005-6H Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. The VerifyNow Systems intended for use with human whole blood…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1851-2012·2012-06-27
Boston Scientific Pediatric Snare Recalled for Extension Difficulty
Boston Scientific is recalling 1,970 Profile Single-Use Pediatric Snares because the loop may be difficult to extend from the catheter.
Product
Boston Scientific Profile Single-Use Pediatric Snare 13mm UPN Outer Box: M00562551 Inner Pouch: M00562550 The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which can be extended and retracted from the snare's flexible outer sheath using a…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1521-2012·2012-06-27
Kerry Foods Recalls Lactic Acid Products Due to Metal Fragment Contamination
Kerry Foods is voluntarily recalling lactic acid products contaminated with metal fragments. The affected items were distributed in 15 US states, Canada, and Chile.
Product
KERRY, KF # 11605R, CONTAINS MILK, Item #B18648.02 , Net Wt 50 Lb (22.68Kg)
Category
Food
Distribution
15 states
ModerateFDA (Drugs)·D-1378-2012·2012-06-20
Luitpold Recalls Concentrated Sodium Chloride Injection Due to Particulate Matter
Luitpold Pharmaceuticals is recalling concentrated sodium chloride injection vials because visual particles were found in retention samples.
Product
CONCENTRATED SODIUM CHLORIDE INJECTION, USP, 23.4% a) 30 mL SINGLE DOSE VIAL, (NDC 0517-2930-25), b) 100 mL PHARMACY BULK PACKAGE (NDC 0517-2900-25), Rx Only, AMERICAN REGENT, INC. SHIRLEY, NY 11967.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1797-2012·2012-06-20
Vygon Recalls Heparin Lock Flush Syringes Due to Voluntary Manufacturer Action
Vygon Corporation is voluntarily recalling specific lots of VY Flush Heparin Lock Flush Syringes and related kits. The recall covers nationwide distribution across 23 states.
Product
Vygon VY(TM)Flush Heparin Lock Flush Syringes, 1 Unit per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box Prefilled syringes are used to maintain the patency of indwelling catheter lumens
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1800-2012·2012-06-20
Vygon Recalls Heparin Lock Flush Syringes Due to Voluntary Manufacturer Action
Vygon Corporation is voluntarily recalling specific lots of VY Flush Heparin Lock Flush Syringes. The recall covers syringes and kits distributed nationwide.
Product
Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are used to maintain the patency of indwelling catheter lumens
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1804-2012·2012-06-20
Vygon Recalls Heparin Lock Flush Syringes and PICC Insertion Kits
Vygon is recalling heparin lock flush syringes and kits containing them due to a voluntary recall of VY Flush Heparin Lock Flush Syringes.
Product
Churchill Medical Systems, Inc. A VYGON Company PICC INSERTION TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1374-2012·2012-06-20
Noven Recalls Daytrana Patches Due to Defective Delivery System
Noven Pharmaceuticals is recalling 244,320 Daytrana patches because the delivery system is miscalibrated or defective, making it difficult to remove the release liner.
Product
Daytrana (methylphenidate) transdermal system patch, Delivers 15 mg over 9 hours (1.6 mg/hr), 1 patch per pouch (NDC 54092-553-01), packaged in 30-count patches per box (NDC 54092-553-30), Rx only, Manufactured for Shire US Inc., Wayne, PA 19087; by Noven Pharmaceuticals, Inc.…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1373-2012·2012-06-20
Daytrana Transdermal Patch Recalled for Defective Delivery System
Noven Pharmaceuticals is recalling Daytrana transdermal patches because the release liner may be difficult to remove. This could affect the patient's ability to apply the medication correctly.
Product
Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3 mg/hr), 1 patch per pouch (NDC 54092-555-01), packaged in 30-count patches per box (NDC 54092-555-30), Rx only, Manufactured for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc.…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1433-2012·2012-06-20
Chicken of the Sea Recalls Oysters Due to Insanitary Conditions
Chicken of the Sea is recalling specific oyster products because they were prepared or packed under insanitary conditions that may have rendered them injurious to health.
Product
1) Chicken of the Sea Whole Oysters Pieces 24 units per case, UPC 4800000069; 2) Pacific Pearl Whole Oysters Pieces 12 units per case, UPC 7175902112
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1377-2012·2012-06-20
Ben Venue Recalls Octreotide Acetate Injection Due to Potential Low Fill Volume
Ben Venue Laboratories is recalling Octreotide Acetate Injection vials because some may have low fill volume. The recall covers 6,515 packs distributed nationwide and in Puerto Rico.
Product
Octreotide Acetate Injection, 50 mcg/mL (0.05 mg/mL), 1 mL single dose vials, packaged in 10 x 1 mL single dose vials per pack, Rx only, Manufactured for: Bedford Laboratories, Bedford, OH 44146; Manufactured by: Ben Venue Laboratories, Inc., Bedford, OH 44146; NDC…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1418-2012·2012-06-20
Napoleon Canned Smoked Oysters Recalled for Insanitary Conditions
The Napoleon Company is recalling canned smoked oysters prepared under insanitary conditions that may have contaminated the product.
Product
Napoleon canned, Smoked Oysters, Large. Item no. 48-313. Net WT. per can is 3.66 oz (106 g). The UPC is 0 41253 00313 4. The product is labeled in parts: "***NAPOLEON***Large***SMOKED OYSTERS***NET WT. 3.66 OZ (106 g)***INGREDIENTS: SMOKED OYSTERS, SOYA OIL, SALT***PRODUCT…
Category
Food
Distribution
3 states
ModerateFDA (Devices)·Z-1807-2012·2012-06-20
Vygon Recalls Heparin Lock Flush Syringes and Dressing Change Kits
Vygon Corporation is voluntarily recalling Heparin Lock Flush Syringes and kits containing them due to a related recall of VY Flush Heparin Lock Flush Syringes.
Product
Churchill Medical Systems, Inc. DRESSING CHANGE KIT Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1794-2012·2012-06-20
Plasma Surgical Recalls PlasmaJet Open Surgery Handpieces Due to Seal Failure
Plasma Surgical Inc. is recalling 36 PlasmaJet Open Surgery Handpieces because a potential seal failure may cause a small drop of distilled water coolant to leak during use.
Product
PlasmaJet Open Surgery Handpiece (Part of the PlasmaJet Neutral Plasma Surgery System) The PlasmaJet system is a neutral plasma surgery system that is designed for cutting and coagulation in open surgery and laparoscopic surgery.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1408-2012·2012-06-20
Newport Creamery Chocolate Peanut Butter Frozen Yogurt Recalled for Aflatoxin
Bliss Bros Dairy is recalling Newport Creamery Chocolate Peanut Butter Frozen Yogurt due to elevated aflatoxin levels in the liquid peanut butter ingredient.
Product
Newport Creamery Chocolate Peanut Butter Frozen Yogurt 3-gallon containers and 80 half gallon containers
Category
Food
Distribution
3 states
ModerateFDA (Food)·F-1401-2012·2012-06-20
Panera Cream Cheese Spread Recalled for Ingredient Labeling Error
Panera Bread LLC is recalling Reduced Fat Hazelnut Cream Cheese Spread because the ingredient statement on the label was reversed. The product name on the label is correct.
Product
Panera ,HAZELNUT CREAM CHEESE SPREAD Reduced Fat, 8 0z , Refrigerated
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1799-2012·2012-06-20
Vygon Recalls Heparin Lock Flush Syringes Due to Voluntary Manufacturer Action
Vygon Corporation is voluntarily recalling multiple lots of VY Flush Heparin Lock Flush Syringes and related kits. The recall covers products distributed nationwide.
Product
Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 5mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are used to maintain the patency of indwelling catheter lumens
Category
Medical Device
Distribution
Distributed nationwide