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.

20526–20550 of 21633

ModerateFDA (Devices)·Z-1223-2013·2013-05-15
Stryker Irrigator Tips Recalled for Incorrect Sterilization Temperature Instructions
Stryker Endoscopy is recalling reusable irrigator tips because the instructions listed incorrect pre-vacuum steam sterilization temperatures.
Product
Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip , Non-Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1225-2013·2013-05-15
Stryker Irrigator Reusable Tips Recalled for Incorrect Sterilization Instructions
Stryker Endoscopy is recalling 147,921 reusable irrigator tips because the instructions for use listed incorrect pre-vacuum steam sterilization temperatures.
Product
Stryker Irrigator Reusable Tips: 5mm X 32cm Aspiration Needle Tip. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1226-2013·2013-05-15
Stryker Irrigator Tips Recalled for Incorrect Sterilization Temperature Instructions
Stryker Endoscopy is recalling reusable irrigator tips because the instructions listed incorrect pre-vacuum steam sterilization temperatures.
Product
Stryker Irrigator Reusable Tips: 2mm X 32cm Regular Tip with 1 Hole, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1255-2013·2013-05-15
Spinal Elements Recalls Mercury Spinal System Rods Due to Raw Material Issue
Spinal Elements, Inc. is recalling 68 units of the Mercury Spinal System DIA 5.5 x 120mm Lordosed Rod due to a raw material issue. The affected units were distributed in Ohio and Pennsylvania.
Product
Mercury Spinal System DIA 5.5 x 120mm Lordosed Rod, Part Number: 60100-120. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-1186-2013·2013-05-08
Discus Dental Recalls SL3 Soft-Tissue Laser Due to Fiber Breakage
Discus Dental LLC is recalling 150 SL3 Soft-Tissue Lasers because the fiber optic system contains a fragile glass filament that broke near the handpiece.
Product
SL3 SOFT-TISSUE Laser (Model LR2002); Manuf: Discus Dental, LLC, 8550 Higuera Street, Culver City CA 90232. The SL3 is a soft-tissue diode laser intended to be used for dental procedures
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1212-2013·2013-05-08
GE Healthcare Recalls Optima MR430s MRI Scanners Due to Coolant Leak Risk
GE Healthcare is recalling 81 Optima MR430s MRI scanners because coolant supply lines may leak liquid onto the floor, creating a slippery surface and fall hazard.
Product
Optima MR430s MRI Scanner; 5000-0002 is indicated to use as a magnetic resonance imaging device of the leg (excluding the thigh), knee, ankle, foot, elbow, forearm, wrist, and hand.
Category
Medical Device
Distribution
20 states
ModerateFDA (Drugs)·D-296-2013·2013-05-08
Jubilant Cadista Recalls Pantoprazole Sodium Tablets Due to Manufacturing Deviations
Jubilant Cadista Pharmaceuticals is recalling specific lots of Pantoprazole Sodium Delayed Release Tablets because they were not manufactured in accordance with Good Manufacturing Practices.
Product
Pantoprazole Sodium Delayed Release Tablets USP, 40 mg, 90 count bottles, Manufactured by Jubilant Life Sciences Ltd, Roorkee-247661 India ;Marketed by Jubilant Cadista Pharmaceuatical Inc Salisbury, MD 21801 NDC 59746-284-90
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1365-2013·2013-05-08
Vanilla Dessert Bar Recalled for Undeclared FD&C Yellow # 6
Paleteria Y Neveria La Rosita, LLC is recalling 4 oz. Vanilla Dessert Bars because the product contains undeclared FD&C Yellow # 6. The bars were sold in retail stores in Michigan and Indiana.
Product
Vanilla Dessert Bar , 4 oz. Undeclared FD&C Yellow # 6 packaged in clear flexible plastic, ingredients: water, sugar, partially hydrogenated palm kernel oil, nonfat milk solids, corn syrup, whey powder, raisins....red 40, yellow 5 UPC Code 8 94163 00220 5
Category
Food
Distribution
2 states
ModerateFDA (Devices)·Z-1207-2013·2013-05-08
GE Healthcare Recalls MRI Systems Due to Image Flip Defect
GE Healthcare is recalling 4,338 MRI systems because axial and coronal images from certain sagittal 3D series may display a left-to-right flip.
Product
GE Healthcare, Discovery MR750, Discovery 450, Optima 450W (with and without GEM), Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant. Indicated for use as a diagnostic imaging device.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1353-2013·2013-05-08
Pineapple Fruit Bar Recalled for Undeclared Food Dyes
Paleteria Y Neveria La Rosita, LLC is recalling 4 oz Pineapple Fruit Bars because the packaging fails to list FD&C Yellow #6 and Red #40.
Product
Pineapple Fruit Bar, 4 oz. Undeclared FD&C Yellow # 6 and Red # 40 packaged in clear flexible plastic ingredients: water, pineapple, sugar, citric acid, yellow 5 UPC Code 8 94163 00210 6
Category
Food
Distribution
2 states
ModerateFDA (Food)·F-1354-2013·2013-05-08
Mango Dessert Bar Recalled for Undeclared Food Dyes
Paleteria Y Neveria La Rosita, LLC is recalling 4 oz. Mango Dessert Bars because they contain undeclared FD&C Yellow # 6 and Blue # 1.
Product
Mango Dessert Bar, 4 oz. Undeclared FD&C Yellow # 6 and Blue # 1 in clear flexible plastic. Ingredients: water, sugar, mango, partially hydrogenated palm kernel oil, nonfat milk solids UPC Code 8 94163 00220 5
Category
Food
Distribution
2 states
ModerateFDA (Drugs)·D-303-2013·2013-05-08
Warner Chilcott Recalls Femhrt Tablets Due to Chemical Contamination
Warner Chilcott is recalling specific lots of Femhrt tablets because 2-phenylphenol was found in the product. The chemical migrated from the cardboard cartons used for packaging.
Product
Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 0.5 mg/2.5 mcg, 90 count bottle (NDC#: 0430-0145-23), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Marketed by Warner Cholcott (US), LLC, Rockaway, NJ 07866
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1358-2013·2013-05-08
Guava Fruit Bar Recalled for Undeclared FD&C Red #40 Color
Paleteria Y Neveria La Rosita, LLC is recalling 4 oz. Guava Fruit Bars because the product contains undeclared FD&C Red #40 and Blue #1 colors.
Product
Guava Fruit Bar , 4 oz. Undeclared FD&C Red # 40 in clear flexible plastic, ingredients: water, guava fruit, sugar, tumeric, blue 1, UPC Code 8 94163 00210 6
Category
Food
Distribution
2 states
ModerateFDA (Drugs)·D-307-2013·2013-05-08
Benjamins Infants Gripe Mixture Recalled for Manufacturing Violations
Carib Import & Export is recalling 480 bottles of Benjamins Infants Gripe Mixture because FDA inspections found it was not manufactured under current good manufacturing practices.
Product
Benjamins Infants Gripe Mixture, Each 5 mL contains: Light Magnesium Carbonate BP, 200.0 mg; Sodium Bicarbonate BP, 100.0 mg; Sucrose, 487.5 mg; Alcohol, 0.362 mL; Fennel Oil BP, 0.004 mL; Dill Oil BP, 0.005 mL), 120 mL bottle, Manufactured by: P.A. Benjamin Manufacturing Co.…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1209-2013·2013-05-08
GE Healthcare Recalls MRI Systems Due to Image Flip Issue
GE Healthcare is recalling specific MRI systems because reformatted images may display a left-to-right flip, potentially affecting diagnostic accuracy.
Product
GE Healthcare, Optima MR360/Brivo MR355 (HDsv), GE 0.35T Signa Ovation HD MR System, GE 0.2T Signa Profile HD MR System. Indicated for use as a diagnostic imaging device.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1356-2013·2013-05-08
Spicy Mango Dessert Bar Recalled for Undeclared Food Dyes
Paleteria Y Neveria La Rosita, LLC is recalling 4 oz. Spicy Mango Dessert Bars because the product contains undeclared FD&C Yellow # 6 and Blue # 1.
Product
Spicy Mango Dessert Bar , 4 oz. Undeclared FD&C Yellow # 6 and Blue # 1 in clear flexible plastic, ingredients: water, mango, sugar, lime juice, salt, citric acid, chili powder, yellow 5, red 40
Category
Food
Distribution
2 states
ModerateFDA (Devices)·Z-1213-2013·2013-05-08
Encore Medical Recalls 3DKnee e+ Tibial Inserts Due to Labeling Errors
Encore Medical is recalling five 3DKnee e+ Tibial Inserts because they were shipped with incorrect color-coded labels. The devices were distributed to California and Venezuela.
Product
3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1211-2013·2013-05-08
GE Healthcare Recalls MSK Extreme MR Scanners Due to Coolant Leak Risk
GE Healthcare is recalling 70 MSK Extreme MR Scanners because coolant supply lines may leak liquid onto the floor, creating a slippery surface and fall hazard.
Product
MSK EXTREME MR SCANNER, MODEL AA5000 The intended for use as a diagnostic imaging device to produce axial, sagittal, coronal and oblique images of the internal structures of the leg (excluding the thigh), knee, ankle, foot, forearm, elbow, wrist and hand.
Category
Medical Device
Distribution
20 states
ModerateFDA (Drugs)·D-312-2013·2013-05-08
Noven Recalls Daytrana Patches Due to Defective Delivery System
Noven Pharmaceuticals is recalling Daytrana (methylphenidate) transdermal patches because the release liner may be difficult to remove.
Product
DAYTRANA — DAYTRANA (METHYLPHENIDATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1357-2013·2013-05-08
Spicy Cucumber Fruit Bar Recalled for Undeclared Food Dyes
Paleteria Y Neveria La Rosita, LLC is recalling Spicy Cucumber Fruit Bars because they contain undeclared FD&C Yellow # 6 and Blue # 1.
Product
Spicy Cucumber Fruit Bar , 4 oz. Undeclared FD&C Yellow # 6 and Blue # 1 in clear flexible plastic ingredients: water, cucumber, sugar, orange juice, lime juice, salt, citric acid, chili powder, yellow 5, red 40 UPC Code 8 94163 00210 6
Category
Food
Distribution
2 states
ModerateFDA (Devices)·Z-1094-2013·2013-05-08
Trophy CareStream Dental X-ray System Recalled for Bent Connector Defect
Trophy Sas is recalling CareStream Dental Kodak 2100 Intraoral X-ray systems due to a bent connector defect that indicates poor contact of the HT transformer power pin.
Product
CareStream Dental Kodak 2100 Intraoral X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1214-2013·2013-05-08
NxStage PureFlow-B Solution Recalled for Potential Mislabeled Product
NxStage Medical is recalling 1,480 cases of PureFlow-B Solution due to potential mislabeling. The product is used for hemodialysis.
Product
NxStage PureFlow-B Solution, Model/Catalog Number: RFP-401, packaged in a case The NxStage PureFLow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1095-2013·2013-05-08
Trophy CareStream Dental Kodak 2200 Intraoral X-ray System Recall
Trophy Sas is recalling CareStream Dental Kodak 2200 Intraoral X-ray systems due to a bent connector defect that indicates poor contact of the HT transformer power pin.
Product
CareStream Dental Kodak 2200 Intraoral X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1359-2013·2013-05-08
Watermelon Fruit Bar Recalled for Undeclared FD&C Blue # 1
Paleteria Y Neveria La Rosita, LLC is recalling 4 oz. Watermelon Fruit Bars because they contain undeclared FD&C Blue # 1. The product was sold in Michigan and Indiana.
Product
Watermelon Fruit Bar , 4 oz. Undeclared FD&C Blue # 1 packaged in clear flexible plastic ingredients: water, watermelon, sugar, red 40 UPC Code 8 94163 00210 6
Category
Food
Distribution
2 states
ModerateFDA (Devices)·Z-1208-2013·2013-05-08
GE Healthcare Recalls 1.5T SIGNA HDe MR Systems for Image Flip Issue
GE Healthcare is recalling 822 GE 1.5T SIGNA HDe MR systems worldwide due to a software issue that may cause left-to-right image flips in specific reformatted views.
Product
GE Healthcare, GE 1.5T SIGNA HDe MR SYSTEM. Indicated for use as a diagnostic imaging device.
Category
Medical Device
Distribution
Distributed nationwide