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.

18701–18725 of 21645

ModerateFDA (Drugs)·D-1094-2014·2014-03-12
Teva Recalls Dextroamphetamine Tablets Due to CGMP Deviations
Teva Pharmaceuticals is recalling specific lots of Dextroamphetamine tablets because they were manufactured using unapproved material and not properly quarantined.
Product
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1135-2014·2014-03-12
KCI Prevena Peel and Place System Kit Recalled for Connector Issues
KCI USA is recalling Prevena Peel and Place System Kits because the male tubing connector is difficult to connect to the female canister connector.
Product
PRE1001: Prevena Peel and Place System Kit Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1065-2014·2014-03-12
Elekta Digital Accelerators Recalled for Default Value Reset Issues
Elekta, Inc. is recalling 472 digital accelerators because customers are resetting default values outside recommended factory settings.
Product
All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1146-2014·2014-03-12
Dr. Reddy's Recalls Lansoprazole Capsules Due to Microbial Contamination
Dr. Reddy's is recalling multiple brands of Lansoprazole Delayed Release Capsules due to out-of-specification microbial counts.
Product
a) Walgreens Lansoprazole Delayed Release Capsules, USP 15 mg/Acid Reducer, 14 capsules per Bottle, Dist by Walgreen Company, 200 Wilmot RD Deerfield IL 60015 b) Family Wellness Lansoprazole Delayed Release Capsules, USP 15 mg/Acid Reducer, 14 capsules per Bottle, Distributed…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1122-2014·2014-03-12
WalkMed Recalls Triton FP Infusion Pumps Due to Labeling Error
WalkMed Infusion is recalling 797 Triton FP Infusion Pumps because the label on the right side contains an incorrect instruction.
Product
Triton FP Infusion Pump, Part Number 400000, packaged in boxes. The Triton Volumetric Infusion Pump is indicated for delivering infusions of medications, as well as providing TPN (Total Parenteral Nutrition) and PCA (Patient Control Analgesia). It is intended for use in…
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-1060-2014·2014-03-12
McKesson Anesthesia Care System Recalled for Data Mismatch
McKesson Technologies is recalling 10 units of the Anesthesia Care system because patient case data did not match the patient data, including data from another case.
Product
McKesson Anesthesia Care Product Usage: The McKesson Anesthesia Care system is a computer based system which collects, processes,and records data both through manual entry and from monitors which themselves are attached to patients, such as in the operating room environment.…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1144-2014·2014-03-12
Focus Diagnostics Recalls Simplexa Flu and RSV Assay Kits
Focus Diagnostics is recalling Simplexa Flu A/B & RSV Direct Assay Kits due to the potential for false positive test results.
Product
Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C. Model Number MOL2650.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1126-2014·2014-03-12
Hospira Recalls LifeShield Blood Sets Due to Assembly Errors
Hospira Inc. is recalling specific lots of LifeShield Latex-Free HEMA Y-Type Blood Sets because they were assembled incorrectly.
Product
*** 1) List number 126970465 labeled in part: 12697-65 LifeShield LATEX-FREE HEMA; Y-TYPE BLOOD SET, Nonvented, 88 Inch with 210 Micron Filter Pump, Prepierced Injection Site and Secure Lock; Made in Costa Rica; Product Inquiries should be directed to Hospira, Inc., Lake Forest…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1140-2014·2014-03-12
KCI USA Recalls Prevena Customizable Dressing 5-Pack Due to Connector Issue
KCI USA is recalling 20,850 units of the Prevena Customizable Dressing 5-Pack because the male connector on the tubing is difficult to connect to the female connector on the canister tubing.
Product
PRE2055: Prevena Customizable Dressing 5-Pack Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1136-2014·2014-03-12
KCI USA Recalls Prevena Peel and Place System Kits
KCI USA is recalling Prevena Peel and Place System Kits because the tubing connector is difficult to connect to the canister.
Product
PRE1001US: Prevena Peel and Place System Kit (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1139-2014·2014-03-12
KCI Recalls Prevena Incision Management System Kits Due to Connector Issues
KCI USA is recalling Prevena Incision Management System kits because the male tubing connector is difficult to attach to the female canister connector.
Product
PRE2001: Prevena Incision Management Customizable System Box Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1137-2014·2014-03-12
KCI Recalls Prevena Dressing Kits Due to Connector Connection Issues
KCI USA is recalling 20,850 Prevena Dressing kits because the male tubing connector is difficult to connect to the female canister connector.
Product
PRE1055: Prevena Dressing, 5 Pack Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1092-2014·2014-03-12
Teva Recalls Ethambutol Hydrochloride Tablets Due to Incorrect Excipient
Teva Pharmaceuticals is recalling specific lots of Ethambutol Hydrochloride Tablets because they were manufactured with an unapproved gelatin excipient.
Product
Teva Ethambutol Hydrochloride Tablets, USP, 400 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA., NDC 0555-0923-02.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1133-2014·2014-03-12
BencoDental Tartar and Stain Remover Recalled for Incorrect Labeling
Heraeus Kulzer is recalling BencoDental tartar and stain remover due to incorrect labeling on the immediate container.
Product
BencoDental tartar & stain remover ultrasonic cleaning solution Product Usage: Formulated especially for removal of calculus, tartar, tobacco and food stains from dentures, bridges, orthodontic appliances, etc. Use also for removal of permanent cement.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1603-2014·2014-03-12
Heart of the Valley Parsnips Recalled for Pesticide Residue
Ed Fields & Sons, Inc. is recalling Heart of the Valley brand parsnips because they contained pesticide linuron above the maximum residue level.
Product
Heart of the Valley brand Parsnips, produce of U.S.A., packaged in the following sizes: 16 ounces (453 grams), UPC 31446-22016; 20 ounces (566 grams), UPC 31446-22020; 20 lb. bags; and 40 lb boxes
Category
Food
Distribution
5 states
ModerateFDA (Devices)·Z-1138-2014·2014-03-12
KCI Recalls Prevena Dressing Kits Due to Connector Connection Difficulty
KCI USA is recalling 20,850 Prevena Dressing kits because the tubing connector is difficult to connect to the canister.
Product
PRE1055US: Prevena Dressing, 5 Pack (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1113-2014·2014-03-12
Toshiba CT Systems Recalled for X-Ray Output Software Defect
Toshiba is recalling 338 Aquilion CT systems because a software defect may prevent X-ray exposure from starting during contrast studies.
Product
TSX-101A Aquilion 32/64 ONE Computed Tomography X-Ray System; TXS-101/R Aquilion RXL Computed Tomography X-Ray System; TSX-301A Aquilion One Computed Tomography X-Ray System; TSX-301B Aquilion Premium Computed Tomography X-Ray System; TSX-302A Aquilion Prime Computed Tomography…
Category
Medical Device
Distribution
Distributed nationwide
ModerateCPSC·14128·2014-03-06
Canon Recalls PowerShot SX50 HS Cameras for Chemical Irritation Risk
Canon is recalling about 14,000 PowerShot SX50 HS digital cameras because a chemical in the viewfinder rubber can cause skin or eye irritation. Consumers should stop using the cameras and contact Canon for a free repair.
Product
Canon PowerShot SX50 HS Digital Cameras
Category
Consumer Product
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1567-2014·2014-03-05
Mars Recalls Uncle Ben's Saffron Rice Due to Mild Flushing Reports
Mars Food US is recalling Uncle Ben's Infused Rice Saffron Flavor after reports of mild flushing reactions that resolved within two hours.
Product
Uncle Ben's (R), Infused(R) Rice Saffron Flavor, net weight 5 LB (2.27kg), Distributed by MARS foodservices US, P.O. Box 11547, Carson, CA 90749-11547
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1071-2014·2014-03-05
GE Healthcare Recalls Infant Resuscitation Systems Due to Reversed Fittings
GE Healthcare is recalling Giraffe and Panda infant resuscitation systems because oxygen and air inlet fittings were reversed during assembly.
Product
GE Healthcare - Giraffe and Panda Bag and Mask Resuscitation System;Giraffe Stand-alone Infant Resuscitation System. Product Usage: The Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1088-2014·2014-03-05
Actavis Recalls Subpotent Gelnique Oxybutynin Chloride Gel Samples
Actavis is recalling Gelnique (oxybutynin chloride) Gel 10% physician samples because drug potency was compromised during shipment.
Product
Gelnique (oxybutynin chloride) Gel 10%, 100 mg in 1 g sachet, for topical use only. Physician sample in clamshell container with seven heat-sealed sachets. Rx Only. Watson Pharmaceuticals Inc, Corona, CA, 92890. NDC: 52544-084-77.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1564-2014·2014-03-05
Mars Recalls Uncle Ben's Rice Due to Mild Flushing Reports
Mars Food US is recalling Uncle Ben's Infused Rice Roasted Chicken Flavor after reports of mild flushing reactions that resolved within two hours.
Product
Uncle Ben's (R), Infused(R) Rice Roasted Chicken Flavor, net weight 5 LB (2.27 kg) and 25 LB (11.34 kg), Distributed by MARS foodservices US, P.O. Box 5059, Rancho Dominguez, CA 90224-5059
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1563-2014·2014-03-05
Mars Recalls Uncle Ben's Infused Rice Mexican Flavor Due to Flushing Reports
Mars Food US is recalling Uncle Ben's Infused Rice Mexican Flavor after reports of mild flushing reactions that resolved within two hours.
Product
Uncle Ben's (R), Infused(R) Rice Mexican Flavor, net weight 5 LB (2.27 kg) and 25 LB (11.34 kg), Distributed by MARS foodservices US, P.O. Box 5059, Rancho Dominguez, CA
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1590-2014·2014-03-05
Mars Recalls Uncle Ben's Infused Rice Cheese Flavor Due to Flushing Reports
Mars Food US is recalling Uncle Ben's Infused Rice Cheese Flavor nationwide after reports of mild flushing reactions that resolved within two hours.
Product
Uncle Ben's (R), Infused(R) Rice Cheese Flavor, net weight 5 LB (2.27 kg), Distributed by MARS foodservices US, P.O. Box 11547, Carson, CA 90749-1547
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1592-2014·2014-03-05
Newman's Own Coffee K-Cups Recalled for Decaffeinated Labeling Errors
Green Mountain Coffee Roasters is recalling 8,928 boxes of Newman's Own Organic Coffee K-Cups because some caffeinated packs were incorrectly labeled as decaffeinated.
Product
Newmans Own¿ Organics Newmans Special Blend 80 Count K-Cup¿ Packs; UPC 09955515593; Product Code: 15593 281792
Category
Food
Distribution
2 states