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.

20876–20900 of 21633

ModerateFDA (Drugs)·D-103-2013·2013-01-02
Lloyd Inc. of Iowa Recalls Subpotent Levothroid 75 mcg Tablets
Lloyd Inc. of Iowa is recalling 16,548 bottles of Levothroid 75 mcg tablets because the product is subpotent and has a 9-month stability interval.
Product
Levothroid (levothyroxine sodium tablets, USP), 75 mcg., 100-count bottles, Rx only, NDC 0456-1322-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0479-2013·2013-01-02
Philips CT System Software Update Addresses Nonhazardous Reliability Issues
Philips is updating Extended Brilliance Workspace software to version 4.5.5 to fix nonhazardous reliability issues and improve system functionality.
Product
Computed Tomography X-Ray System, Extended Brilliance Workspace (EBW), Model #728260 Philips Healthcare, Highland Heights, OH The Extended Brilliance Workspace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0615-2013·2013-01-02
Arjo Flowtron Trio DVT Pump Recalled for Lack of FDA Approval
Arjo, Inc. is recalling 2,859 Flowtron Trio DVT Pumps because they were marketed without proper FDA approval.
Product
Flowtron Trio DVT Pump; an Rx intermittent pneumatic compression deep vein thrombosis pump; ArjoHuntleigh AB, Eslov, Sweden; Model 512003; a non-invasive prophylaxis system for reducing the incidence of deep vein thrombosis.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0536-2013·2012-12-26
Biomet Polaris 5.5 Button Lock Screw Inserter Recalled for Hardness Defect
Ebi, LLC is recalling 15 units of Biomet Polaris 5.5 Button Lock Screw Inserters because the hardness of broken units was found to be below acceptable limits.
Product
Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0532-2013·2012-12-26
Medline Total Knee CDS Recalled for Sterile Component Misplacement
Medline Industries is recalling 18 Total Knee CDS packs because a back table cover was placed in the non-sterile portion of the pack instead of the sterile portion.
Product
Medline Total Knee CDS; a single patient prescription procedure pack and disposables, including a back table cover; Product Usage: This Complete Delivery Systems (CDS) custom pack includes components necessary for a total knee replacement surgical procedure.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0828-2013·2012-12-26
Garden Fresh Recalls El Matador Salted Tortilla Chips for Quality Standards
Garden Fresh Salsa, Inc. is recalling El Matador Salted Tortilla Chips because the ingredients used did not meet quality standards.
Product
El Matador Mexican Style Salted Tortilla Chips 16oz (454 g) bags &32 oz (908 g) bags
Category
Food
Distribution
3 states
ModerateFDA (Devices)·Z-0568-2013·2012-12-26
Medline Angio Drape Pack Recall Due to Sterility Misidentification
Medline is recalling 105 Angio Drape Packs because a non-sterile waste bag was assumed to be sterile by customers.
Product
Medline Angio Drape Pack Radiology-LF; a sterile custom single patient prescription procedure pack, including a waste bag, for use by the Interventional Radiology Department; Packaged for Medline Industries, Inc.; Reorder #DYNJ35993D This custom pack includes components…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0572-2013·2012-12-26
Beckman Coulter Recalls Access hLH Calibrators Due to Stability Test Failures
Beckman Coulter is recalling Access hLH Calibrators because stability testing failed to verify expiration dating. The affected lots did not meet procedural requirements for shelf-life.
Product
The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of luteinizing hormone (LH) levels in human serum and plasma using the Access Immunoassay Systems. The Access hLH Calibrators are intended to calibrate the Access…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0564-2013·2012-12-26
BD Recalls Oral Dispensing Syringes Due to Mixed Tip Complaints
Becton Dickinson is recalling 2,786,000 units of 1 mL Oral Dispensing Syringes because a complaint reported mixed oral and non-oral syringe tips within the same lot.
Product
Case Carton: BD Oral Dispensing Syringe 1 mL Clear with Tip Cap BD, Franklin Lakes, NJ 07417 USA Made in USA www.bd.com BD, Laagstraat 57, B-9140 Temse, Belgium On 100 unit plastic bag: BD oral syringes are intended to dispense oral medications.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0569-2013·2012-12-26
DePuy Recalls Pinnacle Cancellous Screws Due to Labeling Error
DePuy Orthopaedics is recalling 118 Pinnacle Cancellous Screws because the labels incorrectly identify them as Cannulated Screws.
Product
Pinnacle Cancellous Screw Packaging: Product is housed within a polyurethane protector; this is placed inside an uncoated Tyvek/PET peel pouch and sealed. This package is placed into a paperboard carton, labeled and shrink-wrapped. PINNACLE¿ CANCELLOUS Bone Screws are…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0846-2013·2012-12-26
Arnold's Candies Wintergreen Puffs Recalled for Missing Color Additives on Label
Arnold's Candies Wintergreen Puffs are being recalled because the label failed to list Yellow #5 and Blue #1. The product was distributed in New York, Ohio, and Pennsylvania.
Product
Arnold's Candies Handmade Since 1953 www.arnoldscandies.com Wintergreen Puffs***INGREDIENTS: Sugar, Cream of Tarter, Artificial Flavoring and Coloring WARNING: Manufactured in a facility that also handles peanuts NET WT 6 oz (170g) 0 73629 00308 0 931 High Grove Blvd Akron, OH…
Category
Food
Distribution
3 states
ModerateFDA (Devices)·Z-0607-2013·2012-12-26
Varian Segmented Cervix Applicator Set Recalled for Difficult Disconnection
Varian Medical Systems is recalling 15 units of the Segmented Cervix Applicator Set because the guide tube is difficult to disconnect from the cervical sleeve.
Product
Segmented Cervix Applicator Set, part number GM11004310, a component used with the tube for segments and cervical sleeves The guide tube for segments and cervical sleeves in the Segmented Cervix Applicator Set was developed to treat cancer of the cervix, vagina, endometrium…
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0563-2013·2012-12-26
Dako CoverStainer Slide Rack Recalled for Performance Defects
Dako Denmark A/S is recalling CoverStainer Slide Racks because their expected lifetime does not meet performance requirements due to manufacturing variations.
Product
CoverStainer Slide Rack The CoverStainer Slide Rack is an accessory to the CoverStainer instrument. The purpose is to hold microscopic slides, during transfer through the staining process. The rack can hold up to 10 slides at a time, and is necessary for optimal CoverStainer…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0847-2013·2012-12-26
Arnold's Candies Root Beer Puffs Recalled for Missing Color Labeling
Arnold's Candies is recalling Root Beer Puffs because the label failed to list Yellow #5 and Blue #1. The product was distributed in New York, Ohio, and Pennsylvania.
Product
Arnold's Candies Handmade Since 1953 www.arnoldscandies.com Root Beer Puffs Puffs***INGREDIENTS: Sugar, Cream of Tarter, Artificial Flavoring and Coloring WARNING: Manufactured in a facility that also handles peanuts NET WT 6 oz (170g) 0 73629 00307 3 931 High Grove Blvd Akron…
Category
Food
Distribution
3 states
ModerateFDA (Devices)·Z-0602-2013·2012-12-26
Bayer Recalls Medrad Continuum MR Infusion System Tubing Sets
Bayer HealthCare is recalling Medrad Continuum MR Infusion System tubing sets due to a variation that may cause flow rate accuracy issues when used with Continuum pumps.
Product
Medrad(R) Continuum MR Infusion System Secondary Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0538-2013·2012-12-26
Zimmer Recalls Coonrad/Morrey Elbow Replacement Kits Due to Pin Error
Zimmer is recalling specific lots of Coonrad/Morrey elbow replacement kits because they may contain an incorrect small inner pin instead of the required regular pin.
Product
Coonrad/Morrey New Ulnar Revision Kit for Use with Non-Interchangeable Regular Humerals STERILE Rx, Tivanium QTY/PKG:1 Product Usage: The ulnar and humeral components are connected by placing the hollow, outer axis pin across the two components and securing It with the…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0527-2013·2012-12-26
Biomet Recalls EBI XFIX DFS Rail System Due to Missing Markings
Biomet is recalling 49 units of the EBI XFIX DFS Rail System because graduation markings were missing on 14 swivel clamps.
Product
EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp). The Biomet Rail System consists of a unilateral external fixator rail, modular bone screw clamps, and compression and distraction units. The device is used in the treatment of bone fractures.
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-0565-2013·2012-12-26
Del Mar Reynolds Medical Recalls BleaseFocus Anesthesia Workstations Due to Manual Error
Del Mar Reynolds Medical is recalling BleaseFocus Anesthesia Workstations and 700/900 Series Ventilators because the user manuals describe a secondary oxygen supply failure alarm that is not actually installed in the devices.
Product
BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. In most cases, the customer ordered both a BleaseFocus anesthesia workstation and a 700/900 ventilator. In some cases, the customer may order a 700/900 stand-alone ventilator would…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0526-2013·2012-12-26
EEG Info Recalls EEG NeuroAmp Devices Due to Mislabeling
EEG Info is recalling EEG NeuroAmp devices because of a potential risk associated with mislabeling.
Product
EEG NeuroAmp, Model Number: CS 10090; CS 10137. Biofeedback and Relaxation
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0596-2013·2012-12-26
Medrad Continuum MR Infusion System Tubing Sets Recalled for Flow Rate Issues
Bayer HealthCare is recalling Medrad Continuum MR Infusion System tubing sets because a variation may cause flow rate accuracy issues when used with Continuum pumps.
Product
Medrad(R) Continuum MR Infusion System Standard Administration Kit Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0571-2013·2012-12-26
BioMotion SpineSix Medical Device Field Correction for Regulatory Deficiencies
BioMotion Medical Systems is issuing a field correction for SpineSix treatment tables to address regulatory deficiencies and prepare for premarket clearance.
Product
SpineSix consists of a motorized treatment table that is controlled by an integral computer. The system is operated by means of 12-inch Color LCD touch screen that displays treatment time, positioning and magnitude and direction of motion. There are eight fully customizable…
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-0535-2013·2012-12-26
Titan Spine Recalls Endoskeleton TA VBR Implants for Labeling Errors
Titan Spine is recalling 92 Endoskeleton TA VBR implants because their labels contain incorrect indications for use.
Product
Titan Spine Endoskeleton TA Implant products. 2107-0118 18mm Standard Endoskeleton Implant VBR 2107-0120 20mm Standard Endoskeleton Implant VBR 2107-0218 18mm Large Endoskeleton Implant VBR 2107-0220 20mm Large Endoskeleton Implant VBR Endoskeleton TA VBR is intended…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0598-2013·2012-12-26
Medrad Continuum MR Infusion System Tubing Sets Recalled for Flow Accuracy Issues
Bayer HealthCare is recalling Medrad Continuum MR Infusion System tubing sets because a variation may cause flow rate accuracy issues when used with Continuum pumps.
Product
Medrad(R) Continuum MR Infusion System Primary Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0529-2013·2012-12-26
DePuy Mitek Sterile Reamers Recalled for Incorrect Size Labeling
DePuy Mitek is recalling 20 sterile reamers because 7 units were labeled as 11MM but contained 10MM reamers.
Product
DePuy Mitek 11 MM Fully Fluted Reamer, Sterile Product Number: 232423 DePuy Mitek Sterile Reamers are intended to cut through cortical and cancellous bone during Cruciate Ligament Repair/Reconstruction of the knee.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0593-2013·2012-12-26
Bausch + Lomb Stellaris PC Vision Enhancement System Recall
Bausch & Lomb is recalling 124 Stellaris PC Vision Enhancement System modules because they may need recalibration.
Product
Bausch + Lomb Stellaris PC Vision Enhancement System, Posterior Fluidics Module (PFM). The system is intended for the emulsification and removal of cataracts, anterior, and posterior segment vitrectomy.
Category
Medical Device
Distribution
0 states