The Recall Desk

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.

10051–10075 of 21617

  • ModerateFDA (Devices)·Z-2994-2018·2018-09-19

    Diagnostica Stago Recalls STA N¿oplastine¿ CI Reagents Due to Quality Control Issues

    Diagnostica Stago is recalling STA N¿oplastine¿ CI in-vitro diagnostic kits because quality control values fell outside assigned ranges, potentially affecting prothrombin time test results.

    Product
    Diagnostica Stago STA N¿oplastine¿ CI, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. REF: 00666 The STA¿ - N¿oplastine¿ CI kits provide reagents for the determination of the prothrombin time (PT) in plasma with STA-R¿, STA Compact¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·080-2018·2018-09-13

    Bob Evans Pork Sausage Links Recalled for Plastic Contamination

    Bob Evans Farms is recalling pork sausage links due to possible clear hard plastic contamination. No illnesses have been reported.

    Product
    BEF Foods, Inc. — Bob Evans Farms Inc. Recalls Pork Sausage Link Products due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2967-2018·2018-09-12

    Encore Medical Recalls Foundation Modular Femoral Stem for Lack of Clearance

    Encore Medical is recalling 12 units of the Foundation Modular Femoral Stem because the device lacks FDA clearance.

    Product
    Foundation Modular Femoral Stem, Part Number, 220-10-110. Knee prosthesis component. The Foundation Revision Knee is a total knee system indicated as knee joint replacement for patients suffering from pain and dysfunction.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Food)·F-1932-2018·2018-09-12

    Virtus Pharmaceuticals Recalls Virt-Nate and Virt Gard Tablets for Labeling Error

    Virtus Pharmaceuticals is recalling Virt-Nate and Virt Gard Tablets because the labels do not reflect the correct amount of Dietary Folate Equivalents.

    Product
    Virt-Nate Tablets, Number of units per package: 100 Tablets Package Type: 100 Tablets/Bottle
    Category
    Drug
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-2974-2018·2018-09-12

    Quasar MD Plus Light Therapy System Recalled for Uncleared Claims

    Quasar Bio-Tech, Inc. is recalling the Quasar MD Plus Light Therapy System because the packaging and user manuals contain claims for collagen and elastin production that were not cleared by the FDA.

    Product
    Quasar MD Plus, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1183-2018·2018-09-12

    Akorn Recalls Ethosuximide Capsules Due to Impurity Failures

    Akorn, Inc. is recalling Ethosuximide Capsules, 250 mg, due to out-of-specification results for an unspecified impurity.

    Product
    Ethosuximide Capsules, USP, 250 mg, 100 capsules per bottle, Rx only, Mfg For VersaPharm Incorporated, Maroerre, GA 30062. Mfg By: Swiss Caps AG, Kirchberg, Switzerland. NDC: 61748-025-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1933-2018·2018-09-12

    Virtus Pharmaceuticals Recalls Virt-Nate and Virt Gard Tablets for Labeling Error

    Virtus Pharmaceuticals is recalling Virt-Nate and Virt Gard tablets because the labels do not reflect the correct amount of Dietary Folate Equivalents.

    Product
    Virt Gard Tablets, Number of units per package: 100 Tablets Package Type: 100 Tablets/Bottle
    Category
    Food
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-2965-2018·2018-09-12

    Zimmer Biomet Recalls 2.5mm Orthopedic Pegs Due to Packaging Error

    Zimmer Biomet is recalling 2.5mm orthopedic pegs because a larger 22mm peg was found in the package. The error affects 25 units distributed to Japan and the Netherlands.

    Product
    Peg Fully Threaded, Locking, 2.5mm x 10mm, Item Number 131212610 Orthopedic device used for stabilization and fixation of small bone fragments Intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstruct
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2975-2018·2018-09-12

    Quasar Pure Rayz Light Therapy System Recalled for Uncleared Claims

    Quasar Bio-Tech is recalling 6,783 Pure Rayz Light Therapy Systems because the packaging and manuals make claims about collagen and elastin production that were not cleared by the FDA.

    Product
    Pure Rayz, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2982-2018·2018-09-12

    Alden Optical Recalls Zen RC Toric Contact Lenses with Incorrect Contents

    Alden Optical is recalling Zen RC Toric contact lenses because vials labeled for specific prescriptions contained incorrect lenses.

    Product
    Zen RC Toric-Gas permeable contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx)as follows: Zen RC TPC (Toric Peripheral Curve) Zen RC FT (Front Toric Optics) Catalog Number: AOZNT Zenlens Toric - Zenlens contact lenses are indicated for daily wear for the corr
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-2973-2018·2018-09-12

    Quasar Bio-Tech Recalls Baby Quasar Plus Light Therapy System

    Quasar Bio-Tech is recalling the Baby Quasar Plus Light Therapy System because it lacks FDA clearance for specific collagen and elastin claims.

    Product
    Baby Quasar Plus, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2969-2018·2018-09-12

    Inspire II Implantable Pulse Generator Recalled for Incorrect Use-By Date

    Inspire Medical Systems is recalling 93 Inspire II Implantable Pulse Generators because the device registration labels contain an incorrect use-by date.

    Product
    Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep Apnea, Inspire Part #900-003-020, Product Usage: The device is an implanted component of the Inspire Upper Airway Stimulation (UAS) system. The UAS therapy is used to treat a subset of patients wit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2966-2018·2018-09-12

    Exactech Recalls Tibial Alignment Guides Due to Incorrect GTIN Labeling

    Exactech is recalling 7 Tibial Alignment Guides because the Global Trade Item Number (GTIN) printed on the devices is incorrect.

    Product
    Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle replacements.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2981-2018·2018-09-12

    Alden Optical Recalls Zenlens Toric Contact Lenses Due to Labeling Errors

    Alden Optical is recalling 36 vials of Zenlens Toric-Gas Permeable Contact Lenses because the vials contained incorrect lenses for the prescriptions labeled on them.

    Product
    Zenlens Toric-Gas Permeable Contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx) as follows: Zenlens FT(Front Toric); Zenlens Toric-Zenlens FT + MV (Front Toric+Microvault); Zenlens TPC-(Toric Peripheral Curve); Zenlens TPC + FT- (Toric Peripheral Curve + FrontTor
    Category
    Medical Device
    Distribution
    13 states
  • ModerateNHTSA·18V596000·2018-09-07

    Micro Bird Recalls 2018 School Buses for Missing Seat Warning Labels

    Micro Bird is recalling 252 2018 MB II school buses because certain child restraint seats are missing warning labels, which may lead to improper use and injury.

    Product
    MICRO BIRD — MICRO BIRD MB II SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2948-2018·2018-09-05

    Medline Sodium Chloride Injection Recalled for Incorrect Overwrap Packaging

    Medline Industries is recalling 90,870 units of 0.9% Sodium Chloride Injection due to incorrect overwrap packaging. The product is intended for flushing IV catheters and tubing.

    Product
    Medline 0.9 % Sodium Chloride Injection, USP 5 mL in 10 mL Syringe ZR Intended for flushing IV catheters and IV tubing only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1170-2018·2018-09-05

    Validus Recalls Calcitriol Oral Solution Due to Subpotency

    Validus Pharmaceuticals is recalling 7,864 bottles of Calcitriol Oral Solution because testing showed lower than expected potency at the 18-month stability time point.

    Product
    Calcitriol Oral Solution, 1 mcg/mL, 15 mL bottle, Rx Only, Distributed by: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA, NDC 63304-241-59
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2924-2018·2018-09-05

    Stryker Mako Vizadisc Knee Procedure Tracking Kit Recalled for Detection Issues

    Mako Surgical Corporation is recalling specific lots of the Stryker Mako Vizadisc Knee Procedure Tracking Kit because the reflective material may be damaged, preventing camera detection.

    Product
    Stryker Mako Vizadisc Knee Procedure Tracking Kit
    Category
    Medical Device
    Distribution
    35 states
  • ModerateFDA (Devices)·Z-2901-2018·2018-09-05

    Stryker QUIKFLAP Burr Hole Cover Recall Due to Packaging Compromise

    Stryker is recalling QUIKFLAP burr hole covers because the sterile packaging may become compromised after three years.

    Product
    QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01524S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2957-2018·2018-09-05

    Baxter Recalls FLOSEAL Special Applicator Tips Due to Plastic Formulation Error

    Baxter Healthcare is recalling FLOSEAL Special Applicator Tips because an incorrect plastic formulation was used in the blue luer component.

    Product
    FLOSEAL Special Applicator Tips in cartons labeled in part, "Floseal SPECIAL APPLICATOR TIPS***6 x Malleable Tip Trimmable Tip***Baxter***." The pouches inside the cartons are labeled in part, "Floseal SPECIAL APPLICATOR TIPS***Baxter***"."
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2910-2018·2018-09-05

    Stryker AXS PP Cranium Plates Recalled for Packaging Compromise

    Stryker is recalling 22,831 AXS PP cranium plates because the sterile packaging may become compromised after three years.

    Product
    AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01540S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2944-2018·2018-09-05

    Roche cobas p 612 Pre-Analytical System Recalled for Contamination Risk

    Roche is recalling 12 units of the cobas p 612 pre-analytical system because sample material may contact the pipetting nozzle, potentially causing false positive test results.

    Product
    Roche cobas p 612 pre-analytical system (63x) Model: 07563116001 The cobas p 612 pre-analytical system is a computer controlled fully automatic system for sorting of open and closed barcoded and centrifuged and non-centrifuged sample tubes. The cobas p 612 is intended for u
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-2908-2018·2018-09-05

    Stryker QUIKFLAP Burr Hole Cover Recall Due to Packaging Compromise

    Stryker is recalling QUIKFLAP burr hole covers because the sterile packaging may become compromised after three years.

    Product
    QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01536S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states