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.

10101–10125 of 21617

  • ModerateFDA (Devices)·Z-2953-2018·2018-09-05

    Sysmex Fluorocell PLT Reagent Recalled for Inaccurate Platelet Counts

    Sysmex America is recalling Fluorocell PLT reagent because it may cause falsely low platelet and immature platelet fraction results.

    Product
    Sysmex XN-Series Fluorocell PLT, Catalog #CD994563. Distributed in the U.S.A. by Sysmex America, Inc., Lincolnshire, IL. Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2943-2018·2018-09-05

    Bard Midstream Urine Collector Recalled for Iodine Prep Pad Deficiency

    Bard Medical Division is recalling 131,950 urine collection kits because the included iodine prep pads failed to meet required assay levels for their expiration dating.

    Product
    Bard Midstream Urine Collector with Rigid Funnel and Iodophor Prep Pads. Product Packaging: Three (3) PVP-I prep pads are packed into each urine collection kit carton along with a pre-connected drainage funnel, specimen container, funnel lid, specimen lid and a room label.
    Category
    Medical Device
    Distribution
    24 states
  • ModerateFDA (Devices)·Z-2874-2018·2018-08-29

    BioMérieux VITEK 2 NH ID Test Kit Recalled for Missing Desiccant

    BioMérieux Inc. is recalling 57 cartons of VITEK 2 NH ID Test Kits because they are missing desiccant, which may affect product stability.

    Product
    bioM¿rieux VITEK 2 NH ID Test Kit Product Usage: Is an automated system consisting of instruments, software and reagent cards designed for the ID and antimicrobial susceptibility testing of bacteria and yeast.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2880-2018·2018-08-29

    In2Bones Recalls CoLink Lapidus Plates Due to Incorrect Laser Marking

    In2Bones USA, LLC is recalling 48 units of CoLink Lapidus Plates because right and left plates were laser marked incorrectly.

    Product
    CoLink(TM) Lapidus Plate XP, +2 mm, Left, REF P40 ST265, QTY 1, In2Bones Product Usage: The In2Bones USA LLC, CoLink¿ Plating System is indicated for stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bones
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2876-2018·2018-08-29

    Zimmer Biomet Recalls Persona Partial Knee System Spacer Block Alignment Tower

    Zimmer Biomet is recalling 385 units of the Persona Partial Knee System Spacer Block Alignment Tower because an undersized mating feature could cause device connection issues and minor surgical delays.

    Product
    Persona Partial Knee System Spacer Block Alignment Tower, Item No. 42-5399-006-35 Product Usage: Intended to aid in preparatory surgical procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2879-2018·2018-08-29

    In2Bones Recalls CoLink Lapidus Plates Due to Incorrect Laser Marking

    In2Bones USA, LLC is recalling 47 CoLink Lapidus Plate XP units because right and left plates were incorrectly laser-marked.

    Product
    CoLink(TM) Lapidus Plate XP, +2 mm, Right, REF P40 ST165, QTY 1, In2Bones Product Usage: The In2Bones USA LLC, CoLink¿ Plating System is indicated for stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2918-2018·2018-08-29

    Euro Diagnostica Immunoscan CCPlus Test Kits Recalled for Decreasing Performance

    Euro Diagnostica AB is recalling 25 Immunoscan CCPlus test kits due to decreasing performance over time. The kits were distributed in Minnesota, Texas, and Iran.

    Product
    Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semiquantitative determination of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2881-2018·2018-08-29

    Back 2 Basics Recalls Dymaxeon 5.5 Curved Spinal Rods Due to Labeling Error

    Back 2 Basics Direct LLC is recalling 10 Dymaxeon 5.5 Curved Rods because packages labeled as 110mm may contain 100mm rods.

    Product
    Dymaxeon 5.5 Curved Rod Size 5.5 x 110mm (Yellow), Model Number 06.6441B Product Usage: The Dymaxeon Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2888-2018·2018-08-29

    Civco Infiniti Needle Guide Bracket Recalled for Leak Testing Failure

    Civco Medical Instruments is recalling Infiniti Needle Guide Brackets because a cover failed leak testing during validation of new needle guides.

    Product
    CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers. Product Usage: The bracket and disposable guide provide physicians with a tool for performing needle-guided (or catheter) proced
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2891-2018·2018-08-29

    Ortho Kinematics Recalls Vertebral Motion Analyzer Software Due to Report Errors

    Ortho Kinematics is recalling VMA software versions 2.3.239 through 2.3.254 because administrative errors caused incorrect data in radiological and VMA reports.

    Product
    Vertebral Motion Analyzer (VMA), 2.3.239 - 2.3.254. Product Usage: VMA software is a quantitative imaging software application intended to be used to process digital image files.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1843-2018·2018-08-29

    Asian Gourmet Spicy Chili & Garlic Sauce Recalled for Labeling Error

    Asian Gourmet Spicy Chili & Garlic Sauce is being recalled because the sodium values on the label are not consistent with the current value.

    Product
    ASIAN GOURMET SPICY Chili & Garlic Sauce, NET WT. 12.3 OZ (380g), Distributed by Asian Gourmet 313 Iron Horse Way, Providence, RI 02908 USA, Product of Costa Rica
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1842-2018·2018-08-29

    Tropical Pepper Co. Crushed Chili Pepper Sauce Recalled for Labeling Error

    Alimentos Kamuk Internacional is recalling Tropical Pepper Co. Crushed Chili Pepper Sauce because the sodium values on the label are inconsistent with the current value.

    Product
    TROPICAL PEPPER CO. Crushed Chili Pepper Sauce, 11.5 FL. OZ. (325ml), PRODUCT OF COSTA RICA, Packed Exclusively for: H.L. Benndorf Corp. Medford, NJ 08055
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2883-2018·2018-08-29

    Smith & Nephew Recalls Mispackaged Genesis II Knee Prosthesis Components

    Smith & Nephew is recalling two lots of Genesis II knee prosthesis components because they were packaged with the wrong size and side.

    Product
    GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026 Knee prosthesis
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2882-2018·2018-08-29

    Ortho Kinematics Recalls Vertebral Motion Analyzer Software Due to Error

    Ortho Kinematics is recalling Vertebral Motion Analyzer (VMA) software version 2.3.252 due to a software bug that caused errors in released testing results.

    Product
    Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quantitative imaging software application intended to be used to process digital image files.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2890-2018·2018-08-29

    Ortho Kinematics Recalls Vertebral Motion Analyzer Software Due to Bug

    Ortho Kinematics, Inc. is recalling VMA DataLink Software versions 2.3.231 and 2.3.232 because a software bug caused erroneous test results.

    Product
    Vertebral Motion Analyzer (VMA), VMA DataLink Software.2.3.231, 2.3.232. Product Usage: VMA software is a quantitative imaging software application intended to be used to process digital image files.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2889-2018·2018-08-29

    Ortho Kinematics Recalls Vertebral Motion Analyzer Software Due to Report Error

    Ortho Kinematics is recalling the Vertebral Motion Analyzer (VMA) software because a bug caused errors in the Radiological Read Report.

    Product
    Vertebral Motion Analyzer (VMA), 2.3.250. Product System, image processing, radiological
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2886-2018·2018-08-29

    Arrow Pediatric Central Venous Catheter Kit Recalled for Labeling Error

    Arrow International is recalling 166 kits of pediatric central venous catheters because the packaging incorrectly identifies the catheter length.

    Product
    Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, Cat. No. AK-22502 Product Usage: The multiple-lumen catheter permits venous access to the central circulation of pediatric patients. The ARROWg+ard antimicrobial surface is i
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Food)·F-1815-2018·2018-08-22

    Confidence Prenatal Multi-V + DHA Recalled for Undeclared Ingredients

    Confidence Inc. is recalling Prenatal Multi-V + DHA tablets because they contain undeclared ingredients, including HPMC and several food dyes.

    Product
    FP0692, Confidence, Prenatal Multi-V + DHA, 90 tablets per bottle, UPC# 8 10891 02056 4
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1814-2018·2018-08-22

    Confidence Nitro-Cross 60s Recalled for Undeclared Ingredients

    Confidence Inc. is recalling Nitro-Cross 60s supplements due to undeclared ingredients including HPMC and Titanium Dioxide.

    Product
    FP0292 Confidence Nitro-Cross 60s, UPC# 8 92483 00155 7
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2748-2018·2018-08-22

    Siemens ARTIS Pheno X-Ray System Recalled for Potential Hardware Thermal Issue

    Siemens Medical Solutions USA is recalling 605 ARTIS Pheno interventional fluoroscopic X-ray systems due to a potential hardware issue that may cause thermal effects and damage to system parts.

    Product
    ARTIS Pheno Model 10849000. Interventional Fluoroscopic X-Ray System Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2818-2018·2018-08-22

    Arrow Hands-Off Central Venous Catheter Recalled for Packaging Seal Defects

    Arrow International Inc. is recalling 7,024 units of Hands-Off Multi-Lumen Central Venous Catheters because packaging may not be sealed, potentially compromising sterility.

    Product
    HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14702 The central venous catheter permits venous access to the central circulation through an indwelling Arrow percutaneous shea
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1079-2018·2018-08-22

    Dr. Reddy's Recalls Atorvastatin Calcium Tablets Due to Impurity Failures

    Dr. Reddy's is recalling 40 mg Atorvastatin Calcium tablets because stability testing showed impurity levels exceeding specifications.

    Product
    ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide