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.

9126–9150 of 21595

  • ModerateFDA (Devices)·Z-1239-2019·2019-05-08

    PerkinElmer AutoDELFIA hCG Kit Recalled for Inaccurate Low-Range Results

    PerkinElmer is recalling AutoDELFIA hCG Kits because hCG concentrations may be decreased by 15-20% at the lower measuring range.

    Product
    AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-112 - Product Usage: Quantitative determination of human gonadotrophin (hCG).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1245-2019·2019-05-08

    Siemens CT Scanner Recall for Potential Scan Abortion in Dual Energy Mode

    Siemens Medical Solutions is recalling 53 SOMATOM Definition Edge CT scanners due to a software issue that may cause scans to abort in Dual Spiral Dual Energy mode.

    Product
    SOMATOM Definition Edge, Model Number 10590000 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1260-2019·2019-05-08

    GE Discovery NM/CT 670 ES Recalled for Potential Detector Screw Issue

    GE Healthcare is recalling three Discovery NM/CT 670 ES systems because detector screws may not have been secured correctly during installation.

    Product
    Discovery NM/CT 670 ES Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormali
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1224-2019·2019-05-08

    Matrix Surgical Recalls 42 OmniPore Implants Due to Mislabeling

    Matrix Surgical Holdings is recalling 42 OmniPore Surgical Implants due to product mislabeling. The recall covers units distributed in the US and several international countries.

    Product
    OMNIPORE Surgical Implant Petite Paranasal - Right - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. OmniPore Surgi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1241-2019·2019-05-08

    Bard Medical Recalls ArcticGel Pads Due to Adhesion Defects

    Bard Medical Division is recalling specific lots of ArcticGel Pads because the hydrogel may not adhere properly to the pad.

    Product
    Medivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads: Description, Catalog Number a) Intrepid ArcticGel Small Pad Kit, 31705I b) Intrepid ArcticGel Medium Pad Kit, 31707I c) Intrepid ArcticGel Large Pad Kit, 31709I d) Intrepid ArcticGel Universal Pad, 31700I e) ArcticGel Universal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1264-2019·2019-05-08

    GE Healthcare Recalls 16 NM/CT 870 CZT Systems for Screw Issue

    GE Healthcare is recalling 16 NM/CT 870 CZT systems because detector screws may not be secured correctly, potentially compromising mounting redundancy.

    Product
    NM/CT 870 CZT, Model/Catalogue/Code # H3906CW Product Usage: The GE Discovery NM/CT 670 CZT system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine syste
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1223-2019·2019-05-08

    Matrix Surgical Recalls 46 OmniPore Implants Due to Mislabeling

    Matrix Surgical Holdings is voluntarily recalling 46 OmniPore Surgical Implants due to product mislabeling. The recall covers units distributed in the US and several international countries.

    Product
    OMNIPORE Surgical Implant Petite Paranasal - Left - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. OmniPore Surgi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1317-2019·2019-05-08

    Harmless Harvest Recalls Dairy-Free Yogurt Drink Due to Packaging Defect

    Harmless Harvest Inc. is voluntarily recalling specific lots of its Dairy-Free Yogurt Drink due to a packaging defect that may cause premature spoilage.

    Product
    Harmless Harvest Dairy-Free Yogurt Drink; Cultured Coconut Drink; Probiotic Original Unsweetened. 8 fl. oz. plastic bottle; UPC 859078-002962 USDA Organic
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1255-2019·2019-05-08

    Randox G-6-PDH Normal Control Recalled for Incorrect Target Values

    Randox Laboratories is recalling 10 kits of G-6-PDH Normal Control because the target values and ranges in specific lots are incorrect.

    Product
    G-6-PDH Normal Control (G-6-PDH CONTROL N), Catalogue Number PD2618 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Glucose-6-Phosphate Dehydrogenase in erythrocytes
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1246-2019·2019-05-08

    Siemens CT Scanner Recall for Potential Scan Abortion in Dual Mode

    Siemens is recalling 53 SOMATOM Edge Plus CT scanners due to a software issue that may cause scans to abort when using the optional Dual Spiral Dual Energy mode.

    Product
    SOMATOM Edge Plus, Model Number 10267000 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1242-2019·2019-05-08

    BioFire FilmArray Gastrointestinal Panel Recalled for False Positive Results

    BioFire Diagnostics is recalling the FilmArray Gastrointestinal (GI) Panel due to elevated rates of false positive results for Campylobacter and Cryptosporidium.

    Product
    FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC REF: RFIT-ASY-0104, and RFIT-ASY-0116), Product Usage: The FilmArray Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with Fil
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1243-2019·2019-05-08

    Molnlycke Recalls EZ Derm Porcine Xenograft Due to Heat Seal Failures

    Molnlycke Health Care is recalling 1,332 units of EZ Derm Porcine Xenograft due to intermittent heat seal failures on the outer pouch.

    Product
    EZ Derm Porcine Xenograft, labeled as the following: a. EZ Derm 3x4 (8x10 cm) Non-Perforated, Part Number: 131703-03; b. EZ Derm 7 x 18 (17 x 46 cm) Non-Perforated, Part Number: 131704-03; c. EZ Derm 2 x 2 (5 x 5 cm) Non-Perforated, Part Number: 131705-03; d.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1254-2019·2019-05-08

    Randox G-6-PDH Deficient Control Recalled for Incorrect Target Values

    Randox Laboratories is recalling 14 kits of G-6-PDH Deficient Control because the target values and ranges in specific lots are incorrect.

    Product
    G-6-PDH Deficient Control (G-6-PDH CONTROL D), Catalogue Number PD2617 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Glucose-6-Phosphate Dehydrogenase in erythrocytes
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Food)·F-1297-2019·2019-05-01

    Patagonia Provisions Mellow Curry Savory Seeds Recalled for Gluten

    Patagonia Provisions is recalling Mellow Curry Savory Seeds labeled gluten-free because they contain gluten in excess of 20 ppm.

    Product
    Patagonia Provisions Mellow Curry Savory Seeds; 1 oz. poly-film pouches. 12 pouches per case Vegan, Gluten Free Distributed by Patagonia Provisions, Inc. Sausalito, CA
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1220-2019·2019-05-01

    Abbott Recalls 32 St. Jude Medical Confirm Rx Insertable Cardiac Monitors

    Abbott is recalling 32 St. Jude Medical Confirm Rx Insertable Cardiac Monitors because the devices incorrectly determine that their security certificates have expired, preventing them from pairing with the mobile app.

    Product
    St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile. Product Usage: The St. Jude Medical Confirm Rx insertable cardiac monitor (ICM) is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network (PCN). It is indi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1208-2019·2019-05-01

    Exactech Recalls Mismarked Truliant Tibial Fit Trays for Knee Replacement

    Exactech is recalling 18 Truliant Tibial Fit Trays because they were mismarked as size 3. The devices were distributed to facilities in 10 US states.

    Product
    Truliant Tibial Fit Tray Cemented SZ 3F / 3T, Catalog Number 02-022-45-3030 Product Usage: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented The OPTETRAK Comprehensive Knee Systems are indicated for use in skeletally mature individuals undergoing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1212-2019·2019-05-01

    Covidien Endo Grasp Auto Suture Grasper Recalled for Sterilization Labeling Error

    COVIDIEN LLC is recalling 240 units of the Endo Grasp Auto Suture Grasper 5mm because the sterilization method used was not consistent with the labeling and approved method.

    Product
    Covidien Endo Grasp Auto Suture Grasper 5mm REF: 173030 The Covidien Endo Grasp" Auto Suture" grasper 5 mm instrument has applications in a variety of gynecologic, general, urologic, thoracic and endoscopic procedures for temporary grasping/clamping of tissue and small tubula
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1306-2019·2019-05-01

    Samira Food Products Soy Chunk Recalled for Undeclared Sulfites

    Traders West Inc is recalling Samira Food Products Vegeterian 100% Soy Chunk due to failure to declare sulfites.

    Product
    Samira Food Products Vegeterian 100% Soy Chunk, Net Wt. 8oz
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1296-2019·2019-05-01

    Patagonia Provisions Classic Barbecue Savory Seeds Recalled for Gluten Contamination

    Patagonia Provisions is recalling Classic Barbecue Savory Seeds labeled gluten-free because they contain gluten in excess of 20 ppm.

    Product
    Patagonia Provisions Classic Barbecue Savory Seeds; 1 oz. poly-film pouches. 12 units per case Vegan, Gluten Free Distributed by Patagonia Provisions, Inc. Sausalito, CA
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1247-2019·2019-05-01

    Lupin Recalls Morphine Sulfate Tablets for Impurity Specification Failures

    Lupin Pharmaceuticals is recalling specific lots of Morphine Sulfate Extended-Release Tablets because they failed impurity and degradation specifications.

    Product
    MORPHINE SULFATE — MORPHINE SULFATE (MORPHINE SULFATE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1101-2019·2019-05-01

    KaVo Orthopantomograph OP 3D Cone-Beam CT System Firmware Recall

    KaVo Dental Technologies is recalling 230 Orthopantomograph OP 3D cone-beam CT systems due to a defect in firmware versions 2.1.0 and 2.1.1.

    Product
    cone-beam CT system
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1213-2019·2019-05-01

    Covidien Procedure Kits Recalled for Sterilization Labeling Inconsistency

    Covidien LLC is recalling 148 procedure kits because the sterilization method used was not consistent with the labeling and approved method.

    Product
    Procedure kits include devices from the affected lots distributed OUS only: (1)BOX KIT00529H KIT COLECISTECTOMIA ACCESO (2)BOX KIT00680 KIT COLECISTECTOMIA- (3)BOX KIT00681 KIT APENDICECTOMIA (4)BOX KIT00897 KIT COLON IZQUIERDO (5)BOX LAPL1 ZESTAW DO CHOLECYSTEKTOMII (6
    Category
    Medical Device
    Distribution
    Distributed nationwide