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.

6576–6600 of 21595

  • ModerateFDA (Devices)·Z-2823-2020·2020-08-26

    CareFusion Alaris Syringe Module LED Display Dimness Recall

    CareFusion 303, Inc. is recalling Alaris Syringe Module Model 8110 units because the LED display may show dim segments, potentially affecting the visibility of infusion or patient monitoring values.

    Product
    Alaris Syringe Module Model 8110 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2825-2020·2020-08-26

    CareFusion Alaris EtCO2 Module Recall for Dim LED Display Segments

    CareFusion 303, Inc. is recalling Alaris EtCO2 Module Model 8300 units because LED display segments may appear dim, potentially affecting the visibility of infusion or patient monitoring values.

    Product
    Alaris EtCO2 Module Model 8300 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1516-2020·2020-08-26

    Calvin Scott Recalls Hydrochlorothiazide Tablets Due to Packaging Defect

    Calvin Scott & Company is recalling Hydrochlorothiazide 50mg tablets because light-sensitive products were repackaged in transparent pouches, violating CGMP standards.

    Product
    Hydrochlorothiazide 50mg tablets, 14-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by Accord Healthcare, Inc., Durham NC 27703; NDC 16729-0184-17
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1514-2020·2020-08-26

    Calvin Scott Recalls Hydrochlorothiazide Tablets Due to Packaging Defect

    Calvin Scott & Company is recalling Hydrochlorothiazide 25mg tablets because light-sensitive products were repackaged in transparent pouches.

    Product
    Hydrochlorothiazide 25mg tablets, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Mfg: Accord Healthcare, Inc, Durham, NC 27703, NDC 16729-0183-17
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2806-2020·2020-08-26

    Argon Medical Devices Recalls ClosureFast Micro Introducer Sheath Sets

    Argon Medical Devices is recalling 1,000 units of ClosureFast Micro Introducer Sheath Sets because the sterile products were manufactured under one lot with different expiration dates.

    Product
    ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. STERILE|EO; Rx ONLY - Product Usage: Introducer Products are stand-alone components, standard kits, or convenience kits built to user specifications. These products facilitate access to a vein or artery,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1528-2020·2020-08-26

    Calvin Scott Recalls Phentermine HCL Capsules Due to Packaging Defect

    Calvin Scott & Company is recalling Phentermine HCL 30mg capsules because they were repackaged in transparent pouches, exposing the light-sensitive medication to potential degradation.

    Product
    Phentermine HCL Blue/Clear capsules, 30mg, packaged in a) 10-count bags (NDC 10702-0028-10), b) 28-count bags (NDC 10702-0028-10) and c) 56-count bags (NDC 10702-0028-10), Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by KVK-Tech Newtown, PA 18940;
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2826-2020·2020-08-26

    CareFusion Alaris SpO2 Module Recall for Dim LED Display Segments

    CareFusion 303, Inc. is recalling Alaris SpO2 Modules because the LED display may have dim segments, potentially affecting the visibility of infusion or patient monitoring values.

    Product
    Alaris SpO2 Module Model 8210 and Model 8220 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1525-2020·2020-08-26

    Calvin Scott Recalls Phentermine 15mg Capsules Due to Packaging Defect

    Calvin Scott & Company is recalling Phentermine 15mg capsules because light-sensitive products were repackaged in transparent pouches, violating CGMP standards.

    Product
    Phentermine 15mg grey/Yellow Capsules, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, MFG: Sunrise Pharm., Rahway NJ, 07065; NDC 11534-0157-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1518-2020·2020-08-26

    Calvin Scott Recalls Thyroid 1 Gr Tablets Due to Packaging Defects

    Calvin Scott & Co. is recalling Thyroid 1 Gr tablets because light-sensitive products were repackaged in transparent pouches, violating CGMP standards.

    Product
    Thyroid 1 Gr tablets, 28-count bags, Rx Only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by RLC Labs Cave Creek, AZ 85331, NDC 64727-3300-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1532-2020·2020-08-26

    Calvin Scott Recalls Phentermine Tablets Due to Packaging Defect

    Calvin Scott & Company is recalling specific lots of Phentermine HCL 37.5 mg tablets because they were repackaged in transparent pouches, violating light-sensitivity requirements.

    Product
    Phentermine HCL Blue Speckled tablets, 37.5 mg, packaged in a) 14-count bags (NDC 10702-0025-10) and b) 28-count bags (NDC 10702-0025-10), Rx Only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, MFG: KVK-Tech., Inc Newtown, PA 18940.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1523-2020·2020-08-26

    Calvin Scott Recalls Phendimetrazine Capsules Due to Packaging Deviation

    Calvin Scott & Co. is recalling specific lots of Phendimetrazine capsules because light-sensitive products were repackaged in transparent pouches, violating CGMP standards.

    Product
    Phendimetrazine Brown/Clear Capsules, 105 mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by Virtus Pharm., LLC Newtown, PA 18940; NDC 69543-0409-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1520-2020·2020-08-26

    Calvin Scott Recalls Topiramate 25mg Tablets Due to Packaging Defect

    Calvin Scott & Company is recalling Topiramate 25mg tablets because light-sensitive drugs were repackaged in transparent pouches, violating CGMP standards.

    Product
    Topiramate 25mg Tabs White/round tablets, 10-count bags, Distributed by: Calvin Scott & Co., Inc. Alb., MN 87123, Mfg: Sun Pharm., Inc. Cranbury, NJ 08512, NDC 47335-0707-13
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2810-2020·2020-08-26

    Philips MRI Patient Monitoring System Battery Recall for Charging Failure

    Philips is recalling 24,545 rechargeable Li-Polymer batteries used in the Expression MR400 MRI Patient Monitoring System. The batteries may fail to charge due to poor electrical contact.

    Product
    Phillips 3.7V Rechargeable Li-Polymer Battery, Product #: 989803191341 - Product Usage: This battery is used in the Expression MR400 MRI Patient Monitoring System (Model MR400) is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for sy
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2819-2020·2020-08-26

    United Imaging uMI 550 PET/CT Systems Recalled for Software Display Issue

    Shanghai United Imaging Healthcare Co., Ltd. is recalling three uMI 550 PET/CT systems because a software defect may prevent the CT Hounsfield unit curve from displaying in real time during specific scans.

    Product
    Positron Emission Tomography and Computed Tomography System, Model: uMI 550, Material Number: 88000057 - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2813-2020·2020-08-26

    Olympus Recalls Mislabeled Smart Stapes Protheses Piston Medical Devices

    Olympus Corporation of the Americas is recalling 16 units of Smart Stapes Protheses Piston due to outer carton mislabeling.

    Product
    Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement Catalog Number: 70142168
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2808-2020·2020-08-26

    Chembio DPP Micro Reader Recalled for Performance Issues

    Chembio Diagnostics is recalling 126 DPP Micro Reader kits because the FDA revoked their Emergency Use Authorization due to performance issues.

    Product
    Chembio DPP¿ Micro Reader for use with the DPP¿ COVID-19 IgM/IgG System- Rapid immunochromatographic test for the qualitative detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to SARS-CoV-2 in fingerstick whole blood, venous whole blood
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1530-2020·2020-08-26

    Calvin Scott Recalls Phentermine HCL Tablets Due to Packaging Deviations

    Calvin Scott & Company is recalling specific lots of Phentermine HCL tablets because light-sensitive products were repackaged in transparent pouches.

    Product
    Phentermine HCL White/Blue Speck Tabs 37.5 mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123 Manufactured by SUN Pharmaceuticals, NDC 53489-0676-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1531-2020·2020-08-26

    Calvin Scott Recalls Phentermine Tablets Due to Packaging Deviations

    Calvin Scott & Company is recalling specific lots of Phentermine HCL tablets because they were repackaged in transparent pouches, violating CGMP requirements for light-sensitive drugs.

    Product
    Phentermine HCL White/Blue Speckled tablets, 37.5 mg, packaged in a) 7-count bags, and b) 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by Lannett Company, Inc. Philadelphia, PA 19136; NDC 00527-1445-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2812-2020·2020-08-26

    Philips Module Charger Recall for MRI Patient Monitoring System

    Philips is recalling Module Chargers used in the Expression MR400 MRI Patient Monitoring System because poor electrical contact prevents the lithium-polymer battery from charging.

    Product
    Phillips Module Charger, Product #: 989803191031 - Product Usage: This Module Charger is used in the Expression MR400 MRI Patient Monitoring System (Model MR400) is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization f
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1524-2020·2020-08-26

    Calvin Scott Recalls Phentermine Capsules Due to Packaging Defect

    Calvin Scott & Co. is recalling specific lots of Phentermine HCL capsules because they were repackaged in transparent pouches, violating CGMP requirements for light-sensitive drugs.

    Product
    Phentermine HCL Gray/Yellow capsules, 15mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123 Manufactured by Kvk-Tech, NDC 10702-0026-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1527-2020·2020-08-26

    Calvin Scott Recalls Phentermine HCL Capsules Due to Packaging Defects

    Calvin Scott & Company is recalling Phentermine HCL 30mg capsules because light-sensitive products were repackaged in transparent pouches, violating CGMP standards.

    Product
    Phentermine HCL Yellow Caps 30mg, packaged in 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, MFG: Tagi Pharma, South Beloit, IL 61080; NDC 51224-0202-70
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2811-2020·2020-08-26

    Philips Charging Station Recalled Due to Battery Charging Failure

    Philips is recalling charging stations for the Expression MR400 MRI system because the battery fails to charge due to poor electrical contact.

    Product
    Phillips Charging Station, Product #: 989803191021 - Product Usage: This charging station is used in the Expression MR400 MRI Patient Monitoring System (Model MR400) is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronizati
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2779-2020·2020-08-19

    HealthFirst STAT KIT Z-1000 Emergency Medical Kits Recalled for Missing Component

    HF Acquisition Co. LLC is recalling two STAT KIT Z-1000 emergency medical kits because they are missing a hand suction pump component.

    Product
    STAT KIT Z-1000 emergency medical kit HealthFirst - Product Usage: is intended to prepare physicians with advanced cardiac life support devices and medications to respond to cardiopulmonary medical emergencies until EMS arrives.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2801-2020·2020-08-19

    Arrow Single Shot Epidural Anesthesia Kit Recalled for Incorrect Expiration Date

    Arrow International Inc. is recalling specific lots of Single Shot Epidural Anesthesia Kits because the lidstock displays an incorrect expiration date, which could lead to the use of expired devices.

    Product
    Arrow Single Shot Epidural Anesthesia Kit - Product Usage: The Arrow Blunt Needle Single Shot Epidural Kit permits access to the epidural space.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2791-2020·2020-08-19

    HF Acquisition Recalls STAT KIT Emergency Medical Kits with Missing Narcan Dose

    HF Acquisition Co., LLC is recalling STAT KIT Model 550AI Emergency Medical Kits because they contain one dose of Narcan Nasal spray instead of two.

    Product
    STAT KIT Model 550AI Emergency Medical Kit. P/N: 1010830 containing various products to include Narcan Nasal spray, item number 1010300
    Category
    Medical Device
    Distribution
    39 states