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.

3201–3225 of 3531

  • ModerateFDA (Devices)·Z-0111-2022·2021-10-20

    Flower Drill Bit Kit missing AO connect feature may delay procedures

    Flower Orthopedics is recalling Flower Drill Bit Kit 2.0 mm kits because drill bits are missing the AO connect feature, which may result in procedural delays. Affected units were distributed across multiple states.

    Product
    Flower Drill Bit Kit 2.0 mm - intended to be used with solid 2.0mm screws and can be used with any plate that has been cleared as part of the Flower Small and Medium Implant Set and uses the small locking mechanism. mechanism. Catalog Number: DBK 020 2013002721
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0006-2022·2021-10-20

    Potassium Chloride Extended-Release Tablets Recalled for Failed Dissolution

    Strides Pharma Inc. is recalling Potassium Chloride Extended-Release Tablets, USP 10 mEq because the tablets fail to meet dissolution specifications, which may affect drug effectiveness.

    Product
    POTASSIUM CHLORIDE — POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0024-2022·2021-10-20

    Driscoll's Fresh Blueberries Recalled for Metal Fragment Contamination

    Driscoll's Inc. is recalling Fresh Blueberries in 6 oz. and 1 pt. clamshell containers due to the presence of small metal spheres (approximately 2.45 mm in diameter) found in berries from this grower. The recall affects products distributed to California, Hawaii, Minnesota, Nevada, and Washington.

    Product
    Driscolls's Fresh Blueberries 6 oz. and 1 pt. clamshell containers Keep refrigerated and rinse before use.
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0113-2022·2021-10-20

    Flower Drill Bit Kit Missing AO Connect Feature, May Delay Procedures

    Flower Orthopedics Corporation is recalling Flower Drill Bit Kit 2.7mm (DBK 027) due to missing AO connect feature that may delay surgical procedures. Affected kits were distributed across multiple U.S. states.

    Product
    Flower Drill Bit Kit 2.7mm- The Drill Bit Kit, 2.7mm (DBK 027) is intended to be used with solid 2.7mm screws and can be used with any the Flower Small and Medium Implant Set Flower Ankle Plating Set , Flower Rear Foot/Calcaneus Plating Set or Flower Upper Extremity Plating Set
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0081-2022·2021-10-20

    Philips HeartStart HS1 OnSite Defibrillator Recall: Notification of Previous Recalls

    Philips North America LLC is recalling 15 units of the HeartStart HS1 OnSite Defibrillator (Models M5066A and M5067A) due to failure to notify customers of previous recalls associated with these devices.

    Product
    Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-0014-2022·2021-10-13

    Scan Abutment NP Dental Implant Components Recalled for Dimensional Deviations

    Paltop Advanced Dental Solutions is recalling Scan Abutment NP dental implant components due to manufacturing tolerance deviations that may affect implant restoration fit and timing.

    Product
    Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0019-2022·2021-10-13

    OPTETRAK Comprehensive Knee System components recalled for inadequate packaging barrier

    Exactech is recalling approximately 242,397 OPTETRAK Comprehensive Knee System tibial components due to inadequate oxygen barrier in vacuum bag packaging. No injuries have been reported.

    Product
    OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, with Product Line Numbers: 200-11-XX, 200-12-XX, 200-13-XX, 200-14-XX, 200-15-XX, 200-16-XX; b. OPTETRAK All-polyethylene PS Tibial Components, with Product L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0032-2022·2021-10-13

    Beckman Coulter Troponin I Reagent Packs Recalled Due to Sample Contamination

    Beckman Coulter is recalling 293,640 Access hsTnI High Sensitivity Troponin I reagent packs due to sample carryover contamination occurring with very high concentration samples, potentially affecting test accuracy.

    Product
    Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
    Category
    Medical Device
    Distribution
    44 states
  • ModerateFDA (Devices)·Z-0018-2022·2021-10-13

    Dental implant scan abutment recalled for dimensional tolerance and marking defects

    Paltop Scan Abutment WP dental implant scanning devices are recalled due to manufacturing defects. Affected units show dimensional tolerance deviations and size marking incongruences that may delay restoration procedures.

    Product
    Scan Abutment WP, Cat. No. 30-70106 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgica
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0063-2022·2021-10-13

    Zoll Cool Line Catheter Kits Recalled Due to Potential Tubing Leaks

    ZOLL Circulation recalls Cool Line (Heparin) IVTM catheter kits due to potential leaks in catheter or start-up kit tubing. The recall affects 144 bundles distributed worldwide.

    Product
    Zoll, REF 8700-000869-40, Cool Line (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0005-2022·2021-10-13

    Meclizine HCl Tablets 25 mg Recalled for Incorrect Instructions

    Rising Pharmaceuticals is recalling Meclizine HCl Tablets 25 mg (Lot # CB21024, expiring 2/2023) due to incorrect labeling instructions on the packaging.

    Product
    Meclizine HCl Tablets, 25 mg, packaged in 100-count HDPE bottle, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816, Manufactured by: Aurex laboratories LLC, East Windsor, NJ 08520, NDC 16571-752-01
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0016-2022·2021-10-13

    Dental implant abutments recalled for orientation and sizing tolerance issues

    Paltop Advanced Dental Solutions is recalling Scan Abutment SU devices (Catalog No. 30-70104) manufactured before July 21, 2021, due to manufacturing tolerance deviations that may delay dental restoration.

    Product
    Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgica
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0042-2022·2021-10-13

    ZOLL Premium Access Kit SOLEX 7 Catheter Kit Labeling Update on Potential Leaks

    ZOLL has issued a labeling update for its Premium Access Kit SOLEX 7 intravascular heat exchange catheter regarding potential leaks from the catheter or tubing. Approximately 5,524 kits were distributed worldwide.

    Product
    ZOLL, REF 8700-0793-01 (SL-2593) Premium Access Kit SOLEX 7, Intravascular Heat Exchange catheter Kit, with central venous infusion capabilities (3 lumens), Use Jugular or Subclavian Vein Approach Only, 20 cm, Sterile EO, Rx Only, UDI:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0020-2022·2021-10-13

    Orthopedic Knee Implants Lack Protective Oxygen Barrier in Packaging

    Exactech OPTETRAK Comprehensive Knee System inserts were packaged in vacuum bags lacking an additional oxygen barrier layer, which could allow material degradation. The recall affects 2,774 devices distributed worldwide.

    Product
    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0013-2022·2021-10-13

    Paltop Scan Abutment SP Recalled for Dimensional Tolerance Deviations

    Paltop Advanced Dental Solutions is recalling Scan Abutment SP devices due to manufacturing tolerance deviations that may delay dental restoration. Affected devices showed orientation misalignment and size engraving errors.

    Product
    Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0039-2022·2021-10-13

    Zoll ICY Intravascular Catheter Kit: Labeling Update on Potential Leaks

    ZOLL is updating labeling for ICY Intravascular Heat Exchange Catheter Kits due to potential leaks in the catheter or tubing. Healthcare providers should review updated guidance from the manufacturer.

    Product
    Zoll REF: 8700-0782-01 (IC-3893), ICY Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens) , Femoral vein Insertion Only, Sterile EO, Rx Only, UDI: (01)00849111075237
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0073-2022·2021-10-13

    AngioDynamics NanoKnife Disposable Probes Recalled for Programming Issue

    AngioDynamics is recalling 37 NanoKnife Disposable Single Electrode Probes (Lot 5577754) due to a RFID programming issue that prevents the devices from being recognized by the NanoKnife generator.

    Product
    AngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Electroporation (IRE) Device, 15 cm IRE Single Electrode RFID Activation, PG. Catalog No. 20400103
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0037-2022·2021-10-13

    Medical cooler-heater device recalled for inadequate maintenance and inspection guidance

    CardioQuip is recalling 1,646 units of its Modular Cooler-Heater 1000(m) due to inadequate labeling. The device documentation lacks guidance on proper water-quality maintenance and inspection procedures required for safe operation.

    Product
    CardioQuip, Modular Cooler-Heater 1000(m),Compact Unit, Model:MCH-1000(m),CE 2797, UDI: (01)00860000846110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0050-2022·2021-10-13

    Zoll ICY Heat Exchange Catheter Kit Labeling Update Due to Potential Leaks

    ZOLL Circulation is updating labeling for its ICY Intravascular Heat Exchange Catheter Kit due to potential leaks in the catheter or start-up kit tubing. The recall affects 1,256 units distributed worldwide.

    Product
    Zoll REF: 8700-0782-14 (IC-3893CO), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075527
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0043-2022·2021-10-13

    ZOLL SOLEX 7 Intravascular Catheter Kit Labeling Update for Potential Leaks

    ZOLL Circulation, Inc. is updating labeling for SOLEX 7 intravascular heat exchange catheter kits to communicate about potential leaks from the catheter or start-up kit tubing. The update affects 5,345 kits with worldwide distribution.

    Product
    ZOLL, REF 8700-0793-40 (SL-2593AE) SOLEX 7, Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (00)849111075312
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0046-2022·2021-10-13

    ZOLL ICY Intravascular Catheter Kit: Labeling Update for Potential Leaks

    ZOLL Circulation recalls 333 units of its ICY Intravascular Heat Exchange Catheter Kit due to potential leaks in the catheter or start-up kit tubing. A labeling update addresses the leak risk affecting medical facilities worldwide.

    Product
    ZOLL, REF 8700-0787-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), STERILE EO, Rx Only, UDI: (01)00849111075220
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0022-2022·2021-10-13

    OPTETRAK Comprehensive Knee System Custom Inserts Recalled for Packaging Defect

    Exactech, Inc. is recalling 41 custom OPTETRAK knee implant inserts due to packaging defects. The inserts were packaged in vacuum bags lacking adequate oxygen barrier protection.

    Product
    OPTETRAK Comprehensive Knee System custom devices labeled as the following: a. CUSTOM OPTETRAK ANGLED PS INSERT (Product Line: 900-06-XX, 900-08-XX); b. CUSTOM OPTETRAK CC TIBIAL INSERT (Product Line: 900-23-XX, 900-30-XX); c. CUSTOM OPTETRAK CC INSERT (Product Line:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0010-2022·2021-10-13

    Brain MD dietary supplement bottles filled with wrong product

    BrainMD is recalling Brain & Memory Power Boost dietary supplement (120-capsule bottles) because some units were filled with NeuroVite Plus, a different multivitamin-mineral product, instead of the labeled contents.

    Product
    Brain MD - Brain & Memory Power Boost Supports Healthy Brain and Memory Performance 120 capsules - Dietary Supplement UPC: 8 57568 00341 3 Serving Size - 4 capsules' Servings per container - 30 Ingredients - amount per serving: Phosphatidylserine (PS) - 100 mg Acetylcarnitine
    Category
    Consumer Product
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0017-2022·2021-10-13

    Scan Abutment PCA dental implant component recalled for tolerance deviations

    Paltop Advanced Dental Solutions is recalling Scan Abutment PCA devices due to manufacturing tolerance deviations that may delay implant restoration. Some devices show up to 2-degree orientation variance and sizing discrepancies.

    Product
    Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0038-2022·2021-10-13

    Cardiac Cooler-Heater Device Lacks Maintenance and Inspection Guidance

    CardioQuip is recalling its Modular Cooler-Heater device because labeling omits proper guidance for water-quality maintenance and device inspection, affecting users' ability to maintain the device correctly.

    Product
    CardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model: MCH-11TEC,CE 2797, UDI: (01) 00860000846134
    Category
    Medical Device
    Distribution
    Distributed nationwide