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.

10301–10325 of 21617

  • ModerateFDA (Devices)·Z-2439-2018·2018-07-25

    Opgen Recalls AdvanDx QuickFISH Slides Due to Diminished Performance

    Opgen Inc is recalling AdvanDx QuickFISH Slides because they may show diminished performance before their expiration date.

    Product
    AdvanDx QuickFISH Slides, a component of the QuickFish BC Fixation Kit - BC, REF QFFIXBC1-25, Catalog Number: CS012 Control slides included as a component of the QFFIXBC1-25. The slides will provide non-fluorescent, wettable surface with dimensions appropriate for testing samp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0920-2018·2018-07-25

    Hain Celestial Recalls alba BOTANICA Sunscreen Due to Incorrect Formulation

    The Hain Celestial Group is recalling alba BOTANICA sport mineral sunscreen because the wrong product formulation was placed in the packages.

    Product
    alba BOTANICA sport mineral sunscreen (titanium dioxide 7.0% and zinc oxide 9.0%), spf 45, 170 g (6 oz) tubes packaged in a) 4 tubes per case; b) 8 pack shipper display; Manufactured By: The Hain Celestial Group, Inc., Lake Success, NY 11042, UPC 7 24742 01102 4.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2481-2018·2018-07-25

    Cardinal Health Recalls Presource PBDS Kits Due to Gatorade Pouch Seal Defect

    Cardinal Health is recalling 8,928 Presource PBDS kits because a defect in the Gatorade pouch seal caused the pouch to leak within the kit.

    Product
    Presource PBDS, Kit, Common. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorhexidine gluconate antiseptic cloths, and Gatorade pouches. Product Usage: The kit is provided to a patient pre-surgery, as part of the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2438-2018·2018-07-25

    Siemens Dimension Vista MULTI 2 SDIL Diluent Recall for Defective Septum

    Siemens is recalling 1,195 units of Dimension Vista MULTI 2 SDIL diluent because a defective septum may cause erroneously elevated test results.

    Product
    Dimension Vista¿ MULTI 2 SDIL, KD694, SMN# 10483586
    Category
    Medical Device
    Distribution
    53 states
  • ModerateFDA (Devices)·Z-2484-2018·2018-07-25

    Stryker Recalls Reprocessed Harmonic Ace Shears Due to Error Code

    Stryker is recalling 180 reprocessed Harmonic Ace shears because they may display an error code preventing use.

    Product
    Reprocessed HARMONIC Ace¿ +7, 5mm Diameter Shears with Advanced Hemostasis (HARH), Item Number HARH36 Product Usage: The Reprocessed HARMONIC ACE¿+7, 5 mm Diameter Shears with Advanced Hemostasis are indicated for soft tissue incisions when bleeding control and minimal therma
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2483-2018·2018-07-25

    Cardinal Health Recalls Presource PBDS Kits Due to Leaking Gatorade Pouches

    Cardinal Health is recalling 8,928 Presource PBDS kits because a defect in the Gatorade pouch seal caused the pouch to leak within the kit.

    Product
    Presource PBDS, Kit, No Spiro Diabetes. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorhexidine gluconate antiseptic cloths, and Gatorade pouches. Product Usage: The kit is provided to a patient pre-surgery, as pa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2468-2018·2018-07-25

    Fx Solutions Proton Beam Therapy Heads Recalled for Blister Breach

    Fx Solutions is recalling specific proton beam therapy heads due to a breach in the external blister packaging.

    Product
    Fx SOLUTIONS CENTERED HEAD CoCr 50x19, REF 106-5019 Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam trea
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2496-2018·2018-07-25

    Philips Ingenuity Digital PET/CT System Recall for Pallet Assembly Defect

    Philips is recalling 32 Ingenuity Digital PET/CT Systems because a block connecting the patient pallet to the couch may be assembled incorrectly, potentially causing a misaligned screw.

    Product
    Ingenuity Digital PET/CT System, Model 882446 with the following UDI's: (01)00884838059559(21)900004 (01)00884838059559(21)900005 (01)00884838059559(21)900006 (01)00884838059559(21)900007 (01)00884838059559(21)900008 (01)00884838059559(21)900009 (01)00884838059559(21)9000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0924-2018·2018-07-25

    Sun Pharmaceutical Recalls Metformin Hydrochloride Tablets Due to Foreign Matter

    Sun Pharmaceutical Industries is recalling one lot of Metformin Hydrochloride Extended Release Tablets because a piece of rubber glove was detected in a tablet.

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2442-2018·2018-07-25

    Health Harmony Mobile App Recalled for Data Synchronization Delays

    Intel-GE Care Innovations LLC is recalling the Health Harmony Mobile application because patient data sometimes failed to sync with the backend database in a timely manner.

    Product
    Health Harmony Mobile application software Product Usage: Care Innovations Health Harmony Mobile is intended as a communication tool to display medical device data from third party devices for patients to view, and to collect assessment (question & answers) from patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2440-2018·2018-07-25

    Canadian Hospital Specialties Recalls Pediatric Feeding Tubes with Incorrect Length Labeling

    Canadian Hospital Specialties is recalling specific lots of pediatric feeding tubes because they may be packaged with the incorrect length as labeled.

    Product
    MED-RX, Ref 54-1650R 5Fr X 16 inch (40cm) Polyurethane Feeding Tube For Pediatric Use with Orange Radiopaque Stripe and Enteral Connector, packaged 10/case, Sterile, RX. The firm name on the label is chs, Oakville, ON, Canada.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-1622-2018·2018-07-18

    Sparkling ICE Cherry Limeade Recalled for Off-Taste and Off-Odor Complaints

    Talking Rain Beverage Co Inc is recalling Sparkling ICE Cherry Limeade after customer complaints reported off-taste and off-odor.

    Product
    Sparkling ICE Cherry Limeade Naturally Flavored Sparking Water, packaged in a PET bottles with a plastic cap, Net Wt. 17 ounces (502.8 ml). UPC code on bottle: 0 16571 95084 2. UPC on Single Pack Wrapper (1 flavor/12 bottles): 016571953126 UPC on Single Pack Wrapper (1 flavo
    Category
    Food
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-2410-2018·2018-07-18

    Ohio Medical Vacuum Regulator Recalled for Incomplete Quality Control Testing

    Ohio Medical Corporation is recalling 11 Vacuum Regulator units because final quality control testing was not completed before distribution.

    Product
    Vacuum Regulator, Push-T-Set Intermittent Suction Unit (PTS-ISU) Product Usage: The vacuum regulator is intended to be used in a medical facility as a means to evacuate media (i.e. fluids) from the body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0918-2018·2018-07-18

    SCA Pharmaceuticals Recalls Subpotent Buffered Lidocaine Injection

    SCA Pharmaceuticals is recalling 3,984 syringes of Buffered Lidocaine 1% Injection because stability data does not support the current expiration dating.

    Product
    Buffered Lidocaine 1% with Sodium Bicarbonate Injection for Local Anesthetic Use (Concentration=10 mg/mL) 0.25 mL Total Volume, Rx only , SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205 877-550-5059
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2428-2018·2018-07-18

    bioMerieux Recalls mini VIDAS Systems Due to Performance Issues

    bioMerieux is recalling 1,866 mini VIDAS systems because pump clogging and label displacement may cause erroneous test results.

    Product
    BioMerieux mini VIDAS System in combination with Quality Control VIDAS* (QCV*) Product Usage: the Quality Control VIDAS (QCV) is an automated test for use on the VIDAS¿ system to detect abnormal operation of the VIDAS and mini VIDAS instrument pipette mechanisms and optical s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0927-2018·2018-07-18

    Lupin Recalls Nitrofurantoin Oral Suspension Due to Subpotent Drug

    Lupin Pharmaceuticals is recalling Nitrofurantoin Oral Suspension because the drug is subpotent and failed content uniformity testing.

    Product
    NITROFURANTOIN — NITROFURANTOIN (NITROFURANTOIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0919-2018·2018-07-18

    Medi-Fare Recalls Potassium Chloride Syringes Due to Fill Volume Error

    Medi-Fare Drug and Home Health Center is recalling 1,116 syringes of Potassium Chloride For Injection Concentrate because they were filled with 19 mL instead of the labeled 20 mL.

    Product
    Potassium Chloride For Injection Concentrate syringe 40 mEq/20 mL (2 mEq/mL), Rx only, Medi-Fare Drug Pharmaceutical Compounding 300 West Pine St., Blacksburg, SC 29702 800-622-0007
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2383-2018·2018-07-18

    Arrow International Recalls VPS Rhythm ECG Accessory Packs Due to Labeling Issues

    Arrow International is recalling 2,070 VPS Rhythm ECG Accessory Packs because the product pouch label may not easily identify the lot number, expiration date, and associated symbols.

    Product
    VPS Rhythm ECG Accessory Pack, REF RHY-100-ECGO Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). The
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2425-2018·2018-07-18

    Dako PD-L1 IHC 22C3 pharmDx Recall for Storage Time Correction

    Dako North America Inc. is recalling 1,051 PD-L1 IHC 22C3 pharmDx kits to correct instructions for use regarding storage time for specific tissue sections.

    Product
    PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine PD-L1 levels for determination of patient treatment options.
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-2382-2018·2018-07-18

    Arrow International Recalls VPS Rhythm ECG Accessory Packs for Labeling Issues

    Arrow International Inc. is recalling 2,070 units of VPS Rhythm ECG Accessory Packs because the product pouch label may not easily identify the lot number, expiration date, and associated symbols.

    Product
    VPS Rhythm ECG Accessory Pack with Johans Adapter, REF RHY-100-ECGJ Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior V
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2385-2018·2018-07-18

    Arrow International Recalls Midline Catheter Kits Due to Labeling Issues

    Arrow International is recalling 2,070 Peripherally Inserted Midline Catheter Kits because the product pouch label may not easily identify the lot number, expiration date, and associated symbols.

    Product
    Peripherally Inserted Midline Catheter Kit with Placement Wire, REF MK-02031-TW Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0912-2018·2018-07-18

    Wockhardt Recalls Enalapril Maleate Tablets Due to Impurity Failures

    Wockhardt Limited is recalling specific batches of Enalapril Maleate Tablets USP because they failed impurity and degradation specifications.

    Product
    Enalapril Maleate Tablets USP; 5 mg NDC code 64679-924-03. 1000 Tablets HDPE container pack with Non CRC cap and 2 desiccants further packed in E-flute cartons.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2387-2018·2018-07-18

    GE Medical Systems Recalls Innova IGS Fluoroscopic X-ray Systems

    GE Medical Systems is recalling 102 Innova IGS fluoroscopic X-ray systems due to a defect that may cause X-ray abort errors, resulting in the loss of imaging mode during use.

    Product
    Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-2423-2018·2018-07-18

    Anika Hyalomatrix Wound Dressings Recalled for Packaging Degradation

    Anika Therapeutics is recalling Hyalomatrix wound dressings because PVC in the packaging degraded during sterilization, potentially compromising product integrity.

    Product
    Hyalomatrix, Product nos. 651105, 651103, 651104, and 651301 Product Usage: Hyalomatrix is a bi-layered, sterile, flexible, and comfortable wound dressing that acts as an advanced wound care device. It is comprised of a non-woven pad entirely composed of HY AFF 11, a benzyl e
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0925-2018·2018-07-18

    Sanofi Recalls Admelog Insulin Pens Due to Temperature Abuse

    Sanofi-Aventis is recalling 3,214 Admelog insulin pens because they may not have been shipped at the proper temperature.

    Product
    ADMELOG — ADMELOG (INSULIN LISPRO)
    Category
    Drug
    Distribution
    Distributed nationwide