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.

7526–7550 of 21595

  • ModerateFDA (Drugs)·D-0799-2020·2020-01-29

    FDA Recalls NETSPOT Kits Due to Defective Aluminum Cap Crimp

    Advanced Accelerator Applications USA, Inc. is recalling NETSPOT kits because the dilution buffer vial has a loose aluminum cap crimp.

    Product
    NETSPOT — NETSPOT (68GA-DOTATATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0831-2020·2020-01-29

    Siemens ADVIA Centaur Folate Test Kits Recalled for Potential Cross-Reactivity

    Siemens is recalling 3,627 ADVIA Centaur Folate test kits because homocysteine assays may cause elevated folate results.

    Product
    Siemens ADVIA Centaur Folate (500 Test Kit Reference)- for IVD of folate in serum or red blood cell SMN: 10331250
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0827-2020·2020-01-29

    Medicrea Pass LP Trocar K-wire Recalled for Fit Issues

    Medicrea International is recalling 30 units of Pass LP Trocar K-wires because they may not fit into conical cannulated screws.

    Product
    Medicrea Pass LP Trocar K-wire 01.6mm x 500mm-Nitinol Product reference : A06010130
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0818-2020·2020-01-29

    Greiner Bio-One Recalls Damaged Vacuette Blood Collection Tubes

    Greiner Bio-One is recalling 1,002,000 Vacuette tubes that may have cap sealing damage, potentially causing vacuum loss and improper blood volume collection.

    Product
    VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P - Product Usage: VACUETTE Tubes, Holders, and Needles are use together as a system for the collection of venous blood. VACUETTE tubes are used to collect, transport, and process blood for testing serum, plasma, or who
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0528-2020·2020-01-29

    Pike Place Chowder Recalled for Gluten Free Labeling Error

    Northwest Gourmet Food Products Inc. is recalling Pike Place Chowder New England Clam Chowder because the outer packaging claims 'Gluten Free' while the inner pouch declares wheat.

    Product
    New England Clam Chowder, Pike Place Chowder brand, item #89200, distributed By PPC Trading Co. M. BOX #262 4580 Klahanie Drive SE Issaquah WA 98029. There are 12/16 oz. retail packages per master case. Retail package net wt. 16 oz. UPC 8 56112 00402 9. The 16 oz. inner i
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0824-2020·2020-01-29

    Acclarent Recalls TruDi NAV Suction Instruments Due to Calibration Issues

    Acclarent, Inc. is recalling TruDi NAV Suction Instruments because calibration issues cause incorrect tip orientation displays.

    Product
    TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)10705031245877
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0828-2020·2020-01-29

    Medicrea Pass LP Blunt K-wire Recalled for Incompatibility with Screws

    Medicrea International is recalling 190 units of Pass LP Blunt K-wires because they may not fit into Conical Cannulated Screws.

    Product
    Medicrea Pass LP Blunt K-wire 01.6mm x 500mm-Nitinol Product reference: A06010140
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0844-2020·2020-01-29

    Arrow Arterial Catherization Kit Recalled for Incorrect MR Labeling

    Arrow International is recalling 80 kits due to a lidstock label error that displays an MR Conditional symbol instead of MR Unsafe.

    Product
    Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane over 22 Ga. TW Introducer Needle with Integral .018" (0.46 mm) dia. Spring-Wire Guide Product Code: ASK-04020-PMC The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial ci
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0825-2020·2020-01-29

    Acclarent Recalls TruDi NAV Suction Instruments Due to Calibration Issues

    Acclarent, Inc. is recalling specific lots of TruDi NAV Suction Instruments because calibration issues cause incorrect tip orientation displays.

    Product
    TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0826-2020·2020-01-29

    Acclarent Recalls TruDi NAV Suction Instruments Due to Calibration Issues

    Acclarent, Inc. is recalling three lots of TruDi NAV Suction Instruments because calibration issues cause incorrect tip orientation displays.

    Product
    TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0836-2020·2020-01-29

    Paltop Dental Implant Recall Due to Incorrect Cover Screw Packaging

    Paltop Advanced Dental Solutions is recalling 67 dental implants because some were packaged with the wrong cover screw, preventing proper fit.

    Product
    Paltop Dynamic Dental Implant Dia 3.25mm L 13.0 mm, Catalog Number 21-70020
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Drugs)·D-0801-2020·2020-01-29

    Hikma Recalls Methylprednisolone Sodium Succinate Injection Due to Labeling Error

    Hikma Pharmaceuticals is recalling 4,840 vials of Methylprednisolone Sodium Succinate Injection because the label incorrectly instructs healthcare professionals to reconstitute the product with 16 mL instead of 8 mL.

    Product
    METHYLPREDNISOLONE SODIUM SUCCINATE — METHYLPREDNISOLONE SODIUM SUCCINATE (METHYLPREDNISOLONE SODIUM SUCCINATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·003-2020·2020-01-24

    Amity Packing Recalls Raw Ground Beef Due to Plastic Contamination

    Amity Packing Company is recalling raw ground beef products that may contain clear, thin pliable plastic. No illnesses have been reported.

    Product
    Amity Packing Co. Inc. — Amity Packing Company Inc. Recalls Raw Ground Beef Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Drugs)·D-0781-2020·2020-01-22

    Wisconsin Pharmacal Recalls Yeast Arrest Vaginal Suppositories Due to cGMP Violations

    Wisconsin Pharmacal Company is voluntarily recalling 44,373 cartons of Yeast Arrest vaginal suppositories due to current Good Manufacturing Practice (cGMP) violations.

    Product
    Yeast Arrest, Homeopathic Formula, Vaginal Support suppositories, packaged in a) 14-count carton (NDC 68093-0730-1 and 68093-0730-3), b) 28-count carton (NDC 68093-0730-2 and 68093-0730-4), Manufactured for: Vitanica, 12401 SW Leveton Drive, Tualatin, OR 97062.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0802-2020·2020-01-22

    McGuff Compounding Pharmacy Recalls Lipoic Acid Injection Due to Particulate Matter

    McGuff Compounding Pharmacy Services is recalling Lipoic Acid Injection vials because filmy or cloudy particulate matter was observed in the product.

    Product
    Lipoic Acid Injection (aka Alpha Lipoic Acid or Thioctic Acid), 1,200 mg/30 mL (40 mg/mL) Sterile 30 mL Multiple Dose Vial, Rx Only, McGuff Compounding Pharmacy Services, Inc., Santa Ana, CA 92704
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0519-2020·2020-01-22

    Columbia Bean & Produce Recalls Dry Garbanzo Beans for Glyphosate

    Columbia Bean & Produce is recalling dry garbanzo beans sold under multiple brands because 11.8 ppm of glyphosate was detected.

    Product
    Dry Garbanzo Beans are sold under different brands and described as follows: -Bulk 2000 lbs. Totes. -CBP brand 25# Paper Bags 035084321925. -FIESTA brand 25# Paper Bags 035084225070. -Home Pride brand 50# Paper Bags 035084225070. -WinCo 24/1 lbs Small Pack 07055
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Drugs)·D-0780-2020·2020-01-22

    Letco Medical Recalls Subpotent Estriol USP Micronized Drug Products

    Letco Medical LLC is voluntarily recalling subpotent Estriol USP Micronized products distributed in the US and internationally.

    Product
    Estriol USP Micronized a) 100 gm NDC 62991-2159-04; b) 1 gm NDC 62991-2159-01; c) 1 kg NDC 62991-2159-06; d) 25 gm NDC 62991-2159-03; e) 500 gm NDC 62991-2159-05; f) 5 gm NDC 62991-2159-02, Rx Only Repackaged by: Letco Medical, LLC. Decatur, AL 35601
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0805-2020·2020-01-22

    Caire FreeStyle Comfort Oxygen Concentrators Recalled for Lack of US Clearance

    Caire, Inc. is recalling four European version FreeStyle Comfort Oxygen Concentrators because they were not cleared for use in the US.

    Product
    CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeStyle Comfort Oxygen Concentrator is intended for the administration of supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0809-2020·2020-01-22

    Medline Thermistor Foley Catheter Recalled for Temperature Deviation

    Degania Silicone is recalling 2,080 units of Medline Thermistor Foley Catheters because temperature readings did not meet release specifications.

    Product
    Medline Thermistor Foley Catheter 14 FR 5-10 ml, non sterile Catalog Number: 102201101463MD {Medline code 55346) Monitor urinary output and bladder temperature in addition to facilitating urine drainage.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0782-2020·2020-01-22

    Sigan Eczema Skin Relief Lotion Recalled for Microbial Contamination

    Sigan Industries is recalling Eczema Skin Relief Lotion due to microbial contamination. The product was distributed in Illinois.

    Product
    Eczema Skin Relief Lotion, 2% Colloidal Oatmeal Skin Protectant Lotion, NET WT 14 OZ (396 g), NDC 65365-266-01, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-0522-2020·2020-01-22

    Bob's Red Mills Recalls Garbanzo Beans for Potential Glyphosate

    Bob's Red Mills is recalling specific 25 oz packages of Garbanzo Beans due to the potential presence of glyphosate. The recall affects products distributed in the US and several international locations.

    Product
    Garbanzo Beans or Chickpeas, sold under brand Bob's Red Mills, packaged into 25 oz Form & Fill Package or 25 oz Standup Package. 25 oz Form & Fill Package Package has UPC 039978004222. 25 oz Standup Package has UPC 039978114228
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Food)·F-0521-2020·2020-01-22

    Bob's Red Mill 13 Bean Soup Mix Recalled for Glyphosate

    Bob's Red Mill is recalling 13 Bean Soup Mix due to the potential presence of glyphosate. The product was distributed in multiple US states and international locations.

    Product
    13 Bean Soup Mix is sold under Bob's Red Mill brand, packaged in Form & Fill (29 oz. and 822 gram), Standup Pouch (29 oz.), and Bulk Bags (25 lbs.) Product has the following UPC: UPC: 039978122513 UPC: 039978002518 UPC: 039978102515 (25 lb. bag) UPC: 039978302519 (distribu
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-0795-2020·2020-01-22

    Riverpoint Medical Recalls 18G Brachy Grids Due to Packaging Integrity

    Riverpoint Medical is recalling 3,234 sterile 18G Brachy Grids because the integrity of the sterile packaging is potentially compromised.

    Product
    Riverpoint Medical 18G Brachy Grid, B&K style, REF RPG-18, Sterile, Rx. The firm name on the label is Riverpoint Medical, LLC, Portland, OR.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Food)·F-0520-2020·2020-01-22

    Columbia Bean 13 Bean Soup Mix Recalled for Glyphosate Contamination

    Columbia Bean & Produce is recalling 13 Bean Soup Mix due to potential glyphosate contamination. The product was distributed in seven US states and Canada.

    Product
    The 13 Bean Soup Mix product is distributed in 2000 lb. totes without a brand name. The 13 Bean Soup Mix product is also packaged 25 lb. paper bags and sold under brand Columbia Bean & Produce, item # 035084322328.
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Drugs)·D-0659-2020·2020-01-22

    Sun Pharmaceutical Recalls Sumatriptan Succinate Tablets Due to Impurities

    Sun Pharmaceutical Industries is recalling specific lots of Sumatriptan Succinate 50 mg tablets because they failed impurity specifications.

    Product
    SUMATRIPTAN SUCCINATE — SUMATRIPTAN SUCCINATE (SUMATRIPTAN SUCCINATE)
    Category
    Drug
    Distribution
    0 states