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.

17701–17725 of 21645

  • ModerateFDA (Devices)·Z-0078-2015·2014-10-22

    Ortho VITROS 5600 Integrated System Recalled for Calibration Anomaly

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems due to a software anomaly that may cause unexpected assay calibration when using specific calibrator kits.

    Product
    VITROS 5600 Integrated System, System Product Code 6802413. For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0022-2015·2014-10-22

    Gyma Laboratories Recalls Propranolol HCl Due to Manufacturing Deviations

    Gyma Laboratories of America, Inc. is recalling Propranolol HCl due to lack of good manufacturing practices identified by the Italian Medicines Agency.

    Product
    Propranolol HCl, NET WT 1 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0004
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0077-2015·2014-10-22

    Ortho-Clinical Diagnostics Recalls VITROS 4600 Chemistry Systems Due to Software Anomaly

    Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems because a software anomaly may cause unexpected assay calibration when using specific calibrator barcode labels.

    Product
    VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), System Product Code 6802445. The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0021-2015·2014-10-22

    Gyma Recalls Dipyridamole API Due to Manufacturing Deviations

    Gyma Laboratories of America, Inc. is recalling Dipyridamole API due to lack of good manufacturing practices identified by the Italian Medicines Agency.

    Product
    Dipyridamole API, NET WT 10 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0084
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0016-2014·2014-10-22

    Avella Recalls Hydroxyprogesterone Caproate Injectable Due to Crystallization

    Avella of Deer Valley, Inc. is recalling 197 vials of Hydroxyprogesterone Caproate 250 mg/mL injectable because crystals were observed in the product.

    Product
    HYDROXYPROGESTERONE CAPROATE 250 MG/ML (IN SESAME OIL), Rx Only 4 mL INJECTABLE IM USE. Manufactured by Avella Specialty Pharmacy, Phoenix, AZ 85085.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0080-2015·2014-10-22

    Baxter 15 L Cycler Drainage Bag Recalled for Potential Drain Tube Leakage

    Baxter Healthcare is recalling 15 L Cycler Drainage Bags because the tube clamp may not fully close, potentially causing leakage.

    Product
    15 L Cycler Drainage Bag Product Usage: For use with Baxter Cycler Tubing sets as a peritoneal dialysis accessory.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0065-2015·2014-10-22

    Stryker T2 Tibia Nail Insertion Sleeve Recall Due to Diameter Mismatch

    Stryker is recalling T2 Tibia Nail Insertion Sleeves because some units have a different inner diameter than labeled.

    Product
    Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13. Product Usage: The T2 Tibial Nailing system is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0023-2015·2014-10-22

    Michael Foods Recalls Shell Eggs Contaminated with Pseudomonas fluorescens

    Michael Foods, Inc. is recalling 40,966 cases of shell eggs under six different brand labels due to contamination with Pseudomonas fluorescens.

    Product
    Shell Eggs packaged under the following labels: (1) Abbotsford Farms Cage Free Pasteurized Shell Eggs, Grade A Large Brown Eggs, packaged as 15 dozen per 1 case. Distributed by Abbotsford Farms, Gaylord, MN 55334. UPC Code 1 00 14616 64010 7. (2) AbbotsFord Farms Cage…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0072-2015·2014-10-22

    Ameditech Recalls ArcPoint Labs 10 Panel Dip Screen Due to Labeling Error

    Ameditech is recalling 80 kits of ArcPoint Labs 10 Panel Dip Screen because the positive interpretation illustration on the cap labels and package insert was incorrect.

    Product
    ArcPoint Labs 10 Panel Dip Screen (BAR), Part No. APD-10M. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0024-2015·2014-10-22

    Gyma Laboratories Recalls Clonidine HCL Due to Manufacturing Deviations

    Gyma Laboratories of America, Inc. is recalling Clonidine HCL chemical product for medicines preparation due to lack of good manufacturing practices.

    Product
    Clonidine HCL, 97 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0002
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0021-2015·2014-10-15

    Biomet Compress Face Reamer Recalled for Missing Helix Angle

    Biomet, Inc. is recalling four Compress Face Reamer units because they were missing the required 4x21 degree helix angle.

    Product
    Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0005-2015·2014-10-15

    Mylan Amiodarone Hydrochloride Injection Recalled for Temperature Abuse

    Mylan Institutional LLC is recalling Amiodarone HCl Injection due to inadvertent refrigeration during distribution. McKesson distributed the affected vials to facilities in WA, OR, and MT.

    Product
    AMIODARONE HYDROCHLORIDE — AMIODARONE HYDROCHLORIDE (AMIODARONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0017-2015·2014-10-15

    Richard-Allan Scientific Recalls Specimen Transportation System Due to Concentration Issues

    Richard-Allan Scientific is recalling 264 cases of its Specimen Transportation System because the NBF concentration may be outside specifications.

    Product
    Richard-Allan Scientific Specimen Transportation System. 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0026-2015·2014-10-15

    Navilyst Medical Recalls BioFlo PICC Kits Due to Syringe Seal Issues

    Navilyst Medical is recalling specific BioFlo PICC kits because they contain BD syringes with open seals that may compromise sterility.

    Product
    BioFlo PICC with ENDEXO Technology and PASV Valve Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750191, REF/Catalog No. 75-019, STERILE --- Indicated for short or long-term peripheral access to the central venous system for intravenous therapy…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0013-2015·2014-10-15

    Hostess Recalls Frozen Donettes Due to Potential Mold Growth

    Hostess Brands LLC is recalling specific lots of frozen Donettes due to potential mold growth caused by higher-than-average moisture content.

    Product
    Hostess Powdered Single-Serve Donettes- FROZEN ONLY, 3 oz., 6 ct.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0039-2015·2014-10-15

    Smith & Nephew Recalls RENASYS EZ Wound Therapy Canisters

    Smith & Nephew is recalling RENASYS EZ and RENASYS EZ Plus canisters due to visible deformation of the inlet port on the canister lid.

    Product
    RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0027-2015·2014-10-15

    Navilyst Medical Recalls BioFlo PICC Kits Due to Syringe Seal Issues

    Navilyst Medical is recalling BioFlo PICC kits because included BD syringes had open seals, potentially affecting sterility.

    Product
    BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750141, REF/Catalog No. 75-014, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0040-2015·2014-10-15

    Smith & Nephew Recalls RENASYS EZ Canisters Due to Deformation

    Smith & Nephew is recalling RENASYS EZ and RENASYS EZ Plus canisters because the inlet port on the lid may be deformed.

    Product
    RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0062-2015·2014-10-15

    Orthohelix MaxLock Reamer Recalled for Incorrect Laser-Etched Sizing

    Orthohelix Surgical Designs is recalling 38 MaxLock Extreme Mod-Foot Concave Reamers because incorrect sizing was laser-etched on the devices.

    Product
    MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag and heat sealed with label on the outside. Used during procedures to clear away bone and cartilage within the desired implant area.
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Food)·F-0011-2015·2014-10-15

    Hostess Frosted Bagged Donettes Recalled for Potential Mold Growth

    Hostess Brands LLC is recalling specific frozen donettes due to potential mold growth caused by higher-than-average moisture content.

    Product
    Hostess Frosted Bagged Donettes- FROZEN ONLY, 11.25 oz.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0016-2015·2014-10-15

    Richard-Allan Scientific Recalls 10% Neutral Buffered Formalin Due to Concentration Issues

    Richard-Allan Scientific is recalling 199 cases of 10% Neutral Buffered Formalin because the chemical concentration may be outside of desired specifications.

    Product
    Richard-Allan Scientific 10% Neutral Buffered Formalin. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0033-2015·2014-10-15

    Navilyst Medical Recalls PICC Kits Due to Potential Sterility Compromise

    Navilyst Medical is recalling specific PICC Convenience Kits because they contain BD syringes with open seals that may affect sterility.

    Product
    PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M0501981, REF/Catalog No. 60M050198, STERILE --- Intended for short or long-term peripheral access to the central venous system for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0009-2015·2014-10-15

    Hostess Powdered Bagged Donettes Recalled for Potential Mold Growth

    Hostess Brands LLC is recalling 17,330 units of Powdered Bagged Donettes due to potential mold growth caused by higher-than-average moisture content.

    Product
    Hostess Powdered Bagged Donettes, 10.5 oz.
    Category
    Food
    Distribution
    Distributed nationwide