The Recall Desk

Severity 1 of 5

Low recalls

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

What “low” means here

Severity 1 (Low) recalls are typically cosmetic defects, documentation issues, packaging-only problems, and Class III administrative corrections. The product itself is unlikely to cause adverse health consequences. The manufacturer is correcting the issue to comply with FDA or USDA rules, not because anyone is at risk. You can almost always continue using a Severity-1 product without concern.

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.

901–925 of 2769

  • LowFDA (Devices)·Z-0062-2019·2018-10-10

    Dannoritzer Laparoscopy Instruments IFU Recalled for Unvalidated Cleaning Instructions

    Dannoritzer Medizintechnik GmbH & Co. KG is recalling Instructions For Use (IFU) for certain laparoscopy instruments because the manual cleaning process was not validated.

    Product
    Laparoscopy Instruments Instructions For Use (IFU) for the following: 1)Monopolar electrode, 2) Insert, handle and/or shaft component of a modular forceps or scissors for electrosurgical coagulation, 3) One-piece forceps or scissors for electrosurgical coagulation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0017-2019·2018-10-10

    Otsuka Recalls Mislabeled treatNOW Abilify Physician Sample Kits

    Otsuka is recalling 17,325 treatNOW Abilify physician sample kits due to labeling errors, including misspelled product names and missing storage instructions.

    Product
    treatNOW ABILIFY (aripiprazole) and ABILIFY MAINTENA (aripiprazole) 400MG for extended release injectable suspension. Kit Contents: 2 packs ABILIFY Tablets 10mg (14 day supply) plus 1 ABILIFY MAINTENA Pre-filled Dual Chamber Syringe Kit. Rx only. Not for sale or reimbursement. Di
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0073-2019·2018-10-10

    Smiths Medical Portex Nasal Cannula Recalled for Labeling Error

    Smiths Medical ASD Inc. is recalling 3,000 Portex First Breath Adult Nasal Cannulas because the 'Manufactured' and 'Use By' labels are transposed, suggesting the product expires before it was manufactured.

    Product
    smiths medical portex First Breath Adult Nasal Cannula, REF 001289, Curved Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0018-2019·2018-10-10

    Otsuka Recalls Mislabeled Abilify and Abilify Maintena Physician Sample Kits

    Otsuka is recalling 4,738 physician sample kits of Abilify and Abilify Maintena due to labeling errors, including misspelled product names and missing storage instructions.

    Product
    treatNOW ABILIFY (aripiprazole) / ABILIFY MAINTENA 400-mg (aripiprazole) for extended release injectable suspension. Kit contents 2 packs Abilify Tablets 10 mg (14 day supply) plus 1 Abilfy Maintena Vial Kit.Rx only. Distributed and Marketed by: Otsuka America Pharmaceutical, Inc
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-3253-2018·2018-10-03

    Medtronic Diagnostic Catheter Recalled for Incorrect French Size Labeling

    Medtronic is recalling 250 units of DxTerity TRA 5F Diagnostic Catheters because the inner pouch may incorrectly display a 6 French size indicator instead of the correct 5 French size.

    Product
    Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Drugs)·D-0103-2019·2018-10-03

    Dr. Reddy's Recalls Zoledronic Acid Injection Due to Unknown Impurities

    Dr. Reddy's Laboratories is recalling Zoledronic Acid Injection vials because they failed impurity specifications with out-of-specification unknown impurities.

    Product
    ZOLEDRONIC ACID — ZOLEDRONIC ACID (ZOLEDRONIC ACID)
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Devices)·Z-3252-2018·2018-10-03

    Biomet Sports Medicine Drill Bit Recalled for Incorrect Expiration Date Labeling

    Zimmer Biomet is recalling 217 units of Biomet Sports Medicine Juggerknot Long Flex Drill Bits because the expiration date is incorrectly listed on the label.

    Product
    Biomet Sports Medii cine Juggerknot Long Flex Drill Bit with Sleeve Nitinol intended to be used for soft tissue to bone fixation with indications for use in: Shoulder, Foot and Ankle, Knee, Hand and Wrist and Hip repair.Stainless Steel, Sterile Item Number: 110016992
    Category
    Medical Device
    Distribution
    10 states
  • LowFDA (Food)·F-1988-2018·2018-10-03

    Caffeine-Free Barq's Root Beer Recalled for Mislabeling

    Swire Coca Cola USA is recalling Caffeine-Free Barq's Root Beer 12 Packs due to mislabeling. The recall covers 2,945 cases distributed nationwide.

    Product
    Caffeine-Free Barq s Root Beer 12 Pack, 12 oz cans
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1970-2018·2018-09-26

    Stewart's Ice Cream Recalled for Incorrect Lid Packaging

    Stewart's Shops Corp. is recalling 5,455 pints of Caramel Cone Crunch ice cream because some containers were packaged with the wrong lid.

    Product
    Stewart's Ice Cream Caramel Cone Crunch Carton, 1 pint, keep frozen, UPC: 082086444718
    Category
    Food
    Distribution
    2 states
  • LowFDA (Devices)·Z-3184-2018·2018-09-26

    Ortho-Clinical VITROS Chloride Slides Recalled for Analytical Performance Issues

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Cl- Slides because they failed to meet performance standards for urine samples.

    Product
    VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage: VITROS Cl Slides (Product Code 684 4471) - For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum, plasma and urine using VI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1214-2018·2018-09-26

    Lupin Recalls Morphine Sulfate Extended-Release Tablets Due to Impurity

    Lupin Pharmaceuticals is recalling specific lots of Morphine Sulfate Extended-Release Tablets because testing found an impurity exceeding safety limits.

    Product
    MORPHINE SULFATE — MORPHINE SULFATE (MORPHINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-3193-2018·2018-09-26

    Ortho-Clinical VITROS Chemistry CREA Slides Recalled for Measurement Accuracy Issues

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry CREA Slides because they failed to meet accuracy standards for low-end creatinine measurements in serum and urine.

    Product
    VITROS Chemistry Products CREA Slides, Product Code 680 2584 Product Usage: VITROS CREA Slides (Product Code 680 2584) - For in vitro diagnostic use only. VITROS Chemistry Products CREA Slides quantitatively measure creatinine (CREA) concentration in serum, plasma, and urine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1212-2018·2018-09-26

    InvaGen Recalls Bupropion Hydrochloride Tablets Due to Impurity Levels

    InvaGen Pharmaceuticals is recalling specific lots of Bupropion Hydrochloride ER tablets because older batches failed impurity specifications.

    Product
    BUPROPION HYDROCHLORIDE — BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1205-2018·2018-09-26

    Jubilant Cadista Recalls Methylprednisolone Tablets for Stability Failure

    Jubilant Cadista Pharmaceuticals is recalling Methylprednisolone Tablets due to failed stability testing. The product was distributed throughout the United States.

    Product
    MethylPREDNISolone Tablets, USP, 4 mg, 21-count blister pack. Rx Only. Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD NDC 59746-001-03
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Devices)·Z-3196-2018·2018-09-26

    Smiths Medical Recalls Mislabeled Arterial Blood Sampling Kits

    Smiths Medical ASD Inc. is recalling 29,600 Portex Pulsator Arterial Blood Sampling Kits because they were mislabeled with incorrect labels.

    Product
    Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2, Sterile, RX. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1185-2018·2018-09-19

    Par Pharmaceutical Recalls Pramipexole Dihydrochloride Extended Release Tablets

    Par Pharmaceutical is recalling Pramipexole dihydrochloride extended release tablets because they contain a known impurity at levels exceeding specifications.

    Product
    Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count bottles, Rx only, Manufactured by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 10370-252-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-3044-2018·2018-09-19

    Ortho-Clinical VITROS Chloride Slides Recalled for Interference Issues

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Cl- Slides because they do not meet maximum allowable interference claims for triglycerides.

    Product
    VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum, plasma and urine using VITROS 250/350/5,1 FS and 4600 Chemistry System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-3043-2018·2018-09-19

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Products Cl- Slides

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Cl- Slides because they do not meet maximum allowable interference claims for triglycerides in serum samples.

    Product
    VITROS Chemistry Products Cl- Slides, Product Code 844 5207 Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum and plasma using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1184-2018·2018-09-19

    Pfizer Recalls Argatroban Injection Vials Due to Stability Testing Failures

    Pfizer is recalling 1,580 vials of Argatroban Injection because stability testing results were out of specification at the 18-month time point.

    Product
    Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial, Rx only, Sterile, Manufactured for: Hospira, Inc, Lake Forest, IL 60045 USA. NDC: 0409-1140-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1187-2018·2018-09-19

    Mylan Recalls Diltiazem HCl Extended-Release Capsules Due to Impurities

    Mylan Pharmaceuticals is recalling 656 bottles of Diltiazem HCl Extended-Release Capsules 120 mg because routine stability testing found out-of-specification related compounds.

    Product
    Diltiazem HCl Extended-Release Capsules, USP 120 mg 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1186-2018·2018-09-19

    Mylan Recalls Diltiazem HCl Extended-Release Capsules Due to Impurities

    Mylan Pharmaceuticals is recalling Diltiazem HCl Extended-Release Capsules 120 mg because routine stability testing revealed out-of-specification results for related compounds.

    Product
    Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1220-2018·2018-09-12

    AutoDELFIA Neonatal IRT Kit Recalled for Missing Quality Control Certificate Information

    PerkinElmer is recalling AutoDELFIA Neonatal IRT kits because missing quality control certificate information may delay reporting of IRT results.

    Product
    AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human immunoreactive trypsin(ogen) (IRT) in blood specimens. (UDI: (01)06438147298716(17)190430(10)656479); Product Number: B005-212
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-2963-2018·2018-09-12

    Zimmer Dental Implants Recalled for Incorrect Inner Package Labeling

    Zimmer Dental Inc. is recalling 299 units of Tapered Screw-Vent Implants because the inner package labels display incorrect item, lot, and size information.

    Product
    Outer Package Label: Tapered Screw-Vent Implant System, 4.1mm X 10mm, 3.5mm, REF:TSVM4B10, Sterile:R, Rx Only; Inner Package Label: Implant, MTX, 3.7mm x 10mm,3.5mm, REF: TSVB10. Zimmer Dental Implants are designed for use in the maxilla or mandible for immediate loading or
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1171-2018·2018-09-05

    Validus Recalls Rocaltrol Oral Solution Due to Lower Potency

    Validus Pharmaceuticals is recalling 696 bottles of Rocaltrol (calcitriol) Oral Solution because testing showed lower than expected potency.

    Product
    Rocaltrol (calcitriol) Oral Solution, 1 mcg/mL, 15 mL bottle, Rx only, Distributed by: Validus Pharmaceuticals, LLC Parsippany, NJ 07054 USA, NDC 30698-911-15
    Category
    Drug
    Distribution
    Distributed nationwide