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.

8026–8050 of 21595

  • ModerateFDA (Devices)·Z-0058-2020·2019-10-16

    BD Microtainer SST- Amber Tubes Recalled for Damaged Reservoirs

    Becton Dickinson is recalling specific lots of BD Microtainer SST- Amber tubes because damaged reservoirs may cause insufficient sample volumes and erroneous test results.

    Product
    BD Microtainer SST- Amber Part/Catalog Number: 365978
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0134-2020·2019-10-16

    Amneal Recalls Benazepril HCl Tablets Due to Foreign Tablet Presence

    Amneal Pharmaceuticals is recalling Benazepril HCl 40 mg tablets because a Promethazine HCl tablet was found in the bottle.

    Product
    BENAZEPRIL HYDROCHLORIDE — BENAZEPRIL HYDROCHLORIDE (BENAZEPRIL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • ModerateUSDA FSIS·096-2019·2019-10-11

    YOUBITE Recalls Pork and Turkey Sausage Due to Undeclared Casings

    YOUBITE, LLC is recalling approximately 7,197 pounds of pork and turkey sausage products because they contain natural sheep or pork casings not declared on the label.

    Product
    The Sausage LLC — YOUBITE, LLC Recalls Pork Sausage and Turkey Sausage Products due to Mislabeling
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0017-2020·2019-10-09

    Inter-Med Recalls Chlor-XTRA Syringes Due to Bung Degradation Risk

    Inter-Med Llc is recalling specific lots of Chlor-XTRA prefilled syringes because the rubber bung may degrade when exposed to the bleach solution.

    Product
    Vista Dental Products Chlor-XTRA - 12mL Prefilled Syringes, QTY: 8, REF 503850
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0012-2020·2019-10-09

    Inter-Med Recalls Sodium Hypochlorite Syringes Due to Bung Degradation

    Inter-Med Llc is recalling 1,992 units of Vista Dental Sodium Hypochlorite syringes because the rubber bung may degrade when exposed to the bleach solution.

    Product
    Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes, REF 502300
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0001-2020·2019-10-09

    Metrix Secure EVA Dual Chamber IV Bags Recalled for Leaking Risk

    The Metrix Company is recalling 1,596 Secure EVA dual chamber IV bags due to a potential for leaking. The affected bags were distributed nationwide.

    Product
    SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 1500mL, (legless) REF 66615 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0011-2020·2019-10-09

    Vista Dental CanalClean Endodontic Irrigation Kit Recalled for Bung Degradation

    Inter-Med LLC is recalling Vista Dental CanalClean kits because the rubber bung may degrade when exposed to bleach solution.

    Product
    Vista Dental Products CanalClean Endodontic Irrigation Kit, (1) 12mL - Chlor-XTRA, 6mL - SmearOFF + 92) + (2) 30ga Irrigation Tips + (1) Micro Aspirator with Tip, REF 504700
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2763-2019·2019-10-09

    Beckman Coulter Access Cortisol Reagent Recalled for Cross-Contamination

    Beckman Coulter is recalling Access Cortisol Reagent due to cross-contamination that may cause falsely decreased patient results.

    Product
    The Access Cortisol Reagent. REF (Catalog Number) 33600, Lot 831755. A paramagnetic particle, chemiluminscent immunoassay. Product Usage: The assay is a paramagnetic particle, chemiluminescent immunoassay for the quanitative determination of cortisol levels in human serum, plasm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0011-2020·2019-10-09

    Scenic Fruit Recalls Frozen Organic Blueberries Due to Foreign Material Contamination

    Scenic Fruit Company is recalling Kirkland Signature frozen organic blueberries due to contamination with foreign materials. The product was distributed in California.

    Product
    Frozen Organic Blueberries Packed into Poly Bag, Net Weight 3 lbs. Product of USA. Item 815544, Kirkland Signature brand. UPC 0 96619 08155 4. Distributed by: Costco Wholesale Corporation P.O. Box 34535 Seattle, WA 98124-1535 USA.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0027-2020·2019-10-09

    Merit Medical Systems Recalls Vein Kits Due to Incorrect Latex Labeling

    Merit Medical Systems is recalling 24 Vein Procedure Kits because they were incorrectly labeled as latex-free.

    Product
    Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX Only, Sterile EO, UDI: (01) 00884450390580
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0018-2020·2019-10-09

    Implant Direct Sybron Recalls Mislabeled Dental Implant Vials

    Implant Direct Sybron Manufacturing is recalling 22 vials of dental implants due to incorrect part numbers on the vial caps.

    Product
    ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0013-2020·2019-10-09

    Inter-Med Recalls Sodium Hypochlorite Syringes Due to Bung Degradation

    Inter-Med Llc is recalling 582 units of Vista Dental Products Sodium Hypochlorite syringes because the rubber bung may degrade after prolonged storage.

    Product
    Vista Dental Products Sodium Hypochlorite - 3%, 10 - 12cc Pre-filled Syringes, REF 502315
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2762-2019·2019-10-09

    Zimmer Sidus Stem-Free Shoulder Humeral Head Recall for Incorrect Labeling

    Zimmer GmbH is recalling 19 Sidus Stem-Free Shoulder Humeral Head implants due to incorrect size labeling on the packaging.

    Product
    Sidus Stem-Free Shoulder Humeral Head 50-18 Item number: 01.04555.500 orthopedic implant - Product Usage: The Sidus Stem-Free Shoulder is designed for long-term implantation into the human shoulder joint as a total shoulder arthroplasty in combination with Zimmer or Biomet s gle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0015-2020·2019-10-09

    Vista Dental Sodium Hypochlorite Syringes Recalled for Bung Degradation

    Inter-Med LLC is recalling Vista Dental 3% Sodium Hypochlorite syringes because the rubber bung may degrade due to chemical interaction with the solution.

    Product
    Vista Dental Products 3% Sodium Hypochlorite, 10- 3cc Pre-filled Syringes, REF 502355
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2766-2019·2019-10-09

    Roche Accu-Chek Performa II Meters Recalled for Damaged Capacitor

    Roche Diabetes Care is recalling Accu-Chek Performa II meters because a damaged capacitor may cause short battery life or prevent the device from turning on.

    Product
    Accu-Chek Performa II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm. The A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0016-2020·2019-10-09

    Inter-Med Recalls Chlor-XTRA Dental Syringes Due to Bung Degradation

    Inter-Med LLC is recalling Chlor-XTRA prefilled syringes because the bung may degrade from chemical interaction with the bleach solution.

    Product
    Vista Dental Products Chlor-XTRA - 3mL Prefilled Syringes, QTY: 12, REF 503825
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0100-2020·2019-10-09

    Sermorelin and GHRP-2 Lyophilized Vials Recalled Due to Sterility Concerns

    KRS Global Biotechnology is recalling 120 vials of Sermorelin and GHRP-2 because the company cannot assure the products are sterile.

    Product
    Sermorelin, 3 mg / GHRP-2, 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674092
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2765-2019·2019-10-09

    Roche Recalls Accu-Chek Aviva II Meters Due to Damaged Capacitor

    Roche Diabetes Care is recalling 26,600 Accu-Chek Aviva II meters because a damaged capacitor may cause short battery life or prevent the device from turning on.

    Product
    Accu-Chek Aviva II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm. The Accu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0012-2020·2019-10-09

    Espinaler Razor Clams Recalled Due to Unknown Object in Tin

    YTM, Inc. is recalling Espinaler Razor Clams because an unknown object was found in a tin. Consumers should check their pantries for the specific lot code.

    Product
    Espinaler Razor Clams (Trimmed) 4/6 Classic Line, " N4R-LE7R printed on the tin AND/OR E7R MM/YYYY printed on the box. (EAN CODE 8427230010494), 120 g, Aluminum tin in paper carton, Manufactured by: Ca l Espinaler SL Barcelona, Spain
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Drugs)·D-0119-2020·2019-10-09

    Alkermes Recalls Vivitrol Kits Due to Needle Labeling Error

    Alkermes is recalling 16,231 Vivitrol kits because 1-inch needles were incorrectly placed in sleeves labeled for 1.5-inch needles. The drug vials are not affected.

    Product
    VIVITROL — VIVITROL (NALTREXONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0026-2020·2019-10-09

    Merit Medical Systems Recalls Custom Procedure Kits Due to Latex Labeling Error

    Merit Medical Systems is recalling 88 Custom Procedure Kits because they were incorrectly labeled as latex-free.

    Product
    Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-03688, single use, RX Only, Sterile EO, LATEX FREE, UDI: (01)00884450389409
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0014-2020·2019-10-09

    Inter-Med Recalls Sodium Hypochlorite Syringes Due to Bung Degradation

    Inter-Med Llc is recalling 768 units of Vista Dental Products Sodium Hypochlorite syringes because the rubber bung may degrade after prolonged storage.

    Product
    Vista Dental Products Sodium Hypochlorite - 6%, QTY: 12, 3mL Pre-filled Syringes, REF 502350
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0010-2020·2019-10-09

    Implant Direct RePlant Dental Implants Recalled for Incorrect Packaging

    Implant Direct Sybron Manufacturing is recalling 158 dental implants because the incorrect device was packaged in the vial.

    Product
    ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Food)·F-2248-2019·2019-10-02

    UNFI Recalls Apetina Marinated Olives and Feta Due to Temperature Violation

    UNFI General Corporate is recalling Apetina Marinated Olives & Feta in Olive Oil because the product was held at room temperature despite requiring refrigeration.

    Product
    Apetina Marinated Olives & Feta in Olive Oil, packed in 3.1 LB pals; 4 pals/case; UPC: 0009393605697
    Category
    Food
    Distribution
    7 states