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.

7876–7900 of 21595

  • ModerateFDA (Devices)·Z-0325-2020·2019-11-13

    Zimmer Biomet Recalls Various Knee Systems Due to Packaging Adhesion

    Zimmer Biomet is recalling various knee systems because non-highly polished implants may adhere to the LDPE bag.

    Product
    Various Knee Systems, Item Nos. 32855411838 32855411840 32855411842 32855411843 32855420307 32855420308 32855420309 32855420310 32855420315 32855430491 32855430497 32855430499 32855430500 32855430502 32855430503 32855430511 32855430526 32855430530 32855430531 3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0321-2020·2019-11-13

    Zimmer Biomet Recalls Various Knee Systems Due to Packaging Adhesion

    Zimmer Biomet is recalling various knee systems because non-highly polished implants may adhere to the LDPE bag packaging.

    Product
    Various Knee Systems for knee joint arthroplasty, knee prosthesis, Item Nos. 00522000100 00522000200 00522000300 00522000400 00522006304 00522006504 00522006600 00522006800 00522006900 00522007000 00522007200 00522007300 00522007400 00522007500 00522007900 00522008
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0187-2020·2019-11-13

    Basic Reset Earth Wash Cleaner Recalled for Lack of FDA Approval

    Basic Reset Inc. is recalling 949 bottles of Earth Wash Cleaner because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Basic Reset Earth Wash Cleaner and Personal Care, Eco Friendly, Non Toxic, 2 fl.oz. bottle, Distributed by: Basic Reset Hendersonville, TN 37075.
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0269-2020·2019-11-13

    Ortho-Clinical Diagnostics Recalls VITROS K+ Slides Due to Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS K+ Slides because a mechanical failure may cause intermittent slide dispense issues.

    Product
    VITROS chemistry Products K+ Slides, Catalog No. 8157596. MicroSlides which contain reagents in a dry, multi-layered form.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0327-2020·2019-11-13

    Zimmer Biomet Recalls Cable-Ready Short and Long GTR Implants

    Zimmer Biomet is recalling Cable-Ready Short and Long GTR implants because non-highly polished units may adhere to the LDPE bag.

    Product
    CABLE-READY SHORT GTR and CABLE-READY LONG GTR, Item Nos. 00223200201 00223200202
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0303-2020·2019-11-13

    Zimmer Biomet Recalls NCB Proximal Lateral Tibia Implants

    Zimmer Biomet is recalling NCB Proximal Lateral Tibia implants because non-highly polished devices may adhere to the packaging bag.

    Product
    NCB Proximal Lateral Tibia, "NCB-PT LAX PROX 3H TIBIA", Various Sizes, Item Nos. 0202261205 0202261207 0202261209 0202261213 0202261305 0202261307 0202261309 0202261313
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0268-2020·2019-11-13

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Cl- Slides Due to Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS chemistry Cl- Slides because the anti-backup platen may fail to advance, causing intermittent slide dispense issues.

    Product
    VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT support Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0267-2020·2019-11-13

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Cl- Slides for Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS chemistry Cl- Slides because an anti-backup platen failure may cause intermittent slide dispense issues.

    Product
    VITROS chemistry Products Cl- Slides, Catalog No. 6844471 (which supports Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0308-2020·2019-11-13

    Zimmer Biomet Recalls Periarticular Femur Plates Due to Packaging Adhesion

    Zimmer Biomet is recalling 5,459,583 periarticular femur plates because non-highly polished implants may adhere to the LDPE bag packaging.

    Product
    PERIARTICULAR PLATES - FEMUR, Item Nos. 00234700106 00234700108 00234700110 00234700112 00234700114 00234700116 00234700118 00234700206 00234700208 00234700210 00234700212 00234700214 00234700216 00234700218 00234703104 00234703106 00234703108 00234703204 002347
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0322-2020·2019-11-13

    Zimmer Biomet Recalls Various Surgical Screws and Reamers

    Zimmer Biomet is recalling various surgical screws and reamers because non-highly polished implants may adhere to the LDPE bag.

    Product
    Various Surgical Instruments: Screws and Reamers, Item Nos. 00579104100 00579104200 00579104300 00579104400 00579105400 00597909526 00597909529 00597909532 00597909535 00597909538 00597909541 00597909546 00597909551 00598304027 00598304033 00598304048 00598304148
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0194-2020·2019-11-13

    Basic Reset CBD Product Recalled for Lack of FDA Approval

    Basic Reset Inc. is recalling 391 bottles of CBD Reset 2400 because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Basic Reset CBD Reset 2400, True Full Spectrum Natural (unflavored), 2400 mg CBD, 1 fl. oz. (29 mL) bottle, Distributed by: Basic Reset Hendersonville, TN 37075
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Food)·F-0164-2020·2019-11-13

    Full Moon Fish Tuna Steaks Recalled for Incorrect Label Information

    ALFA INTERNATIONAL SEAFOOD INC is recalling Full Moon Fish Tuna Steaks because the labels contain incorrect manufacturer numbers, pack dates, and expiration dates.

    Product
    Full Moon Fish Tuna Steaks, Skinless, Boneless, IVP, Size: 8 oz, Net Weight 5 lbs
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0189-2020·2019-11-13

    Basic Reset Nuovi Skin Toner Recalled for Lack of FDA Approval

    Basic Reset Inc. is recalling 1,000 bottles of Nuovi Skin Toner because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Basic Reset Nuovi Skin Toner, Refined Ionyte, 4 FL. OZ., 118.3 mL bottle, Distributed by: Basic Reset Hendersonville, TN 37075
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0314-2020·2019-11-13

    Zimmer Biomet Recalls Periarticular Elbow and Humeral Plates

    Zimmer Biomet is recalling specific periarticular plates because non-highly polished implants may adhere to the packaging bag.

    Product
    Periarticulare Plates - Elbow, Humeral and Ulna Plates, Item Nos. 00234800504 00234800506 00234800508 00234800510 00234800512 00234800514 00234800604 00234800606 00234800608 00234800610 00234800612 00234800614 00234800712 00234800714 00234800716 00234800902 002348
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0283-2020·2019-11-13

    Randox Liquid Protein Calibrators Recalled for Rheumatoid Factor Value Adjustment

    Randox Laboratories is recalling 100 kits of Liquid Protein Calibrators because the assigned value for Rheumatoid Factor over-recovered against the reference material. The calibrator values have been adjusted to re-align to the reference material.

    Product
    Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN: 05055273204032 Product Usage: Liquid Protein Calibrators are intended for in vitro diagnostic use in the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgA, IgG, IgM, Prealb
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0192-2020·2019-11-13

    Basic Reset CBD Oil Recalled for Lack of FDA Approval

    Basic Reset Inc. is recalling 598 bottles of CBD Reset 750 True Full Spectrum Cinnamon because the product was marketed without an approved NDA or ANDA.

    Product
    Basic Reset CBD Reset 750 True Full Spectrum Cinnamon, 750 mg CBD, 1 fl. oz. (30 mL) bottle, Distributed by: Basic Reset Hendersonville, TN 37075
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0197-2020·2019-11-13

    Biogenyx CBD Oil Recalled for Lack of FDA Approval

    Basic Reset Inc. is recalling Biogenyx CBD Oil because it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    BIOGENYX True Full Spectrum CBD Oil Cinnamon, 1 fl. oz. (30 mL) bottle, 750 mg, Distributed by: Biogenyx, Inc. Hendersonville, TN 37075
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0213-2020·2019-11-13

    Philips Forte Gamma Camera System Recalled for Detector Fall Hazard

    Philips is recalling 1,167 Forte Gamma Camera Systems because a detector may fall unimpeded vertically to the end stops of its travel limit.

    Product
    Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0270-2020·2019-11-13

    Pega Medical Recalls SCFE Knobs for Driver Due to Screw Loosening Risk

    Pega Medical Inc. is recalling 31 SCFE Knobs for Driver because screws may loosen during ultrasonic cleaning and fall out.

    Product
    SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument component, for hip surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0326-2020·2019-11-13

    Zimmer Biomet Recalls Various Fixation Systems and Accessories

    Zimmer Biomet is recalling various fixation systems and accessories because non-highly polished implants may adhere to the LDPE bag.

    Product
    Various fixation systems and accessories, Item Nos. 00118100522 00118100527 00118100530 00118100532 00118100535 00118100537 00118100540 00118100542 00118100550 00118100552 00118100562 00118100565 00118100567 00118101022 00118101025 00118101027 00118101030 0011810
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0301-2020·2019-11-13

    Zimmer Biomet Recalls Coorad Morrey Total Elbow Implants

    Zimmer Biomet is recalling Coorad Morrey Total Elbow implants because non-highly polished components may adhere to the packaging bag.

    Product
    Coorad Morrey Total Elbow, Item Nos. 32810502501 32810502701 32810502900 32810503000 32810600012 32810600013 32855510796 32855510797 32855510799 32855510800 32855510801 32855510805 32855510822 32855510843 32855510844
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0329-2020·2019-11-13

    Zimmer Biomet Recalls Temporary Surgical Devices Due to Packaging Adhesion

    Zimmer Biomet is recalling 5.4 million temporary surgical devices because non-highly polished implants may adhere to the packaging bag.

    Product
    Various temporary devices used during the implantation of the device system: bone fixation plates and screws, drill bits, manual surgical instruments for general use. Item Nos. 0202024301 0202024325 0202024330 0202024342 0202024344 0202024346 0202024360 0202024362 4722580
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0335-2020·2019-11-13

    Zimmer Biomet Recalls Metasul Femoral Heads Due to Packaging Adhesion

    Zimmer Biomet is recalling Metasul Femoral Heads because non-highly polished implants may adhere to the LDPE bag packaging.

    Product
    Metasul Femoral Heads, various sizes, Item Nos. 00877004001 00877004002 00877004003 00877004004 00877004005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0346-2020·2019-11-13

    LivaNova VNS Therapy System Recall Due to Impedance Measurement Shift

    LivaNova is recalling VNS Therapy System generators because a timing change causes reported lead impedance values to be higher than previous models, shifting normal ranges relative to existing thresholds.

    Product
    The LivaNova VNS Therapy System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and external programming system used to change stimulation settings. The generator is an implantable, multi-programmable pulse generator that delivers
    Category
    Medical Device
    Distribution
    50 states
  • ModerateFDA (Drugs)·D-0191-2020·2019-11-13

    Basic Reset CBD Oil Recalled for Lack of FDA Approval

    Basic Reset Inc. is recalling 554 bottles of CBD Reset 750 oil because the product was marketed without an approved FDA application.

    Product
    Basic Reset CBD Reset 750 True Full Spectrum Wintergreen, 750 mg CBD, 1 fl. oz. (30 mL) bottle, Distributed by: Basic Reset Hendersonville, TN 37075
    Category
    Drug
    Distribution
    2 states