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.

6926–6950 of 21595

  • ModerateFDA (Devices)·Z-1964-2020·2020-05-20

    Bard PowerPort ClearVUE Slim Implantable Port Recalled for Incorrect Catheter Lock Size

    Bard Peripheral Vascular Inc is recalling 200 units of PowerPort ClearVUE Slim Implantable Ports because the catheter locks may be 8Fr instead of the labeled 6Fr.

    Product
    BARD Access Systems PowerPort ClearVUE Slim Implantable Port With Smooth Septum and Attachable 6 F Polyurethane Open-Ended Single-Lumen Venous Catheter, Product #5676300 - Product Usage: All materials are biocompatible, can be used with virtually all injectable solutions intended
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1971-2020·2020-05-20

    BD Biosciences Recalls CD45 Reagent Due to False Positive Reactions

    Becton, Dickinson and Company is recalling 1,473 vials of Analyte specific reagent (CD45) because of false positive reactions. The product is used for in vitro diagnostic testing.

    Product
    Analyte specific reagent. REF/UDI: 641408/641408-4012-1-1 (US); 641417/641417-1157-1-01 (OUS); 641399/641399-4012-1-01 (US Research Use Only) - Product Usage: CD45 is intended for in vitro diagnostic use in the identification of cells expressing the CD45 antigen, using a BD FAC b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1998-2020·2020-05-20

    ICU Medical Recalls Central Venous Catheters Due to Guidewire Issue

    ICU Medical is recalling 10 Central Venous Catheters because the included guidewire cannot pass through the needles.

    Product
    Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41401-25.
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-1931-2020·2020-05-20

    Ortho-Clinical Diagnostics Recalls VITROS CKMB Slides Due to Incorrect Instructions

    Ortho-Clinical Diagnostics is recalling VITROS CKMB Slides because Spanish and Swedish instructions incorrectly state the assay can be tested with plasma, which could result in biased results.

    Product
    VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 8001133-90 slides, UDI Number 10758750004201 - Product Usage: The VITROS Chemistry Product Slides are used to measure creatine kinase MB (CK-MB) activity in serum which used to be ordered to detect Myocardial
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1996-2020·2020-05-20

    ICU Medical Recalls Central Venous Catheters Due to Guidewire Issue

    ICU Medical is recalling 20 Central Venous Catheters because the included guidewire cannot pass through the needles. The product was distributed to US consignees and Canada.

    Product
    Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. LOT Number 4330832. Product not distributed in US, UDI: 1 0840619 04197 4
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-2000-2020·2020-05-20

    ICU Medical Recalls Central Venous Catheters Due to Guidewire Defect

    ICU Medical is recalling 10 Central Venous Catheters because the included guidewire cannot pass through the needles. The defect prevents proper use of the device.

    Product
    Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41411-25
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-1949-2020·2020-05-20

    Cardiac Assist Recalls TandemHeart Kits Due to Assembly Error

    Cardiac Assist, Inc. is recalling five TandemHeart pump kits because an assembly error may prevent the device from priming.

    Product
    TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A15, Product: 5710-6215 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1930-2020·2020-05-20

    Ortho-Clinical Diagnostics Recalls VITROS CKMB Slides Due to Incorrect Instructions

    Ortho-Clinical Diagnostics is recalling VITROS CKMB Slides because Spanish and Swedish instructions incorrectly state the assay can be tested with plasma, which could result in biased results.

    Product
    VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 805 8232-300 slides, UDI Number 10758750004294 - Product Usage: The VITROS Chemistry Product Slides are used to measure creatine kinase MB (CK-MB) activity in serum which used to be ordered to detect Myocardi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1262-2020·2020-05-20

    Memantine Hydrochloride Extended-Release Capsules Recalled for Dissolution Failures

    The Harvard Drug Group is recalling 678 cartons of Memantine Hydrochloride Extended-Release Capsules due to low stage 3 dissolution results found during routine stability testing.

    Product
    MEMANTINE HYDROCHLORIDE — MEMANTINE HYDROCHLORIDE (MEMANTINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2006-2020·2020-05-20

    Ra Medical Systems Recalls DABRA Catheters Due to Calibration Failure Risk

    Ra Medical Systems is recalling DABRA catheters because the actual shelf life is shorter than labeled, potentially causing calibration failures.

    Product
    Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 18-090400-094, USE BY: 2019-09-24, MFR DATE: 2018-09-24, CE, Laser Radiation, STERILE (Gamma Sterilized), Single Use Only Revised Label: Product Label - Ra Medical Systems DABRA Catheter 5F (1.5mm), REF:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1856-2020·2020-05-13

    Nobel Biocare Universal Base Abutments Recalled for Incorrect Screws

    Nobel Biocare is recalling 238 Universal Base CC RP 1.5 mm abutments because they may contain incorrect screws that could loosen.

    Product
    Universal Base CC RP 1.5 mm; The Universal Base Abutment in combination with Nobel Biocare end osseous implants are indicated for single-unit if screw retained and for multiple-unit if cement retained crowns are used; catalog no. 38214 - Product Usage: Dental implant abutments ar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1259-2020·2020-05-13

    Sandoz Recalls Infuvite Pediatric Injection Due to Defective Container Crimping

    Sandoz is recalling 17,500 units of Infuvite Pediatric Multiple Vitamins Injection due to sub-optimal crimping in the vial. The product was distributed nationwide.

    Product
    INFUVITE PEDIATRIC — INFUVITE PEDIATRIC (MULTIPLE VITAMINS INJECTION)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1850-2020·2020-05-13

    Epimed RF Injector Cannula Recalled for Incorrect Expiration Date Labeling

    Epimed International is recalling 701 units of R-F Injector Cannulas due to incorrect expiration dates on the packaging. The devices were distributed worldwide and across multiple US states.

    Product
    R-F Injector Cannula. 20gx10cm-STERILE. REF/UDI: 257-2010/(01)10818788022124; REF/UDI: 257-2010D(01)00818788022127 - Product Usage:The Epimed RF Introduction Cannula is intended for use in radiofrequency (RF) heat lesion procedures for the relief of pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1845-2020·2020-05-13

    TeDan Recalls Fukushima Suction Tubes Due to Incorrect Raw Material

    TeDan Surgical Innovations LLC is recalling Fukushima suction tubes because incorrect raw material was used in production. The affected units were distributed in New Jersey.

    Product
    Fukushima suction tubes; Fukushima Malleable Tapered Suction, 3 FR, 145 MM; REF: TK-1110 - Product Usage: TSI Fukushima Suction Tubes are nonpowered, hand-held reusable manual surgical instruments for general use intended to be used in various general surgical procedures. They ar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1904-2020·2020-05-13

    Ortho Development Recalls Tibial Tray Components Due to Manufacturing Defect

    Ortho Development Corporation is recalling 29 tibial tray components due to a manufacturing defect that may cause assembly resistance.

    Product
    Tibial Tray Nonporous A Size 4; Model # PN 162-1400-A Material: Ti6Al4V.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1910-2020·2020-05-13

    Gentell Honey Hydrogel Recalled for FDA Registration Deficiency

    Gentell, Inc. is recalling Gentell Honey Hydrogel because the product was not properly registered with the FDA, as discovered during an audit.

    Product
    Gentell Honey Hydrogel Hydrogel 4oz. Tube. Wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11340 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers, first and seco
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1852-2020·2020-05-13

    Nobel Biocare Recalls Dental Implant Abutments Due to Incorrect Screw Risk

    Nobel Biocare is recalling 236 units of temporary dental implant abutments because packages may contain an incorrect screw that could loosen.

    Product
    Temporary Abutment Non-Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36662 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to r
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1858-2020·2020-05-13

    R82 A/S Recalls Chest Supports for Loose Plastic Plug

    R82 A/S is recalling 2,230 chest supports for the R82 Mustang and Rabbit Up because a plastic plug can come loose without tools.

    Product
    Chest Support for R82 Mustang, Model Numbers: 861810, 861820, 861830; and Rabbit Up, Model Numbers: 869810, 869820, 869830
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1853-2020·2020-05-13

    Nobel Biocare Recalls Dental Implant Abutments Due to Incorrect Screw Risk

    Nobel Biocare is recalling 239 units of Temporary Abutment Engaging CC RP components because packages may contain incorrect screws that could loosen.

    Product
    Temporary Abutment Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36664 - - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to res
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1889-2020·2020-05-13

    Inpeco Siemens Aptio Centrifuge Module Recall for Tube Loading Algorithm Defect

    Inpeco S.A. is recalling 313 Siemens Aptio Automation Centrifuge Modules because a tube loading algorithm may cause unbalanced loads that could damage the centrifuge.

    Product
    Siemens Aptio Automation Centrifuge Module, tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versions: CM_1-7-0.H86 or xCMd_2-5-0.elf and CM_1-7-1.H86 or xCMd_2-5-1-849fad9.elf
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-1883-2020·2020-05-13

    Northgate Technologies Recalls 9 FR AUTOLITH Probes for Biocompatibility Testing Failure

    Northgate Technologies is recalling 9 FR AUTOLITH probes because a lot failed biocompatibility testing. The recall covers 298 boxes distributed nationwide.

    Product
    Probe, 9 FR AUTOLITH; NTI Catalog Number 9-900-54 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1857-2020·2020-05-13

    Nobel Biocare Recalls Dental Implant Abutments Due to Incorrect Screws

    Nobel Biocare is recalling 478 Temporary Snap Abutments because packages may contain incorrect screws that could loosen, requiring retightening.

    Product
    Temporary Snap Abutment Engaging CC RP 1.5 mm; Pre-manufactured prosthetic components directly connected to the endosseous implant; catalog no. 38761 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacem
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1922-2020·2020-05-13

    Philips Brilliance iCT SP CT Scanner Recall Due to Bolt Issue

    Philips is recalling two Brilliance iCT SP CT scanners because a cooling unit bolt was not tightened to specification.

    Product
    Philips Brilliance iCT SP Computed Tomography X-Ray System; Model # 728311
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1851-2020·2020-05-13

    Nobel Biocare Dental Implant Recall Due to Incorrect Length Labeling

    Nobel Biocare is recalling 228 dental implants because the packaging label incorrectly lists the length as 7mm instead of the actual 10mm.

    Product
    NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965; UDI (01)07332747091441(10)12129104(17)240203 - Product Usage: are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supporting tooth replacements
    Category
    Medical Device
    Distribution
    0 states