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.

10451–10475 of 21617

  • ModerateFDA (Devices)·Z-1942-2018·2018-06-06

    Olsen Medical Recalls Bipolar Cords Due to Sterile Seal Risk

    Olsen Medical is recalling 323,886 bipolar cords because products may encroach into the sterile pouch seal, increasing the risk of the seal being compromised.

    Product
    Symmetry Olsen bipolar cord: (a) Bipolar Cord, Twin Pin Connector to Shrouded Instrument Connector, 12' (3.6m), REF 87500, QTY 50 (b) Bipolar Cord, Twin Pin Connector, 12' (3.6m), REF 40-1102, QTY 10 (c) Bipolar Cord, Twin Pin Connector, 12' (3.6m), REF 40-1102SPC, QTY 10 (d)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1982-2018·2018-06-06

    Arrow International Recalls Two-Lumen Central Venous Access Kits

    Arrow International Inc. is recalling 416,055 Two-Lumen Central Venous Access Kits because unsealed packaging may compromise product sterility.

    Product
    ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7-7.5 Fr. Catheters; Product Code: ASK-21142-WHC2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2022-2018·2018-06-06

    Arrow International Recalls Echogenic Needles Due to Packaging Sterility Concerns

    Arrow International is recalling 416,055 echogenic needles because unsealed packaging may compromise product sterility. The recall covers products distributed in the US and 34 other countries.

    Product
    Echogenic Needle; Product codes: PN-00215-E and PN-00217-E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1941-2018·2018-06-06

    Olsen Medical Recalls Symmetry Monopolar Pencil Devices Due to Seal Risk

    Olsen Medical is recalling 665,350 Symmetry Monopolar Pencil devices because products may encroach into the sterile pouch seal, increasing the risk of the seal being compromised.

    Product
    Symmetry Olsen Monopolar Pencil: (a) Button Switchpen, w/ Standard Needle Electrode REF 75505, QTY 50 (b) Button Switchpen, w/ Standard Blade Electrode, REF 75530, QTY 50 (c) Rocker Switchpen, w/ Standard Blade Electrode, REF 75610, QTY 50 (d) Button Switchpen, w/ Extendable
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2003-2018·2018-06-06

    Arrow International Recalls Multi-Lumen Central Venous Catheterization Kits

    Arrow International is recalling 416,055 Multi-Lumen Central Venous Catheterization Kits because unsealed packaging may compromise product sterility.

    Product
    Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product code: ASK-45703-AEH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1936-2018·2018-06-06

    Medline Needle Counters Recalled for Potential Packaging Seal Creep

    Medline Industries is recalling 2,600 units of sterile needle counters because packaging seal creep may compromise sterility.

    Product
    MEDLINE O.R. Necessities(R) STERILE R, Needle Counter/Compte-aiguiles/Caja de agujas, Gold Standard/Standard Or/Oro y Estander, 40 Ct. Foam Block / Magnet with Blade Remover, Coussinet en mousse pour 40 aiguilles /Magnetise avec quitte-lame Or, 40 Ct Bloque de espuma / Iman Con e
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1992-2018·2018-06-06

    Arrow International Recalls CVC Kits Due to Unsealed Packaging

    Arrow International is recalling 416,055 ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kits because unsealed packaging may compromise product sterility.

    Product
    ARROWg+ard Blue PLUS¿ Pressure Injectable Two-Lumen CVC Kit; Product Code: CDC-42802-P1A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1976-2018·2018-06-06

    Arrow Percutaneous Sheath Introducer Kits Recalled for Packaging Sterility Issues

    Arrow International is recalling 416,055 Percutaneous Sheath Introducer Kits because unsealed packaging may compromise sterility. The recall covers products distributed in the US and 34 other countries.

    Product
    Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters; Product Code: ASK-09903-UPA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1961-2018·2018-06-06

    Arrow International Recalls Epidural Needles Due to Packaging Sterility Concerns

    Arrow International is recalling 416,055 epidural needles because unsealed packaging may compromise product sterility. The recall covers distribution in the US and 35 other countries.

    Product
    Epidural Needle; Product Codes: AN-05501 and AN-05505
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2045-2018·2018-06-06

    NordicNeuroLab Recalls nordicBrainEX Software Due to Fiber Tract Alignment Error

    NordicNeuroLab AS is recalling 36 licenses of nordicBrainEX version 1.1.2 because a software error can cause fiber tracts to be misaligned when switching between image series with identical resolutions.

    Product
    nordicBrainEX Product Usage: nordicBrainEx is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform im
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1998-2018·2018-06-06

    Arrow International Recalls Central Venous Catheter Kits Due to Packaging Issues

    Arrow International Inc is recalling 416,055 Multi-Lumen Central Venous Catheterization Kits because unsealed packaging may compromise product sterility.

    Product
    Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-42703-RV1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1964-2018·2018-06-06

    Arrow Maximal Barrier Drape Recalled for Potential Sterility Compromise

    Arrow International Inc is recalling Maximal Barrier Drapes because unsealed packaging may compromise product sterility. The recall affects 416,055 units distributed in the US and 34 other countries.

    Product
    Maximal Barrier Drape; Product Codes: ASK-00002-1A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2007-2018·2018-06-06

    Arrow International Recalls 5Fr Catheter Clamps Due to Sterility Concerns

    Arrow International is recalling 5Fr Catheter Clamps with Fasteners because unsealed packaging may compromise product sterility.

    Product
    5Fr. Catheter Clamp with Fastener; Product Code: CC-00005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1939-2018·2018-06-06

    Siemens SOMATOM go.Now CT Scanner Software Recall

    Siemens Medical Solutions is recalling 4 SOMATOM go.Now CT scanners in the US due to a potential software issue that may require patient rescans.

    Product
    SOMATOM go.Now, Material Number 11061618 There is a potential for a software issue that may cause the need for necessary patient rescans.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1935-2018·2018-06-06

    Medline Sterile Needle Counter Recall Due to Packaging Seal Creep

    Medline Industries is recalling sterile needle counters because packaging seal creep may compromise sterility.

    Product
    MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 40 Ct. Double Magnet / Foam Block with Blade Remover, reorder: NC100FBR Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2034-2018·2018-06-06

    Joerns Healthcare Recalls ProCair Mattresses Due to Missing Air Shutoff Valves

    Joerns Healthcare is recalling specific ProCair and P.R.O. Matt mattresses because they were supplied with connectors lacking required internal shutoff valves, which can cause air to escape from the mattress cells.

    Product
    ProCair Mattress: (a) PROCAIR PLUS 42X80, MATERIAL NUMBER 222-4280 (b) PROCAIR PLUS 36X80, MATERIAL NUMBER 222-3680 (c) PROCAIR PLUS 84" MATTRESS, MATERIAL NUMBER 222-6384 Product Usage: Non powered flotation therapy mattress. The device is intended to treat or prevent dec
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1996-2018·2018-06-06

    Arrow Central Venous Catheter Kits Recalled for Unsealed Packaging

    Arrow International is recalling 416,055 central venous catheterization kits because unsealed packaging may compromise product sterility.

    Product
    Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-42703-PHCH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1979-2018·2018-06-06

    Arrow International Recalls Central Venous Catheter Kits Due to Packaging Issues

    Arrow International is recalling 416,055 central venous catheterization kits because unsealed packaging may compromise product sterility.

    Product
    Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-15703-LDP1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1957-2018·2018-06-06

    Arrow International Recalls Catheter Hemostasis Valves Due to Packaging Defect

    Arrow International is recalling 416,055 catheter hemostasis valves because unsealed packaging may compromise product sterility.

    Product
    Catheter Hemostasis Valve For use with .038" (.096 cm) dia. and smaller guide wires; Product Code: AI-07000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1943-2018·2018-06-06

    Olsen Medical Recalls Symmetry Monopolar Cords Due to Seal Risk

    Olsen Medical is recalling 71,890 Symmetry monopolar cords because products may encroach into the sterile pouch seal, increasing the risk of the seal being compromised.

    Product
    Symmetry Olsen monopolar cord: (a) Monopolar Cord, 1/8" Diameter Pin, TUR Connector, 10' (3.0m), REF 92002, QTY 50 (b) Monopolar Cord, Bovie to 90o Female Pin, 10' (3.0m), REF 40-2106, QTY 10 (c) Monopolar Cord, Bovie to 90o Female Pin, 10' (3.0m), REF 40-2110, QTY 10 Des
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1944-2018·2018-06-06

    Olsen Medical Recalls Bipolar Forceps Due to Sterile Seal Risk

    Olsen Medical is recalling specific Symmetry Olsen bipolar forceps because products may encroach into the sterile pouch seal, increasing the risk of the seal being compromised.

    Product
    Symmetry Olsen bipolar forceps: (a1) Insulated Irrigating Bayonet Forceps 6.25" (15.9cm) Smooth 0.5mm Tips, REF 20-0311, QTY 5 (b1) Insulated Irrigating Bayonet Forceps 6.25" (15.9cm) Smooth 0.5mm Tips, REF 20-0311R, QTY 5 (c1) Insulated Irrigating Bayonet Forceps 6.25" (15.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1972-2018·2018-06-06

    Arrow Radial Artery Catheterization Kit Recalled for Unsealed Packaging

    Arrow International Inc is recalling Radial Artery Catheterization Kits because unsealed packaging may compromise product sterility.

    Product
    Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04020-RIHM
    Category
    Medical Device
    Distribution
    Distributed nationwide