The Recall Desk

FDA (Devices) recall action 80080

Olsen Medical recalled 5 products on 2018-06-06

The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.

Products
5
Announced
2018-06-06
Critical
0
Units
1,677,053

Why these products were recalled

Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–5 of 5

  • HighFDA (Devices)··2018-06-06

    Olsen Medical Recalls Symmetry Monopolar Forceps Due to Sterile Seal Risk

    Olsen Medical is recalling 4,110 Symmetry monopolar forceps worldwide because products may encroach into the sterile pouch seal, increasing the risk of the seal being compromised.

    Product
    Symmetry Olsen monopolar forceps: (a) Insulated Potts-Smith Forceps 8" (20.3cm) Serrated Tips, REF 20-2650K, QTY 10 (b) Insulated Bayonet Forceps 8.25" (21.0cm) Serrated 1.5mm Tips, REF 20-2920HK, QTY 10 (c) Insulated Bayonet Forceps 8.5" (21.6cm) Serrated 1.5mm Tips, REF 20-
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··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
    Distribution
    0 states
  • ModerateFDA (Devices)··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
    Distribution
    0 states
  • ModerateFDA (Devices)··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
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    0 states
  • ModerateFDA (Devices)··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
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    0 states