The Recall Desk

FDA (Devices) recall action 67147

Synergetics Inc recalled 28 products on 2014-02-05

The FDA (Devices) publishes a recall like this one as 28 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 28 pages.

Products
28
Announced
2014-02-05
Critical
0
Units
2,855

Why these products were recalled

Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.

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.

1–25 of 28

  • HighFDA (Devices)··2014-02-05

    Synergetics Recalls 25ga Endo Illuminator Due to Faulty Seals

    Synergetics Inc is recalling 96 units of 25ga Endo Illuminator devices because faulty seals on the outer pouch could fail, potentially compromising sterility.

    Product
    25ga Endo Illuminator, Synergetics, inc., length 7.0 ft, sterile / EO, 56.02.25 Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-02-05

    Synergetics Chandelier Infusion Cannula Recalled for Faulty Seals

    Synergetics Inc. is recalling Chandelier Infusion Cannulas due to faulty seals on the outer pouch, which could result in seal failure.

    Product
    Chandelier Infusion Cannula, Synergetics, inc., 20ga, length 7.5 ft, sterile / EO, 56.30.P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
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    Distribution
    0 states
  • HighFDA (Devices)··2014-02-05

    Synergetics Recalls 23ga Wide Field Endo Illuminator Due to Seal Failure

    Synergetics Inc is recalling 568 units of 23ga Wide Field Endo Illuminators because faulty seals on the outer pouch could result in seal failure.

    Product
    23ga Wide Field Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.21.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2014-02-05

    Synergetics Vivid Endo Illuminator Recalled for Faulty Sterile Seals

    Synergetics Inc. is recalling Vivid Endo Illuminators because faulty seals on the outer pouch could fail, compromising the sterile status of the single-use ophthalmic devices.

    Product
    Vivid (tm) Endo Illuminator, 20ga, Synergetics, inc., length 7.5 ft, sterile / EO, 56.20P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
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    Distribution
    0 states
  • HighFDA (Devices)··2014-02-05

    Synergetics Recalls Corona Shielded Wide Field Endo Illuminator Due to Seal Failure

    Synergetics Inc. is recalling specific lots of Corona Shielded Wide Field Endo Illuminators because faulty seals on the outer pouch could fail, compromising sterility.

    Product
    "The Corona" Shielded Wide Field Endo Illuminator, Synergetics, inc. 20ga, length 7.0 ft, sterile / EO, 56.12. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
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    Distribution
    0 states
  • HighFDA (Devices)··2014-02-05

    Synergetics Recalls 25ga Wide Field Corona Endo Illuminator Due to Seal Failure

    Synergetics Inc is recalling 96 units of 25ga Wide Field Corona Endo Illuminators because faulty seals on the outer pouch could fail, compromising sterility.

    Product
    25ga Wide Field Corona Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.12.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-02-05

    Synergetics 25ga Mid-Field Endo Illuminator Recalled for Seal Failure

    Synergetics Inc is recalling 25ga Mid-Field Endo Illuminators because faulty seals on the outer pouch could fail, potentially compromising sterility.

    Product
    25ga Mid-Field Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.22.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
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    Distribution
    0 states
  • HighFDA (Devices)··2014-02-05

    Synergetics Recalls 23ga Chow Illuminated Pick Due to Faulty Seals

    Synergetics Inc. is recalling 38 units of 23ga Chow Illuminated Picks due to faulty seals that could compromise sterility.

    Product
    23ga Chow Illuminated Pick, Synergetics, inc., length 7.5 ft, sterile / EO, 56.07.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-02-05

    Synergetics Recalls 25ga Awh Vivid Chandelier Due to Faulty Seals

    Synergetics is recalling 108 units of 25ga Awh Vivid Chandeliers because faulty seals on the outer pouch could fail, potentially compromising the sterile status of the ophthalmic devices.

    Product
    25ga Awh Vivid Chandelier, Synergetics, length 7.5 ft, sterile / EO, 56.54.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-02-05

    Synergetics Recalls 25ga Awh Chandelier Due to Faulty Sterile Seals

    Synergetics Inc. is recalling 36 units of 25ga Awh Chandeliers because faulty seals on the outer pouch could fail, compromising the sterile status of the ophthalmic devices.

    Product
    25ga Awh Chandelier, Synergetics, inc., length 8.0 ft, sterile / EO, 56.50.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-02-05

    Synergetics Recalls 25ga Aspirating Endo Illuminator Due to Seal Failure

    Synergetics is recalling 25ga Aspirating Endo Illuminators because faulty seals on the outer pouch could fail, compromising the sterile status of the ophthalmic devices.

    Product
    25ga Aspirating Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.24.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-02-05

    Synergetics Recalls Stiff 25ga Chow Illuminated Pick Due to Seal Failure

    Synergetics Inc. is recalling 44 units of Stiff 25ga Chow Illuminated Picks because faulty seals on the outer pouch could fail, compromising sterility.

    Product
    Stiff 25ga Chow Illuminated Pick (Dull), Synergetics, inc., length 8.0 ft, sterile / EO, 56.07.25PS. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
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    Distribution
    0 states
  • HighFDA (Devices)··2014-02-05

    Synergetics Recalls 72 Sterile Ophthalmic Laser Probes Due to Seal Failure

    Synergetics is recalling 72 sterile ophthalmic laser probes because faulty seals on the outer pouch could fail, potentially compromising sterility.

    Product
    23ga Straight Fixed Extended Illuminated Laser Probe, Synergetics, length 7.5 ft, sterile / EO, 55.62.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
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    Distribution
    0 states
  • HighFDA (Devices)··2014-02-05

    Synergetics Recalls 23ga Chandelier Infusion Cannulas Due to Seal Failure

    Synergetics Inc is recalling 240 units of 23ga Chandelier Infusion Cannulas because faulty seals on the outer pouch could fail, compromising sterility.

    Product
    23ga Chandelier Infusion Cannula, Synergetics, inc., length 8.0 ft, sterile / EO, 56.30.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-02-05

    Synergetics Recalls Stiff 25ga Wide Field Endo Illuminator Due to Seal Failure

    Synergetics Inc is recalling specific lots of Stiff 25ga Wide Field Endo Illuminators because faulty seals on the outer pouch could fail, compromising sterility.

    Product
    Stiff 25ga Wide Field Endo Illuminator, Synergetics, inc. length 7.5 ft, sterile / EO, 56.21.25PS. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-02-05

    Synergetics Recalls 27ga Endo Illuminator Due to Faulty Sterile Seals

    Synergetics Inc. is recalling 96 units of 27ga ONE-STEP Endo Illuminator devices because faulty seals on the outer pouch could fail, compromising sterility.

    Product
    27ga ONE-STEP (tm) Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.02.27P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-02-05

    Synergetics Recalls Two-Port Vitrectomy End Irrigators Due to Seal Failure

    Synergetics is recalling specific lots of Two-Port Vitrectomy End Irrigators because faulty seals on the outer pouch could fail, compromising sterility.

    Product
    Two-Port Vitrectomy (TPV (tm)) Wide Field High Flow End Irrigator, Synergetics, inc., 19ga, length 7.0 ft, sterile / EO, 56.14. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
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    0 states
  • HighFDA (Devices)··2014-02-05

    Synergetics Recalls 23ga Wide Field Corona Endo Illuminator Due to Seal Failure

    Synergetics Inc is recalling 108 units of 23ga Wide Field Corona Endo Illuminators because faulty seals on the outer pouch could result in seal failure.

    Product
    23ga Wide Field Corona Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.12.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-02-05

    Synergetics Recalls 23ga Mid-Field Endo Illuminator Due to Seal Failure

    Synergetics Inc is recalling 26 units of 23ga Mid-Field Endo Illuminator devices because faulty seals on the outer pouch could fail, compromising sterility.

    Product
    23ga Mid-Field Endo Illuminator, Synergetics length 7.5 ft, sterile / EO, 56.22.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-02-05

    Synergetics Recalls 23ga Aspirating Endo Illuminator Due to Seal Failure

    Synergetics is recalling 43 units of 23ga Aspirating Endo Illuminators because faulty seals on the outer pouch could result in seal failure.

    Product
    23ga Aspirating Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.24.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-02-05

    Synergetics Recalls 72 Sterile Ophthalmic Endo Illuminators Due to Seal Failure

    Synergetics Inc. is recalling 72 sterile ophthalmic Endo Illuminators because faulty seals on the outer pouch could fail, potentially compromising sterility.

    Product
    Endo Illuminator, Synergetics, inc., 20ga, length 7.0 ft, sterile / EO, 56.02. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-02-05

    Synergetics Recalls 25ga Awh Chandelier Ophthalmic Devices Due to Seal Failure

    Synergetics Inc is recalling 36 units of 25ga Awh Chandelier ophthalmic devices because faulty seals on the outer pouch could fail, compromising sterility.

    Product
    25ga Awh Chandelier, Synergetics, inc., B&L Cannula Compatible, length 8.0 ft, sterile / EO, 56.52.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
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    Distribution
    0 states
  • HighFDA (Devices)··2014-02-05

    Synergetics Recalls 23ga Endo Illuminator Due to Faulty Seals

    Synergetics Inc. is recalling 102 units of 23ga Endo Illuminator devices because faulty seals on the outer pouch could result in seal failure.

    Product
    23ga Endo Illuminator (Eckardt Trocar Compatible), Synergetics, inc., length 8.0 ft, sterile / EO, 56.02.23P Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-02-05

    Synergetics Recalls Sterile Ophthalmic Tubing Sets Due to Seal Failure Risk

    Synergetics Inc. is recalling 12 units of sterile ophthalmic tubing sets because faulty seals could fail, potentially compromising sterility.

    Product
    Standard tubing set, Synergetics, Inc., length 10 ft, sterile / EO, 17570. Packed 6 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-02-05

    Synergetics Recalls 27ga Ophthalmic Chandelier Due to Faulty Sterile Seals

    Synergetics is recalling 24 units of 27ga ONE-STEP Awh/Tano Vivid Chandeliers because faulty seals on the outer pouch could fail, compromising the sterile status of the ophthalmic devices.

    Product
    27ga ONE-STEP (tm) Awh/Tano Vivid Chandelier, Synergetics, length 8.0 ft, sterile / EO, 56.55.27P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Distribution
    0 states