The Recall Desk

Hazard

Sterility Compromise recalls

2,235 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2,235
Critical
4
Severe
260
Most recent
2026-09-30

Of the 2,235 sterility compromise recalls we have scored against our rubric, 4 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 260 (12%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sterility compromise recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

2051–2075 of 2235

  • ModerateFDA (Devices)·Z-1038-2014·2014-02-26

    Zimmer Recalls Bone Screws Due to Unvalidated Packaging Operations

    Zimmer is recalling 7,044,680 units of Herbert Bone Screws and Cannulated Bone Screws because packaging operations at a Puerto Rico facility were not properly validated.

    Product
    HERBERT BONE SCREW, 3.0MM and HERBERT CANNULATED BONE S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0885-2014·2014-02-05

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0899-2014·2014-02-05

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0886-2014·2014-02-05

    Synergetics Recalls Stiff 25ga Endo Illuminator Due to Faulty Seals

    Synergetics Inc is recalling 48 units of Stiff 25ga Endo Illuminators because faulty seals on the outer pouch could result in seal failure.

    Product
    Stiff 25ga Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.02.25PS. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0888-2014·2014-02-05

    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0878-2014·2014-02-05

    Synergetics Recalls 29ga Ophthalmic Chandeliers Due to Faulty Seals

    Synergetics Inc. is recalling 233 units of 29ga Oshima Dual Chandeliers because faulty seals on the outer pouch could fail, compromising the sterile status of the devices.

    Product
    29ga Oshima Dual Chandelier, Synergetics, inc., length 7.5 ft, sterile / EO, 56.50.29P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0894-2014·2014-02-05

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0896-2014·2014-02-05

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0882-2014·2014-02-05

    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0891-2014·2014-02-05

    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0875-2014·2014-02-05

    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0893-2014·2014-02-05

    Synergetics Recalls Vivid Endo Illuminator Due to Faulty Seals

    Synergetics Inc. is recalling Vivid Endo Illuminators because faulty seals on the outer pouch could fail, potentially compromising the sterile status of the device.

    Product
    Wide Field Endo Illuminator, Vivid (tm) Endo Illuminator, 20ga, Synergetics, inc., 20ga, length 7.5 ft, sterile / EO, 56.21P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0876-2014·2014-02-05

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0872-2014·2014-02-05

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0873-2014·2014-02-05

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0879-2014·2014-02-05

    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0887-2014·2014-02-05

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0881-2014·2014-02-05

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0880-2014·2014-02-05

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0898-2014·2014-02-05

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0895-2014·2014-02-05

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0884-2014·2014-02-05

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0883-2014·2014-02-05

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0874-2014·2014-02-05

    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0897-2014·2014-02-05

    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide