The Recall Desk

Hazard

Infection Risk recalls

3,438 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
3,438
Critical
25
Severe
993
Most recent
2026-10-14

Of the 3,438 infection risk recalls we have scored against our rubric, 25 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 993 (29%) 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 infection risk 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.

1201–1225 of 3438

  • HighFDA (Devices)·Z-2461-2020·2020-07-08

    LivaNova Recalls Sterile Standalone Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling 420 units of sterile standalone connectors because internal tests identified potential breaches in the sterile barrier.

    Product
    1/4X3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2140S/ 00803622129315
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2449-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Potential Barrier Breach

    LivaNova USA Inc. is recalling 648 units of Sterile Disposable Connectors because internal tests found the sterile barrier may be breached.

    Product
    Sterile Disposable Connectors ASY ASY STR CONN 3/8 STRLE 24 REF/ GTIN for Insert Label:050506000/ 00803622123238
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2448-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling specific lots of sterile disposable connectors because internal tests found potential breaches in the sterile barrier.

    Product
    Sterile Disposable Connectors ASY S CONN 3/16X1/8 RDR ANLD24 REF/ GTIN for Insert Label:050513000/ 00803622123252
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2444-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling specific lots of Sterile Disposable Connectors because internal tests identified potential breaches in the sterile barrier.

    Product
    Sterile Disposable Connectors ASY 3/16 X 3/16 STR CONNW/LL24. REF/ GTIN for Insert Label:050432000 / 00803622123184
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2454-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling 744 units of sterile disposable connectors because internal tests found potential breaches in the sterile barrier.

    Product
    Sterile Disposable Connectors ASY Y CONN 1/4 X 1/4 X 1/4 24 REF/ GTIN for Insert Label:050524000/ 00803622123306
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2446-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling specific lots of Sterile Disposable Connectors because internal tests found potential breaches in the sterile barrier.

    Product
    Sterile Disposable Connectors ASY STR CONN 3/16 STRLE 24. REF/ GTIN for Insert Label:050503000/ 00803622123214
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2464-2020·2020-07-08

    LivaNova Recalls Vein Irrigation Cannulas Due to Sterile Barrier Breach

    LivaNova is recalling 325 Vein Irrigation Cannulas because internal tests found potential breaches in the sterile barrier, which could compromise sterility.

    Product
    Vein Irrigation Cannula with blunt tip. ASY VIC, STERILE 25/CS REF/ GTIN for Insert Label: VIC/ 00803622133107
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2382-2020·2020-06-24

    Stryker Locking Screw Recall Due to Potential Sterility Compromise

    Stryker is recalling specific lots of Locking Screws because the blister pack seal may be compromised, meaning sterility cannot be assured.

    Product
    Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2383-2020·2020-06-24

    Stryker Locking Screw Recall Due to Compromised Blister Pack Seal Integrity

    Stryker is recalling specific lots of locking screws because the blister pack seal may be compromised, meaning sterility cannot be assured.

    Product
    Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x37,5 mm Catalog Number: 18965037S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2376-2020·2020-06-24

    Stryker End Cap Recall Due to Potential Sterility Compromise

    Stryker GmbH is recalling specific End Cap implants because the blister pack seal may be compromised, meaning sterility cannot be assured.

    Product
    Stryker End Cap, Standard T2 Humerus ¿6 mm Catalog Number: 18300003S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2374-2020·2020-06-24

    Stryker Compression Screw Recalled Due to Potential Sterility Compromise

    Stryker GmbH is recalling specific Advanced T2 Tibia Compression Screws because the blister pack seal integrity may be compromised, meaning sterility cannot be assured.

    Product
    Stryker Compression Screw, Advanced T2 Tibia Catalog Number: 18220001S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2375-2020·2020-06-24

    Stryker End Cap T2 Tibia Recalled Due to Compromised Sterility

    Stryker GmbH is recalling specific lots of End Cap T2 Tibia implants because the blister pack seal may be compromised, meaning sterility cannot be assured.

    Product
    Stryker End Cap T2 Tibia +10 mm Catalog Number: 18220010S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2373-2020·2020-06-24

    Stryker Locking Screw Recall Due to Compromised Sterility

    Stryker is recalling specific locking screws because the packaging seal may be compromised, meaning sterility cannot be assured.

    Product
    Stryker Locking Screw, Fully Threaded S2 05x35 mm Catalog Number: 17965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2384-2020·2020-06-24

    Stryker Locking Screw Recall Due to Compromised Blister Pack Seal Integrity

    Stryker GmbH is recalling specific lots of Locking Screws because the blister pack seal may be compromised, meaning sterility cannot be assured.

    Product
    Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x40 mm Catalog Number: 18965040S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2378-2020·2020-06-24

    Stryker Humerus End Cap Recalled for Potential Sterility Compromise

    Stryker GmbH is recalling specific T2 Humerus End Cap implants because the blister pack seal may be compromised, meaning sterility cannot be assured.

    Product
    Stryker End Cap T2 Humerus ¿6mm, 15mm height Catalog Number: 18300015S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2386-2020·2020-06-24

    Stryker Locking Screw Recall Due to Compromised Blister Pack Seal Integrity

    Stryker GmbH is recalling specific lots of Locking Screws because the blister pack seal may be compromised, meaning sterility cannot be assured.

    Product
    Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x50 mm Catalog Number: 18965050S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2377-2020·2020-06-24

    Stryker Humerus End Cap Recall Due to Compromised Sterility

    Stryker is recalling specific Humerus End Cap implants because the blister pack seal may be compromised, meaning sterility cannot be assured.

    Product
    Stryker 1 End Cap T2 Humerus ¿6mm, 5mm height Catalog Number: 18300005S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2387-2020·2020-06-24

    Stryker Gamma3 End Cap Recalled Due to Compromised Sterility

    Stryker GmbH is recalling specific Gamma3 End Caps because the blister pack seal may be compromised, meaning sterility cannot be assured.

    Product
    Stryker End Cap, Std, Ti Gamma3 Catalog Number: 30051100S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2385-2020·2020-06-24

    Stryker Locking Screw Recall Due to Compromised Blister Pack Seal Integrity

    Stryker GmbH is recalling specific lots of locking screws because the blister pack seal may be compromised, meaning sterility cannot be assured.

    Product
    Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x45 mm Catalog Number: 18965045S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2363-2020·2020-06-24

    Biomet Recalls Screw Instrument Tray Due to Sterilization Validation Failure

    Biomet is recalling 705 units of Screw Instrument Trays because the device and tray failed steam sterilization process validation testing.

    Product
    Biomet Screw Instrument Tray 6.5/80MM- Surgical Tray Product Code: 246111003
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2362-2020·2020-06-24

    Biomet Outer Sheath Recalled Due to Failed Sterilization Validation Testing

    Biomet is recalling 136 units of the Outer Sheath 4.5/5.0,6.5 because the device and tray failed steam sterilization validation testing.

    Product
    Biomet Outer Sheath 4.5/5.0,6.5- Orthopedic Manual Surgical Instrument Product Code: 14235
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2170-2020·2020-06-10

    FDA Recalls Sterile Custom Surgical Packs Due to Unregistered Facility

    American Contract Systems is recalling 2,868 sterile custom surgical packs because they were manufactured in a facility not registered with the FDA.

    Product
    Sterile Custom Packs to be used in surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2154-2020·2020-06-03

    Biomet Recalls Vanguard Knee Implants Due to Endotoxin Levels

    Biomet, Inc. is recalling 91 Vanguard Knee System patella implants because they may contain elevated endotoxin levels that exceed specification limits.

    Product
    Knee Products: 184762 Knees Vanguard Knee System, Series-A Standard Patella, 28 MM; 184764 Knees Vanguard Knee System, Series-A Standard Patella, 31 MM Product Usage: Knee prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1974-2020·2020-05-20

    Access Scientific Recalls Saline Flush Syringes Due to Packaging Holes

    Access Scientific LLC is recalling 7,395 saline flush syringes used in POWERWAND kits because holes in the packaging compromised sterility.

    Product
    BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Quick Kit. REF/UDI / 94104/10859821006169 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast…
    Category
    Medical Device
    Distribution
    Distributed nationwide