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.

1151–1175 of 3438

  • HighFDA (Devices)·Z-0623-2021·2020-12-23

    Biomet OSS Polyethylene Tibial Bushing Recalled for Sterile Seal Breach

    Biomet is recalling specific lots of OSS Polyethylene Tibial Bushings because a breach in the sterile seal could lead to loss of sterility.

    Product
    OSS Polyethylene Tibial Bushing, Item number 150476 - Product Usage: intended for use in limb salvage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0621-2021·2020-12-23

    Biomet Custom Cancellous Thread Recalled for Potential Sterile Seal Breach

    Biomet is recalling specific lots of Custom Cancellous Thread devices because a breach in the sterile seal could lead to loss of sterility.

    Product
    Custom Cancellous Thread, Item numbers CP161941, CP161943 - Product Usage: 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0633-2021·2020-12-23

    Maquet Cardiovascular Recalls HLS Set Advanced Due to Sterility Breach

    Maquet Cardiovascular is recalling the HLS Set Advanced because of breaches in the product's sterility barrier. The device is used with the CARDIOHELP system for cardiac and pulmonary support.

    Product
    HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Product Code/Part Number: 70105.2794 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorporeal circulation for cardiac support and/or pulmonary support.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0632-2021·2020-12-23

    Maquet Cardiovascular Recalls HLS Set Advanced Due to Sterility Breaches

    Maquet Cardiovascular is recalling HLS Set Advanced devices used for cardiac support due to breaches in the product's sterility barrier.

    Product
    HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code/Part Number: 70105.2797 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorporeal circulation for cardiac support and/or pulmonary support.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0172-2021·2020-10-28

    Smith & Nephew Recalls HEALICOIL Absorbable Suture Anchors Due to Seal Issues

    Smith & Nephew is recalling HEALICOIL absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.

    Product
    HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BLK- Absorbable Suture anchor Product Number: 72203708
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0153-2021·2020-10-28

    Smith & Nephew Recalls OSTEORAPTOR Absorbable Suture Anchors Due to Seal Defects

    Smith & Nephew is recalling OSTEORAPTOR absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.

    Product
    OSTEORAPTOR 2.9 W. 2 UB WHITE / BLACK -Absorbable Suture anchor Product Number: 72201996
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0139-2021·2020-10-28

    Smith & Nephew Recalls TWINFIX Absorbable Suture Anchors Due to Seal Issues

    Smith & Nephew is recalling TWINFIX 6.5mm absorbable suture anchors because improper packaging seals may breach the sterile barrier.

    Product
    TWINFIX 6.5MM AB PRELOADED ULTRABRAID- Absorbable Suture anchors Product Number: 7210712
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0156-2021·2020-10-28

    Smith & Nephew Recalls TWINFIX ULTRA Suture Anchors Due to Seal Defects

    Smith & Nephew is recalling TWINFIX ULTRA PLLA/HA 5.5 W/3 UB Absorbable Suture Anchors because improper or incomplete packaging seals may breach the sterile barrier.

    Product
    TWINFIX ULTRA PLLA/HA 5.5 W/3 UB-Absorbable Suture anchor Product Number: 72202603
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0207-2021·2020-10-28

    ICU Medical Recalls Intravascular Administration Sets Due to Seal Defect

    ICU Medical is recalling specific lots of intravascular administration sets because a manufacturing defect may prevent the NanoClave from sealing properly.

    Product
    13 IN(33cm) APPX 1.0 ml, SMALLBORE SET, 4 MicroClave Clear, NanoClave T-Conn, Filter; 1 unit per pouch, 50 pouches per case. UDI:(01)10887709085210(17)250101(30)50(10)4572801; (01)10887709085227(17)250101(30)50(10)4589920; (01)10887709085227(17)250101(30)50(10)4572950. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0144-2021·2020-10-28

    Smith & Nephew Recalls Ultra Fast-Fix Absorbable Suture Anchors

    Smith & Nephew is recalling Ultra Fast-Fix AB Assembly curved absorbable suture anchors due to improper or incomplete packaging seals that may breach the sterile barrier.

    Product
    ULTRA FAST-FIX AB ASSEMBLY - CURVED-Absorbable Suture anchors Product Number: 72201494
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0164-2021·2020-10-28

    Smith & Nephew Recalls TWINFIX ULTRA HA Absorbable Suture Anchors

    Smith & Nephew is recalling TWINFIX ULTRA HA absorbable suture anchors due to improper or incomplete packaging seals that may breach the sterile barrier.

    Product
    TWINFIX ULTRA HA 6.5 W/2 UB (BLUE & BLK)- Absorbable Suture anchor Product Number: 72202631
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0138-2021·2020-10-28

    Smith & Nephew Recalls TWINFIX Suture Anchors Due to Seal Defects

    Smith & Nephew is recalling TWINFIX 5.0MM AB Suture Anchors because improper or incomplete packaging seals may breach the sterile barrier.

    Product
    TWINFIX 5.0MM AB SUTURE ANCHOR-Absorbable Suture anchors Product Number: 7210711
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0199-2021·2020-10-28

    ICU Medical Recalls NanoClave Intravascular Administration Sets Due to Seal Defect

    ICU Medical is recalling specific lots of NanoClave intravascular administration sets due to a manufacturing defect that may prevent a proper seal.

    Product
    9.5 IN (24cm)APPX 1.1ml SMALLBORE TRIFUSE SET,3 MicroClave CLEAR, NanoClave, 3 CHECK VALVES; 1 unit per pouch, 50 pouches per case. UDI:(01)10887709069340(17)250101(30)50(10)4558471. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0167-2021·2020-10-28

    Smith & Nephew Recalls HEALICOIL Absorbable Suture Anchors Due to Seal Defects

    Smith & Nephew is recalling HEALICOIL absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.

    Product
    HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203697
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0136-2021·2020-10-28

    Smith & Nephew Recalls TWINFIX Suture Anchors Due to Seal Issues

    Smith & Nephew is recalling TWINFIX 5.0mm suture anchors because improper packaging seals may breach the sterile barrier.

    Product
    TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO Absorbable Suture anchors Product Number: 7210309
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0145-2021·2020-10-28

    Smith & Nephew Recalls Ultra Fast-Fix Absorbable Suture Anchors

    Smith & Nephew is recalling Ultra Fast-Fix AB Assembly absorbable suture anchors due to improper or incomplete packaging seals that may breach the sterile barrier.

    Product
    ULTRA FAST-FIX AB ASSEMBLY-REVERSE CURVE-Absorbable Suture anchor Product Number: 72201495
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0175-2021·2020-10-28

    Smith & Nephew Recalls Microraptor RegenSorb Suture Anchors for Seal Issues

    Smith & Nephew is recalling Microraptor RegenSorb Suture Anchors because improper or incomplete pouch seals may breach the sterile barrier.

    Product
    MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204984
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0161-2021·2020-10-28

    Smith & Nephew Recalls TWINFIX ULTRA Suture Anchors Due to Seal Issues

    Smith & Nephew is recalling TWINFIX ULTRA PLLA HA 6.5MM suture anchors because improper or incomplete packaging seals may breach the sterile barrier.

    Product
    TWINFIX ULTRA PLLA HA 6.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202620
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0147-2021·2020-10-28

    Smith & Nephew Recalls Raptormite Suture Anchors Due to Seal Defects

    Smith & Nephew is recalling Raptormite suture anchors because improper packaging seals may breach the sterile barrier.

    Product
    RAPTORMITE 3.7MM AB W/ NEEDLES AND TWO-Absorbable Suture anchor Product Number: 72201805
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0143-2021·2020-10-28

    Smith & Nephew Recalls Ultra Fast-Fix Absorbable Suture Anchors

    Smith & Nephew is recalling Ultra Fast-Fix AB Assembly suture anchors due to improper or incomplete packaging seals that may breach the sterile barrier.

    Product
    ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT-Absorbable Suture anchors Product Number: 72201493
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0062-2021·2020-10-14

    Medline Recalls Non-Sterile Vascular Surgery Kits Sold Without Sterilization Capability

    Medline Industries is recalling 80 non-sterile vascular surgery kits sold to accounts without sterilization capabilities. The kits were distributed nationwide, including in CA, CO, CT, OH, TX, and NY.

    Product
    Kit Model #650301018, MTO Vascular Surgery - Cleveland Clinic PG - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0064-2021·2020-10-14

    Medline Recalls Non-Sterile MTO Protection Station Plus Kits

    Medline is recalling 80 non-sterile MTO Protection Station Plus kits because they were sold to facilities without sterilization capabilities.

    Product
    Kit Model #650304917, MTO Protection Station Plus with Drape - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0067-2021·2020-10-14

    Medline Recalls Non-Sterile Left Heart Kits Sold Without Sterilization Capability

    Medline is recalling 16 non-sterile left heart kits sold to accounts without sterilization capabilities. The kits require sterilization prior to use.

    Product
    Kit Model #65220955, MTO Left Heart Kit VA Med San Francisco - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0063-2021·2020-10-14

    Medline Recalls Non-Sterile Radiology Kits Sold Without Sterilization Capability

    Medline Industries is recalling 20 non-sterile radiology kits that were sold to accounts without the ability to sterilize them prior to use.

    Product
    Kit Model #650301023, MTO Radiology Kit Cleveland Clinic - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0061-2021·2020-10-14

    Medline Recalls Non-Sterile Left Heart Kits Sold Without Sterilization Capability

    Medline Industries is recalling 60 non-sterile Left Heart Kits sold to accounts without sterilization capabilities. The kits were distributed nationwide.

    Product
    Kit Model #65021652, MTO Left Heart Kit United Reg Health - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and…
    Category
    Medical Device
    Distribution
    Distributed nationwide