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.

451–475 of 3438

  • SevereFDA (Devices)·Z-1105-2024·2024-03-06

    Medline Dialysis Kits Recalled for Potential Sterility Defects

    Medline Industries is recalling certain dialysis kits and trays due to potential sterility defects in component irrigation solutions and saline products. Non-sterile solutions used in dialysis could cause infection.

    Product
    MEDLINE Kits, trays, and packs labeled as follows: DIALYSIS ON/OFF BNDLE -NO DRSG, REF DYNDC3088
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1133-2024·2024-03-06

    Medline Tracheostomy Care Trays Recalled for Sterility Issues

    Medline Industries is recalling 528 latex-free tracheostomy care trays due to potential sterility failure in component irrigation solutions. Non-sterile solutions pose infection risk.

    Product
    Centurion Kits, trays, and packs labeled as follows: LATEX FREE TRACHEOSTOMY CARE TRAY, REF TC7170
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1128-2024·2024-03-06

    Medline Suction Catheter Kits Recalled for Potential Sterility Defects

    Medline Industries is recalling 1,012,700 suction catheter kits manufactured with irrigation solutions that may lack sterility. The recalled products are distributed nationwide and internationally.

    Product
    Medline Kits, trays, and packs labeled as follows: a) KIT,SUCTION CATH,10FR W/WATER, REF DYND41470; b) KIT,SUCTION CATH,12FR W/H20 12, REF DYND41471; c) KIT,SUCTION CATH,14FR W/SALIN, REF DYND40442; d) KIT,SUCTION CATH,14FR W/WATER, REF DYND41472; e) KIT,SUCTION…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1110-2024·2024-03-06

    Medline wound irrigation kits recalled for potential sterility defects

    Medline Industries is recalling approximately 2,205 wound irrigation kits due to potential lack of sterility in component solutions. Non-sterile irrigation solutions pose a risk of infection during wound care.

    Product
    Medline Kits, trays, and packs labeled as follows: CHP WOUND IRRIGATION KIT, REF DYK1017614W
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1099-2024·2024-03-06

    Medline Centurion maintenance flush kits recalled for sterility failure

    Medline Industries is recalling Centurion maintenance flush and blood draw kits that may lack sterility due to defective components, potentially allowing infections during medical procedures.

    Product
    Centurion Kits, trays, and packs labeled as follows: MAINTENANCE FLUSH KIT/BLOOD DRAW, REF DT19335A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1092-2024·2024-03-06

    MEDLINE Irrigation and Tracheostomy Kits Recalled for Potential Sterility Failure

    MEDLINE Industries is recalling 385,028 units of suction catheter and tracheostomy care kits due to potential lack of sterility in Nurse Assist irrigation components. Affected kits were distributed in the US, Puerto Rico, Canada, UAE, and Panama.

    Product
    MEDLINE kits and trays, labeled as: a) SUCTION CATH 10FR KIT W/SALINE, REF DYND41470SA, DYND41470SAH; b) TRACH CARE TRAY, REF DYNDA1931B, DYNDA1931BH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1104-2024·2024-03-06

    Medline Catheterization Kits Recalled for Potential Sterility Defect

    Medline Industries is recalling catheterization kits for potential sterility defects in component irrigation solutions. Non-sterile solutions used in medical procedures could result in serious infections.

    Product
    MEDLINE Kits, trays, and packs labeled as follows: CATHETERIZATION KIT, REF DYNDA2939
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1090-2024·2024-03-06

    Medline Tracheal Care Trays Recalled Due to Sterility Concerns

    Medline Industries is recalling 385,028 tracheostomy care trays due to potential sterility issues with certain components. The kits were distributed nationwide and internationally.

    Product
    MEDLINE TRAY TRACH BASIC SOLUTION, REF DYND40511
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1096-2024·2024-03-06

    Medline Medical Kits Recalled for Potential Sterility Defect

    Medline Industries is recalling multiple surgical and critical care kits due to a potential lack of sterility in component solutions (sodium chloride irrigation, sterile water for irrigation, and saline flush syringes). Non-sterile solutions could expose patients to infection.

    Product
    MEDLINE Kits, trays, and packs labeled as follows: a) DIALYSIS FISTULA KIT, REF DYNDC3106, b) ENDO KIT, REF DYKE1346D, c) ENDO KIT, REF DYKE1892A, d) ENDO KIT W/ BLUE TOTE BAG, REF DYKE1648G, e) ENDO KIT W/ BLUE TOTE BAG, REF DYKE1648I, f) FREQUENT DAILY VAD, REF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1101-2024·2024-03-06

    Medline Surgical Kits Recalled for Potential Sterility Defects

    Medline is recalling surgical kits and trays with components that may lack sterility. The affected products were distributed nationwide and internationally.

    Product
    MEDLINE Kits, trays, and packs labeled as follows: a) ASC MINOR THYROID CDS, REF CDS983682F; b) BRONCHOSCOPY KIT, REF DYKE1718A; c) BRONCHOSCOPY KIT, REF DYKE1718B; d) DOUBLE CENTRAL LINE CAP CHANGE, REF DYNDC2214G; e) ENT PACK, REF DYNJ55334C; f) ENT PACK, REF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1124-2024·2024-03-06

    Medline Surgical Kits Recalled Due to Sterility Defect in Irrigation Solutions

    Medline Industries recalls certain surgical kits and trays because irrigation solution components may lack sterility, creating potential infection risk.

    Product
    Medline Kits, trays, and packs labeled as follows: C-SECTION, REF DYNJ904653G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1097-2024·2024-03-06

    Medline Medical Kits and Trays Recalled for Non-Sterile Solutions

    Medline Industries is recalling multiple medical kits and trays containing irrigation solutions that may be non-sterile. The affected products are used in surgical and invasive procedures; non-sterile solutions could cause serious infections.

    Product
    MEDLINE Kits, trays, and packs labeled as follows: a) ARTERIAL LINE PACK, REF DYNJ65208A; b) CANCER SERVICE PORT KIT, REF DT22710; c) CAP CHANGE KIT, REF DYNDC2002A; d) CAP CHANGE KIT, REF DYNDC2723A; e) CAP CHANGE KIT, REF DYNDC2723B; f) CENTRAL LINE INSERTION…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1125-2024·2024-03-06

    Medline Irrigation Kits and Packs Recalled for Sterility Defect

    Medline Industries recalls 279 irrigation and saline kits, trays, and packs due to potential lack of sterility in components used to manufacture them. Solutions may be non-sterile.

    Product
    Medline Kits, trays, and packs labeled as follows: a) D&C CDS, REF CDS983911J; b) D&C PACK, REF DYNJ67214F; c) D&C PACK, REF DYNJ67214G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1114-2024·2024-03-06

    Medline Port Removal Kits Recalled for Potential Sterility Loss

    Medline Industries recalls certain port removal kits due to potential loss of sterility in irrigation solutions manufactured using specific component lots.

    Product
    Medline Kits, trays, and packs labeled as follows: a) PORT REMOVAL PACK, REF DYNDA2936; b) PORT REMOVAL PACK, REF DYNDA2936H
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1107-2024·2024-03-06

    Dialysis Irrigation Solutions Recalled for Potential Sterility Defect

    Medline Industries is recalling 10,391 units of dialysis kits and accessory packs due to potential sterility defects in component solutions. Non-sterile irrigation fluids could cause serious infection if used.

    Product
    Centurion Kits, trays, and packs labeled as follows: a) DIALYSIS ACCESSORY PACK W/O CATHETER, REF MNS10750A; b) DIALYSIS ON KIT, REF DT21235A; c) INFUSA PORT KIT, REF DYNDC3166A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1095-2024·2024-03-06

    Medline Medical Kits and Trays Recalled for Potential Sterility Failure

    Medline Industries is recalling certain medical kits and trays that may contain non-sterile solutions. Healthcare facilities should discontinue use of affected batches to prevent patient exposure to potential contamination.

    Product
    MEDLINE Kits, trays, and packs labeled as follows: a) CATH LAB CDS, REF CDS840228F; b) PEDIATRIC PORT A CATH TRAY, REF DYNDC2128B; c) PK, RADIOLOGY, REF DYNJ44087A; d) PORT ACCESS PACK-LF, REF DYNJ0352159C; DYNJ0352159D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1118-2024·2024-03-06

    Medline Laceration Trays Recalled Due to Sterility Defect

    Medline is recalling laceration trays and medical kits with approximately 12,000 units due to sterility defects in component solutions. Non-sterile medical devices could pose infection risk during wound care procedures.

    Product
    Medline Kits, trays, and packs labeled as follows: a) ER LACERATION TRAY - SNAG FREE, REF SUT12825; b) LACERATION TRAY, REF SUT21580; c) LACERATION TRAY, REF DYNDL1484B;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1093-2024·2024-03-06

    Medline Bronchoscopy Tray Components Recalled for Potential Lack of Sterility

    Medline Industries is recalling certain Nurse Assist components used in Bronchoscopy Trays due to potential lack of sterility. Affected irrigation solutions and saline flush syringes may be non-sterile.

    Product
    MEDLINE BRONCHOSCOPY TRAY, REF DYNDL1350A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1112-2024·2024-03-06

    Medline Medical Kits and Trays Recalled for Potential Sterility Failure

    Medline Industries is recalling certain sterile medical kits and trays that contain component solutions with a potential lack of sterility. Non-sterile solutions could result in infection or contamination during medical procedures.

    Product
    Medline Kits, trays, and packs labeled as follows: a) LACERATION KIT, REF SUT13935; b) LACERATION TRAY, REF SUT21215; c) LACERATION TRAY, REF SUT15380; d) LACERATION TRAY W/SNAGFREE NEE, REF SUT19005; e) PLASTICS SUTURE TRAY, REF SUT13535; f) UVC INSERTION TRAY, REF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1094-2024·2024-03-06

    Medline Arterial Irrigation Bundles Recalled Due to Sterility Risk

    Medline Industries recalls arterial irrigation bundles due to potential loss of sterility in Nurse Assist components, which could deliver non-sterile solutions for medical procedures.

    Product
    MEDLINE ARTERIAL BUNDLE NO CATHETER, REF ART995
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1196-2024·2024-03-06

    Integra cranial access kit recalled for sterile packaging failure

    Integra LifeSciences is recalling 1,324 cranial access kits due to sterile packaging defects that may compromise product sterility.

    Product
    Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the lateral ventricles of the brain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1080-2024·2024-02-28

    Surgical ocular packs recalled for loss of saline sterility

    Windstone Medical Packaging recalled 128 surgical eye kits because the included saline cannot be guaranteed sterile, risking post-operative infection.

    Product
    Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1082-2024·2024-02-28

    Medical Closure Kit Recall: Sterility of Saline Cannot Be Guaranteed

    Windstone Medical Packaging is recalling Aligned Medical Solutions Closure Kits due to inability to guarantee sterility of included saline. This FDA Class I recall affects 475 units distributed in Florida, Illinois, and California.

    Product
    Aligned Medical Solutions, Closure Kit, AMS13043, STERILEEO
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1079-2024·2024-02-28

    Surgical Kit with Saline Recalled Over Sterility Assurance Issue

    Windstone Medical Packaging is recalling a surgical kit due to inability to guarantee sterility of the included saline. The recall affects 1,528 units distributed in Florida, Illinois, and California.

    Product
    Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1179-2024·2024-02-28

    Biliary Endoprosthesis Labeling Mismatch Risks Incorrect Device Placement

    W.L. Gore's GORE VIABIL Short Wire Biliary Endoprosthesis may be mislabeled regarding drainage holes, risking extended procedures, infections, and unplanned device removal in 24 units distributed in Georgia.

    Product
    GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 10 mm x 8 cm; with holes; and (2) Catalog Number VSWVN1008, 10 mm x 8 cm; no holes
    Category
    Medical Device
    Distribution
    Distributed nationwide