The Recall Desk

Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

3501–3525 of 29102

  • SevereFDA (Food)·F-1018-2024·2024-03-06

    Sargento Shredded Taco Cheese Blend Recalled for Listeria monocytogenes

    Sargento Foods is recalling Sargento Deep V Shredded Taco Cheese Blend (UPC 46100352281) due to potential Listeria monocytogenes contamination. The recall affects 956 cases distributed across 15 states.

    Product
    Sargento Deep V Shredded Taco Cheese Blend Material #10002484, UPC 46100352281. Pack Size 500/.6 oz. Net Wt 18.750 lbs. Keep Refrigerated. Product of USA. Distributed By Sargento Foods Inc, Plymouth, WI 53073 USA.
    Category
    Food
    Distribution
    15 states
  • SevereFDA (Devices)·Z-1059-2024·2024-03-06

    AirLife Adult Manual Resuscitator recalled for faulty component causing ventilation failure

    Vyaire Medical is recalling 8,220 AirLife Adult Manual Resuscitators with defective duckbill and ring components. The manufacturing defect may prevent proper ventilation and could lead to hypoxia or death.

    Product
    AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, REF 2K8004F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1006-2024·2024-03-06

    Ready Pac Bistro Fresh Mex Chopped Kit recalled for potential Listeria contamination

    Ready Pac Foods is recalling Ready Pac Bistro Fresh Mex Chopped Kit due to potential Listeria monocytogenes contamination. The recall affects 790 cases distributed across the United States.

    Product
    Ready Pac Bistro Fresh Mex Chopped Kit 10.5 oz. UPC 077745256108
    Category
    Food
    Distribution
    21 states
  • 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-1119-2024·2024-03-06

    Medline Tracheostomy Care Kits and Trays Recalled Due to Sterility Concerns

    Medline Industries is recalling tracheostomy care kits and trays due to potential lack of sterility in their component irrigation solutions. The non-sterile solutions pose a risk during patient care procedures.

    Product
    Medline Kits, trays, and packs labeled as follows: a) TRACH CARE KIT, REF DYND40589; b) TRACH CARE KIT, REF DYNDA3004; c) TRACHEOSTOMY CARE TRAY, REF DYND40650; d) TRAY,TRACH,W/PCLNR,14FR CATH N, REF DYND40594
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1004-2024·2024-03-06

    Marketside Southwest Chopped Kit Recalled for Potential Listeria Contamination

    Ready Pac Foods is recalling Marketside Southwest Chopped Kit (10.3 oz.) due to potential Listeria monocytogenes contamination. Consumers should not consume the affected product.

    Product
    Marketside Southwest Chopped Kit 10.3 oz. UPC 681131305129
    Category
    Food
    Distribution
    21 states
  • SevereFDA (Devices)·Z-1060-2024·2024-03-06

    AirLife Adult Manual Resuscitator Kits Recalled for Component Failure

    Vyaire Medical is recalling 3,636 AirLife Adult Manual Resuscitator kits. Manufacturing defects can cause component failure that prevents proper ventilation, potentially resulting in fatal hypoxia.

    Product
    AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Detector, REF 2K8004C2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1129-2024·2024-03-06

    Medical maintenance flush kits recalled for potential sterility defect

    Medline Industries is recalling Centurion maintenance flush and blood draw kits due to potential sterility issues in component solutions. Affected lot numbers are 2022031480 and 2022041180.

    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-1131-2024·2024-03-06

    Medline Centurion Eye Prep Kit Sterilization Defect Recall

    Medline Industries is recalling Centurion Eye Prep Kits due to potential lack of sterility in irrigation solution components manufactured by Nurse Assist.

    Product
    Centurion Kits, trays, and packs labeled as follows: EYE PREP KIT, REF ET1010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1134-2024·2024-03-06

    Medical device kits recalled due to potential sterility failure

    Medline Industries is recalling IV securement kits and neonatal PICC line insertion trays due to potential lack of sterility in Nurse Assist components. Approximately 11,812 units are affected.

    Product
    Centurion Kits, trays, and packs labeled as follows: a) IV SECUREMENT KIT, REF IVS1860B; b) NEONATAL PICC LINE INSERTION TRAY, REF CVI2025; c) NEONATAL PICC LINE INSERTION TRAY, REF CVI4570; d) SECONDARY IV START KIT, REF IV8695A
    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 PACK,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1122-2024·2024-03-06

    Medline kits and trays recalled for potential lack of sterility

    Medline Industries is recalling surgical kits and trays containing irrigation solutions that may not be sterile due to manufacturing issues. The non-sterile solutions could increase infection risk during surgical and obstetrical procedures.

    Product
    Medline Kits, trays, and packs labeled as follows: a) L&B CDS-LF, REF CDS980273D; b) LABOR AND DELIVERY, REF DYNJ907794; c) LACERATION TRAY, REF DYNDL1864A; d) OBSTETRICAL, REF DYNJ908877; e) UMC EP VAGINAL DELIVERY, REF DYNJ83093;
    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 DYNJ4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1132-2024·2024-03-06

    Medline Centurion surgical trays and kits recalled for potential non-sterile solutions

    Medline Industries is recalling 14,234 units of Centurion surgical kits and trays that may contain non-sterile irrigation solutions. The affected products were manufactured using compromised Nurse Assist components.

    Product
    Centurion Kits, trays, and packs labeled as follows: a) BASIC PROCEDURE TRAY, REF MNS13600; b) BWH DAILY DRIVELINE MGMT KIT, REF DM640A; c) CIRCUMCISION TRAY, REF CIT6180; d) INCISION & DRAINAGE TRAY, REF ID1690; e) LACERATION TRAY, REF SUT19510; f) LACERATION TRAY,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1058-2024·2024-03-06

    AirLife Adult Manual Resuscitator tubing may fail to deliver proper ventilation

    Vyaire Medical is recalling 66,078 units of AirLife Adult Manual Resuscitator oxygen tubing worldwide due to component manufacturing defects that can cause device failure and inadequate ventilation.

    Product
    AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, without Mask, REF 2K8001
    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-1109-2024·2024-03-06

    Medline Surgical Kits Recalled for Potential Lack of Sterility

    Medline Industries is recalling 139 surgical kits containing irrigation solutions with potential sterility issues. The recalled products were distributed nationwide and internationally.

    Product
    Medline Kits, trays, and packs labeled as follows: a) BREAST PACK, REF DYNJ56344B; b) SEPTOPLASTY PACK WRO-LF, REF DYNJ62803
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1127-2024·2024-03-06

    Medline Surgical Kits and Trays Recalled Due to Potential Sterility Defect

    Medline Industries is recalling surgical kits and trays that may contain non-sterile irrigation solutions. Affected products were manufactured with certain component lots that have a potential sterility defect.

    Product
    Medline Kits, trays, and packs labeled as follows: a) ANTERIOR PACK, REF DYNJ64814A; b) ARTHROGRAM TRAY, REF DYNDH1629; c) CVL INSERTION KIT-LF, REF DYNJ48587A; d) EXTREMITY CDS, REF CDS983313I; e) EXTREMITY CDS, REF DYNJ902004D; f) EXTREMITY CDS, REF DYNJ902004F;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1126-2024·2024-03-06

    Medline Surgical Kits Recalled for Potential Sterility Failure

    Medline Industries recalls surgical kits and trays manufactured with non-sterile solutions due to contaminated Nurse Assist components. Kits distributed nationwide and internationally may lack proper sterility, posing infection risk.

    Product
    Medline Kits, trays, and packs labeled as follows: a) CATARACT PACK, REF VAL011CTASD; b) CATARACT PACK, REF DYNJ68875F; c) CATARACT PACK, REF DYNJ54869F; d) CATARACT PREP PACK, REF DYNJ44917L; e) E-BLEPH CDS, REF CDS983585G; f) EYE CDS, REF CDS983916G; g) EYE KIT,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-1103-2024·2024-03-06

    Medline surgical kits and trays recalled for sterility defects

    Medline Industries recalls 5,969 surgical kits and trays that may lack sterility due to components from Nurse Assist. The non-sterile irrigation solutions could compromise product safety.

    Product
    MEDLINE Kits, trays, and packs labeled as follows: a) C-SECTION, REF DYNJ904653G; b) DRESSING TRAY, REF M101426; c) ENDO KIT, REF DYKE1387; d) ENDO KIT, REF DYKE1364B; e) ENDO KIT, REF DYKE1892; f) ENDO KIT W/ BLUE TOTE BAG, REF DYKE1648I; g) EYE KIT, REF DYKM2222;
    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-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-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