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.

1151–1175 of 4878

  • 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-1165-2024·2024-03-06

    Medtronic Duet Ventricular Catheter Recalled for Disconnection Risk

    Medtronic is recalling 11,840 units of its Duet External Drainage and Monitoring System due to potential disconnection between the catheter and stopcock connectors. This defect could impair the device's ability to drain cerebrospinal fluid.

    Product
    Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, REF 46916, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.
    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-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-1065-2024·2024-03-06

    AirLife Manual Resuscitator recalled for broken components causing ventilation failure

    Vyaire Medical is recalling approximately 1.8 million AirLife Adult Manual Resuscitators worldwide due to faulty molded components that may fail to deliver proper ventilation, risking hypoventilation and hypoxia.

    Product
    AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8004
    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-1117-2024·2024-03-06

    Medline Surgical Kits Recalled for Potential Lack of Sterility

    Medline Industries recalls multiple surgical and central line kits containing Nurse Assist components that may lack sterility. Approximately 86,699 units of these medical device kits have been distributed nationwide.

    Product
    Medline Kits, trays, and packs labeled as follows: a) CENTRAL LINE TRAY, REF CVI4705; b) DAILY DRIVELINE MGMT KIT w/PER, REF DT18700; c) DRESSING CHANGE TRAY, REF DYNDC3131A; d) DRIVELINE MAINTENANCE PACKAGE, REF DT17405A; e) DRSG CHANGE TRAY W/ CHG, REF DT21460B; f)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-1014-2024·2024-03-06

    Sargento White Cheddar Cheese Recalled for Listeria Monocytogenes

    Sargento Foods is recalling White Cheddar cheese products due to Listeria monocytogenes. The affected products were distributed in 15 states; consumers should discard them.

    Product
    White Cheddar cheese packaged in the following configurations: 1. Sargento Part #23340 Fancy Shredded Sharp White Cheddar Cheese. Pack Size 500/0.5 oz. Material #10001126, UPC 46100329313. 2. Sargento Fancy Shredded Mild White Cheddar Cheese. Pack Size 500/0.5 oz. Ne
    Category
    Food
    Distribution
    15 states
  • SevereFDA (Devices)·Z-1138-2024·2024-03-06

    Medline circumcision surgical kits recalled for sterility concerns

    Medline Industries is recalling circumcision surgical trays due to potential lack of sterility in component solutions. The recall affects 1260 units distributed across the US, Puerto Rico, Canada, UAE, and Panama.

    Product
    Centurion Kits, trays, and packs labeled as follows: CIRCUMCISION TRAY, REF DYNDA2271
    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 (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-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-1063-2024·2024-03-06

    AirLife Adult Manual Resuscitator recalled for ventilation failure risk

    Vyaire Medical is recalling 4,572 units of AirLife Adult Manual Resuscitators due to defective components that may cause improper ventilation or complete ventilation failure, potentially resulting in hypoventilation, hypoxia, or death.

    Product
    AirLife Adult Manual Resuscitator, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask, CO2 Detector, REF 2K8005C2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1012-2024·2024-03-06

    Sargento Shredded Asiago Cheese Recalled for Listeria Contamination

    Sargento Foods is recalling Asiago cheese products contaminated with Listeria monocytogenes. The recall affects 264 cases distributed across 15 states; consumers should not consume affected products.

    Product
    Asiago cheese packaged in the following configurations: 1. Sargento Part #10197, Fancy Shredded Fresh Asiago Cheese Pack Size 500/0.75 oz. Material #10001006, UPC 46100342688. 2. Sargento Shredded Fresh Asiago Cheese. Pack Size 400/1 oz. Net Wt 25.000 lbs. Mat
    Category
    Food
    Distribution
    15 states
  • SevereFDA (Devices)·Z-1164-2024·2024-03-06

    Medtronic Duet External Drainage System catheter disconnection risk recalled

    Medtronic recalls Duet External Drainage and Monitoring System catheter units (REF 46915) due to potential disconnection from stopcock connectors. Worldwide distribution includes 14,139 units.

    Product
    Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, REF 46915, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1166-2024·2024-03-06

    Medtronic Duet Catheter System Recalled for Potential Disconnection Risk

    Medtronic Duet External Drainage System catheters may disconnect from stopcocks, potentially compromising cerebrospinal fluid management. The FDA Class I recall affects 3,889 units distributed worldwide.

    Product
    Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, REF 46917, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.
    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 (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 (Food)·F-1015-2024·2024-03-06

    Sargento Cheddar Cheese Recalled for Listeria Contamination

    Sargento Foods is recalling 349 cases of cheddar cheese products due to potential Listeria monocytogenes contamination. Affected products were distributed to 15 states; consumers should not eat them.

    Product
    Cheddar cheese packaged in the following configurations: 1. Sargento Deep V Shredded Mild Cheddar Cheese. Pack Size 450/1 oz. Net Wt 28.125 lbs. Material #10000537, UPC 46100348611. 2. Sargento Part #29313, Thick "N Hearty Shredded Sharp Cheddar Cheese Pack Size 500/
    Category
    Food
    Distribution
    15 states
  • 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 CATH,1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1016-2024·2024-03-06

    Sargento Shredded Cheese Recalled for Listeria Contamination

    Sargento Fancy Shredded Bistro Blends Nacho & Taco Cheese Blend is being recalled due to potential Listeria monocytogenes contamination. The affected product was distributed to retailers in 15 states.

    Product
    Sargento Part #10129 Fancy Shredded Bistro Blends Nacho & Taco Cheese Blend. Pack Size 500/.75 oz. Material #10000281, UPC 46100334157 Keep Refrigerated. Product of USA. Distributed By Sargento Foods Inc, Plymouth, WI 53073 USA.
    Category
    Food
    Distribution
    15 states
  • SevereFDA (Devices)·Z-1130-2024·2024-03-06

    Medline Centurion dialysis kits recalled due to sterility concerns

    Medline Industries is recalling approximately 10,391 Centurion dialysis kits due to potential lack of sterility in Nurse Assist components. Products were distributed nationwide and in select international locations.

    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-1111-2024·2024-03-06

    Medline Medical Device Kits Recalled for Potential Sterility Loss

    Medline Industries is recalling 26,171 kits and trays containing potentially non-sterile irrigation solutions and syringes supplied by Nurse Assist, which could pose risks if used in medical procedures.

    Product
    Medline Kits, trays, and packs labeled as follows: a) 709E RECOVERY PACK A,B,C II SS, REF DYNJ55960G; b) ABDOMEN PACK, REF DYNJ53643C; c) BAG TRUNK STOCK KIT, REF DYKM1880; d) BEDSIDE BRONCH PACK, REF DYKE1601; e) BIOPSY TRAY, REF DYNDH1242; f) BRONCH KIT, REF DYKE18
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1100-2024·2024-03-06

    MEDLINE Serum Tear Kit Irrigation Solutions Recalled for Sterility Concerns

    Medline is recalling serum tear kit irrigation solutions due to potential sterility defects. The solutions may not be sterile, posing contamination risks during medical use.

    Product
    MEDLINE Kits, trays, and packs labeled as follows: SERUM TEAR KIT, REF DYNDA1545
    Category
    Medical Device
    Distribution
    Distributed nationwide