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.

3476–3500 of 29102

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-1108-2024·2024-03-06
Medline Instrument Trays Recalled for Potential Sterility Defect
Medline Industries is recalling 228 medical device trays due to potential sterility defects in component solutions used in medical procedures.
Product
Medline Kits, trays, and packs labeled as follows: TRAY,L&D INSTRUMENT, REF DYNDL1550
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 CATH,1
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-1017-2024·2024-03-06
Sargento Italian Cheese Blend Recalled for Listeria Contamination
Sargento Fancy Shredded Italian Cheese Blend is recalled for potential Listeria monocytogenes contamination. 97 cases were distributed across 15 states.
Product
Italian Cheese Blend packaged in the following configurations: 1. Sargento Part #23613, Fancy Shredded Italian Cheese Blend Pack Size 500/0.5 oz. Material #10000946, UPC 46100344583. 2. Sargento Fancy Shredded Italian Cheese Blend. Pack Size 400/1 oz. Net Wt 25.000
Category
Food
Distribution
15 states
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 (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 (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
SevereNHTSA·24V178000·2024-03-06
Prevost Recalls H3-45 Buses Due to Steering Column Joint Failure Risk
Prevost is recalling 2022-2023 H3-45 and H3-45 VIP buses because steering column joints may fail, causing loss of steering control and increasing crash risk.
Product
PREVOST — PREVOST H3-45 VIP, H3-45
Category
Vehicle
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 (Food)·F-1013-2024·2024-03-06
Sargento Monterey Jack Cheese Recalled for Listeria Contamination
Sargento Monterey Jack cheese in specific batches has been recalled due to potential Listeria monocytogenes contamination. The recall affects 1,104 cases distributed to 15 states.
Product
Monterey Jack cheese packaged in the following configurations: 1. Sargento, Part #23602 Deep V Shredded Monterey Jack Cheese Pack Size 500/0.5 oz. Material #10001592, UPC 46100343999. 2. Sargento Fancy Shredded Monterey Jack Cheese Pack Size 400/1 oz. Net Wt 25.00
Category
Food
Distribution
15 states
SevereFDA (Devices)·Z-1061-2024·2024-03-06
AirLife Adult Manual Resuscitator Recalled for Ventilation Failure Risk
Vyaire Medical recalls 3.6 million AirLife Adult Manual Resuscitators due to defective oxygen tubing components that may fail to deliver proper ventilation, risking hypoxia. Affected units were manufactured in 2017 or earlier.
Product
AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8005
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-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-1062-2024·2024-03-06
AirLife manual resuscitator component defect risks ventilation failure
Vyaire Medical is recalling AirLife Adult Manual Resuscitators with defective duckbill and ring components that may fail to provide ventilation, risking hypoventilation or hypoxia. The defect affects units manufactured in 2017 and earlier.
Product
AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, Expiratory Filter, REF 2K8005F
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1064-2024·2024-03-06
AirLife Manual Resuscitator Recall Due to Broken Components Preventing Ventilation
Vyaire Medical is recalling 1,020,330 AirLife Adult Manual Resuscitators due to defective components that can fail to deliver proper ventilation. When components break or disassemble, users may experience hypoventilation or hypoxia, potentially fatal complications.
Product
AirLife Adult Manual Resuscitator, Variable Volume Oxygen Reservoir Tubing, Adult Mask, REF 2K8017
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1137-2024·2024-03-06
Centurion breast biopsy kits recalled due to potential sterility issues
Medline Industries is recalling Centurion breast biopsy kits due to a potential lack of sterility in component solutions.
Product
Centurion Kits, trays, and packs labeled as follows: BREAST BIOPSY KIT, REF MNS4360
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
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-1115-2024·2024-03-06
Blood Draw and Lab Collection Kits Recalled for Potential Sterility Defect
Medline Industries is recalling blood draw and lab collection kits due to potential lack of sterility in component solutions. The affected kits could contain non-sterile solutions, posing risks in clinical procedures.
Product
Medline Kits, trays, and packs labeled as follows: a) BLOOD DRAW KIT, REF DYNDV2183A; b) LCPH LAB DRAW KIT, REF DYNDH1641A; c) LCPH LAB DRAW KIT, REF DYNDH1641AH; d) OB LAB COLLECTION KIT, REF DYNDH1719A;
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-1019-2024·2024-03-06
Sargento Bevel Shredded Queso Quesadilla Cheese Recalled for Listeria Contamination
Sargento Foods is recalling Bevel Shredded Queso Quesadilla Cheese due to potential Listeria monocytogenes contamination affecting 30 cases in 15 states.
Product
Sargento Bevel Shredded Queso Quesadilla Cheese. Pack Size 450/1 oz. Net Wt 28.125 lbs. Material #10003481. UPC 46100356593. Keep Refrigerated. Product of USA. Distributed By Sargento Foods Inc, Plymouth, WI 53073 USA.
Category
Food
Distribution
15 states
SevereFDA (Food)·F-1009-2024·2024-03-06
Sargento Cotija Cheese Products Recalled for Potential Listeria Contamination
Sargento Foods is recalling specific Cotija cheese lots due to possible Listeria monocytogenes contamination. The recalled products were distributed across 15 U.S. states and consumers should discard or return them to retail.
Product
Cotija cheese packaged in the following configurations: 1. Sargento Course Grated Cotija Cheese Pack Size 6/5 lb. Material #10002578, UPC 46100352601. 2. Sargento Coarse Grated Cotija Cheese. Pack Size 500/0.5 oz. Net Wt. 15.625 lbs. Material #10003245, UPC 4610035517
Category
Food
Distribution
15 states
SevereFDA (Food)·F-1005-2024·2024-03-06
Marketside Bacon Ranch Crunch Kit recalled due to Listeria contamination risk
Ready Pac Foods is recalling Marketside Bacon Ranch Crunch Kit due to potential Listeria monocytogenes contamination. The recall affects 1,691 cases distributed across multiple U.S. states.
Product
Marketside Bacon Ranch Crunch Kit 9.8 oz. UPC 681131305440
Category
Food
Distribution
21 states
SevereFDA (Devices)·Z-1163-2024·2024-03-06
Medtronic Duet External Drainage System Recalled for Catheter Disconnection Risk
Medtronic is recalling its Duet External Drainage and Monitoring System due to potential catheter disconnection from patient line stopcock connectors. This device is used to drain cerebrospinal fluid and reduce intracranial pressure.
Product
Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection Sites, REF 46914, 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-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