The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.

FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.

Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.

12351–12375 of 27206

  • 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-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-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 (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-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-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-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-1106-2024·2024-03-06

    MEDLINE Surgical Kits Recalled Due to Potential Sterility Failure

    MEDLINE is recalling surgical kits, trays, and packs due to potential lack of sterility in component solutions. The recalled products were distributed nationwide and internationally.

    Product
    MEDLINE Kits, trays, and packs labeled as follows: a) ENDO KIT, REF DYKE1350D; b) PANENDOSCOPY-LF, REF DYNJ36728C; c) UMBILICAL VESSEL INSERTION, REF UVT1170; d) UMBILICAL VESSEL INSERTION, REF UVT1170H
    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-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-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-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 DYN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1162-2024·2024-03-06

    Medtronic Duet External Drainage System Recalled for Catheter Disconnection Risk

    Medtronic is recalling 30,711 units of its Duet External Drainage System because of the potential for catheter disconnection from patient line stopcock connectors.

    Product
    Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, REF 46913, 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-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 (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-1057-2024·2024-03-06

    AirLife Adult Manual Resuscitator units recalled for component failure

    Vyaire Medical is recalling 106,656 units of AirLife Adult Manual Resuscitator bags due to faulty components that may break during use, causing ventilation failure and potentially leading to hypoxia or death.

    Product
    AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask, REF 2K8000,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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
  • 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-1135-2024·2024-03-06

    Medline recalls Centurion Laceration Trays for potential sterility defect

    Medline Industries recalls 576 units of Centurion Laceration Trays nationwide because Nurse Assist-supplied components may lack sterility, posing potential health risks in medical procedures.

    Product
    Centurion Kits, trays, and packs labeled as follows: LACERATION TRAY, REF ST11670A
    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-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-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 (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 (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