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.

12326–12350 of 27206

  • 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-1116-2024·2024-03-06

    Medline Prep Kits Recalled Due to Non-Sterile Components

    Medline is recalling 1,270 prep kits containing components that may lack sterility. Solutions from Nurse Assist used in the kits may not be sterile.

    Product
    Medline Kits, trays, and packs labeled as follows: a) C L PREP, REF DYNJ69664; b) DMEK PREP PACK, REF DYNJ81659A; c) PRE OP KIT 1, REF DYKS1377; d) PRE OP KIT 1, REF DYKS1377A
    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 (Food)·F-1003-2024·2024-03-06

    Rojo Black Bean 6 Layer Dip Recalled for Potential Listeria Contamination

    Lakeview Farms LLC is recalling Rojo Black Bean 6 Layer Dip due to potential Listeria monocytogenes contamination. Consumers should not consume the product and should discard or return it.

    Product
    Rojo Black Bean 6 Layer Dip packaged in 20oz PET plastic containers, sold in sleeve with two containers per sleeve. 12 sleeves per case.
    Category
    Food
    Distribution
    0 states
  • 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-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-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-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-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-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-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-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 (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 (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-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 (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 (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-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 (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 (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-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-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-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-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 (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