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.

9376–9400 of 27089

  • HighFDA (Devices)·Z-3006-2024·2024-09-18

    Medline Convenience Kits with Plastic Syringes Recalled for Defects

    Medline medical convenience kits containing plastic syringes are being recalled due to identified quality issues including leaks and breakage that may pose a risk to patient health. Products were distributed worldwide.

    Product
    Medline Convenience kits labeled as: 1) COMPREHENSIVE PROCEDURE PACK, Pack Number 7791 ; 2) LAVH CDS, Pack Number CDS760049AC; 3) LAPAROSCOPY CDS , Pack Number CDS760051AB; 4) LAPAROSCOPY CDS , Pack Number CDS760051AC; 5) LAPAROSCOPY CDS , Pack Number CDS760051AD; 6) ABDOM
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3105-2024·2024-09-18

    Medline semi-rigid suction liners recalled due to potential suction loss

    Medline Industries is recalling specific lots of semi-rigid suction liners due to potential loss of suction or low suction during use. About 1.25 million units distributed in the US, Canada, and Panama are affected.

    Product
    Medline Semi-rigid suction liners labeled as follows: a) SEMI RIGID SUCTION LINER, REF OR515; b) SEMI RIGID SUCTION LINER WITH TUBING, REF OR526K; c) SEMI RIGID SUCTION LINER WITH TUBING, REF OR527K; d) SEMI RIGID SUCTION LINER WITH TUBING, REF OR529K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3009-2024·2024-09-18

    Medline Convenience Kits Recalled Due to Leaks and Breakage in Syringes

    Medline Industries is recalling convenience kits containing plastic syringes with leaks, breakage, and other quality issues. The defects were identified in an FDA Safety Alert and may pose a risk to patient health.

    Product
    Medline Convenience kits labeled as: 1) GYN ENDOSCOPY KIT , Pack Number CDS981309O ; 2) GB GENERAL ENDO , Pack Number CDS984155F ; 3) ENDOSCOPY KIT , Pack Number DYKE1112 ; 4) ENDOSCOPY KIT , Pack Number DYKE1133A; 5) ENDOSCOPY PACK, Pack Number DYKE1264 ; 6) ENDOSCO
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3128-2024·2024-09-18

    Medtronic Venous Cannulae: Wrong Product in Incorrect Packaging

    Medtronic Perfusion Systems is recalling 290 units of DLP Single Stage Venous Cannulae due to a manufacturing error where straight-tip cannulae were placed into packaging labeled for right-angle metal-tip cannulae.

    Product
    Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3015-2024·2024-09-18

    Medline medical convenience kits with syringes recalled due to leakage and breakage

    Medline is recalling multiple medical convenience kits containing plastic syringes due to identified leaks, breakage, and quality issues that may pose a risk to patient health. The recall affects kits distributed worldwide.

    Product
    Medline Convenience kits labeled as: 1) PSP - VAMC LONG BEACH, Pack Number 146255; 2) INSERTION TRAY, Pack Number CVI5080; 3) INCISION & DRAINAGE TRAY, Pack Number DYNDA1063; 4) DRAINAGE ACCESS PACK 319701 , Pack Number DYNJ44599I ; 5) PROCEDURE DRAINAGE KIT, Pack Numb
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2989-2024·2024-09-18

    Medline Spinal Block Syringes Recalled for Quality Defects

    Medline is recalling spinal block syringes due to leaks, breakage, and other quality issues identified in an FDA safety alert. The recalled lots have worldwide distribution and span from 2019 to 2023.

    Product
    Medline Convenience kits, labeled as: SPINAL BLOCK 22G QUINCKE 5S BU, Pack Number DYNJRA9026
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3072-2024·2024-09-18

    Sterile Anesthesia Kits Recalled for Non-Sterile Component Mixing

    Medline Industries recalled anesthesia kits containing an unlabeled non-sterile Mastisol component that could be mistakenly assumed sterile during use, creating infection risk. The recall affects 315 units distributed in Texas, Illinois, and California.

    Product
    ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377A
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2975-2024·2024-09-18

    HeNe Laser System Allows Key Removal While Operating

    Pacific LaserTech's 25-LHP-828 HeNe laser systems allow the key to be removed while operating, violating federal safety requirements. Four units distributed nationwide lack proper controls to prevent unintended laser operation.

    Product
    25-LHP-828, HeNe Laser System, 35 mW
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3089-2024·2024-09-18

    Proton Therapy System Software Allows Safety Verification Mechanisms to Be Disabled

    The IBA Proton Therapy System (PROTEUS 235 and related models) has a software defect allowing safety parameter verification mechanisms to be deactivated during clinical use. This affects 35 units distributed worldwide.

    Product
    IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and PTS-12 versions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3010-2024·2024-09-18

    Medline Medical Convenience Kits Recalled for Syringe Leaks and Breakage

    Medline is recalling medical convenience kits due to plastic syringe leaks, breakage, and quality issues that may pose a risk to patient health.

    Product
    Medline Convenience kits labeled as: 1) CVC INSERTION PACK, Pack Number CVI4720A ; 2) CVC INSERTION PACK, Pack Number CVI4720AH; 3) CATHETER INSERTION KIT CLABSI , Pack Number CVI4880; 4) CHEST INSERTION PACK-LF , Pack Number DYNJ17634D ; 5) URETEROSCOPY, Pack Number D
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3059-2024·2024-09-18

    Medline Medical Convenience Kits Recalled Due to Plastic Syringe Defects

    Medline is recalling multiple convenience kits containing plastic syringes affected by a March 2024 FDA safety alert. The syringes may leak or break, potentially posing a risk to patient health.

    Product
    Medline Convenience kits, labeled as: 1) BLOOD CULTURE COLLECTION KIT, Pack Number BP115; 2) NICU CNTRL LINE BLOOD DRAW KIT, Pack Number DYLAB1044; 3) NEURO ANGIO PACK, Pack Number DYNDA1431A; 4) BLOOD WITHDRAWAL KIT #2, Pack Number DYNDA1683A; 5) LCPH LAB DRAW KIT ,
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3034-2024·2024-09-18

    Medline Convenience Kits With Syringes Recalled for Leaks and Breakage

    Medline convenience kits containing plastic syringes are being recalled worldwide due to leaks and breakage that may pose patient health risks. The kits are linked to an FDA Safety Alert issued March 19, 2024.

    Product
    Medline Convenience kits labeled as: 1) KIT, MIDSTREAM, W/BZK/FUNNL,3O, Pack Number DYND30212; 2) PROCESSING KIT 3 PTE0000204 , Pack Number DYNJ65728A ; 3) 30ML KIT, Pack Number DYNJ82155A ; 4) DISSECTION, Pack Number DYNJ85191; 5) FLAP HARVEST PACK , Pack Number DYNJ5
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3125-2024·2024-09-18

    Proton therapy system may display insufficient CBCT images during positioning

    Hitachi PROBEAT-FR proton therapy systems may display an insufficient number of CBCT images during 3D positioning when the Float Image Selection button is pressed, potentially affecting treatment planning accuracy.

    Product
    Brand Name: PROBEAT Product Name: PROBEAT-FR Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-FR is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam wit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2987-2024·2024-09-18

    Medline Convenience Kits Recalled for Syringe Leaks and Breakage

    Medline is recalling medical convenience kits containing defective plastic syringes that may leak or break. The kits are used for epidural and spinal anesthesia procedures and have been distributed worldwide.

    Product
    Medline Convenience kits, labeled as: 1) SINGLE SHOT EPIDURAL PACK-LF, Pack Number DYNJ0708470K ; 2) EPIDURAL CSTM PACK-LF , Pack Number DYNJ0844004; 3) CUSTOM EPIDURAL PACK-LF , Pack Number DYNJ0934752F ; 4) EPIDURAL PACK-LF, Pack Number DYNJ0957053D ; 5) EPIDURAL PACK-LF,
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2983-2024·2024-09-18

    Medline Medical Convenience Kits with Plastic Syringes Recalled for Quality Defects

    Medline Industries is recalling medical convenience kits containing plastic syringes due to leaks, breakage, and quality defects that may pose patient health risks following an FDA Safety Alert.

    Product
    Medline Convenience kits, labeled as: 1) GAS SAM LINE .06ID 10FT MM FLT, Pack Number 35772 ; 2) ANES CIRC 90 EXP PEDS 2BV-LF, Pack Number 81842 ; 3) AIRWAY EXAM KIT, Pack Number DYKE1796 ; 4) INTUBATION KIT , Pack Number DYKSCRIPPSIN4; 5) INTUBATION KIT , Pack Number D
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3002-2024·2024-09-18

    Medline Convenience Kits with Defective Plastic Syringes Recalled Globally

    Medline recalls convenience kits with defective plastic syringes due to leaks, breakage, and quality issues identified in an FDA Safety Alert. The defects may pose a risk to patient health.

    Product
    Medline Convenience kits labeled as: 1) HEAD & NECK TRAY, Pack Number AM310B ; 2) HEAD & NECK CDS , Pack Number CDS780161K ; 3) HEAD & NECK CDS , Pack Number CDS780161L ; 4) HEAD & NECK PROCEDURE , Pack Number CDS780170R ; 5) HEAD & NECK PROCEDURE , Pack Number CDS780170S ;
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1801-2024·2024-09-18

    Pasta Salad Product Recalled Due to Foreign Material Contamination

    Reser's American Classics Garden Pasta Salad (UPC 71117 19063) is being recalled due to potential foreign material contamination. The recall affects 278 cases distributed to nine states.

    Product
    UPC 71117 19063, Reser's American Classics Garden Pasta Salad 16oz, refrigerated, packaged in an opaque printed plastic tub with a plastic red printed lid. There are 6 tubs per case.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·F-1798-2024·2024-09-18

    Yummy Monkey Organics Popcorn Recalled for Undeclared Milk Allergen

    Yummy Monkey Organics Real Movie Theater Popcorn is recalled because the label lists butter and ghee but fails to declare milk, a major allergen. Consumers with milk allergies should not consume this product.

    Product
    Yummy Monkey Organics Real Movie Theater Popcorn, Made With Purified Ghee & Himalayan Sea Salt. UPC 9 96692 66654 2, packaged in a Clear Polyethylene Gusseted Re-closable Bag measured 9 x 12 x 2". Net Wt. 5.25 oz (149g). Manufactured By: Yummy Monkey Organics, LLC 243 Grimes St.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2976-2024·2024-09-18

    HeNe Laser System Key Control Can Be Removed While Operating

    PACIFIC LASERTECH's 25-LHP-928 HeNe laser systems have a safety defect: the key control can be removed while the laser is operating. The company is replacing affected units with corrected key switches.

    Product
    25-LHP-928, HeNe Laser System, 25 mW
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2996-2024·2024-09-18

    Medline Convenience Kits Recalled Due to Defective Plastic Syringes

    Medline Industries is recalling multiple convenience kits containing plastic syringes with identified quality issues including leaks and breakage. These defects may pose a risk to patient health.

    Product
    Medline Convenience kits labeled as: 1) DIALYSIS CATHETER INSERTION KIT, Pack Number CVI4815; 2) ANGIO PACK, Pack Number CVI5045; 3) CHILDRENS INFANT SP TRAY, Pack Number DYNDA2906; 4) ULTRASOUND GUIDE BREAST BIOPSY, Pack Number DYNDH1319; 5) BIOPSY TRAY, Pack Number D
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3041-2024·2024-09-18

    Medline Medical Convenience Kits with Plastic Syringes Recalled Due to Leaks and Breakage

    Medline Industries is recalling medical convenience kits containing plastic syringes with leaks, breakage, and other quality issues that may pose a risk to patient health.

    Product
    Medline Convenience kits labeled as: 1) CHEST TUBE INSERTION TRAY, Pack Number DYNDA2063; 2) PULL D/C PACK, Pack Number DYNDA2080; 3) STERILE 3CC SYR W/ 23GX1 NDL, Pack Number DYNDA2495; 4) STERILE 1CC SYR W/ 25GX5/8 NDL, Pack Number DYNDA2497; 5) ARTHROGRAM TRAY, Pack
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2984-2024·2024-09-18

    Medline medical convenience kits with defective plastic syringes recalled

    Medline is recalling medical convenience kits containing plastic syringes with identified quality defects including leaks and breakage. The worldwide-distributed kits may pose a risk to patient health.

    Product
    Medline Convenience kits, labeled as: 1) TRACHEOTOMY TRAY, Pack Number DYNDA1894; 2) TRACHEOSTOMY, Pack Number DYNJ45495G ; 3) TRACH PACK, Pack Number DYNJ46518G ; 4) EH EMERGENCY TRACH TRAY , Pack Number DYNJ50007A ; 5) EH EMERGENCY TRACH TRAY , Pack Number DYNJ50007B
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3131-2024·2024-09-18

    Surgical Dissector Recalled for Brown Discoloration on Hinge Area

    Technomed Europe is recalling NEUROSIGN Disposable Stimulating Dissectors due to brown discoloration or substance on the hinge area. The recall affects 71 units distributed across seven US states.

    Product
    NEUROSIGN Disposable Stimulating Dissector, REF 5888-00
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-3119-2024·2024-09-18

    Medline Surgical Suction Kits Recalled for Potential Loss of Suction

    Medline Industries recalls specific lots of semi-rigid suction liners in C-section convenience kits due to reported adverse events. The liners may lose suction during intermittent use.

    Product
    Medline convenience kits containing semi-rigid suction liners labeled as follows: MERCY TIFFIN C-SECTION, Pack Number DYNJ909732
    Category
    Medical Device
    Distribution
    Distributed nationwide