The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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9601–9625 of 40095

  • HighFDA (Devices)·Z-2197-2023·2023-07-26

    Medline Probe Cover Kits recalled for inadequate barrier at seams

    Medline is recalling Probe Cover Kits (Model MNS10750A) used in diagnostic ultrasound procedures because the probe covers may have an inadequate barrier at the seams, potentially affecting protective effectiveness.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: DIALYSIS ACCESSORY PACK W/O CATHETER, Model Number MNS10750A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2186-2023·2023-07-26

    Medline Ultrasound Probe Cover Kits Recalled for Inadequate Seam Barrier

    Medline is recalling 14,848 ultrasound probe cover kits due to potentially inadequate barriers at the seams. The kits were distributed worldwide between December 2017 and May 2023 for use in diagnostic procedures.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VISCERAL ANGIOGRAM PACK-LF, Model Number DYNJ0429121G; b) DBS PACK-LF, Model Number DYNJ0878178J; c) DBS PACK-LF, Model Number DYNJ0878178K; d) NEURO ARTERIOGRAM PACK-LF, Model Numbe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2191-2023·2023-07-26

    Medline Ultrasound Probe Covers Recalled for Inadequate Sterility Barriers

    Medline is recalling ultrasound probe cover kits used in diagnostic procedures because inadequate barriers at the seams may allow bacterial contamination. The recall affects 19,940 units distributed worldwide.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CRANIOTOMY CDS-1, Model Number CDS982889I; b) JOINT INJECTION TRAY, Model Number DYNDH1722; c) LOWER EXTREMITY PACK-LF, Model Number DYNJ0604434X; d) ARTHROSCOPY PACK, Model Number D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2161-2023·2023-07-26

    Medline Ultrasound Probe Cover Kits Recalled for Defective Seam Barriers

    Medline Industries recalls probe cover kits used in diagnostic ultrasound procedures because the covers may have inadequate barriers at the seams. Approximately 3.7 million units are affected.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY PACK, Model Number DYNJ55252C; b) CATH LAB PACK, Model Number DYNJ55455A; c) CATH LAB 2, Model Number DYNJ55680A; d) IR ANGIO TRAY, Model Number DYNJ56038A; e) CATH PACK, Mod
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2193-2023·2023-07-26

    Medline Probe Cover Kits Recalled for Inadequate Seam Barriers

    Medline is recalling probe cover kits containing sterile ultrasound gel due to inadequate barriers at the seams, which may compromise sterility during diagnostic ultrasound procedures. The recall affects 2,590 units distributed worldwide between December 2017 and May 2023.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) RADIAL ARTERIAL LINE KIT, Model Number ART1070A; b) ARTERIAL LINE START KIT, Model Number ART1160; c) ARTERIAL LINE TRAY W/O CATHETER, Model Number ART1180; d) ARTERIAL LINE INSERTION
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2159-2023·2023-07-26

    Medline Probe Cover Kits Recalled for Inadequate Seam Barrier

    Medline is recalling probe cover kits used during diagnostic ultrasound procedures due to an inadequate barrier at the seams that may compromise sterile integrity.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY DRP PK PEDI CATH, Model Number 00-401318M; b) ANGIOGRAPHY OR, Model Number CDS984944C; c) ANGIOGRAM, Model Number DYNJ0149444M; d) EP LAB DEVICE PACK-LF, Model Number DYNJ0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2157-2023·2023-07-26

    Medline Ultrasound Probe Cover Kits Recalled Due to Barrier Defect

    Medline is recalling Pediatric EP Pack ultrasound probe cover kits with sterile gel because the probe covers may have inadequate barriers at the seams, potentially compromising sterility during diagnostic procedures.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PEDIATRIC EP PACK, Model Number DYNJ45158A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2200-2023·2023-07-26

    Medline Ultrasound Probe Covers Recalled for Inadequate Seam Barrier

    Medline Industries is recalling 70,648 ultrasound probe cover kits used in diagnostic and interventional procedures due to inadequate barriers at the seams.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ARTERIAL LINE START KIT , Model Number ART920; b) ULTRASOUND GUIDED PIV KIT , Model Number BSIPIV1005; c) ULTRASOUND GUIDED IV START KIT W/SHIELD , Model Number BSIPIV1006; d) PIV BSI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2195-2023·2023-07-26

    Medline Probe Cover Kits recalled for inadequate seam barrier

    Medline is recalling 620 Probe Cover Kits due to an inadequate seam barrier that could compromise sterility during ultrasound procedures. The kits were distributed worldwide between December 2017 and May 2023.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATHETERLESS INSERTION KIT, Model Number CVI4510; b) VANTEX 7FR 3L 16CM CVC BUNDLE, Model Number STCVC01145B; c) VANTEX TRIPLE LUMEN BUNDLE, Model Number STCVC2000;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2205-2023·2023-07-26

    Medline Ultrasound Probe Cover Kits recalled for inadequate seam barrier

    Medline Industries is recalling 4,500 Probe Cover Kits because the covers have inadequate barriers at the seams, which may compromise sterility.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) TOTAL JOINT, Model Number CDS985555S; b) TOTAL KNEE, Model Number CDS985566Q; c) MAJOR ORTHO-LF, Model Number DYNJ0949139I; d) BSHR TOTAL KNEE-LF, Model Number DYNJ24525K; e) BSHR TO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2190-2023·2023-07-26

    Medline ultrasound probe cover kits recalled for inadequate seam barriers

    Medline probe cover kits used in diagnostic ultrasound procedures may have inadequate barriers at the seams. The recall affects 540 units distributed worldwide between December 2017 and May 2023.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: CATH LAB PACK, Model Number DYNJ58351A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2183-2023·2023-07-26

    Medline Ultrasound Probe Cover Kits Recalled for Seam Defects

    Medline is recalling ultrasound probe cover kits containing sterile ultrasound gel due to an inadequate seam barrier. The defect may compromise sterility during diagnostic ultrasound procedures.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) IV SECUREMENT KIT, Model Number DYNDV2407A; b) USG IV START KIT, Model Number DYNDV2435; c) ULTRASOUND GUIDED IV START KIT, Model Number DYNDV2518; d) VI PACK, Model Number DYNJ64871
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2169-2023·2023-07-26

    Medline Ultrasound Probe Cover Kits recalled for inadequate seam barrier

    Medline is recalling 770,147 ultrasound probe cover kits worldwide due to inadequate barriers at the seams. The defect could allow contamination during diagnostic ultrasound procedures.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETAL SURGERY CDS-LF, Model Number CDS840214Q; b) MINOR PROCEDURE TRAY, Model Number DYNDA2418; c) CLOSUREFAST PROCEDURE PACK-LF, Model Number DYNJ0365463J; d) BARIATRIC PACK, Model Nu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2173-2023·2023-07-26

    Medline Probe Cover Kits recalled for inadequate seam barriers

    Medline Industries is recalling 4,148 units of Probe Cover Kits used in diagnostic ultrasound procedures due to inadequate barriers at the seams.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETOSCOPY CDS-LF, Model Number CDS840215O; b) US BREAST BIOPSY TRAY, Model Number DYNDH1187A; c) PACK,FETOSCOPY, Model Number DYNJ906905B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2192-2023·2023-07-26

    Medline Ultrasound Probe Cover Kits Recalled for Inadequate Sterile Barrier

    Medline Probe Cover Kits used during ultrasound procedures may have an inadequate barrier at the seams that could compromise sterility. The manufacturer is recalling 180 units distributed worldwide between December 2017 and May 2023.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: ARTHROSCOPY PACK, Model Number DYNJ44322G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2158-2023·2023-07-26

    Medline Ultrasound Probe Covers Recalled for Inadequate Seam Barriers

    Medline Industries is recalling approximately 23,938 units of sterile ultrasound probe cover kits distributed worldwide from December 2017 to May 2023 due to inadequate barriers at seams that could compromise sterility during diagnostic ultrasound procedures.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) NERVE BLOCK ACCESSORY PACK, Model Number DYNJRA1220; b) PERI NEURO BLOCK PACK-LF, Model Number DYNJRA1773; c) PERI NEURO BLOCK PACK-LF, Model Number DYNJ51107B; d) PERI NEURO BLOCK PAC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2189-2023·2023-07-26

    Medline Probe Cover Kits Recalled for Inadequate Seam Barrier

    Medline is recalling Probe Cover Kits with sterile Ultrasound Gel because the probe covers may have an inadequate barrier at the seams. These diagnostic ultrasound kits are distributed worldwide.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETAL SURGERY CDS-LF, Model Number CDS840214P; b) ABLATION PACK, Model Number DYNJ82725
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2210-2023·2023-07-26

    RET Distal Probe Recalled Due to Manufacturing Defect in DNA Sequences

    FDA recalls RET Distal Probe due to manufacturing defect where DNA sequences used in production were inverted. The defect affects 61 units distributed in California, Florida, Ohio, and South Carolina and may impact diagnostic accuracy.

    Product
    RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2174-2023·2023-07-26

    Medline Ultrasound Probe Cover Kits Recalled for Inadequate Seam Barrier

    Medline is recalling Probe Cover Kits (model DYNJ60126B) with an inadequate barrier at the seams that may compromise sterile protection during ultrasound procedures. The kits were distributed worldwide between December 2017 and May 2023.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PACK ENDO AAA HYBRID CHRG, Model Number DYNJ60126B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2211-2023·2023-07-26

    Blood Glucose Meters Display Glucose Levels in Wrong Unit of Measure

    Ascensia is recalling blood glucose meters that display measurements in mmol/L instead of mg/dL. If not caught, the incorrect unit may cause patients to misread their glucose levels with serious health consequences.

    Product
    Contour¿ next GEN Blood Glucose Monitoring System
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-2187-2023·2023-07-26

    Medline Ultrasound Probe Covers Recalled for Seam Barrier Defects

    Medline is recalling ultrasound probe cover kits with sterile gel due to inadequate seam barriers that may compromise sterility during diagnostic procedures. Approximately 8,974 units distributed worldwide from 2017 to 2023 are affected.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VAD/PICC IV KIT, Model Number DYNDV2200; b) ULTRASOUND PIV KIT, Model Number DYNDV2397; c) VAD ACCESS, Model Number DYNJ24276C; d) FETAL INTERVENTION, Model Number DYNJ66041; e) FE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2146-2023·2023-07-26

    Aesculap Surgical Needle Recalled for Incorrect Product Code Marking

    Aesculap Implant Systems is recalling Aesculap Surgical Needles (MD610) because they are etched with an incorrect product code. The needles are marked MD611 when they should be marked MD610.

    Product
    Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2214-2023·2023-07-26

    Ultrasound reporting software recalled by manufacturer for software issue

    Digisonics has voluntarily recalled OBView ultrasound reporting software versions 4.8.2 SP6 through 4.8.3 due to a software issue. The recall affects 32 units distributed across multiple U.S. states and Aruba.

    Product
    Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2103-2023·2023-07-19

    Baxter SIGMA Spectrum Infusion Pump false upstream occlusion alarm correction

    Baxter is correcting false upstream occlusion alarms in SIGMA Spectrum and Spectrum IQ infusion pumps following software upgrades affecting approximately 3,306 units distributed nationwide in the US.

    Product
    SIGMA Spectrum Infusion Pump, Product Code 35700BAX2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2018-2023·2023-07-19

    Oxylog 3000 Plus ventilator may stop working during operation

    The Draeger Oxylog 3000 Plus emergency and transport ventilator may stop working when transitioning from battery to AC operation. Approximately 300 units distributed nationwide and internationally are affected.

    Product
    Oxylog 3000 Plus emergency and transport ventilator
    Category
    Medical Device
    Distribution
    Distributed nationwide