The Recall Desk

Archive

July 2023 recalls

787 recalls were announced in July 2023.

What the numbers show

Critical
65
Severe
372
High
300
Moderate
50

Of the 787 recalls this month scored against our rubric, 8% are Critical, 47% are Severe.

Which agencies issued them

101–200 of 787

  • 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-2153-2023·2023-07-26

    Simplexa Direct Amplification Disc Kit recalled for potential liquid spillage

    DiaSorin Molecular is recalling the Simplexa Direct Amplification Disc Kit due to potential malfunction that could cause liquid to spill from the device.

    Product
    Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 box containing 3 Direct Amplification Discs (DADs). Each box contains discs individually pouch-sealed and labeled with REF: MOL1452
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2181-2023·2023-07-26

    Medline Probe Cover Kits Recalled for Inadequate Seam Barriers

    Medline is recalling probe cover kits with ultrasound gel due to inadequate barriers at the seams that may compromise sterility during diagnostic ultrasound procedures.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BLOCK SUPPLIES NDL CNTR, Model Number DYNJRA1755; b) VNUS TEST KIT CFP-LF, Model Number DYNJTESTCFP4; c) ULTRASOUND PIV BUNDLE, Model Number IV8635D; d) ULTRASOUND GUIDED PIV KIT, Model…
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1250-2023·2023-07-26

    Botanas Michoacanas Churritos Corn Flour Sticks Recalled for Undisclosed Sesame

    Botanas Michoacanas is recalling Churritos Corn Flour sticks due to undisclosed sesame in the product label. Sesame is present in the ingredient list but not disclosed in the Contains statement.

    Product
    Churritos Corn Flour sticks, shelf stable, 6 months shelf life, packed in a rectangular shape clear polypropylene bag with net wt.11 oz (311.845g.), UPC# 6-0972233599-7. Product labeled in part, "***BOTANAS MICHOACANS CHURRITOS CORN FLOUR STICKS***Best By:***Ingredients: Corn…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1290-2023·2023-07-26

    Frozen Salmon Spread Recalled for Incomplete Allergen Labeling

    Kenai Red Fish Company is recalling Frozen Wild Alaska Smoked Salmon Spread due to incomplete allergen labeling. The label does not properly declare the presence of salmon and anchovies, major fish allergens that could affect consumers with fish allergies.

    Product
    Frozen Wild Alaska Smoked Salmon Spread packaged in 6 oz. (net weight) rigid plastic tubs. Product packed in 10 units per case. Product is labeled in part, "***KENAI*RED FISH COMPANY***WILD ALASKA SMOKED SALMON SPREAD KEEP FROZEN - STIR & REFRIGERATE AFTER OPENING Ingredients…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2213-2023·2023-07-26

    MRI Biomet Pin Guide for Knee Surgery Shipped to Wrong Patient

    Materialise N.V. is recalling MRI Biomet Pin Guides for total knee arthroplasty because the wrong patient-specific device was included in a shipment. Using an incompatible guide could affect surgical planning and implant placement.

    Product
    MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- patient-matched device designed to fit the patients anatomy to transfer a patient-specific pre-operative plan to the OR. Ref: KNM-ZB02-00-01
    Category
    Medical Device
    Distribution
    0 states
  • 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2182-2023·2023-07-26

    Medline Probe Cover Kits Recalled Due to Inadequate Seam Barrier

    Medline is recalling Probe Cover Kits (Models CVI4325 and DT13351A) distributed worldwide from December 2017 to May 2023. The probe covers may have inadequate barrier protection at the seams, posing a contamination risk during diagnostic ultrasound procedures.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) UNIVERSAL INSERTION TRAY, Model Number CVI4325; b) PPE BUNDLE KIT, Model Number DT13351A
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2184-2023·2023-07-26

    Medline Ultrasound Probe Covers Recalled for Inadequate Seam Barriers

    Medline Industries is recalling ultrasound probe cover kits used in invasive procedure trays due to inadequate seam barriers that may allow contamination. The recall affects 11,413 units distributed worldwide between December 2017 and May 2023.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) LACERATION TRAY, Model Number DYNDL1134A; b) ULTRASOUND GUIDED IV/MIDLINE K, Model Number DYNDV2385; c) PEDIATRIC CENTRAL LINE KIT, Model Number DYNJ38885B; d) CENTRAL LINE TRAY…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2196-2023·2023-07-26

    Medline Probe Cover Kits recalled for inadequate seam barriers

    Medline is recalling probe cover kits used in ultrasound procedures due to potential inadequate barriers at the seams that could affect product protection.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VNUS TRAY, Model Number DYNJ44410G; b) INTRAUTERINE TRNSFUSION -LF, Model Number DYNJ9048708I; c) PERI NEURO BLOCK PACK-LF, Model Number PHS762887001B; d) TVS4700 CUSTOM PACK, Model…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2199-2023·2023-07-26

    Medline probe cover kits recalled for inadequate seam barrier protection

    Medline probe cover kits used in diagnostic ultrasound procedures are being recalled due to inadequate barriers at the seams, which may compromise sterile integrity during use. A total of 39,391 units are affected.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FEMORAL ARTERIAL LINE BUNDLE, Model Number ART1005; b) 20GX6" FEMORAL ART LINE KIT, Model Number ART1165; c) 3" RADIAL ARTERIAL LINE KIT, Model Number ART240A; d) 6" FEMORAL ARTERIAL…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1289-2023·2023-07-26

    Romaine lettuce recalled for possible contamination with deer droppings

    C&E Farms is recalling 2,580 mini-bins of bulk romaine lettuce distributed to Massachusetts and Minnesota due to possible contamination with deer droppings. Consumers should not consume the recalled product.

    Product
    Romaine lettuce packed in bulk 45 pound mini-bins
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1281-2023·2023-07-26

    Snack Mix Recalled for Undeclared Walnut Allergen in Michigan

    Fry Daddy's Gluten Free Original Party Mix is recalled due to undeclared walnut. The recall affects approximately 2,757 retail units distributed in Michigan with sell-by dates from June 1 to December 31, 2023.

    Product
    Fry Daddy's Gluten Free Original Party Mix 10oz bag UPC 860007669545. 12 bags per wholesale case
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2202-2023·2023-07-26

    Medline Sterile Probe Covers Recalled for Inadequate Seam Barriers

    Medline is recalling 572 sterile probe cover kits due to inadequate barriers at the seams that may compromise sterility during ultrasound procedures. The affected products were distributed worldwide between December 2017 and May 2023.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CVC INFANT INSERTION PACK, Model Number CVI4770A; b) INSERTION BUNDLE, Model Number DT21275; c) VA MAINTENANCE PACK, Model Number EBSI1382; d) MIDLINE DRESSING CHANGE KIT, Model…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0933-2023·2023-07-26

    Norepinephrine injectable recalled due to lack of sterility assurance

    SterRx is recalling 92,148 bags of norepinephrine injectable due to lack of assurance of sterility. The prescription medication was distributed nationwide.

    Product
    Norepinephrine 16 mg per 250 mL (64 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per carton, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-602-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2185-2023·2023-07-26

    Medline ultrasound probe covers recalled for inadequate seam barrier

    Medline Probe Cover Kits used in diagnostic ultrasound procedures are recalled because probe covers may have an inadequate barrier at the seams, potentially allowing contamination.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: UNIVERSAL DRESSING & PPE KIT, Model Number DT22065
    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-2166-2023·2023-07-26

    Medline Probe Cover Kits Recalled for Inadequate Seam Barriers

    Medline is recalling probe cover kits used in cardiac and vascular ultrasound procedures due to inadequate seam barriers. Over 3.7 million units were distributed worldwide from December 2017 through May 2023.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) SILVER CROSS OPEN HEART, Model Number DYNJ906102G; b) SILVER CROSS OPEN HEART, Model Number DYNJ906102I; c) CUSTOM CARDIAC CABG, Model Number DYNJ906108C; d) VASCULAR STENT INOVA, Model…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2175-2023·2023-07-26

    Medline Probe Cover Kits Recalled for Inadequate Seam Barriers

    Medline is recalling 2739 units of probe cover kits used in diagnostic ultrasound and catheter insertion procedures due to inadequate barriers at seams that could compromise sterility.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATHETER INSERTION KIT CLABSI, Model Number CVI4880; b) CENTRAL CATHETER INSERTION TRA, Model Number CVI680C; c) CVL INSERTION TRAY, Model Number DYNDC1786A; d) UNIVERSAL INSERTION…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0923-2023·2023-07-26

    Tizanidine Tablets Recalled Nationwide for Failed Dissolution Specification

    Dr. Reddy's Laboratories is recalling Tizanidine 4 mg tablets nationwide because 24-month stability testing revealed dissolution specification failures. No illnesses or injuries have been reported.

    Product
    TIZANIDINE — TIZANIDINE (TIZANIDINE)
    Category
    Drug
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2206-2023·2023-07-26

    Medline O.R. Scissors Recalled Due to Sterile Packaging Compromise Risk

    Medline is recalling approximately 189,221 surgical scissors because they were manufactured without a tip protector, allowing them to break through sterile packaging and compromise product sterility.

    Product
    Medline O.R. Scissors, S/B, Sterile, 5.5, Model #DYND04000
    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 (Food)·F-1284-2023·2023-07-26

    Fry Daddy's Gluten Free Ranch Party Mix recalled for undeclared walnut

    Fry Daddy's Gluten Free Ranch Party Mix is being recalled due to undeclared walnut allergen. The recall affects 1,356 retail units distributed in Michigan with sell-by dates from June 1 to December 31, 2023.

    Product
    Fry Daddy's Gluten Free Ranch Party Mix 10oz bag UPC 860007669576. 12 bags per wholesale case
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2198-2023·2023-07-26

    Medline Probe Cover Kits recalled due to inadequate seam barriers

    Medline Probe Cover Kits may have inadequate seam barriers that could allow contamination during diagnostic ultrasound procedures. Approximately 575 units have been distributed worldwide since December 2017.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ULTRASOUND PACK, Model Number DYNDH1112; b) PARA THORACENTESIS TRAY, Model Number DYNDH1165A; c) ULTRASOUND TRAY, Model Number DYNDH1204;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1280-2023·2023-07-26

    Snack food recalled for undeclared walnut allergen in Michigan

    Fry Daddy's Super Ranch Jalapeno Party Mix is recalled due to undeclared walnut. The voluntary recall affects 5,477 units distributed in Michigan with sell-by dates from June 1 to December 31, 2023.

    Product
    Fry Daddy's Super Ranch Jalapeno Party Mix 3.75oz and 12oz bags UPCs 860007991547 and 850058648044. 12 bags per wholesale case
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2144-2023·2023-07-26

    Beckman Coulter DxA Automation System software defect may produce erroneous patient test results

    A software defect in the Beckman Coulter DxA Automation System may cause tests to be performed on incompatible tube types, potentially producing inaccurate patient results. Affected systems were distributed in the US and internationally.

    Product
    Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Food)·F-1253-2023·2023-07-26

    Three Apple Cider Brands Recalled for Patulin Contamination

    Bevovations, LLC is recalling apple cider from three brands—CN Smith, Wilson Farms, and Carlson Orchards—due to patulin contamination above FDA safety limits. Affected products were distributed in Massachusetts, Pennsylvania, Connecticut, and New Hampshire.

    Product
    1/2 gallon CN Smith brand Apple Cider; 1/2 gallon and 16 oz. Wilson Farms brand Apple Cider; 1 gallon, 1/2 gallon, and 16 oz. Carlson Orchards brand Apple Cider - all packaged in HDPE bottles and shipped in corrugated closed boxes.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-2154-2023·2023-07-26

    Medline ultrasound probe cover kits recalled for inadequate seam barriers

    Medline Industries has recalled 1,505,262 Probe Cover Kits used in diagnostic ultrasound procedures due to an inadequate barrier at the seams. The recall affects units distributed worldwide between December 2017 and May 2023.

    Product
    Medline Probe Cover Kits, Model Numbers: DYNJE5900, DYNJE5910, DYNJE5920, DYNJE5930, DYNJE5940, DYNJEX5900. for use during diagnostic ultrasound procedures
    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-2145-2023·2023-07-26

    Beckman Coulter DxA Automation System software defect may cause incorrect test results

    Beckman Coulter DxA Automation Systems contain a software defect that may cause tests to run on incompatible sample tube types, potentially producing erroneous patient results.

    Product
    Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2148-2023·2023-07-26

    Aeris Balloon Dilation Catheter Mislabeled — FDA Class II Recall

    Bryan Medical Inc is recalling the Aeris Balloon Dilation Catheter distributed nationwide in Georgia, New York, and Pennsylvania due to mislabeling of the devices.

    Product
    Aeris Balloon Dilation Catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0928-2023·2023-07-26

    Rocuronium Bromide Injectable Recalled Due to CGMP Violations

    Advanced Compounding Solutions is recalling Rocuronium Bromide 10 mg/mL injectables (lot #20230524-530F73) nationwide due to CGMP violations. Production spaces adjacent to the manufacturing area may have been compromised.

    Product
    ROcuronium Bromide 50 mg/5 mL ( 10 mg/mL), 5mL Syringe, RX Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC: 71546-090-05
    Category
    Drug
    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-2209-2023·2023-07-26

    FDA Recalls RET Proximal Probe Laboratory Diagnostic Kits for Inverted DNA

    Cytocell Ltd. RET Proximal Probe kits distributed to laboratories in California, Florida, Ohio, and South Carolina are being recalled due to inverted DNA sequences introduced during manufacturing.

    Product
    RET Proximal 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
  • HighNHTSA·23V515000·2023-07-26

    2023 Kawasaki ZX400 motorcycles recalled for alternator failure risk

    Kawasaki is recalling certain 2023 ZX400 motorcycles because the alternator may fail due to a loose rotor connection, potentially causing engine stall and increasing crash risk. Dealers will inspect and tighten the rotor bolt at no charge.

    Product
    KAWASAKI — KAWASAKI ZX400
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2155-2023·2023-07-26

    Medline Ultrasound Probe Cover Kits recalled for inadequate seam barrier

    Medline is recalling Probe Cover Kits that may have inadequate barrier at the seams, potentially compromising sterility during diagnostic ultrasound procedures. The recall affects kits distributed worldwide from December 2017 through May 2023.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: ANESTHESIA OH TOTE, Model Number DYNJ61476
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0932-2023·2023-07-26

    Norepinephrine injectable medication recalled nationwide for sterility assurance

    SterRx recalled 125,598 bags of norepinephrine injectable medication nationwide because the manufacturer could not guarantee the product's sterility. The recalled medication has expiration dates from July 2023 to April 2024.

    Product
    Norepinephrine 8 mg per 250 mL (32 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-577-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0930-2023·2023-07-26

    Sodium Bicarbonate Injectable Solution Recalled for Sterility Assurance Issues

    SterRx is recalling 137,304 bags of Sodium Bicarbonate in 5% Dextrose Injection nationwide because the manufacturer cannot assure the product meets sterility standards. Affected lots have expiration dates from July 2023 through February 2024.

    Product
    Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL Single Dose bag, packaged in 1000 mL x 6 units per case, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2172-2023·2023-07-26

    Medline Ultrasound Probe Cover Kits Recalled for Inadequate Seam Barriers

    Medline is recalling probe cover kits used with diagnostic ultrasound procedures due to inadequate seam barriers that may compromise sterility. The recall affects 1,861 units distributed worldwide from December 2017 through May 2023.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CHP COCHLEAR SUPPLEMENT CDS, Model Number CDS983069I; b) HEAD AND NECK PACK, Model Number DYNJ30245; c) IR THYROID PACK (THLUF)642-LF, Model Number DYNJ47716B; d) CENTRAL LINE…
    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-2180-2023·2023-07-26

    Medline Ultrasound Probe Cover Kits Recalled for Inadequate Seam Barriers

    Medline Industries is recalling ultrasound probe cover kits with inadequate barriers at the seams that could allow contamination during procedures. Approximately 3.7 million units distributed worldwide between December 2017 and May 2023 are affected.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VEIN KIT, Model Number DYNJ55841B; b) FACELIFT PACK, Model Number DYNJ55954B; c) CLOT RETRIEVAL PACK, Model Number DYNJ56140B; d) VENOUS PACK, Model Number DYNJ56260B; e) WMC…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2204-2023·2023-07-26

    Medline Probe Cover Kits Recalled Due to Inadequate Seam Barriers

    Medline is recalling Probe Cover Kits because probe covers may have inadequate seam barriers that could allow contamination during ultrasound procedures. Approximately 24,192 units were distributed worldwide from December 2017 to May 2023.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: KIT,SUCTION CATH,14FR W/WATER, Model Number DYND41472
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2167-2023·2023-07-26

    Medline Probe Cover Kits: Inadequate Seam Barrier Risk

    Medline probe cover kits used in ultrasound-guided medical procedures may have inadequate barriers at the seams, posing a contamination risk. Approximately 270,000 units distributed worldwide since December 2017 are affected.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ARTERIAL BUNDLE NO CATHETER, Model Number ART995; b) ART LINE KIT NO CATH, Model Number ARTNC145; c) CENTRAL LINE TRAY, Model Number CVI4705; d) CENTRAL LINE INSERTION PACK, Model Number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2177-2023·2023-07-26

    Medline Probe Cover Kits recalled for inadequate seam barriers

    Medline is recalling 4,398 probe cover kits used in ultrasound procedures due to inadequate seam barriers that may compromise sterility. The kits were distributed worldwide from December 2017 through May 2023.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BREAST PACK, Model Number DYNDH1306; b) BRST BX TRAY, Model Number DYNDH1389B; c) PLASTIC PACK, Model Number DYNJ35262A; d) VNUS RFS PROCEDURE PACK, Model Number DYNJ39508A; e)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2179-2023·2023-07-26

    Medline Ultrasound Probe Cover Kits Recalled for Inadequate Seam Barrier

    Medline has recalled approximately 3.7 million ultrasound probe cover kits due to inadequate barriers at the seams that could affect sterile field integrity during diagnostic procedures.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) NO-CATH RADIAL ARTERIAL PREMIU, Model Number ARTNC115; b) MAJOR VASCULAR, Model Number CDS980752I; c) PICC LINE DOUBLE LUMEN CDS, Model Number CDS982858F; d) PICC LINE TRIPLE LUMEN CDS…
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2163-2023·2023-07-26

    Medline Ultrasound Probe Covers Recalled for Inadequate Seam Barriers

    Medline is recalling 172,722 ultrasound probe cover kits due to inadequate barrier protection at the seams. The defect may compromise protective function during diagnostic ultrasound procedures.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a. NORTON CHILDRENS CATH LAB-LF, Model Number 00-401185Q; b. PERCUTANEOUS VASCULAR CDS, Model Number CDS840487I; c. BAPTIST SOUTH OPEN HEART CV PK, Model Number CDS983147I; d. ENDOVASCULAR…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2201-2023·2023-07-26

    Medline probe covers with inadequate seam barrier may allow contamination

    Medline is recalling Probe Cover Kits due to inadequate barriers at the seams, which may allow contamination during ultrasound procedures. The recall affects 51,200 units distributed worldwide between December 2017 and May 2023.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PROBE COVER PACK, Model Number DYNDA1219
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2147-2023·2023-07-26

    Infant Heel Warmer Recalled Due to Burst and Leaking

    Cardinal Health is recalling 44,500 NovaPlus Infant Heel Warmers from lot V2S056 due to reports of bursting and leaking. Units were distributed nationwide.

    Product
    NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V11460-010
    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 (Drugs)·D-0929-2023·2023-07-26

    Vancomycin IV Bags Recalled Due to Manufacturing Environment Contamination Risk

    New England Life Care is recalling Vancomycin HCl IV bags due to potential CGMP violations that may have compromised the production environment. The recall affects 209 bags distributed nationwide.

    Product
    Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 500 mL, 500 mL IV Bag (515 total volume), Rx Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC 71546-310-50;
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1278-2023·2023-07-26

    Fry Daddy's Cheddar Party Mix Recalled Due to Undeclared Walnut

    Fry Daddy's Cheddar Party Mix is being recalled because it contains undeclared walnut, which poses a risk to consumers with walnut allergies. The recall affects approximately 6,613 retail units sold in Michigan.

    Product
    Fry Daddy's Cheddar Party Mix 3.75oz and 12oz bags UPCs 860007991523 and 850047648020. 12 bags per wholesale case
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1279-2023·2023-07-26

    Fry Daddy's Ranch Party Mix recalled for undeclared walnut allergen

    Fry Daddy's Brand is recalling Fry Daddy's Ranch Party Mix (3.75oz and 12oz bags) distributed in Michigan due to undeclared walnut content. Approximately 4,505 units with sell-by dates from June 1 through December 31, 2023 are affected.

    Product
    Fry Daddy's Ranch Party Mix 3.75oz and 12oz bags UPCs 86007991530 and 850047648037. 12 bags per wholesale case
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2176-2023·2023-07-26

    Medline Probe Cover Kits Recalled for Inadequate Seam Barriers

    Medline is recalling 4,644 sterile ultrasound gel probe cover kits with potentially inadequate seams that could compromise barrier integrity during ultrasound procedures.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CVC PACK, Model Number DYNJ46967F; b) ENDOVENOUS CORE PACK, Model Number DYNJ62557; c) ENSEMBLE CATHETER DIALYSE-LF, Model Number DYNJ81973; d) TVS4000 ENDOVENOUS PACK, Model…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1252-2023·2023-07-26

    Food product recall: Undeclared milk in Phillips Butterscotch Cone Coating

    Lyons Magnus LLC recalls Phillips Butterscotch Cone Coating due to undeclared milk, which was not listed on the label. Consumers with milk allergies face a health risk.

    Product
    Phillips Butterscotch Cone Coating; packaged in 96fl oz metal cans, 6 cans per case
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0931-2023·2023-07-26

    Norepinephrine injectable recalled due to sterility assurance concerns

    SterRx is recalling norepinephrine injections due to lack of assurance of sterility. The recall affects 132,299 bags distributed nationwide.

    Product
    Norepinephrine 4 mg per 250 mL (16 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-552-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0934-2023·2023-07-26

    Norepinephrine Injectable Recalled Due to Lack of Sterility Assurance

    SterRx recalled 2,088 bags of Norepinephrine 32 mg per 250 mL (Lot #490100) distributed nationwide due to lack of sterility assurance. The recall affects a critical care medication used in intensive care settings.

    Product
    Norepinephrine 32 mg per 250 mL (128 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-702-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0924-2023·2023-07-26

    Loteprednol Etabonate Eye Drops Recalled for Out-of-Specification Potency

    Sun Pharmaceutical recalls Loteprednol Etabonate eye drops due to out-of-specification unit dose content in certain lots. Affected bottles may contain incorrect potency levels.

    Product
    LOTEPREDNOL ETABONATE — LOTEPREDNOL ETABONATE (LOTEPREDNOL ETABONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0927-2023·2023-07-26

    FDA Recalls Phenylephrine HCl IV Solution Over Manufacturing Contamination

    Advanced Compounding Solutions is recalling 82 bags of phenylephrine HCl intravenous solution due to potential contamination from manufacturing facility violations. No illnesses have been reported.

    Product
    PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride 250mL, 250 mL IV Bag @60 Total volume), RX only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC: 71546-450-25;
    Category
    Drug
    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 (Drugs)·D-0939-2023·2023-07-26

    Famotidine tablets recalled for carton labeling error on strength

    Glenmark Therapeutics is recalling famotidine 20 mg tablets after some cartons were labeled with a side label indicating 10 mg instead. The medication inside is correct; only the external carton label is mislabeled.

    Product
    FAMOTIDINE — FAMOTIDINE (FAMOTIDINE)
    Category
    Drug
    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
  • ModerateFDA (Drugs)·D-0925-2023·2023-07-26

    Prescription drug recall: Fingolimod capsules fail dissolution specifications

    Ascend Laboratories is recalling 2,652 bottles of Fingolimod capsules nationwide because they failed to meet dissolution specifications, potentially affecting medication effectiveness.

    Product
    FINGOLIMOD — FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·23E057000·2023-07-25

    RevHD Recalls Oil Hubcaps Due to Fire and Crash Risk

    RevHD is recalling specific oil and PSI oil hubcaps because the lens may become loose, causing lubricant leaks that can overheat wheel bearings and increase the risk of fire or a crash.

    Product
    WHEELS:HUBCAP/COVER recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V514000·2023-07-24

    Mack Recalls 2022-2023 LRBE Electric Trucks Due to Battery Fire Risk

    Mack Trucks is recalling 2022-2023 LRBE electric trucks because over-tightened battery inserts may break, causing a short circuit and increasing fire risk.

    Product
    MACK — MACK LRBE (ELECTRIC)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V512000·2023-07-24

    Volvo Recalls 2020-2024 VNR Electric Trucks Due to Battery Fire Risk

    Volvo Trucks is recalling 2020-2024 VNR Electric vehicles because over-tightened battery inserts may break, causing a short circuit and increasing fire risk.

    Product
    VOLVO — VOLVO VNRE (ELECTRIC)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23E056000·2023-07-24

    Allison Transmission Recalls Emergency Vehicle Transmission Control Modules

    Allison Transmission is recalling 584 Emergency Vehicle Series 6th Generation Transmission Control Modules that may fail to engage 4th gear lockup, preventing the water pump from operating.

    Product
    POWER TRAIN:AUTOMATIC TRANSMISSION:CONTROL MODULE (TCM/PCM/TECM) recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V511000·2023-07-24

    2022-2024 Volvo Trucks Windshield Wiper Motor Failure Recall

    Volvo Trucks is recalling 2022-2024 commercial trucks due to windshield wiper motor gears that may wear and fail, reducing visibility. Dealers will replace the motor assembly at no cost.

    Product
    VOLVO — VOLVO VNR, VAH, VNL, VHD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V510000·2023-07-21

    2023 Ford F-53 and F-59 Recalled for Inoperative Instrument Panel

    Corrosion in the Smart Data Link Connector may prevent the instrument panel from displaying critical safety information like the speedometer and warning lights in certain 2023 Ford F-53 and F-59 vehicles, increasing crash risk.

    Product
    FORD — FORD F-59, F-53
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V504000·2023-07-21

    Peterbilt and Kenworth trucks recalled for loose driveline fasteners

    PACCAR is recalling certain 2023-2024 Peterbilt and Kenworth trucks due to improperly applied thread-lock on driveline fasteners. Loose fasteners could allow the driveline to separate, increasing crash risk.

    Product
    KENWORTH — KENWORTH, PETERBILT T280, 536, 537, T480
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V507000·2023-07-21

    2023 Ford Super Duty Trucks Door Window Auto-Reverse May Fail

    Ford is recalling 2023 Super Duty F-250, F-350, F-450, and F-550 trucks due to a door module power issue that may prevent the power window anti-pinch function from detecting obstructions and automatically reversing.

    Product
    FORD — FORD F-550 SD, F-250 SD, F-450 SD, F-350 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V503000·2023-07-21

    Forest River Recalls 2023 Impression Fifth Wheels Due to Fire Risk

    Forest River is recalling 2023 Impression fifth wheels because the exterior griddle may be stowed while connected to the LP gas line, increasing fire risk.

    Product
    FOREST RIVER — FOREST RIVER IMPRESSION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·032-2023·2023-07-21

    Nuevo Garcia Foods Recalls Pulled Pork for Undeclared Soy Allergen

    Nuevo Garcia Foods is recalling 4,784 pounds of fully cooked pulled pork because the label fails to list soy lecithin, a known allergen.

    Product
    Nuevo Garcia Foods, LLC Recalls Fully Cooked Pulled Pork Product Due to Misbranding and Undeclared Allergen
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·23V506000·2023-07-21

    2023 Ford Super Duty Trucks and Escape Instrument Panel Illumination Defect

    Ford is recalling certain 2023 Super Duty F-250, F-350, F-450, F-550 and Escape models. The instrument panel module may fail to illuminate due to improper soldering, preventing drivers from seeing critical safety information like the speedometer and warning lights.

    Product
    FORD — FORD F-350 SD, ESCAPE, F-550 SD, F-450 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V500000·2023-07-20

    2023 Chrysler Pacifica Plug-In Hybrid Fuel Line Defect Recall

    Certain 2023 Chrysler Pacifica Plug-In Hybrid Electric vehicles may have deformed fuel lines that could leak, increasing fire risk. Dealers will replace the fuel lines free of charge.

    Product
    CHRYSLER — CHRYSLER PACIFICA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23774·2023-07-20

    CUPKIN Stainless Steel Children's Cups Recalled for Excessive Lead Content

    SOOJIMUS is recalling about 346,000 CUPKIN Double-Walled Stainless Steel Children's Cups because they contain lead levels that exceed the federal ban. Lead ingestion poses a health risk to young children.

    Product
    CUPKIN Double-Walled Stainless Steel Children's Cups
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23247·2023-07-20

    Wild Country Superlight Rocks climbing chocks recalled for fall hazard

    Salewa USA recalls Wild Country Superlight Rocks cable wire climbing chocks due to corrosion from seaside exposure that weakens and breaks the chocks, creating a fall hazard for climbers. No injuries have been reported in the U.S.

    Product
    Superlight Rocks
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·23775·2023-07-20

    Pottery Barn Kids Penny Convertible Cribs Recalled for Laceration Hazard

    Williams-Sonoma Inc., operating as Pottery Barn Kids, is recalling about 310 Penny Convertible Cribs because the end panel can become loose and expose sharp edges, creating a laceration hazard to children. No injuries have been reported.

    Product
    Pottery Barn Kids Penny Convertible Cribs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1236-2023·2023-07-19

    FDA Recalls Rader Farms Organic Fresh Start Smoothie for Hepatitis A

    Rader Farms Organic Fresh Start Smoothie, a frozen fruit and vegetable blend, has been recalled due to potential Hepatitis A contamination. The recall affects 62,380 bags distributed across 31 states.

    Product
    Rader Farms Organic Fresh Start Smoothie Blueberry, Strawberry, Raspberry, Kale, Spinach. Item # 1399671. Frozen, packed into 8oz. flexible plastic pouches and six 8oz pouches are packed into one flexible plastic bag. Net Wt. 48oz. UPC on retail bag: 8 84038 08326 2. A total…
    Category
    Food
    Distribution
    32 states
  • CriticalFDA (Drugs)·D-0921-2023·2023-07-19

    Artificial Tears Eye Drops Recalled for Bacterial Contamination

    Delsam Pharma's Artificial Tears eye drops are being recalled nationwide due to bacterial contamination found in unopened bottles. Consumers should stop using affected products immediately.

    Product
    Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1%, 1/2 fl oz (15 ml) bottle, Distributed By: Delsam Pharma Llc, Bronx, New York 10467, NDC 72570 121 15.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1240-2023·2023-07-19

    Jumbo Deviled Crabs recalled for undeclared milk and sesame allergens

    SANTOS FROZEN FOODS is recalling Jumbo Deviled Crabs (6oz packages) because they contain undeclared milk and sesame seeds. Consumers with allergies or sensitivities to these allergens should not consume this product.

    Product
    Jumbo Deviled Crabs, 6oz
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Drugs)·D-0938-2023·2023-07-19

    Prescription albuterol inhalers recalled nationwide due to defective valve seals

    Cipla USA is recalling 278,538 albuterol sulfate inhalers nationwide with specific lot numbers due to defective valve gaskets that cause empty inhalers or medication leakage. Check your lot number and contact your healthcare provider if affected.

    Product
    ALBUTEROL SULFATE — ALBUTEROL SULFATE (ALBUTEROL SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1242-2023·2023-07-19

    Multiple Pretzel Brands Recalled for Undeclared Milk Allergen

    Honey mustard pretzel products from multiple brands are being recalled due to potential undeclared milk. The recall affects 334,357 bags distributed nationwide.

    Product
    1. Hy-Vee Honey Mustard Braided Pretzels, 10oz poly bags, UPC: 75450-24309, 12 pack; 2. Dakota Style Honey Mustard Pretzel Kravings, 10oz poly bags, UPC 84872-60031, 12 pack and 6 pack; 3. Four Brothers Honey Mustard Pretzels, 10oz poly bags, UPC: 33147-89145, 12 pack; 4.…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V497000·2023-07-19

    Vanguard Recalls 2023-2024 Trailers with Tire Inflation System Defect

    Vanguard is recalling 2023-2024 trailers equipped with a specific tire inflation system that may cause tires to deflate, increasing crash risk.

    Product
    VANGUARD — VANGUARD REFRIGERATED TRAILER, VAF TRAILER, VTD TRAILER, MAXCUBE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1241-2023·2023-07-19

    Pretzel products recalled for undeclared milk allergen nationwide

    Dakota Style, Inc. is recalling salt and vinegar pretzel products nationwide because they may contain undeclared milk. Consumers with milk allergies should not consume these products.

    Product
    1. Hy-Vee Salt & Vinegar Braided Pretzels, 10 oz poly bags, UPC: UPC: 75450-27706, 12 pack; 2. Dakota Style Salt & Vinegar Pretzel Kravings, 4.5 oz poly bags, UPC: 84872-60030, 6 pack; 3. Dakota Style Salt & Vinegar Pretzel Kravings, 10 oz poly bags, UPC 84872-60018, 12 pack…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1243-2023·2023-07-19

    Multiple Brands of Dill Pickle Pretzels Recalled for Undeclared Milk

    Dakota Style, Inc. is recalling multiple brands of dill pickle pretzels nationwide because they may contain undeclared milk, a major allergen. Consumers with milk allergies should not consume these products.

    Product
    1. Hy-Vee Dill Pickle Braided Pretzels, 10oz poly bags, UPC: UPC: 75450-24308, 12 pack; 2. Schnucks Dill Pickle Pretzel Schticks, 10oz poly bags, UPC: 41318-25268, 12 pack; 3. Best Choice Dill Pickle Pretzel Twists, 10oz poly bags, UPC: 700038-66480, 12 pack; 4. Gelson's Dill…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1239-2023·2023-07-19

    Frozen Deviled Crabs Recalled for Undeclared Milk and Sesame Seeds

    SANTOS FROZEN FOODS is recalling Regular Deviled Crabs (4oz) for undeclared milk and sesame allergens. Approximately 520 cases were distributed domestically in affected lots beginning with 23 and ending in 03, 04, or 05.

    Product
    Regular Deviled Crabs, 4oz
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2110-2023·2023-07-19

    Abbott Cardiac Catheter Sheath Recalled Due to Air Embolism Risk

    Abbott is recalling the Amplatzer Steerable Delivery Sheath (ASDS), a cardiac catheter, due to a 0.77% reported incidence rate of air embolism during procedures. The recalled 675 units are distributed worldwide.

    Product
    Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1238-2023·2023-07-19

    Mini Deviled Crabs recalled for undeclared milk and sesame allergens

    SANTOS FROZEN FOODS is recalling Mini Deviled Crabs, 1oz, due to undeclared milk and sesame seeds. Consumers with allergies to these allergens should not consume the product.

    Product
    Mini Deviled Crabs, 1oz
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1232-2023·2023-07-19

    Great Value Sliced Strawberries recalled for potential Hepatitis A contamination

    Walmart's Great Value Sliced Strawberries are being recalled due to potential Hepatitis A contamination. Approximately 28,650 bags distributed across 32 states are affected.

    Product
    Great Value Sliced Strawberries. Item # 107356. Frozen, packaged flexible plastic bags. Net wt. 4 lbs (64oz). UPC on retail bag: 0 78742 25387 9. A total of 6 sellable units (4lbs. each) are placed into a case for distribution to retailer. DISTRIBUTED BY: Walmart Inc.…
    Category
    Food
    Distribution
    32 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
  • SevereNHTSA·23V498000·2023-07-19

    Sportsmobile Recalls 2021-2022 Vans Due to Fuel Hose Fire Risk

    Sportsmobile is recalling 2021-2022 Dodge Pro Master and Ford Transit vans because an improperly secured fuel hose may leak gas, increasing fire risk.

    Product
    SPORTSMOBILE — SPORTSMOBILE DODGE PROMASTER, FORD TRANSIT
    Category
    Vehicle
    Distribution
    Distributed nationwide

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