The Recall Desk

Archive

July 2023 recalls

787 recalls were announced in July 2023.

What the numbers show

Critical
65
Severe
365
High
307
Moderate
50

Of the 787 recalls this month scored against our rubric, 8% are Critical, 46% are Severe.

101–200 of 787

  • 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 F
    Category
    Food
    Distribution
    2 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-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-2212-2023·2023-07-26

    UFSK Treatment Chair 500 XLE Seat Drive Failure Risk

    The UFSK Treatment chair 500 XLE's electrical seat drive may wear unexpectedly, causing the chair to fail to hold position while the patient is seated in an inclined position. Healthcare facilities should contact the manufacturer regarding affected units.

    Product
    UFSK Treatment chair 500 XLE- Treatment chair for positioning and support of the patient during diagnostic and therapeutic treatments of temporary to short-term duration, especially in ophthalmology Art.no. / REF no.: 15000004 Art.no. / REF no.: 15000006
    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 (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 (Devices)·Z-2170-2023·2023-07-26

    Medline Ultrasound Probe Cover Kits Recalled for Inadequate Seam Barriers

    Medline is recalling probe covers used in ultrasound procedures that may have inadequate seam barriers. No illnesses have been reported.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BREAST BIOPSY KIT, Model Number DYNDA1224B; b) U/S CORE BIOPSY KIT, Model Number DYNDH1121C; c) BIOPSY PACK, Model Number DYNDH1124; d) REVAMP BIOPSY TRAY, Model Number DYNDH1147A; e
    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-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-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-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 (Food)·F-1283-2023·2023-07-26

    Gluten-Free Cheddar Party Mix Recalled for Undeclared Walnut

    Fry Daddy's Brand recalls Gluten Free Cheddar Party Mix 10oz bags due to undeclared walnut, a major allergen. The recall affects 1,624 retail units distributed in Michigan.

    Product
    Fry Daddy's Gluten Free Cheddar Party Mix 10oz bag UPC 860007669569. 12 bags per wholesale case
    Category
    Food
    Distribution
    1 state
  • 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 (Food)·F-1274-2023·2023-07-26

    Frozen Fruit Smoothie Blend Recalled Due to Listeria Risk

    Townsend Farms is recalling Private Selection frozen strawberry, mango, and pineapple smoothie blend due to potential Listeria monocytogenes contamination. The product was distributed across 16 states.

    Product
    Private Selection 16oz Strawberry, Mango & Pineapple Blend for Smoothie, frozen product, 10/16oz. bags per case. UPC 0 11110 87853 3. Distributed by The Kroger Co. Cincinnati, OH
    Category
    Food
    Distribution
    16 states
  • 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-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-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-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
  • 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-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
  • 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 (Drugs)·D-0926-2023·2023-07-26

    Succinylcholine Chloride Injectable Drug Recalled Nationwide for Manufacturing Facility Contamination Risk

    Advanced Compounding Solutions is recalling 493 syringes of succinylcholine chloride injection due to potential contamination from manufacturing facility violations affecting product sterility.

    Product
    SUCCINYLcholine Chloride 200 mg/10mL (20 mg/mL), 10 mL BD Syringe, Rx Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042; NDC: 71546-083-10
    Category
    Drug
    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, Mod
    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-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-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 (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: W
    Category
    Food
    Distribution
    1 state
  • 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-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 Number
    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-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-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 (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
  • 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-2203-2023·2023-07-26

    Medline Probe Cover Kits Recalled for Inadequate Seam Barrier

    Medline Industries is recalling 1,240 Probe Cover Kits used in diagnostic ultrasound procedures. The covers may have inadequate barriers at the seams, potentially compromising sterility during medical procedures.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: BREAST BIOPSY TRAY, Model Number SPEC0130C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1277-2023·2023-07-26

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

    Fry Daddy's Jalapeno Party Mix is recalled due to undeclared walnut allergen. Affected bags were sold in Michigan with sell-by dates from June 1 to December 31, 2023.

    Product
    Fry Daddy's Jalapeno Party Mix 3.75oz and 12oz bags UPCs 860007991516 and 850047648013. 12 bags per wholesale case
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2168-2023·2023-07-26

    Medline Probe Cover Kits Recalled for Inadequate Seam Barrier

    Medline is recalling multiple probe cover kits used in diagnostic ultrasound and vascular access procedures due to inadequate barriers at the seams. No illnesses or injuries have been reported.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) PORT PACK, Model Number DYNJ64675; b) PICC LINE TRAY, Model Number DYNJ64725B; c) VEIN OHH, Model Number DYNJ65560C; d) PORT PICC TUNNEL PACK, Model Number DYNJ65775; e) ENSEMBLE POWER P
    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-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, Mod
    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 (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 (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 ULTRASOUND
    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 (Food)·F-1282-2023·2023-07-26

    Food Manufacturer Recalls Gluten Free Jalapeno Party Mix Due to Undeclared Walnut

    Fry Daddy's Brand voluntarily recalled its Gluten Free Jalapeno Party Mix (10 oz, UPC 860007669552) distributed in Michigan due to undeclared walnut allergen. Affected product has sell-by dates from June 1 through December 31, 2023.

    Product
    Fry Daddy's Gluten Free Jalapeno Party Mix 10oz bag UPC 860007669552. 12 bags per wholesale case
    Category
    Food
    Distribution
    1 state
  • 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-2165-2023·2023-07-26

    Medline Ultrasound Probe Cover Kits Recalled for Inadequate Seams

    Medline Industries is recalling probe cover kits used in diagnostic ultrasound procedures due to inadequate barrier protection at the seams. Over 3.7 million units distributed worldwide from December 2017 through May 2023 are affected.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) EP PACER PACK, Model Number DYNJ67770A; b) EP PROCEDURE PACK, Model Number DYNJ67771; c) EP PACK, Model Number DYNJ68019; d) GWINNETT ENDOVASCULAR WSTE MGT, Model Number DYNJ68198; e) TA
    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 (Food)·F-1287-2023·2023-07-26

    Soft Cream Spread Recalled for Undeclared Milk Allergen

    Central America Products Corporation is recalling Soft Cream Spread (16oz bags, lot code 0725/23) distributed in Florida due to undeclared milk. The product was not properly labeled for milk content, posing a risk to consumers with milk allergies.

    Product
    Soft Cream Spread, Net Wt 16oz (1lb)
    Category
    Food
    Distribution
    1 state
  • 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-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 Num
    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-2207-2023·2023-07-26

    Medtronic Durepair Dura Matrix Recalled Due to Endotoxin Contamination

    Medtronic is recalling Durepair Dura Regeneration Matrix surgical implants worldwide due to potential endotoxin contamination that may cause inflammation similar to infection.

    Product
    Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; DUREPAIR DURA SUBSTITUTE 3 X 3, 61105; DUREPAIR DURA SUBSTITUTE 1 X 3, 61106; DUREPAIR DURA SUBSTITUTE 4 X 5, 61110; DUREPAIR DURA SUBSTITUTE 1 X 1, 61111; DURA 62100 SUBSTITUTE DUREPAIR 2X2IN NCE, 6
    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-2194-2023·2023-07-26

    Medline Ultrasound Probe Cover Kits Recalled for Inadequate Barrier Seals

    Medline is recalling 10,080 ultrasound probe cover kits because the seams may not seal properly, potentially compromising barrier protection. 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) VANTEX CVC BNDL, 3L 7F 16CM W MICROCLAVE, Model Number ECVC1320; b) CENTRAL VENOUS CATH INSERTION BUNDLE PI, Model Number ECVC1345A; c) TRIPLE LUMEN CVC INSERTION TRAY, Model Number ECVC149
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2178-2023·2023-07-26

    Medline Ultrasound Probe Covers Recalled for Inadequate Seam Barriers

    Medline is recalling 2,304 probe cover kits because the seams may not provide adequate barrier protection during ultrasound procedures. Affected kits were distributed worldwide from December 2017 to May 2023.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: CATH LAB BASIN PACK, Model Number DYNJ69864A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2208-2023·2023-07-26

    GEM FLOW COUPLER Monitor LCD Display Fails to Show Correct Active Channel

    Baxter Healthcare is recalling the GEM FLOW COUPLER Monitor due to an LCD display error that may fail to indicate the correct active channel when powered on using battery power. This could lead to incorrect channel selection during use.

    Product
    GEM FLOW COUPLER Monitor, PN 5156-00000-011
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2188-2023·2023-07-26

    Medline Ultrasound Probe Cover Kits Recalled for Inadequate Seam Barriers

    Medline Industries is recalling ultrasound probe cover kits due to inadequate barriers at the seams. The defect may allow contaminants to reach the patient during diagnostic ultrasound procedures.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: CHN OR DAVINCI PROSTATE, Model Number DYNJ902540N
    Category
    Medical Device
    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-2162-2023·2023-07-26

    Medline Ultrasound Probe Cover Kits Recalled for Inadequate Seam Barrier

    Medline is recalling ultrasound probe cover kits due to inadequate barrier protection at the seams, which may allow contamination during diagnostic procedures. The recall affects multiple model numbers distributed worldwide from December 2017 through May 2023.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATH PACK, Model Number DYNJ83105; b) TESIO, Model Number DYNJ83251; c) ANGIOGRAPHY PACK-LF, Model Number DYNJ83508; d) OR ANGIOGRAM PACK-LF, Model Number DYNJ83656; e) FERRELL-DUCAN ANG
    Category
    Medical Device
    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 (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 (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-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·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
  • 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
  • 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·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·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
  • 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·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·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·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
  • 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 (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-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 (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. Schn
    Category
    Food
    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-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
  • SevereFDA (Food)·F-1248-2023·2023-07-19

    Fromagerie Ottavi Tome Corse Sheep Milk Cheese Recalled for Listeria

    FMA International LLC is recalling Fromagerie Ottavi Tome Corse Sheep Milk Cheese due to Listeria monocytogenes contamination. The product was distributed in Oregon.

    Product
    Fromagerie Ottavi Tome Corse Sheep Milk Cheese
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0919-2023·2023-07-19

    EzriCare Artificial Tears Eye Drops Recalled for Bacterial Contamination

    EzriCare Artificial Tears eye drops are being recalled nationwide due to bacterial contamination found in unopened bottles. The FDA identified non-sterile products that could pose a risk to eye health.

    Product
    Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1/2 fl oz (15 ml) bottle, Distributed by. EzriCare, LLC, Lakewood, NJ, NDC 79503-0101-15.
    Category
    Drug
    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 P
    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 (Food)·F-1233-2023·2023-07-19

    Walmart Great Value Mixed Fruit Recalled for Potential Hepatitis A Contamination

    Walmart is recalling Great Value Mixed Fruit due to potential Hepatitis A contamination. The frozen product was distributed across 33 states; consumers should not consume it.

    Product
    Great Value Mixed Fruit Pineapple, Strawberries, Peaches and Mango. Item # 107355. Frozen, packed into flexible plastic bags. Net wt. 4lbs (64oz). UPC on retail bag: 0 78742 12423 0. A total of 6 sellable units (4lbs. each) are placed into a case for distribution to retailer.
    Category
    Food
    Distribution
    32 states
  • SevereFDA (Food)·F-1231-2023·2023-07-19

    Frozen strawberries recalled for potential Hepatitis A contamination

    Wawona Frozen Foods recalls Organic Daybreak Blend frozen strawberries sold at Costco due to potential Hepatitis A. Approximately 9,878 cases were distributed to Costco locations in five western states with lot codes dated through October 2023.

    Product
    Organic Daybreak Blend Brand Name: Wawona Frozen Foods 4 lb. plastic bags - 10 bags per case Keep Frozen Item# 684779 UPC: 0 34742 07244 5 Sold by Costco
    Category
    Food
    Distribution
    5 states
  • 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
  • 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
  • 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 VTD TRAILER, MAXCUBE, VSD TRAILER, VIP 4000
    Category
    Vehicle
    Distribution
    Distributed nationwide

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