The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

12501–12525 of 53082

  • 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