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.

12476–12500 of 53081

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 (Food)·F-1268-2023·2023-07-26
Trader Joe's Organic Tropical Fruit Blend recalled for potential Listeria contamination
Trader Joe's Organic Tropical Fruit Blend frozen fruit is being recalled nationwide due to potential Listeria monocytogenes contamination affecting 2,588 cases.
Product
Trader Joe's Organic Tropical Fruit Blend, Pineapple, Bananas, Strawberries & Mango. Net Wt. 16 oz (1 lb) 454g. UPC Keep Frozen.
Category
Food
Distribution
Distributed nationwide
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