Recalls

All US Product Recalls

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

How to read this listing

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

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

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

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

17151–17175 of 27769

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-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 (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 (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-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-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 (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 (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 N
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2183-2023·2023-07-26
Medline Ultrasound Probe Cover Kits Recalled for Seam Defects
Medline is recalling ultrasound probe cover kits containing sterile ultrasound gel due to an inadequate seam barrier. The defect may compromise sterility during diagnostic ultrasound procedures.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) IV SECUREMENT KIT, Model Number DYNDV2407A; b) USG IV START KIT, Model Number DYNDV2435; c) ULTRASOUND GUIDED IV START KIT, Model Number DYNDV2518; d) VI PACK, Model Number DYNJ64871
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2164-2023·2023-07-26
Medline Ultrasound Probe Cover Kits Recalled for Inadequate Seam Barrier
Medline is recalling ultrasound probe cover kits containing sterile gel due to inadequate barriers at the seams, which may fail to maintain sterility during diagnostic procedures.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) MHC VASCULAR HYBRID PK-LF, Model Number DYNJ53433K; b) VEIN SPECIALISTS PACK, Model Number DYNJ53616A; c) SUMMIT SKIN AND VEIN PACK, Model Number DYNJ54014B; d) VEIN PACK, Model Number DY
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-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 (Devices)·Z-2197-2023·2023-07-26
Medline Probe Cover Kits recalled for inadequate barrier at seams
Medline is recalling Probe Cover Kits (Model MNS10750A) used in diagnostic ultrasound procedures because the probe covers may have an inadequate barrier at the seams, potentially affecting protective effectiveness.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: DIALYSIS ACCESSORY PACK W/O CATHETER, Model Number MNS10750A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1276-2023·2023-07-26
Fry Daddy's Original Party Mix recalled for undeclared walnut
Fry Daddy's Original Party Mix is recalled due to undeclared walnut. Approximately 10,343 retail units were distributed in Michigan with sell-by dates from June 1, 2023 through December 31, 2023.
Product
Fry Daddy's Original Party Mix 3.75oz and 12oz bags UPCs 860007991509 and 850047648006. 12 bags per wholesale case
Category
Food
Distribution
1 state
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 (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-2210-2023·2023-07-26
RET Distal Probe Recalled Due to Manufacturing Defect in DNA Sequences
FDA recalls RET Distal Probe due to manufacturing defect where DNA sequences used in production were inverted. The defect affects 61 units distributed in California, Florida, Ohio, and South Carolina and may impact diagnostic accuracy.
Product
RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-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-2171-2023·2023-07-26
Medline Ultrasound Probe Cover Kits Recalled for Inadequate Seam Barriers
Medline is recalling ultrasound probe cover kits for an inadequate barrier at the seams that could compromise sterility. The recall affects 1,130 units distributed worldwide.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: STERILE SET FOR IMPLANT-LF, Model Number OST011F
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 (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
0 states
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
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-2156-2023·2023-07-26
FDA Recalls Medline Probe Cover Kits Due to Seam Defects
Medline is recalling probe cover kits used in diagnostic ultrasound procedures. The probe covers may have an inadequate barrier at the seams, which could compromise sterility during procedures.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BLOCK PACK, Model Number DYNJ81722; b) PAIN BLOCK TRAY, Model Number DYNJRA0827A; c) PAIN PREP TRAY W/PROBE COVER, Model Number DYNJRA0881; d) PAIN PREP TRAY W/PROBE COVER, Model Numbe
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

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17151–17175 of 27769