January 2023 recalls

460 recalls were announced in January 2023.

What the numbers show

Critical: 4
Severe: 47
High: 306
Moderate: 103

Of the 460 recalls this month scored against our rubric, 1% are Critical, 10% are Severe.

Which agencies issued them

201–300 of 460

HighFDA (Drugs)·D-0116-2023·2023-01-18
TriMix Injection Recalled Due to Lack of Sterility Assurance
Northern VA Compounders is recalling TriMix Injection due to lack of sterility assurance. The compounded injectable medication may not meet required sterility standards.
Product
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 100mcg/30mg/3mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0254-2023·2023-01-18
Martinelli's Gold Medal Apple Juice Recalled for Elevated Patulin Levels
S Martinelli & Company is recalling Martinelli's Gold Medal Apple Juice due to elevated patulin levels detected during product testing. Distribution was limited to California, Texas, New York, Washington, Utah, Georgia, Oregon, and Arizona.
Product
Martinelli's Gold Medal Apple Juice 1 liter (33.8 oz.) glass bottle UPC: 4124400102 6 Bottles per bundled shrink-wrapped pack/case.
Category
Food
Distribution
8 states
HighFDA (Devices)·Z-0915-2023·2023-01-18
Medtronic Vanta/Seqenita LT Neurostimulation Programmer Software Anomalies Recalled
Medtronic recalls the Vanta/Seqenita LT Clinician Programmer Application due to software anomalies generating error messages that may affect device operation. The recall affects 22 units distributed worldwide.
Product
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900E
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0954-2023·2023-01-18
Orthopedic Implant Cage Recalled for Incorrect Internal Material
Specific lots of CoreLink FLXFIT 15 orthopedic implant cages contain stainless steel internal components instead of the specified titanium alloy. The 18 affected units were distributed nationwide.
Product
CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0123-2023·2023-01-18
TriMix Plus 002 Injectable Medication Recalled for Sterility Concerns
FDA is recalling TriMix Plus 002, a compounded injectable medication, due to lack of assurance of sterility. The affected lot may not meet required sterility standards.
Product
TriMix Plus 002 (PGE1/Papaverine HCl/Phentolamine Mesylante) 25mcg/30mg/2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0936-2023·2023-01-18
HCT 500mL Sterile Medical Bags Recalled for Potential Pinhole Leaks
Stradis Healthcare is recalling HCT 500mL sterile medical bags due to potential pinhole leaks near the seal that could compromise sterility. The recall affects 644 units distributed across nine U.S. states.
Product
HCT 500mL BAGS, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0104-2023·2023-01-18
Compounded Injectable Medication Recalled Due to Lack of Sterility Assurance
Northern VA Compounders PLLC is recalling QuadMix Standard 002 injectable medication because sterility of one lot cannot be assured. The recall affects 12 vials distributed nationwide.
Product
QuadMix Standard 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/2mg/0.2MG/ML INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0124-2023·2023-01-18
Compounded Injectable Medication Recalled Due to Sterility Assurance Concerns
Northern VA Compounders is recalling QuadMix Injectable due to lack of assurance of sterility. The FDA Class II recall affects compounded injectable medication distributed nationwide.
Product
QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 50mcg/40mg/4mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0262-2023·2023-01-18
Take & Toast Sourdough Waffles Recalled for Undeclared Milk and Wheat Allergens
Take & Toast Sourdough Waffles (UPC 44216-26602) distributed in Texas are being recalled because the product label does not include the common names for milk and wheat allergens. Consumers with allergies to these ingredients should not consume this product.
Product
Take & Toast Sourdough Waffles UPC 44216-26602 packaged in clear flexible plastic bag
Category
Food
Distribution
1 state
HighFDA (Drugs)·D-0106-2023·2023-01-18
Compounded TriMix Injectable Recalled for Lack of Sterility Assurance
Northern VA Compounders is recalling 750 vials of TriMix Original injectable nationwide due to lack of assurance of sterility. Patients should discontinue use and consult their healthcare provider.
Product
TriMix Original (PGE1/Papaverine HCl/Phentolamine Mesylate) 5.88mcg/18mg/0.6mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighNHTSA·23V011000·2023-01-18
Certain BMW R 1250 motorcycles recalled for gearbox input shaft defect
BMW is recalling certain 2019-2023 R1250GS, R1250GS Adventure, and R1250RT motorcycles because the gearbox input shaft may become damaged or break, possibly blocking the rear wheel and increasing crash risk.
Product
BMW — BMW R 1250 RT, R 1250 GS ADVENTURE, R 1250 GS
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0923-2023·2023-01-18
Adult Craniotome Attachment Recalled for Ball Bearing Failure Risk
The ANSPACH CRANI-A Adult Craniotome Attachment is recalled because ball bearings can separate during use or removal, creating an intra-operative hazard. The Anspach Effort, Inc. is recalling 6,059 units distributed nationwide and internationally.
Product
6.5 cm Pediatric Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-P Intended for cutting and shaping bone including the spine and cranium
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0117-2023·2023-01-18
Injectable Compounded Drug Recall Due to Lack of Sterility Assurance
Northern VA Compounders PLLC is recalling 525 vials of TriMix Plus 001 injectable medication nationwide due to lack of assurance of sterility. Patients who received this product should consult their healthcare provider.
Product
TriMix Plus 001 (PGE1/Papaverine HCl/Phentolamine Mesylate) 20mcg/30mg/2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0920-2023·2023-01-18
Large Craniotome Attachment Ball Bearings Risk Loosening During Surgery
Ball bearings in The Anspach Effort's 7.5 cm Large Craniotome Attachment may come loose during removal or surgery, potentially causing serious patient injury. 6,059 units are affected worldwide.
Product
7.5 cm Large Craniotome Attachment Use with XMax¿, microMax, and eMax¿ Systems. Ref: CRANI-L Intended for cutting and shaping bone including the spine and cranium
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0119-2023·2023-01-18
Methylcobalamin Injection Recalled Due to Lack of Sterility Assurance
Northern VA Compounders PLLC is recalling Methylcobalamin Injection Solution (12.5mg/ml, 2 mL vials) due to lack of assurance of sterility. The affected lot was distributed nationwide.
Product
Methylcobalamin Injection Solution, 12.5mg/ml, packaged in 2 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0914-2023·2023-01-18
Medtronic Vanta Seqenita LT Neurostimulation Device Recalled for Software Anomalies
Medtronic is recalling 1,337 Vanta Seqenita LT neurostimulation programmer units worldwide due to software anomalies that generate specific error messages in the clinician application.
Product
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900D
Category
Medical Device
Distribution
0 states
HighFDA (Food)·F-0246-2023·2023-01-18
True Goodness Yogurt Alternative Recalled for Almond-Based Mislabeling
Meijer is recalling 1,590 tubs of True Goodness Yogurt Alternative because the product contains almond but is mislabeled as oat-based. This poses a risk to consumers with tree nut allergies.
Product
True Goodness by Meijer Oat-Based Plain Yogurt Alternative, 24oz plastic tub, UPC: 7-13733-03918-5
Category
Food
Distribution
6 states
HighFDA (Devices)·Z-0953-2023·2023-01-18
Medtronic RadiaLux Lighted Retractor recalled for defective sterile pouch seal
Medtronic is recalling 2,317 RadiaLux Lighted Retractor units due to defects in the sterile pouch seal that increase contamination risk and potential post-operative infection.
Product
RadiaLux Lighted Retractor (Pink), REF: 50-101-1
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0228-2023·2023-01-18
TOHATO Nagewa Snack Products Recalled for Undeclared Milk Allergen
TOHATO Nagewa Snack Salty Taste products are recalled for containing undeclared milk allergen (sodium caseinate). The recall affects 11,989 units distributed to Daiso stores in California, Washington, Nevada, Texas, New York, New Jersey, and Canada.
Product
TOHATO Nagewa Snack Salty Taste 27g and 73g units UPC numbers: 4901940112036 & 4901940112005 Product sold individually, shipped 12 units per case Exported by: DAISO INDUSTRIES CO., LTD. 1-4-14 Saljo-Yoshiyukihigashi, Higashihiroshima-City, Hiroshima 739-8501 JAPAN
Category
Food
Distribution
6 states
HighFDA (Food)·F-0255-2023·2023-01-18
Beijing Hawthorne Candy Recalled Due to Undeclared Sulfites
Northern Food I/E Inc. is recalling Beijing Hawthorne Candy due to undeclared sulfites. The product contains 7.32 mg sulfites per serving and has been distributed to 24 states.
Product
Beijing Hawthorne Candy
Category
Food
Distribution
24 states
HighFDA (Drugs)·D-0113-2023·2023-01-18
TriMix Injection Recall Due to Lack of Sterility Assurance
Northern VA Compounders PLLC is recalling TriMix Injection nationwide due to lack of assurance of sterility. The affected compounded injectable product comes in 2.5 mL vials with lot number 11142022@12.
Product
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 30mcg/60mg/2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0102-2023·2023-01-18
Mitomycin Injection Solution Recalled Due to Lack of Sterility Assurance
Mitomycin Injection Solution manufactured by Northern VA Compounders PLLC is being recalled because sterility cannot be assured. Patients receiving this product should contact their healthcare provider.
Product
Mitomycin Injection Solution, 4mg/ml, packaged in a 10 mL Multiple-Dose vial, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0251-2023·2023-01-18
Sanders Milk Chocolate Sea Salt Pecan Cluster Recalled for Brush Bristles
Sanders Candy LLC recalls Sanders Milk Chocolate Sea Salt Pecan Cluster due to foreign material—pieces of cleaning brush bristles—found in the product. The recall affects nearly 1 million units distributed nationwide and in Canada.
Product
Sanders Milk Chocolate Sea Salt Pecan Cluster: 0-35900-25550-2 .5OZ Individual Wrapped 0-35900-27486-2 25OZ Tub 0-35900-30971-7 18OZ Tub 0-35900-30170-4 7OZ Pouch
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-0253-2023·2023-01-18
Sanders Dark Chocolate Maple Sea Salt Caramel Recalled for Foreign Material
Sanders Candy LLC is recalling Sanders Dark Chocolate Maple Sea Salt Caramel due to brush bristles found in the product. Consumers should not consume affected units.
Product
Sanders Dark Chocolate Maple Sea Salt Caramel: No UPC 6oz. foil bag
Category
Food
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0098-2023·2023-01-18
Rifampin Capsules Recalled Due to Failed Quality Specifications
RemedyRepack Inc. is recalling Rifampin Capsules, 300 mg, due to failed impurities and degradation specifications. The affected product was distributed to a single pharmacy account in Pennsylvania.
Product
Rifampin Capsules, 300 mg, 30 count blister card, Rx only, Mfg: Lupin Pharma, Baltimore, MD 21202, original NDC 68180-0659-07, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, Repackaged NDC 70518-2404-00.
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0126-2023·2023-01-18
TriMix Injection Recalled Due to Lack of Sterility Assurance
Northern VA Compounders is recalling TriMix Injection due to inability to assure the product meets sterility standards required for injectable medications. The recall affects 2 vials distributed nationwide.
Product
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 10mcg/20mg/1mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0933-2023·2023-01-18
Cystoscopy kits recalled for potential sterility breach from packaging defects
Henry Shein CYSTO SET UP PACK units are being recalled due to potential pinhole leaks in the outer bag that could compromise the sterility of the kit.
Product
Henry Shein CYSTO SET UP PACK, 20 per case. Distributed by Henry Schein.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0921-2023·2023-01-18
Adult Craniotome Ball Bearing Separation Risk During Neurosurgery
The Anspach Adult Craniotome Large attachment ball bearings may separate during surgical removal or intra-operatively, potentially causing serious patient injury.
Product
Adult Craniotome, Large Ref: CRANI-L-G1 Intended for cutting and shaping bone including the spine and cranium
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0942-2023·2023-01-18
Stradis Healthcare Neonatal PICC Trays recalled for potential sterility breach
Stradis Healthcare is recalling 2,500 units of Neonatal PICC Trays due to potential pinhole leaks in the outer bag that could compromise sterility. The affected trays were distributed nationwide.
Product
Stradis Healthcare NEONATAL PICC Tray *PGBK* 20 trays per case. Manufactured by Stradis Healthcare, Distributed by Med Alliance Group
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0939-2023·2023-01-18
HCT 6 CC Syringe Kits recalled for potential sterility breach from packaging leaks
Stradis Healthcare recalls 76,260 HCT 6 CC Syringe Kits due to potential pinhole leaks in outer packaging that may compromise sterility. The kits were distributed nationwide.
Product
HCT 6 CC SYRINGE KIT, 25/TRAY, 4 TRAYS/BAG, 5 BAGS/CASE. Distributed by Health Care Technology.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0121-2023·2023-01-18
TriMix Injection Recalled Nationwide for Lack of Sterility Assurance
Northern VA Compounders recalls TriMix Injectable due to lack of sterility assurance in 8 vials distributed nationwide. Patients should consult their healthcare provider about affected doses.
Product
TriMix Injection (PGE1/Papaverine HCl/Phentolamine) 100mcg/30mg/2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0252-2023·2023-01-18
Sanders Dark Chocolate Peppermint Recalled for Cleaning Brush Bristles
Sanders Dark Chocolate Peppermint Sea Salt Caramel is recalled nationwide and in Canada due to contamination with cleaning brush bristles. Products with Best By dates from October and December 2023 are affected.
Product
Sanders Dark Chocolate Peppermint Sea Salt Caramel: UPC 0-35900-30857-4 18OZ Tub UPC 0-35900-30919-9 32OZ Tub
Category
Food
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0100-2023·2023-01-18
Prescription Rifampin Capsules Recalled for Failed Impurity Specifications
Lupin Pharmaceuticals is recalling Rifampin Capsules (300 mg) nationwide due to failed impurity and degradation specifications found during stability testing. Lot A200171 (exp. 12/2023) is affected, with over 16,000 bottles distributed.
Product
RIFAMPIN — RIFAMPIN (RIFAMPIN)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0257-2023·2023-01-18
Take & Bake Sourdough Biscuits recalled for unlabeled milk and wheat allergens
Hippos and Hashbrowns is recalling Take & Bake Sourdough Biscuits (UPC 44216-26512) because the label does not declare milk and wheat allergens. Consumers with these allergies should not consume this product.
Product
Take & Bake Sourdough Biscuits UPC 44216-26512 packaged in metal tin with clear plastic nonflexible lid
Category
Food
Distribution
1 state
HighFDA (Drugs)·D-0099-2023·2023-01-18
Rocuronium Bromide Injection Recalled for Lack of Sterility Assurance
Rocuronium Bromide Injection syringes from Nephron Sterile Compounding Center are being recalled because the manufacturer cannot verify the product is sterile. The recall affects approximately 38,830 pre-filled syringes distributed nationwide.
Product
Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), 5 x 5 mL Pre-Filled Syringe, 6 x 5 syringe carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Extension, West Columbia, SC 29172, NDC: 69374-924-05
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0256-2023·2023-01-18
Take & Bake Everything Biscuits recalled for undeclared milk and wheat allergens
Hippos and Hashbrowns is recalling Take & Bake Everything Biscuits due to missing allergen labeling for milk and wheat. The product label does not include the common names for these allergens.
Product
Take & Bake Everything Biscuits UPC 44216-26532 packaged in metal tin with clear plastic nonflexible lid
Category
Food
Distribution
1 state
HighFDA (Food)·F-0247-2023·2023-01-18
Taro Flavor Powder Recalled for Undeclared Milk and Color Additive Mislabeling
RED SUN TARO FLAVOR POWDER is recalled due to undeclared milk (sodium caseinate) and incorrect color additive labeling. The product was distributed in Iowa and may pose a risk to consumers with milk allergies.
Product
RED SUN TARO FLAVOR POWDER NET WT 1000g (2.2 LBS) packaged in PEP and aluminum foil bag
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-0952-2023·2023-01-18
Medical device software bug may cause patient sample order mismatches in rare cases
A software bug in Roche Diagnostics' cobas infinity central lab may cause orders to be mismatched to wrong patient samples under rare circumstances. The issue affects 224 US units and 2,797 devices worldwide.
Product
cobas infinity central lab, Material Number 07154003001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0944-2023·2023-01-18
Stradis Healthcare TCTR Convenience Kit recalled for potential sterility compromise
Stradis Healthcare is recalling the TCTR Convenience Kit due to potential pinhole leaks near the seal that could compromise the kit's sterility. The recall affects 80 units distributed across ten states.
Product
Stradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0910-2023·2023-01-18
Source Administration Set medical device recalled for contamination
The FDA has recalled 2,840 units of the Source Administration Set, a medical device used for PET imaging, due to contamination with black specks on needles.
Product
Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile Catalog number: INT CSS Affected material number: 86566621 Intended to deliver accurate doses of 18F Fluorodeoxyglucose (FDG) or 18F Sodium Fluoride (NaF) radiopharmaceuticals and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0120-2023·2023-01-18
Compounded QuadMix injectable recalled for sterility assurance concerns
Northern VA Compounders PLLC recalled QuadMix Injectable nationwide due to lack of assurance of sterility. Patients who received this compounded medication should contact their healthcare provider immediately.
Product
QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/20mg/2mg/0.2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0114-2023·2023-01-18
TriMix Injection Recalled Due to Sterility Assurance Failure
Northern VA Compounders is recalling TriMix Injection due to lack of assurance of sterility. The affected lot (11142022@11, exp. 12/29/2022) was distributed nationwide. No illnesses have been reported.
Product
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 40mcg/30mg/2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0937-2023·2023-01-18
Sterile EVA Medical Bags Recalled Due to Pinhole Leak Risk
Stradis Healthcare recalls HCT 50mL sterile EVA bags due to potential pinhole leaks near the seal that could compromise sterility. Approximately 2,779 units were distributed nationwide.
Product
HCT 50mL EVA BAGS, 2 Port, Sterile, Tripple Packaged, 20 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0916-2023·2023-01-18
Craniotome Attachment Ball Bearings May Detach During Surgery
The Anspach 6.5 cm Adult Rotating Craniotome Attachment may have ball bearings that detach during surgical use or removal. The manufacturer recommends following inspection intervals to prevent serious patient injury.
Product
6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems. Ref: CRANI-A Intended for cutting and shaping bone including the spine and cranium
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0940-2023·2023-01-18
Central Line Insertion Trays Recalled for Potential Sterility Breaches
Stradis Healthcare is recalling HCT Central Line Insertion Trays due to potential pinhole leaks in the outer bag that may compromise sterility. Approximately 1,176 units were distributed nationwide.
Product
HCT CENTRAL LINE Insertion Tray, I2 per case. Distributed by Health Care Technology
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0946-2023·2023-01-18
Tacy Medical Syringe Convenience Packs Recalled Due to Potential Sterility Loss
Tacy Medical syringe convenience packs may have pinhole leaks near the seal that compromise sterility. Affected lots 222270319 and 220834335 were distributed across 10 U.S. states.
Product
Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0949-2023·2023-01-18
IMMULITE 2000 Thyroglobulin test kits recalled for reduced analytical sensitivity
Siemens is recalling 717 IMMULITE 2000 Thyroglobulin test kits because they may not accurately measure thyroglobulin levels. Inaccurate results could affect monitoring of thyroid cancer patients.
Product
IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers (IMMULITE 2000/ IMMULITE 2000 XPi) for the quantitative measurement of thyroglobulin in serum or heparinized plasma, as an aid in monitoring patients who have undergone…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0924-2023·2023-01-18
Pediatric Craniotome Recalled for Ball Bearing Detachment Risk
The Anspach Effort, Inc. is recalling 6,059 Pediatric Craniotome units (CRANI-P-G1) because ball bearings in the CRANI-A attachment may detach during surgery, potentially causing serious patient injury.
Product
Pediatric Craniotome Ref:CRANI-P-G1
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0261-2023·2023-01-18
Take and Bake Blueberry Biscuits Recalled for Missing Allergen Labeling
Hippos and Hashbrowns is recalling Take & Bake Blueberry Biscuits due to missing common allergen names on the label. The product contains milk and wheat but the packaging does not clearly identify these allergens.
Product
Take & Bake Blueberry Biscuits no UPC packaged in metal tin with clear plastic nonflexible lid
Category
Food
Distribution
1 state
HighFDA (Drugs)·D-0111-2023·2023-01-18
FDA Recalls Prostaglandin E1 Injection for Lack of Sterility Assurance
Northern VA Compounders PLLC is recalling Prostaglandin E1 Injection Solution due to lack of sterility assurance. The recall affects 108 vials distributed nationwide.
Product
Prostaglandin (E1) Injection Solution, 25mcg/ml, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0931-2023·2023-01-18
Stradis Healthcare Foley Catheter Insertion Tray Recalled for Sterility Breach Risk
Stradis Healthcare is recalling Foley Catheter Insertion Trays due to potential pinhole leaks in the outer bag that could compromise sterility. The recall affects 920 units distributed across multiple US states.
Product
Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0918-2023·2023-01-18
Adult Craniotome Bearings May Detach During Surgical Use
Ball bearings in the Anspach Adult Craniotome attachment may detach during removal or during surgery. Failure to follow recommended inspection intervals increases the risk of serious patient injury.
Product
Adult Craniotome Ref: CRANI-A-G1 Intended for cutting and shaping bone including the spine and cranium
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0934-2023·2023-01-18
Henry Shein Sterile Gloves Recalled for Potential Sterility Breach
Stradis Healthcare is recalling Henry Shein sterile gloves due to pinhole leaks in outer packaging that may compromise sterility. The recall affects approximately 21,755 units distributed nationwide.
Product
Henry Shein GLOVES, packaged in the following sizes and descriptions: a. Glove 6.5 Pack, 25 Pairs, 10 packs per case; b. Glove 7.0 Pack, 25 Pairs, 10 packs per case; c. Glove 7.5 Pack, 25 Pairs, 10 packs per case; d. Glove 8.0 Pack, 25 Pairs, 10 packs per case…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0107-2023·2023-01-18
Injectable Drug Recall: QuadMix Standard 001 Lacks Sterility Assurance
Northern VA Compounders recalls QuadMix Standard 001 injectable vials due to lack of sterility assurance. No illnesses reported.
Product
QuadMix Standard 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/1mg/0.2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0108-2023·2023-01-18
Compounded Injectable Drug Recalled Due to Lack of Sterility Assurance
Northern VA Compounders has recalled QuadMix Super 002 injectable medication due to lack of assurance of sterility. The affected lot is distributed nationwide.
Product
QuadMix Super 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/30mg/4mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0922-2023·2023-01-18
Surgical Craniotome Attachment Ball Bearings Have Detached During Surgery
The Anspach 7.5 cm Large Rotating Craniotome Attachment ball bearings have come out during surgery or device removal. Failure to follow proper inspection intervals may result in serious patient injury.
Product
7.5 cm Large Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-L-R Intended for cutting and shaping bone including the spine and cranium
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0913-2023·2023-01-18
Medtronic Neurostimulation Programmer Software Errors Affect 18 Devices
Medtronic is recalling 18 units of its Vanta/Seqenita LT Clinician Programmer Application due to software anomalies causing error messages that may prevent proper operation.
Product
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900C
Category
Medical Device
Distribution
0 states
HighFDA (Drugs)·D-0110-2023·2023-01-18
Prostaglandin Injectable Recalled Nationwide Due to Sterility Assurance Concerns
Northern VA Compounders PLLC is recalling a compounded Prostaglandin (E1) Injection due to lack of sterility assurance. Patients should consult their healthcare provider immediately.
Product
Prostaglandin (E1) Injection Solution, 20 mcg/ml, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0947-2023·2023-01-18
Stradis Healthcare Recalls Sterile Port Access Tray Kits for Potential Sterility Breach
Stradis Healthcare is recalling 600 units of Tacy Medical sterile port access trays due to potential pinhole leaks in the outer packaging that could compromise sterility.
Product
Tacy Medical, Inc PORT ACCESS TRAY, Sterile, QTY 20. Manufactured for Tracy Medical, Inc.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0928-2023·2023-01-18
BD Pyxis MedBank System may dispense wrong medication due to software error
The BD Pyxis MedBank medication dispensing system has a software error that may cause the wrong medication to be loaded in a drawer compared to what the label shows, risking patient harm.
Product
BD Pyxis MedBank System - Product Label/labeling pending
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0907-2023·2023-01-18
VENTANA PD-L1 (SP142) Assay kits recalled for light staining causing false-negative results
Ventana Medical Systems recalled 8,927 VENTANA PD-L1 (SP142) Assay kits worldwide due to light staining that can cause false-negative immunotherapy marker test results affecting cancer treatment decisions.
Product
VENTANA PD-L1 (SP142) VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 07709374001 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 08008540001 VENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical) 07011571001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0911-2023·2023-01-18
Neurostimulation Clinician Programmer Software Anomalies Affecting Device Control
Medtronic Neuromodulation is recalling 440 units of the Vanta/Seqenita LT Clinician Programmer Application due to software anomalies causing error messages that interfere with device control. Affected units were distributed worldwide.
Product
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900A
Category
Medical Device
Distribution
0 states
HighFDA (Drugs)·D-0105-2023·2023-01-18
Injectable drug recalled due to lack of sterility assurance
Northern VA Compounders PLLC recalls compounded injectable QuadMix Super 001 (56 vials) nationwide due to lack of assurance of sterility. Affected lot #11162022@7, expiration 12/31/2022.
Product
QuadMix Super 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/30mg/2mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0250-2023·2023-01-18
Sanders Milk Chocolate Sea Salt Caramels Recalled for Foreign Material
Sanders Candy LLC is recalling Sanders Milk Chocolate Sea Salt Caramels due to potential cleaning brush bristles contamination. The product poses a choking and injury hazard.
Product
Sanders Milk Chocolate Sea Salt Caramels: UPC 0-35900-27636-1 36OZ Tub UPC 0-35900-25551-9 .5OZ Individual Wrapped UPC 0-35900-27436-7 28OZ Tub UPC 0-35900-27636-1 2 pack 36OZ Tub UPC 0-35900-30781-2 6OZ Pouch UPC 0-35900-30970-0 18OZ Tub UPC 0-35900-30986-1 18OZ Tub UPC…
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0951-2023·2023-01-18
FDA Recalls BIOSTOP G Cement Restrictor Due to Elevated Endotoxin Levels
DePuy Ireland is recalling all lots of BIOSTOP G Bioresorbable Cement Restrictor because endotoxin levels exceeded FDA regulatory guidance. Endotoxins can cause inflammatory responses, from mild fever to potential organ damage.
Product
BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR Catalog Numbers: 546308000 (Size 8); 546310000 (Size 10); 546312000 (Size 12); 546314000 (Size 14); 546316000 (Size 16); 546318000 (Size 18); 546320000 (Size 20)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0225-2023·2023-01-18
Smoked Nova Salmon Recalled for Possible Pathogen and Toxin Formation
ACME Smoked Nova Salmon products from Lidl are being recalled due to possible pathogen growth and toxin formation. Affected products should not be consumed.
Product
ACME Smoked Nova Salmon Net Wt. 4 OZ (113G) UPC: 23384104065
Category
Food
Distribution
10 states
HighFDA (Devices)·Z-0948-2023·2023-01-18
Neonatal PICC Tray Recalled Due to Potential Sterility Breach
Vital Care Products' Neonatal PICC Tray kits may have pinhole leaks in the outer bag near the seal, potentially compromising sterility. Affected units were distributed nationwide.
Product
Vital Care Products NEONATAL PICC TRAY, Sterile, QTY 20. Manufactured for Vital Care Products, Inc.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0938-2023·2023-01-18
Syringe Kit Recall: Potential Sterility Breach from Outer Bag Leaks
Stradis Healthcare is recalling HCT 12 CC Syringe Kits due to potential pinhole leaks in the outer bag that could compromise sterility. The recall affects 112,675 units distributed nationwide.
Product
HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care Technology.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0226-2023·2023-01-18
Smoked salmon recalled for possible pathogen growth and toxin formation
ACME Everything Bagel Smoked Salmon products are being recalled due to possible pathogen growth and toxin formation. The recall involves 11,391 units distributed to stores across multiple states.
Product
ACME Everything Bagel Smoked Salmon Net Wt. 4 OZ (113G) UPC:2338410420
Category
Food
Distribution
10 states
HighFDA (Devices)·Z-0927-2023·2023-01-18
DeRoyal surgical procedure pack recalled for sterile barrier defect
DeRoyal is recalling certain surgical procedure packs containing Medtronic non-absorbable sutures due to a manufacturing error that may breach the sterile barrier protecting the surgical field.
Product
DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0950-2023·2023-01-18
IMMULITE 2000 Thyroglobulin Diagnostic Kit Accuracy Issues
Siemens is recalling 7,543 kits of IMMULITE 2000 Thyroglobulin diagnostic tests due to potential accuracy and precision issues affecting diagnostic reliability.
Product
IMMULITE 2000 Thyroglobulin (OUS). For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitative measurement of thyroglobulin in serum or heparinized plasma, as an aid in monitoring patients who have undergone thyroidectomy. Catalog # Catalog #…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0103-2023·2023-01-18
QuadMix Plus Injectable Medication Recalled for Lack of Sterility Assurance
Northern VA Compounders is recalling QuadMix Plus injectable medication due to lack of assurance of sterility. The recall affects 78 vials distributed nationwide.
Product
QuadMix Plus (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/30mg/2mg/0.2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0941-2023·2023-01-18
HCT MAX BARRIER PICC Insertion Tray Recalled for Potential Sterility Breach
Stradis Healthcare is recalling HCT MAX BARRIER PICC Insertion Trays due to potential pinhole leaks in the outer bag that may compromise sterility. No illnesses have been reported, but affected healthcare facilities should immediately discontinue use of the affected lot.
Product
HCT MAX BARRIER PICC INSERTION TRAY 12 per case. Distributed by Health Care Technology
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0909-2023·2023-01-18
Codman Surgical Patties Recalled for Out-of-Specification Endotoxin Levels
Integra LifeSciences is recalling one lot of Codman Surgical Patties due to out-of-specification endotoxin levels. The potential risk is a minor, transient fever.
Product
Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0242-2023·2023-01-18
Simply Nature Organic Spring Mix Recalled for Wash Chemical Contamination
Dole Fresh Vegetables Inc is recalling Simply Nature Organic Spring Mix (16 oz, UPC 4099100088632) because foam detergent was incorrectly added to wash systems during processing.
Product
Simply Nature Organic Spring Mix Mix of Baby Lettuces, Greens & Radicchio Thoroughly Washed No Preservatives Keep Refrigerated NET WT 16 OZ (454g) UPC 4099100088632
Category
Food
Distribution
12 states
ModerateFDA (Food)·F-0231-2023·2023-01-18
Dole Chopped Salad Kit Recalled for Incorrect Chemical Used in Vegetable Washing
Dole Fresh Vegetables is recalling certain Dole Chopped Kit Bacon & Bleu salads (6,451 cases) because foam detergent was mistakenly added during vegetable washing instead of the correct chemical.
Product
Dole Chopped Kit Bacon & Bleu Green Cabbage, Green Leaf Lettuce, Carrots, Bleu Cheese Dressing, Bacon Crumbles, Green Onions, Red Cabbage, with Kale Thoroughly Washed Perishable/Keep Refrigerated Salad & Toppings NET WT: 8.7 OZ (248 g) Dressing NET: 3.0 FL OZ (87 mL) Total NET…
Category
Food
Distribution
12 states
ModerateFDA (Food)·F-0240-2023·2023-01-18
Salad Kits Recalled Due to Incorrect Chemical in Wash Systems
Dole Fresh Vegetables is recalling Little Salad Bar and Peak Harvest Asian Chopped Salad Kits because foam detergent was incorrectly added to wash systems. No illnesses have been reported.
Product
Little Salad Bar Asian Chopped Salad Kit Green Cabbage, Green Leaf Lettuce, Kale, Red Cabbage, Carrots, Green Onion, Wonton Strips, Asian Sesame Dressing Sliced Almonds Salad & Toppings NET WT 9.5 OZ (269g) Dressing NET 2.2 FL OZ (66mL) Keep Refrigerated Perishable UPC…
Category
Food
Distribution
12 states
ModerateFDA (Food)·F-0238-2023·2023-01-18
Dole Salad Kit Recalled for Incorrect Chemical in Wash Process
Dole Fresh Vegetables is recalling Dole Premium Kit Southwest Salad packages distributed to 12 states due to incorrect foam detergent being used in the vegetable wash system instead of the proper chemical.
Product
Dole Premium Kit Southwest Salad Iceberg Lettuce, Green Leaf Lettuce, Tortilla Strips, Taco Ranch Dressing, White Cheddar, Red Cabbage, Radishes, Carrots Thoroughly Washed Perishable/Keep Refrigerated Salad & Toppings NET WT: 10.6 OZ (301 g) Dressing NET: 2.2 FL OZ (86 mL) Total…
Category
Food
Distribution
12 states
ModerateFDA (Food)·F-0244-2023·2023-01-18
Marketside Avocado Ranch Salad Kit Recalled for Washing Chemical Residue
Dole Fresh Vegetables is recalling Marketside Avocado Ranch Chopped Salad Kit due to an incorrect chemical used in the washing process. The product may contain foam detergent residue.
Product
Marketside Avocado Ranch Chopped Salad Kit Cabbage Blend, Four Cheese Blend, Blue Corn Tortilla Strips with Avocado Ranch Dressing Thoroughly Washed Perishable/Keep Refrigerated Salad & Toppings NET WT 10.3 OZ (292g) Dressing 1.94 FL OZ (57mL) UPC 681131305136
Category
Food
Distribution
12 states
ModerateFDA (Food)·F-0241-2023·2023-01-18
Peak Harvest salad kits recalled due to incorrect washing chemical
Peak Harvest salad kits are being recalled because an incorrect foam detergent was used during the vegetable washing process. The recall affects products distributed across 12 U.S. states.
Product
Peak Harvest by Lidl Bacon Sunflower Crunch Chopped Salad Kit green cabbage, green leaf lettuce, kale, red cabbage, carrots, green onion, sunflower seeds, bacon with dressing Perishable Keep Refrigerated NET WT 12.2 OZ (346g) Salad & Toppings 9.5 OZ (269g) Dressing 2.4 FL OZ…
Category
Food
Distribution
12 states
ModerateFDA (Food)·F-0234-2023·2023-01-18
Dole Coleslaw Products Recalled Due to Incorrect Chemical in Wash Systems
Dole coleslaw products distributed across 12 U.S. states were recalled due to incorrect foam detergent chemical added to vegetable wash systems during processing.
Product
Dole Diced Southern Slaw Green Cabbage, Carrots Preservative Free Thoroughly Washed Perishable/Keep Refrigerated NET WT 14 OZ (397 g) UPC 7143001036 Also Classic Coleslaw under Little Salad Bar NET WT 14 OZ (397g) UPC 4099100154887 Also Classic Coleslaw under Peak Harvest by…
Category
Food
Distribution
12 states
ModerateFDA (Food)·F-0236-2023·2023-01-18
Dole Salad Blends Butter Lettuce Recalled for Incorrect Chemical in Wash System
Dole Fresh Vegetables Inc is recalling Salad Blends Butter Lettuce because foam detergent was inadvertently added to the wash system. No illnesses have been reported.
Product
Salad Blends Butter Lettuce butter lettuce and leaf lettuce Packaged By: Dole Exclusively Thoroughly Washed Ready To Eat Perishable Keep Refrigerated NET WT 7 OZ (198 g) UPC 68826721143
Category
Food
Distribution
12 states
ModerateFDA (Food)·F-0243-2023·2023-01-18
Peak Harvest Bacon Avocado Ranch Salad Kit Recalled for Chemical Contamination
Dole Fresh Vegetables Inc is recalling Peak Harvest by Lidl Bacon Avocado Ranch Chopped Salad Kits due to incorrect chemical use in the washing process. Foam detergent was used instead of the proper washing chemical.
Product
Peak Harvest by Lidl Bacon Avocado Ranch Chopped Salad Kit Green cabbage, green leaf lettuce, kale, red cabbage, carrots, green onion, shredded cheddar cheese, corn, bacon with avocado ranch dressing Thoroughly Washed Perishable/Keep Refrigerated NET WT 11.3 OZ (320g) Salad &…
Category
Food
Distribution
12 states
ModerateFDA (Food)·F-0230-2023·2023-01-18
Dole Very Veggie Salad Mix Recalled for Incorrect Wash Chemical
Dole Very Veggie salad mix is being recalled because foam detergent (an incorrect chemical) was used in vegetable wash systems, causing excessive foaming. The recall affects 6,451 cases distributed to twelve US states.
Product
Dole Very Veggie Green Leaf Lettuce, Iceberg Lettuce, Carrots, Red Cabbage, Pea Pods, Radishes Preservative Free Thoroughly Washed Perishable/Keep Refrigerated NET WT 10 OZ (283 g) UPC 7143001008
Category
Food
Distribution
12 states
ModerateFDA (Food)·F-0237-2023·2023-01-18
Dole Chopped Kit Salad Recalled Due to Chemical Contamination
Dole Fresh Vegetables is recalling Dole Chopped Kit Buffalo Ranch salads because foam detergent was incorrectly added to the wash system during production. No illnesses have been reported.
Product
Dole Chopped Kit Buffalo Ranch Green Cabbage, Green Leaf Lettuce, Kale, Carrots, Red Cabbage, Green Onions, Blue Cheese Crumbles, Fried Onions, Buffalo Ranch Dressing Thoroughly Washed Perishable/Keep Refrigerated Salad & Toppings NET WT: 9.6 OZ (272 g) Dressing NET: 2.4 FL OZ…
Category
Food
Distribution
12 states
ModerateFDA (Food)·F-0245-2023·2023-01-18
Salad kit recall due to incorrect chemical used in wash systems
Dole Fresh Vegetables is recalling Marketside Southwest Chopped Salad Kit and Little Salad Bar Blend products due to incorrect foam detergent being added to vegetable wash systems.
Product
Marketside Southwest Chopped Salad Kit Green Cabbage, Green Leaf Lettuce, Kale, Red Cabbage, Carrots, Green Onions, Tortilla Strips, Cheddar Cheese and Chipotle Dressing Perishable/Keep Refrigerated Salad & Toppings NET WT 10.3 OZ (293g) Dressing 3 FL OZ (89mL) UPC 681131305129…
Category
Food
Distribution
12 states
ModerateFDA (Devices)·Z-0955-2023·2023-01-18
COVIDIEN Emprint Ablation Catheter recalled for incorrect expiration date
COVIDIEN Emprint Ablation Catheters (Lot 520200) are recalled because they are labeled with an incorrect expiration date. The 21 affected units were distributed to Hong Kong.
Product
COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1
Category
Medical Device
Distribution
0 states
ModerateFDA (Drugs)·D-0101-2023·2023-01-18
Moxifloxacin Ophthalmic Solution Recalled Due to Manufacturing Quality Deviation
Direct Rx recalled 11 bottles of Moxifloxacin Ophthalmic Solution (0.5%, 3 mL) due to a cGMP deviation and discontinued stability support.
Product
Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL, Rx Only, Packaged and Distributed By: Direct Rx, LLC 94 Worldwide Drive, Dawsonville, GA 30534, NDC 72189-0334-05
Category
Drug
Distribution
1 state
ModerateFDA (Food)·F-0233-2023·2023-01-18
Dole Chopped Kit Salad Recalled for Foam Detergent Contamination
Dole Fresh Vegetables Inc is recalling 6,451 cases of Dole Chopped Kit Chipotle & Cheddar salad kits because an incorrect foam detergent was added to vegetable wash systems, potentially leaving residue on the product.
Product
Dole Chopped Kit Chipotle & Cheddar Green Leaf Lettuce, Green Cabbage, Kale, Carrots, Red Cabbage, Green Onions, White Cheddar, Chipotle Ranch Dressing, Tortilla Strips Thoroughly Washed Perishable/Keep Refrigerated Salad & Topping NET WT: 9.75 OZ (276 g) Dressing NET: 2.1 FL…
Category
Food
Distribution
12 states
ModerateFDA (Food)·F-0229-2023·2023-01-18
Dole Chopped Salad Kit Recalled for Detergent Contamination
Dole Fresh Vegetables Inc is recalling Dole Chopped BBQ Ranch Salad Kit due to foam detergent accidentally added during vegetable washing. The product was distributed across 12 states in 6,451 cases.
Product
Dole Chopped Kit BBQ Ranch Green Cabbage, Green Leaf Lettuce, Kale, Carrots, Red Cabbage, Green Onions, Fried Onions, Smoky BBQ Ranch Dressing, Tortilla Strips Thoroughly Washed Perishable/Keep Refrigerated Salad & Toppings NET WT 9.5 OZ (269 g) Dressing NET: 3.1 FL OZ (93 mL)…
Category
Food
Distribution
12 states
ModerateFDA (Food)·F-0248-2023·2023-01-18
Sanders Dark Chocolate Sea Salt Caramels Recalled for Foreign Material Contamination
Sanders Candy LLC is recalling its Dark Chocolate Sea Salt Caramels because cleaning brush bristles were found in the product. The affected products were distributed nationwide and in Canada.
Product
Sanders Dark Chocolate Sea Salt Caramels: UPC 0-35900-26442-9 36OZ Tub UPC 0-35900-27488-6 28OZ Tub UPC 0-35900-26442-9 2/36OZ Tub UPC 0-35900-30167-4 7OZ Pouch UPC 0-35900-30852-9 7OZ Gift Box UPC 0-35900-30987-8 18OZ Tub UPC 0-35900-30988-5 9OZ Pouch UPC 0-35900-30969-4 18OZ…
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0232-2023·2023-01-18
Dole Chopped Kit Salad Recalled for Potential Chemical Residue from Washing Error
Dole Fresh Vegetables is recalling certain Chopped Kit salads because an incorrect foam detergent was used in the vegetable wash system. The recall affects approximately 6,451 cases distributed to 12 U.S. states.
Product
Dole Chopped Kit Avocado Ranch Green Leaf Lettuce, Green Cabbage, Red Cabbage, Kale, Carrots, Green Onions, Cheddar Cheese, Creamy Avocado Ranch Dressing, Crispy Corn Thoroughly Washed Perishable/Keep Refrigerated Salad & Toppings NET WT: 8.8 OZ (248 g) Dressing NET: 2.5 FL OZ…
Category
Food
Distribution
12 states
ModerateFDA (Food)·F-0235-2023·2023-01-18
Dole Salad Blends recalled due to chemical contamination in wash systems
Dole salad blends may contain foam detergent residue due to an error in wash systems. Affected packages bear codes N33011A or N33011B.
Product
Salad Blends American Style iceberg lettuce, green leaf lettuce, carrots, red cabbage, and radishes Packaged By Dole Exclusively Thoroughly Washed Ready To Eat Perishable Keep Refrigerated NET WT 12 OZ (340g) UPC 68826721153 Also under Peak Harvest by Lidl NET WT 12 OZ (340g)…
Category
Food
Distribution
12 states
ModerateFDA (Food)·F-0239-2023·2023-01-18
Salad Kit Recalled for Chemical Contamination in Wash System
Dole Fresh Vegetables is recalling Marketside Chopped Salad Kit because incorrect foam detergent was added to the wash system during processing. The recall affects 6,451 cases distributed to 12 U.S. states.
Product
Chopped Salad Kit Marketside Bacon Ranch Crunch Green Cabbage, Green Leaf Lettuce, Carrots, Kale, Red Cabbage, Green Onions, Taco Seasoned Shredded Cheese, Bacon and Tortilla Strips with Jalapeno Ranch Dressing Perishable Keep Refrigerated Salad & Toppings NET WT 9.8 OZ (277g)…
Category
Food
Distribution
12 states
HighNHTSA·23V010000·2023-01-17
Chrysler Pacifica Electrical Short Circuit May Cause Engine Shutdown
Chrysler is recalling certain 2017-2023 Pacifica Plug-In Hybrid vehicles due to a wiring connector short circuit that may cause unexpected engine shutdown and loss of drive power.
Product
CHRYSLER — CHRYSLER PACIFICA
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·23V007000·2023-01-16
Peterbilt 579 and Kenworth T680 electronic stability control software defect
PACCAR is recalling approximately 46 Peterbilt 579 (2022-2023) and Kenworth T680 (2023) vehicles with faulty electronic stability control software that may underestimate vehicle mass, reducing crash prevention performance. Dealers will provide a free software update.
Product
KENWORTH — KENWORTH, PETERBILT T680, 579
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·23E002000·2023-01-16
Suburban SDS2 Cooktops Recalled for Potential Gas Leak and Fire Risk
Suburban is recalling SDS2 2-Burner Drop-in Cooktops because internal aluminum burner tubes may fracture, causing a gas leak that could lead to fire.
Product
EQUIPMENT:APPLIANCE:OVEN/STOVE/COOKTOP recall
Category
Consumer Product
Distribution
Distributed nationwide
HighNHTSA·23V006000·2023-01-16
2023 Triumph Speed Triple RR Radiator Fan Overheat Recall
Triumph is recalling 2022-2023 Speed Triple RR and RS motorcycles because the radiator fan may overheat and fail, causing hot coolant to leak or spray and increasing the risk of injury and crash.
Product
TRIUMPH — TRIUMPH SPEED TRIPLE RS, SPEED TRIPLE RR
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·23V009000·2023-01-13
Lode King Prestige Semi-Trailers Recalled for Winch Weld Defect
Lode-King is recalling 2016-2023 Prestige SDE and SDF semi-trailers because improperly welded winch mounts may fail, causing cargo to fall and create road hazards.
Product
LODE KING — LODE KING PRESTIGE
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·23V008000·2023-01-13
McElrath Trailers Recall VX75 Xcel Models for Taillight and Impact Guard Defects
Gratimax is recalling 2013-2023 McElrath VX75 Xcel trailers because taillights are misplaced and the rear impact guard may fail, increasing crash and injury risks.
Product
MCELRATH TRAILERS — MCELRATH TRAILERS VX75 XCEL
Category
Vehicle
Distribution
Distributed nationwide

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