The Recall Desk

Archive

June 2022 recalls

857 recalls were announced in June 2022.

What the numbers show

Critical
29
Severe
246
High
439
Moderate
141
Low
2

Of the 857 recalls this month scored against our rubric, 3% are Critical, 29% are Severe.

Which agencies issued them

601–700 of 857

  • HighFDA (Drugs)·D-0966-2022·2022-06-08

    Phenylephrine HCl Injection recalled for lack of sterility assurance

    Nephron Sterile Compounding Center is recalling Phenylephrine HCl Injection syringes nationwide due to lack of assurance of sterility affecting 76,860 units.

    Product
    Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Pre-Filled Syringes, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-956-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1169-2022·2022-06-08

    Epidural Tray Recalled Due to Manufacturing Validation Uncertainty

    Busse Hospital Disposables recalls approximately 425 units of its Single Shot Epidural Tray nationwide due to inadequate validation of manufacturing test methods for swab components.

    Product
    Single Shot Epidural Tray Catalog Number: 6183R1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1210-2022·2022-06-08

    Surgical Instrument Seal Defect Recall: da Vinci Energy SynchroSeal

    Intuitive Surgical recalls da Vinci Energy SynchroSeal surgical instruments due to potential seal failure. Excessive tissue in the instrument jaws can result in insufficient sealing.

    Product
    DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument 8mm, REF 480440
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0953-2022·2022-06-08

    Nephron Epinephrine Injection Recalled for Lack of Sterility Assurance

    Nephron Sterile Compounding Center is recalling 134,415 pre-filled syringes of Epinephrine Injection due to lack of assurance of sterility. Affected lots were distributed nationwide; patients and providers should contact their healthcare provider.

    Product
    Epinephrine Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-925-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1175-2022·2022-06-08

    Swab and Swabstick Drug Products Recalled for Manufacturing Validation Uncertainty

    Busse Convenience kits containing swab/swabstick drug products manufactured by Professional Disposables International are being recalled due to uncertainty about manufacturing test method validation.

    Product
    Joint Injection Tray Catalog Number: 8561R1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1154-2022·2022-06-08

    Swab and Swabstick Drug Products Recalled for Inadequate Manufacturing Validation

    Busse Convenience kits containing swab/swabstick drug products manufactured by Professional Disposables International (PDI) have been recalled due to uncertainty regarding the adequacy of manufacturing test method validation.

    Product
    Universal Tray Catalog 1567
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0961-2022·2022-06-08

    Injectable Labetalol HCl Syringes Recalled for Lack of Sterility Assurance

    Nephron Sterile Compounding Center has recalled 115,640 units of Labetalol HCl Injection due to lack of assurance of sterility. The affected product was distributed nationwide.

    Product
    Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), Preservative Free, 4 mL Pre-Filled Syringe, 5 x 4 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-946-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1205-2022·2022-06-08

    Proton Therapy System Delivers Incorrect Radiation Dose in First Layer

    The Proteus235 Proton Therapy System may deliver radiation to initial treatment fields with incorrect scanning magnet settings. The radiation field may be smaller than expected and may deliver higher dose than prescribed.

    Product
    Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0962-2022·2022-06-08

    Lidocaine Injectable Recalled Due to Sterility Assurance Failure

    Nephron Sterile Compounding Center recalled Lidocaine HCl Injection due to lack of sterility assurance. The recalled lot affects 65,590 pre-filled syringes distributed nationwide.

    Product
    Lidocaine HCl Injection, USP, 2%, 100 mg/5 mL (20 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-FIlled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-949-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0952-2022·2022-06-08

    EPINEPHrine Pre-filled Syringes Recalled for Sterility Assurance Issue

    Nephron Sterile Compounding Center is recalling 35,850 pre-filled syringes of EPINEPHrine Injection due to lack of sterility assurance. The affected syringes were distributed nationwide.

    Product
    EPINEPHrine Injection, USP, 0.1 mg/10 mL (10 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-544-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1091-2022·2022-06-08

    Potato and Cheese Pierogi Recalled for Undeclared Milk and Wheat

    Dymski Pierogi LLC is recalling potato and cheese pierogi products due to undeclared milk and wheat allergens. Affected products were distributed to retail stores, restaurants, and distribution centers in NJ, MA, and PA.

    Product
    Potato and Cheese Pierogi Grandma s Cuisine Potato-Cheese Pierogi UPC: 7 1375737813 0 & 8 67355 0030 3lb/3 dozen & 14oz (397g)/1dozen Bernat s Potato & Cheese 16oz (450g) Golden Eagle Potato and Cheese Pierogis UPC: 0 94922 10425 0 16oz Zuzanna s Potato-Cheese Pierogi 16 oz.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Drugs)·D-0969-2022·2022-06-08

    Succinylcholine Chloride Injection Recalled Due to Lack of Sterility Assurance

    Nephron Sterile Compounding Center LLC is recalling succinylcholine chloride injection due to lack of sterility assurance. The recall involves 181,560 pre-filled syringes distributed nationwide.

    Product
    Succinylcholine Chloride Injection, USP, 100 mg/5 mL (20 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-920-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1167-2022·2022-06-08

    Busse Nerve Block Tray Swabs Recalled for Test Method Validation Uncertainty

    Busse Hospital Disposables is recalling Nerve Block Tray kits containing swab drug products due to uncertainty regarding adequate validation of test methods during manufacturing. The recall involves 250 units distributed nationwide.

    Product
    Nerve Block Tray Catalog Number: 3764R2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1208-2022·2022-06-08

    Bio-Rad Sickle Cell Testing Software CD-ROM Defect Overwrites Custom Settings

    Bio-Rad is recalling Resin Update CD-ROM software (Model 250-3020) for the VARIANT nbs Sickle Cell Program because the update procedure overwrites custom laboratory settings, potentially causing incorrect pattern assignment in tested samples.

    Product
    Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000
    Category
    Medical Device
    Distribution
    24 states
  • HighFDA (Drugs)·D-0973-2022·2022-06-08

    Losartan Potassium Tablets Recalled for Elevated AZIDO Impurity Levels

    Strides Pharma Inc. is recalling Losartan Potassium 50 mg tablets distributed nationwide due to AZIDO impurity levels exceeding acceptable FDA manufacturing standards.

    Product
    LOSARTAN POTASSIUM — LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·22V402000·2022-06-08

    Keystone Coachworks Recalls 2020-2021 Mercedes Metris Vans for Gas Leak Risk

    Keystone Coachworks is recalling 2020-2021 Mercedes-Benz Metris Custom Camper Vans because damaged burner control valves may cause a gas leak, increasing fire risk.

    Product
    KEYSTONE COACHWORKS — KEYSTONE COACHWORKS MERCEDES METRIS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0967-2022·2022-06-08

    Phenylephrine HCl Injection Recalled Due to Sterility Assurance Failure

    Nephron Sterile Compounding Center is recalling Phenylephrine HCl Injection syringes nationwide because the manufacturer cannot assure the product met sterility standards required for injectable medications.

    Product
    Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-957-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1099-2022·2022-06-08

    Frozen Spinach-Feta Pierogis Recalled for Undeclared Milk Allergen

    DYMSKI PIEROGI LLC is recalling spinach-feta pierogis (865 units) because they contain undeclared milk, a common allergen not disclosed on labels. Products were distributed to retail stores, restaurants, and distribution centers in NJ, MA, and PA.

    Product
    Spinach-Feta Pierogi Grandma s Cuisine Spinach-Feta Pierogi UPC: 8 67355 00037 2 14oz (397g) / 1 dozen Golden Eagle Spinach & Feta Pierogis 16 oz (454g) Bernat s Spinach and Feta Cheese 16oz (450g)
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1170-2022·2022-06-08

    Sterile Epidural Tray Recalled Due to Validation Uncertainty

    Busse Hospital Disposables is recalling Sterile Epidural Trays nationwide due to uncertainty about whether test method validation was adequate. No illnesses or injuries have been reported.

    Product
    Sterile Epidural Tray Catalog Number: 6259R2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1093-2022·2022-06-08

    Frozen Food Recall: Mini Potato-Cheddar Pierogi Due to Undeclared Milk

    DYMSKI PIEROGI LLC is recalling Mini Potato-Cheddar Pierogi due to the presence of undeclared milk. Individuals with milk allergies may be affected by this product.

    Product
    Mini Potato-Cheddar Pierogi Grandma s Cuisine Mini Potato-Cheddar Pierogi UPC:7 05105 70390 9 3lb/3 dozen
    Category
    Food
    Distribution
    3 states
  • HighFDA (Drugs)·D-0955-2022·2022-06-08

    Glycopyrrolate Injection Recalled Due to Sterility Assurance Failure

    Nephron Sterile Compounding Center recalls glycopyrrolate injection (1 mg/5 mL, preservative-free) due to lack of assurance of sterility. Approximately 32,550 pre-filled syringes from lot GL2002B have been distributed nationwide.

    Product
    Glycopyrrolate Injection, USP, 1 mg/5 mL (0.2 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-903-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1198-2022·2022-06-08

    Busse Convenience Kits Recalled Due to Manufacturing Test Validation Issue

    Busse Hospital Disposables is recalling Busse Convenience kits containing swab/swabstick drug products due to uncertainty about the adequacy of manufacturing test method validation.

    Product
    SS 3.2MM Pellet Insertion Tray Catalog Number: B8110R1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0965-2022·2022-06-08

    Phenylephrine HCl Injection Recalled for Lack of Sterility Assurance

    Nephron Sterile Compounding Center LLC is recalling Phenylephrine HCl Injection due to lack of assurance of sterility. Approximately 57,810 syringes were distributed nationwide.

    Product
    Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-955-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1102-2022·2022-06-08

    Dawson Belgian Style Waffle Mix Recalled for E. coli Contamination

    Dawson Food Products is recalling Belgian Style Waffle Mix that tested positive for E. coli at low levels. Consumers should not consume the affected product.

    Product
    Dawson Food Products Belgian Style Waffle Mix, 5 lbs. bag, bag UPC 758162120844, item code D6000A0; 6, 5 lbs. bags per case
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1158-2022·2022-06-08

    Nerve Block Tray Recalled Due to Manufacturing Validation Uncertainty

    Busse Hospital Disposables recalled Nerve Block Tray units (catalog #8415) containing swab components due to uncertainty about adequate test method validation. The recall affects 420 units distributed nationwide.

    Product
    Nerve Block Tray Catalog Number: 8415
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1135-2022·2022-06-08

    Delta 8 Gummy Edibles Recalled for Undeclared Soy and Coconut Allergens

    TWISTED BRANDS LLC is recalling Cosmic Crunch Bites By Twisted Delta 8 edibles due to undeclared soy lecithin and coconut oil, which may pose a serious allergy risk to consumers with these allergies.

    Product
    Cosmic Crunch Bites By Twisted, Delta 8 1000mg 25 mg per piece, 40 pieces 446g
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1202-2022·2022-06-08

    Convenience Kits With Swab Drug Products Recalled for Test Validation Failure

    Busse Convenience kits containing swab/swabstick drug products from Professional Disposables International are being recalled due to inadequate validation of manufacturing test methods.

    Product
    Male SS 4.5MM Pellet Insertion Tray Catalog Number: B9176R1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1101-2022·2022-06-08

    Keto Living Sugar Control Recalled: Undeclared Wheat in Gluten-Free Product

    Natural Organics, Inc. is recalling 4,650 bottles of Keto Living Sugar Control nationwide and internationally due to undeclared wheat in a product labeled gluten-free. Consumers with wheat allergies or celiac disease should not use this product.

    Product
    Keto Living Sugar Control
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1145-2022·2022-06-08

    Peritoneal Dialysis Extension Sets Recalled for Missing FDA Clearance

    Baxter Healthcare Corporation is recalling 3.65 m peritoneal dialysis extension sets from Lot H19G12025 that were distributed without FDA regulatory clearance. The devices were distributed in error and should not be used.

    Product
    3,65 m Extension Set with Luer-lock Connector
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1094-2022·2022-06-08

    Potato-Cheddar-Jalapeno Pierogi Recalled for Undeclared Milk Allergen

    Grandma's Cuisine Potato-Cheddar-Jalapeno Pierogi is recalled for containing undeclared milk, an allergen. The product was distributed to retailers and restaurants in New Jersey, Massachusetts, and Pennsylvania.

    Product
    Potato-Cheddar-Jalapeno Pierogi Grandma s Cuisine Potato-Cheddar-Jalapeno Pierogi UPC: 8 67355 00043 3 16 oz (454g) / 1 dozen
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1222-2022·2022-06-08

    Medical Device Recall: DYNEX Agility Analyzer Control Sample Aspiration Defect

    Dynex Technologies is recalling the DYNEX Agility Analyzer (Model 67000) due to a software defect that could cause control samples from the wrong SmartKit to be used during testing, potentially leading to delayed patient results.

    Product
    DYNEX Agility, Agility Analyzer, Model No. 67000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1186-2022·2022-06-08

    Busse Pellet Insertion Tray Kits Recalled for Manufacturing Validation Issues

    Busse Hospital Disposables is recalling Pellet Insertion Tray Kits due to uncertainty about whether manufacturing test methods were adequately validated. No illnesses or injuries have been reported.

    Product
    4.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1362
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1212-2022·2022-06-08

    Organ Preservation Device Recalled Due to Incomplete Weld Seal

    XVIVO Perfusion AB is recalling the XVIVO Organ Chamber REF 19020 due to an incomplete weld seal on the primary pouch that prevents sterility assurance. Approximately 80 devices were distributed in the U.S. and internationally.

    Product
    XVIVO Organ Chamber REF 19020
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Food)·F-1100-2022·2022-06-08

    Wegmans lobster bisque recalled due to inadequate food safety controls

    Wegmans Food You Feel Good About Lobster Bisque is being recalled because its HACCP food safety plan was not fully implemented. No illnesses have been reported.

    Product
    Wegmans Food You Feel Good About Lobster Bisque - 16 oz packaged in a 4 x 4 x 3.75" clear plastic tub with a snap on lid.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Drugs)·D-0951-2022·2022-06-08

    Calcium Gluconate Injection Syringes Recalled for Sterility Assurance

    Nephron Sterile Compounding Center is recalling 30,180 pre-filled Calcium Gluconate Injection syringes due to lack of sterility assurance. Affected lots CG1003A and CG2001A were distributed nationwide.

    Product
    Calcium Gluconate Injection, USP 10%, 0.465 mEq Ca++/mL, 1 g/10 mL (100 mg/mL), 10 mL Pre-Filled Syringe, 5 x 10 Pre-filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-950-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0954-2022·2022-06-08

    Fentanyl Injection Recalled Due to Lack of Sterility Assurance

    Nephron Sterile Compounding Center has recalled 3,532 bags of fentanyl citrate injection due to lack of sterility assurance. The affected lots (FN1088A and FN1089A) were distributed nationwide.

    Product
    Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP, 2500 mcg/250 mL (10 mcg/mL), 150 mL IV Bag, 10 x 1 IV Bag, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-523-21
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1090-2022·2022-06-08

    Ardent Mills Whole Wheat Flour Recalled for Stainless Steel Contamination

    Ardent Mills is recalling BBU Fine Whole Wheat Flour and SG Whole Wheat Fine Flour due to potential contamination with small pieces of stainless steel from milling equipment discovered during inspection.

    Product
    BBU Fine Whole Wheat Flour Bulk-AA-50251, Bulk Tanker; SG Whole Wheat Fine Flour 2,000 lb. Tote-AA Storage instructions - Any product made from raw agricultural commodities, such as wheat, rye and other grains, may be subject to infestation if not properly inspected when…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-0968-2022·2022-06-08

    Rocuronium Bromide Injection Recalled Due to Lack of Sterility Assurance

    Nephron Sterile Compounding Center is recalling Rocuronium Bromide Injection pre-filled syringes nationwide due to lack of sterility assurance. Approximately 604,080 syringes are affected.

    Product
    Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-924-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0950-2022·2022-06-08

    Sodium Bicarbonate Injection Recalled for Lack of Sterility Assurance

    Nephron Sterile Compounding Center is recalling approximately 13,612 units of 8.4% Sodium Bicarbonate Injection due to lack of assurance of sterility. The product was distributed nationwide.

    Product
    8.4% Sodium Bicarbonate Injection, USP, 1 mEq/mL, 4.2 g/50 mL (84 mg/mL), 1 x 50 mL Pre-Filled Syringe, packaged in a) 10 x 1 syringe carton, b) 30 x 1 syringe carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-214-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0960-2022·2022-06-08

    Ketamine Hydrochloride Injection Recalled Due to Lack of Sterility Assurance

    Nephron Sterile Compounding Center is recalling Ketamine Hydrochloride Injection due to lack of assurance of sterility. The recall affects 107,530 pre-filled syringes distributed nationwide.

    Product
    Ketamine Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-982-55
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1188-2022·2022-06-08

    Busse Convenience Kits Recalled Due to Manufacturing Test Validation Uncertainty

    Busse Hospital Disposables is recalling convenience kits containing swab and swabstick products due to uncertainty regarding the adequacy of manufacturing test method validation. Affected lot numbers are 2110127 and 2110269.

    Product
    SS 4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1363R1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1209-2022·2022-06-08

    da Vinci Vessel Sealer May Fail to Adequately Seal Tissue

    Intuitive Surgical is recalling da Vinci Vessel Sealer instruments worldwide because placing excessive tissue in the instrument jaws can result in an insufficient seal. Surgeons should follow proper technique guidelines when using the device.

    Product
    VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1187-2022·2022-06-08

    Busse Convenience Kit Swab Products Recalled Due to Manufacturing Test Validation Issue

    Busse Convenience kits containing swab/swabstick products manufactured by Professional Disposables International have been recalled due to uncertainty about the adequacy of manufacturing test method validation.

    Product
    SS 4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1363
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1171-2022·2022-06-08

    Busse Convenience Kits Recalled: Drug Swabs Face Manufacturing Validation Uncertainty

    Professional Disposables International's swab and swabstick drug products, sold in Busse Convenience kits, are recalled due to uncertainty about whether manufacturing validation test methods were adequate.

    Product
    Nerve Block Tray Catalog Number: 6796R3
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1172-2022·2022-06-08

    Single Shot Epidural Tray recalled due to inadequate test method validation

    Busse Hospital Disposables is recalling Single Shot Epidural Trays because swab components from Professional Disposables International were manufactured with unvalidated test methods.

    Product
    Single Shot Epidural Tray Catalog Number: 6797R2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1155-2022·2022-06-08

    Swab Drug Products Recalled Due to Manufacturing Validation Uncertainty

    Convenience kits containing swab/swabstick drug products are being recalled due to uncertainty about whether test methods used during manufacturing adequately validated the products. Affected products include 80 units distributed nationwide.

    Product
    Epidural Tray Catalog 1577
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1106-2022·2022-06-08

    Wisco Pop Strawberry Soda Recalled for Possible Yeast Contamination

    Karben4 Brewing LLC is recalling Wisco Pop Strawberry Soda because cans may contain yeast. The product was distributed in Illinois, Minnesota, and Wisconsin.

    Product
    Wisco Pop Strawberry Soda, 12 FL OZ. 355 ML, UPC 50037-32406. Handcrafted for Wisco pop Bev. Co. Madison, WI 53704
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1201-2022·2022-06-08

    Swab drug products recalled due to inadequate test method validation

    Busse Hospital Disposables is recalling convenience kits containing swab drug products manufactured by Professional Disposables International due to uncertainty about the adequacy of test methods used in manufacturing.

    Product
    Female SS 3.5MM Pellet Insertion Tray Catalog Number: B9175R1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1196-2022·2022-06-08

    Busse Hospital Disposables Recalls Convenience Kits with Swab Products

    Busse Hospital Disposables is recalling Convenience kits containing swab products due to uncertainty about manufacturing validation adequacy. The kits were distributed nationwide.

    Product
    Pellet Insertion Tray Catalog Number: B1654
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0970-2022·2022-06-08

    Equate Tartar Control Plus Mouthwash Recalled for Out-of-Specification Formula

    Walmart is recalling Equate Tartar Control Plus mouthwash from certain lots because they were found to have active ingredients outside the approved specification.

    Product
    Equate Tartar Control Plus (Eucalyptol 0.092%, Menthol 0.042%, Methyl salicylate 0.060%, Thymol 0.064%) Antiseptic Mouthrise Plus, Antigingivitis/Antiplaque, Blue Mint, 1.5 Liter (50.7 FL OZ) bottle, Distributed By: Wal-Mart Stores, Inc., Bentonville, AR 72716, UPC 6 81131 14800…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1160-2022·2022-06-08

    Nerve Block Tray Recalled Due to Manufacturing Validation Uncertainty

    Busse Hospital Disposables is recalling Nerve Block Trays containing swab and swabstick products due to uncertainty about manufacturing test method validation. Affected lot numbers should be discontinued.

    Product
    Nerve Block Tray Catalog Number: 9342
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1206-2022·2022-06-08

    Medtronic cardiac catheter system recalled due to sterility barrier defect

    Medtronic recalls its C304-HIS cardiac catheter device due to potential sterility barrier defects in certain manufacturing lots. Approximately 1,385 devices distributed worldwide were affected.

    Product
    The C304-HIS device features a guide wire to access the vein, a valve to reduce blood loss during the implant procedure, a deflectable catheter to introduce a transvenous device, a catheter dilator to facilitate deflectable catheter passage, and a guide catheter slitter to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22V404000·2022-06-08

    2020-2022 Porsche Taycan center screen display malfunction increases crash risk

    Porsche is recalling 2020-2022 Taycan vehicles for a software error causing the center screen and touch panel to go black or flicker. This blocks the driver's view of rear-view camera functions, increasing crash risk.

    Product
    PORSCHE — PORSCHE TAYCAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0956-2022·2022-06-08

    Glycopyrrolate Injection Recalled Due to Lack of Sterility Assurance

    Nephron is recalling 6,150 units of Glycopyrrolate Injection due to lack of sterility assurance. Healthcare providers should stop using affected lots and contact their supplier for return instructions.

    Product
    Glycopyrrolate Injection, USP, 0.6 mg/3 mL (0.2 mg/mL), Preservative Free, 3 mL Pre-Filled Syringe, 5 x 3 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-903-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1176-2022·2022-06-08

    Core Biopsy Tray Recall Due to Manufacturing Validation Uncertainty

    Busse Hospital Disposables is recalling Core Biopsy Trays (Catalog 8673R4) distributed nationwide because the test methods used to validate manufacturing processes may not have been adequately validated. The affected 285 units may lack proper quality verification.

    Product
    Core Biopsy Tray Catalog Number: 8673R4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1157-2022·2022-06-08

    I.V. Start Kit Recall Due to Uncertain Manufacturing Process Validation

    Busse Hospital Disposables is recalling I.V. Start Kit (Catalog 8172) due to inadequate validation of manufacturing processes for the included swab drug products. The recall affects 4,218 units distributed nationwide.

    Product
    I.V. Start Kit Catalog 8172
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1152-2022·2022-06-08

    Busse Single Shot Epidural Tray recalled for test method validation uncertainty

    Busse Hospital Disposables is recalling Single Shot Epidural Trays nationwide due to uncertainty about the adequacy of test method validation used to manufacture swab components. The FDA classified this as a Class II recall.

    Product
    Single Shot Epidural Tray Catalog 1292
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1095-2022·2022-06-08

    Potato-Cheddar-Broccoli Pierogi recalled by Dymski for undeclared milk

    Dymski Pierogi LLC recalled 836 units of Potato-Cheddar-Broccoli Pierogi products due to undeclared milk allergen. Products were distributed to retail stores and restaurants in New Jersey, Massachusetts, and Pennsylvania.

    Product
    Potato-Cheddar-Broccoli Pierogi Grandma s Cuisine Potato-Cheddar-Broccoli Pierogi UPC: 8 67355 00042 6 16oz (454g) / 1 dozen Bernat s Potato, Cheddar & Broccoli 16oz (450g)
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1092-2022·2022-06-08

    DYMSKI Pierogi Recalled Due to Undeclared Milk and Wheat Allergens

    DYMSKI PIEROGI LLC is recalling Potato & Cheddar Cheese Pierogi products sold in NJ, MA, and PA because they contain undeclared milk and wheat allergens. Consumers with allergies to milk or wheat should not consume these products.

    Product
    Potato & Cheddar Cheese Pierogi Grandma s Cuisine Potato & Cheddar Cheese Pierogi UPC: 8 67355 00033 4 16 0z (454g) /1 dozen Zuzanna s Potato-Cheddar Pierogi 16 oz Golden Eagle Potato & Cheddar Cheese Peirogies 16 oz (454 g)
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1203-2022·2022-06-08

    FDA Recalls Pellet Insertion Trays Due to Validation Method Uncertainty

    Busse Hospital Disposables is recalling 3.2MM Pellet Insertion Trays due to inadequate validation of manufacturing test methods. The recall affects 150 units distributed nationwide.

    Product
    3.2MM Pellet Insertion Tray Catalog Number: B9743
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1219-2022·2022-06-08

    MEDLINE Polyurethane Bedside Cleaning Kits Recalled Due to Microbial Contamination

    MEDLINE is recalling certain lots of its Polyurethane Bedside Cleaning Kits due to confirmed microbial contamination on the foam sponge. The kits were distributed in the US and Panama.

    Product
    MEDLINE Polyurethane Bedside Cleaning Kit, REF DYK500FSAW
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1098-2022·2022-06-08

    Cheese and Scallion Pierogi Recalled Due to Undeclared Milk Allergen

    Dymski Pierogi LLC is recalling Cheese & Scallion Pierogi (Grandma's Cuisine brand) due to undeclared milk. The product was distributed to retail stores and restaurants in New Jersey, Massachusetts, and Pennsylvania.

    Product
    Cheese & Scallion Pierogi Grandma s Cuisine Cheese & Scallion Pierogi UPC: 8 67355 00040 2 16oz (454g) / 1 dozen
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1174-2022·2022-06-08

    Single Shot Epidural Tray Kits Recalled Due to Manufacturing Validation Uncertainty

    Busse Hospital Disposables recalls Single Shot Epidural Tray kits due to uncertainty about the adequacy of test method validation in manufacturing. No illnesses reported.

    Product
    Single Shot Epidural Tray - 18G Catalog Number: 8139R2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0974-2022·2022-06-08

    Losartan Potassium Tablets Recalled for CGMP Deviations and Elevated Impurity

    Strides Pharma Inc. is recalling Losartan Potassium 100 mg tablets nationwide due to CGMP deviations with AZIDO impurity levels above acceptable limits. Patients should contact their healthcare provider to verify if they are affected.

    Product
    LOSARTAN POTASSIUM — LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1143-2022·2022-06-08

    Baxter Peritoneal Dialysis Manifold Sets Recalled for Lack of FDA Clearance

    Baxter Healthcare Corporation is recalling 180 units of 5 Prong Manifold Sets used in peritoneal dialysis. These products were distributed without FDA regulatory clearance to facilities across nine US states.

    Product
    5 Prong Manifold Set (with Luer Connectors)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1096-2022·2022-06-08

    Potato & American Cheese Pierogi Recalled for Undeclared Milk

    Dymski Pierogi LLC is recalling Potato & American Cheese Pierogi products because they contain undeclared milk. The recall affects products distributed in New Jersey, Massachusetts, and Pennsylvania.

    Product
    Potato & American Cheese Pierogi Grandma s Cuisine Potato & American Cheese Pierogi UPC: 8 67355 00032 7 16oz (454g) / 1 dozen Golden Eagle Potato & American Cheese Pierogis UPC: 7 05105 70400 5 16 oz
    Category
    Food
    Distribution
    3 states
  • HighFDA (Drugs)·D-0957-2022·2022-06-08

    Hydromorphone Injection Recalled Due to Lack of Sterility Assurance

    Nephron Sterile Compounding Center is recalling Hydromorphone HCl Injection 50 mg/50 mL pre-filled syringes due to lack of sterility assurance. The recalled product was distributed nationwide.

    Product
    Hydromorphone HCl Injection, USP, 50 mg/50 mL (1 mg/mL), 50 mL Pre-Filled Syringe, 5 x 50 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-559-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1132-2022·2022-06-08

    Cherry Coca-Cola Zero Sugar Recalled for Undeclared Phenylalanine

    Cherry Coca-Cola Zero Sugar in 12 oz cans were mislabeled as regular Cherry Coca-Cola and failed to declare phenylalanine on the label, a concern for people with phenylketonuria.

    Product
    Cherry Coca-Cola Zero Sugar Case UPC: 0 49000 04751 6 12 pack fridge pack Single 12 oz. cans if sold individually from the fridge pack.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0959-2022·2022-06-08

    Ketamine Hydrochloride Injectable Recalled Due to Sterility Assurance Issues

    Nephron Sterile Compounding Center LLC is recalling 30,290 syringes of Ketamine Hydrochloride Injection due to lack of assurance of sterility. The injectable drug was distributed nationwide.

    Product
    Ketamine Hydrochloride Injection, USP, 30 mg/3 mL (10 mg/mL), 3 mL Pre-Filled Syringe, 5 x 3 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-982-33
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1225-2022·2022-06-08

    Hip Stem Prosthetic Missing Plasma Coating in Manufacturing Lot

    MicroPort Orthopedics is recalling one manufacturing lot of PROFEMUR PLASMA Z CLASSIC hip stem prosthetics due to missing plasma-spray coating in the proximal region of the implant stem.

    Product
    PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1097-2022·2022-06-08

    Dymski Pierogi Recalls Sweet Cheese Pierogi for Undeclared Milk and Wheat

    Dymski Pierogi LLC is recalling Sweet Cheese Pierogi products with undeclared milk and wheat allergens. Approximately 1,721 units were distributed to retail and food service locations in NJ, MA, and PA.

    Product
    Sweet Cheese Pierogi Grandma s Cuisine Sweet Cheese Pierogi 0 67355 00034 5 16oz (454g) / 1 dozen Bernat s Sweet Cheese 16oz (450g) Golden Eagle Sweet Cheese Pierogis 14 oz
    Category
    Food
    Distribution
    3 states
  • HighFDA (Drugs)·D-0964-2022·2022-06-08

    Oxytocin Injectable Drug Recalled for Lack of Sterility

    Nephron Sterile Compounding Center has recalled 3,587 bags of Oxytocin injectable nationwide due to lack of assurance of sterility.

    Product
    Oxytocin 30 Units/500 mL (0.06 Units/mL) in 0.9% Sodium Chloride Injection, USP, 500 mL Single-Dose Container Bag, 10 x 1 IV Bag, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-543-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0958-2022·2022-06-08

    Injectable Hydromorphone Recalled for Lack of Sterility Assurance

    Nephron Sterile Compounding Center is recalling Hydromorphone HCl Injection due to lack of assurance of sterility. The recall affects 6,210 pre-filled syringes distributed nationwide.

    Product
    Hydromorphone HCl Injection, USP, 6 mg/30 mL (0.2 mg/mL), 30 mL Pre-Filled Syringe, 5 x 30 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-529-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1217-2022·2022-06-08

    MEDLINE Enzymatic Cleaning Sponges Recalled Due to Microbial Contamination

    MEDLINE Polyurethane Foam Enzymatic Cleaning Sponges (REF DYK1000TSE) are being recalled due to microbial contamination identified on certain lots. The affected product was distributed in the US and Panama.

    Product
    MEDLINE Polyurethane Foam Enzymatic Cleaning Sponge, REF DYK1000TSE
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0963-2022·2022-06-08

    Neostigmine Methylsulfate Injection Recalled Due to Sterility Assurance Failure

    Nephron Sterile Compounding Center is recalling Neostigmine Methylsulfate Injection due to lack of assurance of sterility. The compounded injectable drug may not meet sterile product standards.

    Product
    Neostigmine Methylsulfate Injection, USP, 5 mg/5 mL (1 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-902-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0976-2022·2022-06-08

    AMBI Skincare Fade Cream Recalled for Temperature Storage Deviations

    AMBI Skincare Fade Cream is being recalled nationwide due to cGMP violations. The product was stored outside its labeled temperature requirements during manufacturing.

    Product
    AMBI Skincare Fade Cream Normal Skin, Net Wt. 2 OZ. (56g)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1147-2022·2022-06-08

    I.V. Start Kit with Swab Products Recalled for Manufacturing Validation Issues

    Busse Hospital Disposables is recalling I.V. Start Kits containing swab products due to inadequate validation of manufacturing test methods. Approximately 2,475 units nationwide may be affected.

    Product
    I.V. Start Kit - Tegaderm Dressing - Catheter Securement - Prevantics Catalog Number: 822
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1213-2022·2022-06-08

    Abbott FIRMap Catheter Recalled for Incorrect Product Labeling

    Abbott is recalling 40 units of FIRMap® Catheter, 60mm Basket due to incorrect product labeling. The recall affects devices distributed in Missouri, California, Ohio, Washington and internationally in Italy and Netherlands.

    Product
    FIRMap" Catheter, 60mm Basket
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1180-2022·2022-06-08

    Swab and Swabstick Drug Products Recalled Due to Validation Uncertainty

    Busse Convenience kits with swab and swabstick drug products are being recalled because the validation of the test methods used during manufacturing is uncertain.

    Product
    "3.2MM Pellet Insertion Tray with Medium Gloves" Catalog Number: B1351
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1104-2022·2022-06-08

    Wisco Pop Ginger Soda Recalled Due to Possible Yeast Contamination

    Karben4 Brewing LLC is recalling specific lots of Wisco Pop Ginger Soda because cans may contain yeast. The recall affects products distributed in Illinois, Minnesota, and Wisconsin.

    Product
    Wisco Pop Ginger Soda, 12 FL OZ. 355 ML, UPC 50037-32410. Handcrafted for Wisco pop Bev. Co. Madison, WI 53704
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1142-2022·2022-06-08

    Locking Cap for PD Catheter Adapter Distributed Without FDA Clearance

    Baxter Healthcare is recalling locking caps for peritoneal dialysis catheters that were distributed without FDA regulatory clearance. These devices were released into the U.S. market in error.

    Product
    Locking Cap for PD Catheter Adapter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1193-2022·2022-06-08

    Busse Convenience Kit Swab Products Recalled for Test Method Validation Issues

    Busse Convenience kits containing swab and swabstick drug products manufactured by Professional Disposables International are being recalled due to uncertainty about test method validation during manufacturing.

    Product
    SS 4.5MM DIAMOND TIP TROCAR WITH MEDIUM GLOVES Catalog Number: B1560
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1195-2022·2022-06-08

    Convenience Kits with Drug Swab Products Recalled for Validation Uncertainty

    Busse Convenience kits containing swab/swabstick drug products are being recalled nationwide due to uncertainty about the adequacy of the validation of manufacturing test methods.

    Product
    Male SS 4.5MM Pellet Insertion Tray Catalog Number: B1570
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1184-2022·2022-06-08

    Pellet Insertion Tray Recall for Uncertain Manufacturing Test Validation

    Busse Hospital Disposables is recalling SS 3.5MM Pellet Insertion Tray kits nationwide. The kits contain swab products with uncertain manufacturing test method validation.

    Product
    SS 3.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1354R1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1144-2022·2022-06-08

    Baxter Effluent Sample Bags Recalled for Lack of FDA Clearance

    Baxter Healthcare recalled 78 Effluent Sample Bags that were distributed without FDA regulatory clearance. The product was distributed in error across eight states.

    Product
    Effluent Sample Bag
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1214-2022·2022-06-08

    BD Anti-Kappa Flow Cytometry Reagents Recalled for Uncharacteristic Flow Profiles

    BD Anti-Kappa APC and PE reagents used in flow cytometry testing may exhibit uncharacteristic flow profiles, potentially affecting test accuracy. Worldwide distribution to 249 units across US states and Taiwan.

    Product
    BD Anti-Kappa APC (Cat. No. 341098) is an analyte specific reagent for the Anti-Kappa antibody, which specifically recognizes the kappa light chains of human immunoglobulins. Anti-Kappa is used for in vitro identification of cells expressing the kappa light chains using flow…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0981-2022·2022-06-08

    Aveeno Daily Moisturizing Lotion recalled due to improper storage conditions

    Family Dollar and Johnson & Johnson Consumer are recalling Aveeno Daily Moisturizing Lotion due to cGMP violations involving improper storage temperature. No illnesses have been reported.

    Product
    Aveeno Daily Moisturizing lotion Fragrance Free with Soothing Oat & Rich Emollients, Net Wt. 5 oz (141 g), Distributed by Johnson & Johnson Consumer, Inc. Skillman, NJ 08558, UPC 3 81137-001530 7
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1178-2022·2022-06-08

    Procedural Accessory Kit Recalled for Manufacturing Validation Uncertainty

    Busse Hospital Disposables is recalling Procedural Accessory Kits containing swabs due to uncertainty regarding the validation of manufacturing test methods. No illnesses or injuries have been reported.

    Product
    Procedural Accessory Kit Catalog Number: 9665R2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0980-2022·2022-06-08

    Hand Sanitizer Recall: Storage Temperature Non-Compliance at Family Dollar

    Family Dollar Stores is recalling Luxury Hygiene Hand Sanitizer Moisturizing Formula due to cGMP deviations related to improper storage outside labeled temperature requirements.

    Product
    Luxury Hygiene Hand Sanitizer Moisturizing Formula with Vitamin E, 8 FL. OZ. (236 mL), TSM Brands LLC 540 Equinox Ln Manalapan, NJ 07726, UPC 6 86275 96536 9
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1161-2022·2022-06-08

    Universal Nerve Block Tray swab products recalled for manufacturing test validation concerns

    Busse Hospital Disposables is recalling Universal Nerve Block Tray units (catalog 9779) due to uncertainty regarding test method validation in manufacturing the included swab/swabstick drug products. No illnesses or injuries have been reported.

    Product
    Universal Nerve Block Tray Catalog Number: 9779
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1190-2022·2022-06-08

    FDA Recalls Swab Products for Manufacturing Validation Uncertainty

    Busse Convenience kits containing swab/swabstick products from Professional Disposables International have been recalled by the FDA due to uncertainty about adequate validation of manufacturing test methods.

    Product
    SS 3.5MM Diamond Tip Trocar - Large Gloves Catalog Number: B1547
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1221-2022·2022-06-08

    MEDLINE Polyurethane Foam Bedside Cleaning Kit Recalled for Microbial Contamination

    MEDLINE has recalled certain lots of its Polyurethane Foam Bedside Cleaning Kit due to microbial contamination detected on the foam sponge. Sporadic reports of discoloration were identified as contamination.

    Product
    MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK100FS
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1153-2022·2022-06-08

    Swab Drug Products Recalled for Manufacturing Test Method Validation Uncertainty

    Busse Convenience kits containing swab/swabstick drug products manufactured by Professional Disposables International (PDI) are being recalled due to uncertainty about the adequacy of test method validation used in manufacturing.

    Product
    Epidural Tray Catalog 1307
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1185-2022·2022-06-08

    Swab and Swabstick Drug Products Recalled Due to Manufacturing Validation Defects

    Busse Hospital Disposables is recalling convenience kits containing swab and swabstick drug products due to uncertainty about the adequacy of manufacturing test method validation. Products were distributed nationwide.

    Product
    4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1360
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1179-2022·2022-06-08

    Busse swab and swabstick products recalled for validation uncertainty

    Busse Convenience kits containing swab and swabstick drug products are recalled nationwide due to uncertainty about whether manufacturing test methods were adequately validated.

    Product
    3.2MM Pellet Insertion Tray Catalog Number: B1144
    Category
    Drug
    Distribution
    Distributed nationwide

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