The Recall Desk

Archive

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

101–200 of 460

  • HighFDA (Food)·F-0263-2023·2023-01-25

    Pepper Collection 8 Tube Gift Set recalled for mold and ochratoxin contamination

    Something South African LLC recalls Pepper Collection 8 Tube Gift Set due to mold (Aspergillus brasiliensis) and Ochratoxin A contamination. The recall affects 4,200 units distributed nationwide.

    Product
    Pepper Collection 8 Tube Gift Set - a colorful assortment of dried peppers. This product contains peppers in 8 different glass tube and packaged in a printed paperboard sleeve and are visible through a window in the sleeve. Net wt. is 4.87oz/138g. The UPC is 6 009686 793712.…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1000-2023·2023-01-25

    Medical X-ray equipment patient table footrests recalled due to detachment risk

    Siemens recalls four fluoroscopy and radiographic imaging equipment models worldwide because patient table footrests may detach during clinical use, potentially causing patient injury.

    Product
    AXIOM Luminos TF, AXIOM Iconos R100, AXIOM Iconos R200 and AXIOM Luminos dRF
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0983-2023·2023-01-25

    Cardinal Health Jackson-Pratt Channel Drain Recalled for Performance Defects

    Cardinal Health is recalling Jackson-Pratt Channel Drains (19 Fr, REF JP-2225) due to multiple performance issues including lack of radiopacity, dull trocars, reduced flexibility, and broken wound tips. Approximately 4,112 units were distributed worldwide.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2225
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0997-2023·2023-01-25

    Thoracic Stent-Graft System Recalled Due to Dimensional Defect

    Bolton Medical's RELAY PRO thoracic stent-graft system is being recalled because affected units may be shorter than their packaging indicates. The recall affects 129 units distributed worldwide.

    Product
    RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0302-2023·2023-01-25

    Superior Fresh Lettuce Blend Recalled for Small Glass Particles

    Superior Fresh Lettuce Blend products have been recalled due to the presence of small glass particles. Affected products include Spring Mix, Midwest Medley, and Midwest Medley Family Pack distributed in Indiana, Pennsylvania, Virginia, and Wisconsin.

    Product
    Superior Fresh Lettuce Blend Ingredients May Contain Red Leaf, Green Leaf, Green Romaine, Red Romaine, Red Oak Leaf, Green Oak Leaf, Butter lettuce, Arugula, Kale, Spinach, Mustard, Mizuna, Pax Choi. Keep Refrigerated. Packaged under the following Names and sizes: 1.…
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0981-2023·2023-01-25

    Cardinal Health Jackson-Pratt Channel Drains recalled for multiple performance defects

    Cardinal Health is recalling Jackson-Pratt Channel Drains (10 Fr, REF JP-2221) due to multiple performance issues including broken wound tips, dull trocars, lack of radiopacity, and reduced flexibility affecting 179 units distributed worldwide.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2221
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0996-2023·2023-01-25

    Vasoshield Syringe Packs Recalled Due to Chipping Ink Risk

    Maquet Cardiovascular is recalling Vasoshield Syringe Packs (Model VH-5001) because ink on the syringe logo may chip, creating a risk of foreign body complications and embolic events. The recall affects 530 units in the United States and 215 units outside the United States.

    Product
    Vasoshield Syringe Packs, Model VH-5001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0166-2023·2023-01-25

    Hand Sanitizer Recalled for Chemical Impurities and Manufacturing Defects

    SIREtizer Hand Sanitizer is recalled for containing acetal and acetaldehyde above allowable limits and manufacturing defects, including one superpotent lot.

    Product
    SIREtizer Hand Sanitizer (Ethyl Alcohol) 80%, packaged in a) 3.38 oz (100 mL), b) 10 oz (295 ml), UPC 8 60003 85882 0, and c) 16.9 oz (500 ml), UPC 8 60003 85880 6 bottles, Southwest Iowa Renewable Energy, 10868 189th Street, Council Bluffs, IA 51503; Bottled by Southwest 6th…
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Devices)·Z-0971-2023·2023-01-25

    Cardinal Health Jackson-Pratt Channel Drains Recalled for Multiple Performance Defects

    Cardinal Health is recalling 3,507 Jackson-Pratt Channel Drains (19 Fr) due to performance defects including lack of radiopacity, dull trocars, lack of flexibility, and broken tips. Drains were distributed worldwide.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0156-2023·2023-01-25

    Eye-drop drug recall: Timolol solution due to manufacturing deviations

    Akorn is recalling over 1.3 million bottles of Timolol Maleate eye drops distributed nationwide due to manufacturing process violations. The voluntary recall addresses risks from Current Good Manufacturing Practice deviations.

    Product
    Timolol Maleate Ophthalmic Solution, USP, 0.5%, Packaged in (a) 5 mL dropper bottle, NDC 17478-288-10; (b) 10 mL dropper bottles: NDC 17478-288-11; (c) 15 mL dropper bottles, NDC 17478-288-12; Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0272-2023·2023-01-25

    Focaccia bread recalled due to storage in insanitary conditions

    Klosterman Baking Company recalled focaccia bread held under insanitary conditions. The recall affects approximately 109,343 units distributed in Indiana, Ohio, and Tennessee.

    Product
    Breads: Focaccia product 8518 Clear Bag Loaf 1 56 oz.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0143-2023·2023-01-25

    Lidocaine Hydrochloride Jelly Recalled for Manufacturing Quality Deviations

    Akorn, Inc. is voluntarily recalling 2,369,258 tubes of Lidocaine Hydrochloride Jelly due to manufacturing quality deviations. The product, distributed nationwide, is available in 5 mL and 30 mL prescription-only tubes.

    Product
    Lidocaine Hydrochloride Jelly USP, 2%, Packaged as (a) 5 mL tube (NDC 17478-711-10) x10 per box NDC 17478-711-31; (b) 30 mL tube NDC 17478-711-30; Rx only, Manufactured by: Akorn, Inc., Lake Forest, Il 60045.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0999-2023·2023-01-25

    R&D CBC-3D Hematology Control Recalled for Potential Microbial Contamination

    R&D Systems is recalling one lot of CBC-3D Hematology Control due to potential microbial contamination that may cause hemolysis or deterioration in the Normal control level.

    Product
    R&D CBC-3D Hematology Control: (1) CBC-3D Normal Pack Hematology Control, REF 3D501, containing 10 x 2.0mL Control N; (2) CBC-3D TRI PACK Hematology Control, REF 3D503, containing 4 x 2.0 mL Controls L, N, and H; (3) CBC-3D for Mythic 18 Hematology Control, REF 3D503RX…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0266-2023·2023-01-25

    Klosterman ciabatta bread rolls recalled for insanitary holding conditions

    Klosterman Baking Company is recalling ciabatta bread rolls distributed to Indiana, Ohio, and Tennessee because they were held under insanitary conditions. Consumers should dispose of affected products.

    Product
    Breads: Ciabatta product 8000 Clear Bag Rolls 8 3.4 oz. Ciabatta product 8652 Clear Bag Rolls 6 5.5 oz.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0158-2023·2023-01-25

    FDA Recalls Tobramycin Ophthalmic Solution for Manufacturing Compliance Issues

    Akorn, Inc. is recalling 91,692 bottles of Tobramycin Ophthalmic Solution (0.3%) nationwide due to Current Good Manufacturing Practice deviations. The voluntary recall was initiated on October 13, 2022.

    Product
    Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045; Distributed by: MWI, Boise, ID 83705. NDC 13985-604-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0152-2023·2023-01-25

    FDA Recalls Akorn PAREMYD Eye Medication for Manufacturing Quality Deviations

    Akorn, Inc. is voluntarily recalling 51,601 bottles of PAREMYD eye medication nationwide due to manufacturing process deviations. The firm initiated the recall in October 2022.

    Product
    PAREMYD (hydroxyamphetamine hydrobromide/ tropicamide ophthalmic solution) 1%/0.25%, 15 mL per dropper bottle, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-704-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0161-2023·2023-01-25

    Triamterene and Hydrochlorothiazide Capsules Recalled for Failed Quality Specifications

    Lannett Company is recalling Triamterene and Hydrochlorothiazide Capsules nationwide because the medication failed quality testing for impurity and degradation specifications. The recall affects 20,040 bottles.

    Product
    Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, [100 or 1000 ] Capsules per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 100 Count bottle: 0527-1632-01; NDC 1,000 bottle: 0527-1632-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0150-2023·2023-01-25

    Antihistamine eye drops recalled due to manufacturing process deviations

    Akorn, Inc. is recalling 163,996 bottles of Olopatadine HCl Ophthalmic Solution 0.1% due to manufacturing process deviations. Affected lot numbers expire from October through December 2023.

    Product
    Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL (0.17 FL OZ) per bottle, Antihistamine and Redness Reliever, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC: 51407-499-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0148-2023·2023-01-25

    Ophthalmic solution recalled due to manufacturing quality control deviations

    Akorn, Inc. is recalling 1,752 bottles of Olopatadine HCL Ophthalmic Solution, USP 0.1% nationwide due to manufacturing quality control deviations. Lot 1L03A with expiration 10/31/2023 is affected.

    Product
    Olopatadine HCL Ophthalmic Solution, USP 0.1%, Antihistamine and Redness Reliever, 5 mL (0.17 FL OZ) per bottle, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-308-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0134-2023·2023-01-25

    Akorn Artificial Tears Eye Drops Recalled for Manufacturing Quality Deviations

    Akorn, Inc. is voluntarily recalling 967,075 bottles of Artificial Tears Solution eye drops nationwide due to manufacturing process deviations identified during quality inspections.

    Product
    Artificial Tears Solution, Lubricant Eye Drops, Polyvinyl Alcohol 1.4%, 15 mL (0.5 fl. oz.) per bottle, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-060-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0145-2023·2023-01-25

    FDA recalls Akorn ophthalmic ointment for manufacturing process deviations

    Akorn, Inc. is recalling 2,082 tubes of Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment nationwide due to manufacturing process deviations. The recall is voluntary and initiated by the manufacturer.

    Product
    Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, USP, Net Wt. 3.5 g (1/8 oz.), Rx Only, Manufactured by: Akorn, INC., Lake Forest, IL 60045. NDC: 17478-235-35
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0274-2023·2023-01-25

    Garlic Bread Products Recalled for Insanitary Holding Conditions

    Klosterman Baking Company is recalling garlic bread rolls and breadsticks held under insanitary conditions. Approximately 109,343 units were distributed in Indiana, Ohio, and Tennessee from December 12-16.

    Product
    Breads: Garlic product 8013 Clear Bag Rolls 140 1.5 oz. 3 Garlic product 8014 Clear Bag Breadsticks 110 1.5 oz. 23
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0287-2023·2023-01-25

    White Breads and Buns Recalled for Insanitary Storage Conditions

    Klosterman Baking Company is recalling certain white bread and bun products due to storage under insanitary conditions. The recall affects products distributed in Indiana, Ohio, and Tennessee between December 12-16, 2022.

    Product
    Breads: White product 1003 Clear Bag Loaf 1 24 oz. White product 1005 Clear Bag Loaf 1 24 oz. White product 1015 Clear Bag Loaf 1 24 oz. White product 1020 Clear Bag Loaf 1 24 oz. White product 1040 Klosterman Foodservice UPC # 0005172100450 Loaf 1 32 oz. White product…
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0136-2023·2023-01-25

    Ciprofloxacin ophthalmic solution recalled for manufacturing practice deviations

    Akorn, Inc. is recalling 1,584 bottles of Ciprofloxacin Ophthalmic Solution nationwide due to Current Good Manufacturing Practice (CGMP) deviations. This is a voluntary recall.

    Product
    Ciprofloxacin Ophthalmic Solution, USP 0.3% (Ciprofloxacin HCl), 2.5mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-714-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0958-2023·2023-01-25

    Abbott Alinity Reaction Vessels Recalled for Potential Contaminant

    Abbott Laboratories recalled 70 cases of Alinity Reaction Vessels due to potential contamination that could affect optical performance. Units were distributed across multiple U.S. states.

    Product
    Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Food)·F-0283-2023·2023-01-25

    Klosterman Rye Bread Recalled Due to Insanitary Holding Conditions

    Klosterman Baking Company is recalling rye bread products held under insanitary conditions. Approximately 109,343 units were distributed to Indiana, Ohio, and Tennessee between December 12–16.

    Product
    Breads: Rye product 1495 Klosterman Retail UPC # 0005172100109 Loaf 1 16 oz. Rye product 1505 Clear Bag Loaf 1 32 oz. Rye product 1525 Klosterman Foodservice UPC # 0005172100456 Loaf 1 24 oz. Rye product 1545 Klosterman Retail UPC # 0005172100108 Loaf 1 16 oz. Rye product 1550…
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0149-2023·2023-01-25

    Olopatadine HCl ophthalmic solution recalled for manufacturing deviations

    Olopatadine HCl Ophthalmic Solution 0.2% manufactured by Akorn, Inc. is being recalled nationwide due to Current Good Manufacturing Practice (CGMP) deviations affecting 173,928 bottles.

    Product
    Olopatadine HCl Ophthalmic Solution, USP 0.2%, 2.5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-305-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0162-2023·2023-01-25

    Levofloxacin Tablets Recalled for Embossing and Packaging Insert Mismatch

    Macleods Pharma USA recalls Levofloxacin Tablets 500 mg due to mismatched embossing on tablets versus the package insert labeling. The distributed bottles do not match the documented tablet markings.

    Product
    Levofloxacin Tablets, USP 500 mg; 50-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540; Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India. NDC 33342-022-08
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0267-2023·2023-01-25

    Klosterman Baking Company cornmeal buns recalled due to insanitary storage conditions

    Klosterman Baking Company is recalling cornmeal buns due to insanitary storage conditions. About 109,343 units distributed in IN, OH, and TN between December 12-16 are affected. No illnesses have been reported.

    Product
    Breads: Cornmeal product 3630 Clear Bag Buns 12 100 g
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0164-2023·2023-01-25

    Hand Sanitizer Recalled Due to Manufacturing Practice Deviations

    Fisher Scientific voluntarily recalls hand sanitizer due to manufacturing deviations. The recall affects products distributed after March 31, 2022.

    Product
    Hand Sanitizer, HSANI4LI, (Isopropyl Alcohol), 75% Topical Solution, packaged in 4 L bottles, Thermo Fisher Scientific: Janssen Pharmaceuticalaan 3a, 2440 Geel - Belgium, 1 Reagent Lane, Fair Lawn, NJ 07410.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0163-2023·2023-01-25

    Hand Sanitizer Recalled for Manufacturing Practice Deviations

    Fisher Scientific voluntarily recalls HSANI500ML hand sanitizer (75% isopropyl alcohol) due to manufacturing practice deviations. The product was made under expired temporary FDA approval.

    Product
    Hand Sanitizer, HSANI500ML, (Isopropyl Alcohol), 75% v/v, packaged in a) 500 mL bottle and b) 6 x 500 mL bottles per case, Thermo Fisher Scientific: Janssen Pharmaceuticalaan 3a, 2440 Geel - Belgium, 1 Reagent Lane, Fair Lawn, NJ 07410.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0265-2023·2023-01-25

    Blueberry Bagels Recalled Due to Insanitary Storage Conditions

    Klosterman Baking Company recalls Old World brand blueberry bagels due to products being held under insanitary conditions. Approximately 109,343 units were distributed to Indiana, Ohio, and Tennessee.

    Product
    Breads: Blueberry product 9531 Old World Bagels 6 3 oz. Blueberry product 9541 Old World Bagels 6 4 oz.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0140-2023·2023-01-25

    FDA recalls GONAK ophthalmic drug solution for manufacturing deviations

    Akorn voluntarily recalled 196,254 bottles of GONAK ophthalmic solution nationwide due to CGMP manufacturing practice deviations. This professional-use eye solution is employed in gonioscopic examinations.

    Product
    GONAK Hypromellose Ophthalmic Demulcent Solution, (25 mg) 2.5%, 15 mL per dropper bottle, For Professional Use in Goinoscopic Examinations, Mfd. by: Akorn, INc., Lake Forest, IL 60045. NDC: 17478-064-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0137-2023·2023-01-25

    FDA Recalls Cromolyn Sodium Eye Drops Nationwide for Manufacturing Defects

    Akorn, Inc. is recalling 188,550 bottles of Cromolyn Sodium Ophthalmic Solution nationwide due to manufacturing quality control deviations.

    Product
    Cromolyn Sodium Ophthalmic Solution, USP 4%, 10mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-291-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0142-2023·2023-01-25

    Akorn recalls Levofloxacin eye drops due to manufacturing compliance issues

    Akorn, Inc. is recalling Levofloxacin Ophthalmic Solution due to manufacturing process deviations. The voluntary recall affects 3,108 bottles distributed nationwide.

    Product
    Levofloxacin Ophthalmic Solution 0.5%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, Il 60045. NDC: 17478-106-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0144-2023·2023-01-25

    Akorn Recalls Moxifloxacin Ophthalmic Solution for CGMP Deviations

    Akorn, Inc. is recalling 2,563 bottles of Moxifloxacin Ophthalmic Solution nationwide due to manufacturing deviations. The recall is voluntary and affects lot 1E28A with expiration date 4/30/2023.

    Product
    Moxifloxacin Ophthalmic Solution, USP, 0.5%, 3 mL per dropper bottle, Rx only, Manufactured by: Akorn, Lake Forest, IL 60045. NDC: 17478-519-19
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0146-2023·2023-01-25

    Ofloxacin Ophthalmic Solution Recalled Nationwide for Manufacturing Quality Issues

    Akorn, Inc. is recalling Ofloxacin Ophthalmic Solution 0.3% due to manufacturing quality deviations. The recall affects 65,006 bottles distributed nationwide.

    Product
    Ofloxacin Ophthalmic Solution, USP 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045; Distributed by: MWI, Boise, ID 83705. NDC: 13985-602-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0154-2023·2023-01-25

    Drug recall: Proparacaine eye solution due to manufacturing deviations

    Akorn, Inc. is recalling Proparacaine Hydrochloride Ophthalmic Solution due to manufacturing process deviations. The voluntary recall affects 23,026 bottles distributed nationwide.

    Product
    Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per bottle, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Distributed By: MWI Boise, ID 83705, NDC: 13985-611-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0277-2023·2023-01-25

    Klosterman Baking Company Breads Recalled for Insanitary Handling Conditions

    Klosterman Baking Company is recalling breads and buns distributed in Indiana, Ohio, and Tennessee due to products being held under insanitary conditions.

    Product
    Breads: Milk & Egg product 8098 Clear Bag Buns 8 2.5 oz. Milk & Egg product 8099 Clear Bag Buns 8 2.65 oz Milk & Egg product 8608 Clear Bag Buns 6 1.5 oz.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0269-2023·2023-01-25

    Klosterman Cuban Bread Recalled Due to Insanitary Storage Conditions

    Klosterman Baking Company recalls 109,343 loaves of Cuban bread held under insanitary storage conditions. The affected products were distributed in Indiana, Ohio, and Tennessee between December 12 and 16.

    Product
    Breads: Cuban product 8506 Clear Bag Loaf 1 16 oz.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0160-2023·2023-01-25

    Triamterene and Hydrochlorothiazide Capsules Recalled for Failed Quality Specifications

    Lannett Company is recalling Triamterene and Hydrochlorothiazide Capsules nationwide because certain lots failed impurity and degradation quality specifications. Consumers taking affected lots should consult their pharmacist or physician.

    Product
    Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, 1000 Capsules per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC: 0527-1632-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0167-2023·2023-01-25

    SINUVA Sinus Implant Recalled for Failed Drug Release Specification

    Intersect ENT, Inc. is recalling 9,898 pouches of SINUVA sinus implants nationwide after detecting failed drug release specifications during stability testing. The implant may not deliver the medication as intended.

    Product
    SINUVA — SINUVA (MOMETASONE FUROATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0271-2023·2023-01-25

    Klosterman Baking Bagels Recalled Due to Insanitary Storage Conditions

    Klosterman Baking Company is recalling approximately 109,343 Everything bagels distributed in Indiana, Ohio, and Tennessee because products were held under insanitary conditions.

    Product
    Breads: Everything product 9545 Old World Bagels 6 4 oz.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0138-2023·2023-01-25

    Drug Recall: Erythromycin Ophthalmic Ointment Due to Manufacturing Deviations

    Akorn, Inc. recalls 1.1 million tubes of Erythromycin Ophthalmic Ointment nationwide due to manufacturing deviations. The voluntary, Class II recall was initiated by the firm.

    Product
    ERYTHROMYCIN OPHTHALMIC OINTMENT USP 0.5%, Net Weight: 3.5g (1/8 oz) per tube, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-070-35
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0151-2023·2023-01-25

    Prescription eye drop recall due to manufacturing compliance issues

    Akorn, Inc. is recalling Olopatadine HCl Ophthalmic Solution due to manufacturing process deviations. The nationwide voluntary recall involves 121,176 bottles distributed across the United States.

    Product
    Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC: 60429-957-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0155-2023·2023-01-25

    Sodium Chloride Ophthalmic Ointment Recalled for Manufacturing Deviations

    Akorn, Inc. has voluntarily recalled 524,506 tubes of Sodium Chloride Ophthalmic Ointment, USP 5%, nationwide due to Current Good Manufacturing Practice deviations.

    Product
    Sodium Chloride Ophthalmic Ointment, USP, 5%, Net Wt. 3.5 g (1/8 oz.) per tube, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-622-35
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V024000·2023-01-23

    Mack Recalls LRBE Electric Trucks Due to Cabin Heater Relay Fire Risk

    Mack Trucks is recalling 2019 and 2021-2023 LRBE electric trucks because a failing cabin heater relay can cause the coolant heater to overheat, increasing the risk of fire.

    Product
    MACK — MACK LRBE (ELECTRIC)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V023000·2023-01-23

    Autocar Recalls Trucks Due to Parking Brake Release Risk

    Autocar is recalling specific trucks because a worn parking brake valve may cause the brake to release unexpectedly, increasing the risk of a crash.

    Product
    AUTOCAR — AUTOCAR XPEDITOR, WXLL, WX, XPERT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V022000·2023-01-23

    2021 Lincoln Aviator rearview camera video output may fail

    Ford is recalling 2021 Lincoln Aviators with 360-degree camera systems because the rearview camera video may fail to display, reducing driver rear visibility and increasing crash risk.

    Product
    LINCOLN — LINCOLN, FORD AVIATOR, EXPLORER, CORSAIR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V017000·2023-01-23

    2022-2023 Isuzu N-Series and related commercial vehicles recalled for safety system miscalibration

    Certain 2022-2023 Isuzu, Chevrolet, and Hino commercial vehicles with improperly calibrated ABS and optional ADAS camera systems are being recalled. The miscalibration could prevent the automatic emergency braking and electronic steering control systems from functioning properly, increasing crash risk.

    Product
    CHEVROLET — CHEVROLET, ISUZU, HINO LOW CAB FORWARD 5500, N-SERIES, S52
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V025000·2023-01-23

    Volvo Recalls 2019-2023 VNRE Electric Trucks Due to Fire Risk

    Volvo Trucks is recalling 2019-2023 VNRE electric trucks because a faulty cabin heater relay may cause the coolant heater to overheat, increasing the risk of fire.

    Product
    VOLVO — VOLVO VNRE (ELECTRIC)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V021000·2023-01-23

    2023 Ford Bronco Sport recalled for ABS module brake defect

    Ford is recalling certain 2023 Bronco Sport vehicles because valves inside the ABS module may have been damaged during manufacturing, causing an internal leak. This can lead to unexpected brake pedal travel or unexpected movement, increasing crash risk.

    Product
    FORD — FORD BRONCO SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V018000·2023-01-23

    AUTOCAR Xpeditor Trucks: Software Error in Fuel Gauge May Cause Stalling

    Autocar is recalling 2021-2023 Xpeditor natural gas vehicles due to a software error in the instrument cluster fuel gauge. The inaccurate fuel gauge may cause the vehicle to unexpectedly run out of fuel and stall, increasing crash risk.

    Product
    AUTOCAR — AUTOCAR XPEDITOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateNHTSA·23V016000·2023-01-23

    2022 Subaru WRX Owner's Manual Contains Incorrect High Beam Assist Instructions

    Subaru is recalling 2022 WRX vehicles with Eyesight because the owner's manual contains incorrect instructions for adjusting the High Beam Assist function. Owners will receive a corrected manual insert by mail.

    Product
    SUBARU — SUBARU WRX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V014000·2023-01-20

    2021 Forest River Berkshire Coach Unintended Awning Extension Recall

    Forest River Bus is recalling certain 2021 Berkshire coaches due to a faulty retractable awning that may extend unintentionally while the vehicle is in transit. The unintended extension could distract the driver or become a road hazard, increasing the risk of a crash.

    Product
    FOREST RIVER — FOREST RIVER BERKSHIRE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V012000·2023-01-19

    Volvo Recalls 2023 Models Due to Brake Control Software Error

    Volvo is recalling 27,457 2023 vehicles because a software error may disable ABS, ESC, and traction control, increasing crash risk.

    Product
    VOLVO — VOLVO XC90, V90CC, XC60, XC40
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23100·2023-01-19

    NewCosplay Children's Sleepwear Recalled for Flammability Violation

    Weihai Juanhai Decoration Material's NewCosplay children's sleepwear fails to meet federal flammability standards, posing a burn risk. About 280 units were sold on Amazon between December 2021 and May 2022.

    Product
    Children's sleepwear
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23103·2023-01-19

    NewCosplay Children's Sleepwear Recalled for Flammability Standards Violation

    NewCosplay long-sleeved children's sleepwear fails to meet federal flammability standards and poses a burn hazard. The recalled garments were sold exclusively on Amazon from October 2021 through May 2022.

    Product
    Children's sleepwear
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23104·2023-01-19

    NewCosplay Children's Sleepwear Recalled for Flammability Standards Violation

    About 2,140 units of NewCosplay children's sleepwear fail to meet federal flammability standards and pose a burn injury risk. The recalled garments were sold on Amazon from October 2021 through May 2022.

    Product
    Children's sleepwear
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23097·2023-01-19

    Children's Pajama Sets Recalled for Flammability Standards Violation

    Selfie Craft Company children's pajama sets fail to meet federal flammability standards for sleepwear, posing a burn injury risk. About 38,740 units sold online and in boutiques from November 2017 through June 2022 are affected.

    Product
    Children's Pajama Sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23101·2023-01-19

    NewCosplay Children's Sleepwear Recalled for Flammability Standards Violation

    Hainan Chong Yu Industrial's NewCosplay children's sleepwear fails federal flammability standards and poses a burn injury risk. About 2,360 units sold on Amazon from October 2021 through May 2022 are affected.

    Product
    Children's sleepwear
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23095·2023-01-19

    Vaenait Baby Children's Robes Recalled for Flammability Hazard

    Vaenait Baby children's robes fail federal flammability standards for sleepwear, posing a burn injury risk. About 2,400 robes sold nationwide between December 2019 and June 2022 are affected.

    Product
    Children's robes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23099·2023-01-19

    NewCosplay Children's Sleepwear Recalled for Flammability Violation

    NewCosplay branded children's sleepwear fails to meet federal flammability standards, posing a burn risk. About 780 units sold on Amazon from November 2021 through May 2022 are subject to recall.

    Product
    Children's sleepwear
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23094·2023-01-19

    Taylor and Finch Six-Wick Scented Candles Recalled for Fire and Injury Hazards

    Ross Stores is recalling about 5,800 Taylor and Finch six-wick scented candles because they can combust while lit, causing the glass container to break and posing fire and injury hazards. Ross has received five reports of combustion, including one report of minor injury.

    Product
    Taylor and Finch six-wick scented candles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-01192023-01·2023-01-19

    Hy-Vee Beef Pot Roast Entrées Recalled for Undeclared Wheat Allergen

    USDA issued a public health alert for Hy-Vee beef pot roast entrées because the gravy may contain undeclared wheat. Consumers with wheat allergies should not eat these products.

    Product
    HY-VEE FRESH COMMISSARY — FSIS Issues Public Health Alert for Ready-To-Eat Hy-Vee Beef Pot Roast Entrée Products due to Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    1 state
  • HighCPSC·23096·2023-01-19

    Lifetime Brands Recalls Hot Chocolate Pots Due to Fire Hazard

    Lifetime Brands has recalled about 2,700 hot chocolate pots sold at Williams-Sonoma because they are mislabeled as microwave safe. If microwaved, the metallic paint can spark and cause a fire.

    Product
    Hot Chocolate Pots
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23105·2023-01-19

    Meguiar's Heavy Duty Headlight Sealant recalled for non-compliant packaging

    Meguiar's is recalling about 140,000 units of Heavy Duty Headlight Sealant because the packaging does not meet federal child-resistant requirements. Young children could be poisoned if they swallow the contents.

    Product
    Heavy Duty Headlight Sealant
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23098·2023-01-19

    Sakar International Recalls Three Helmet Models Due to Head Injury Risk

    Sakar International is recalling about 33,100 Credhedz Lizard, Crayola Dry-Erase, and Tony Hawk multi-purpose helmets because they do not meet federal safety standards for positional stability and retention, posing a risk of head injury in a crash.

    Product
    Credhedz Lizard Helmets, Crayola Dry Erase Helmets and Tony Hawk Multi-Purpose Helmets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23093·2023-01-19

    Vanessa 42-inch Fire Tables Recalled for Fire Hazard

    Ove Decors' Vanessa 42-inch fire tables are recalled because the gas hose can melt when contacting the heat shield, causing the table to catch fire. About 470 units sold online from April 2020 through October 2022.

    Product
    Vanessa 42-inch Fire Tables
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·23V013000·2023-01-19

    2022 Chevrolet Equinox fuel pump module may cause engine stall

    General Motors is recalling certain 2021-2022 Chevrolet Equinox and 2022 GMC Terrain vehicles because the fuel pump module may not provide sufficient fuel to the engine, causing it to stall and increasing crash risk.

    Product
    GMC — GMC, CHEVROLET TERRAIN NA, EQUINOX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0882-2023·2023-01-18

    Philips Trilogy 100 Ventilator Foam May Separate and Block Air Inlet

    Silicone sound abatement foam in some Philips Trilogy 100 ventilators may separate and block the air inlet, potentially reducing delivered therapy volume or pressure and causing device alarms.

    Product
    Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U1054260B, 1054260B, CA1054096B, BT1054260, 1054096B, R1054260, RSL1054260, CA1054096, R1054260B, R1054655TPV, AU1054096, AU1054096B, 1054096B, 1054097, BR1054096, LA1054096, CN1054096, KO1054096…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0773-2023·2023-01-18

    RSDL Reactive Skin Decontamination Lotion Kit recalled for leaking packets

    Emergent Protective Products USA Inc recalls RSDL Decontamination Lotion Kits due to complaints of leaking packets. Approximately 4,000 units were distributed to Virginia, Canada, and Switzerland.

    Product
    RSDL (Reactive Skin Decontamination Lotion) Kit, NSN 6505-21-912-5229. Used to remove and/or neutralize chemical warfare agents and T-2 Toxin from the skin.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0884-2023·2023-01-18

    Philips Garbin Ventilator Foam May Separate, Blocking Air Intake

    Silicone foam in some Philips Garbin Ventilators may separate and block the air inlet, reducing therapy volume and causing alarms. Nine units are affected.

    Product
    Philips Garbin Ventilator, Model Number 1058180B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0877-2023·2023-01-18

    Mahurkar Dialysis Catheters Recalled Due to Leaking Hub Defect

    Covidien LP is recalling Mahurkar dialysis catheters for a potential leaking condition in the hub that may cause unanticipated fluid return during use. Over 359,000 units are affected worldwide.

    Product
    MAHURKAR 13.5Fr High Flow Dual Lumen Acute Dialysis Catheter, Sterile, Single Use, Rx Only: 13.5cm, Straight Extensions, Kit - Model No. 8888135131; 13.5 cm, Curved Extensions, Kit - Model No. 8888135132; 13.5cm, Pre-Curved, Kit - Model No. 8888135133; 13.5cm, Straight…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0883-2023·2023-01-18

    Philips Trilogy 100 and 200 Ventilators Recalled for Foam Separation Risk

    Silicone foam in some Philips Trilogy 100 and 200 ventilators may separate and block the air inlet, potentially reducing therapy delivery. This is an FDA Class I recall.

    Product
    Philips Trilogy 200 Ventilator, Model Numbers 1040005, U1040005, 1040005B, U1040005B, CA1032800B, CA1032800, KO1032800, 1032800, R1032804TP, R1032804B, R1032804TPV, 1032804B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0908-2023·2023-01-18

    Philips Fetal Spiral Electrode may break off during labor monitoring

    Philips is recalling fetal spiral electrodes used for labor monitoring because the spiral tip can break off during use, requiring surgery to remove the fragment from the newborn.

    Product
    Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN: 989803137631
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0917-2023·2023-01-18

    Craniotome Attachment Ball Bearings May Separate During Surgery

    The FDA is recalling a surgical craniotome attachment after ball bearings can separate from the device. Failure to follow inspection protocols may result in serious patient injury during neurosurgery.

    Product
    6.5 cm Adult Craniotome, Thin Foot Plate Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-A-01 intended for cutting and shaping bone including the spine and cranium by trained medical/surgical personnel
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0115-2023·2023-01-18

    TriMix Injectable Medication Recalled for Lack of Sterility Assurance

    Northern VA Compounders PLLC is recalling TriMix Injection due to lack of sterility assurance. The injectable was distributed nationwide; affected patients should not use these vials and should contact their healthcare provider.

    Product
    TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 60mcg/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-0249-2023·2023-01-18

    Sanders Assorted Milk and Dark Sea Salt Caramels recalled for brush bristle contamination

    Sanders Candy LLC is recalling Sanders Assorted Milk and Dark Sea Salt Caramels nationwide and in Canada due to cleaning brush bristles found in the product. Consumers should not eat affected candy and should return it to the retailer.

    Product
    Sanders Assorted Milk and Dark Sea Salt Caramels UPC 0-35900-31080-5 7oz Gift Box UPC 0-35900-29782-3 .5OZ Silver Box UPC 0-35900-29793-9 7OZ Silver Box
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0943-2023·2023-01-18

    McCormick Medical Distribution PORT TRAY recalled for potential sterility breaches

    Stradis Healthcare is recalling McCormick Medical Distribution PORT TRAY units due to potential pinhole leaks in the outer bag that could compromise sterility. Affected units were distributed nationwide.

    Product
    McCormick Medical Distribution PORT TRAY, 25 trays per case. Distributed by McCormick Medical Distribution.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0227-2023·2023-01-18

    Pietrzyk Pierogi Recalled Due to Undeclared Soy Lecithin

    Pietrzyk Foods is recalling The Holy Gouda Pierogi due to undeclared soy lecithin. Consumers with soy allergies should not consume this product.

    Product
    PIETRZYK PIEROGI THE HOLY GOUDA PIEROGI, NET WT. 26.5oz (742g), 1 DOZEN UPC 850014236069
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0118-2023·2023-01-18

    TriMix Injectable Recalled for Lack of Sterility Assurance

    Northern VA Compounders PLLC is recalling TriMix Injection (11.8mcg/18mg/0.6mg/mL) due to lack of assured sterility. Patients using affected vials should contact their healthcare provider immediately.

    Product
    TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 11.8mcg/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
  • HighFDA (Drugs)·D-0109-2023·2023-01-18

    Prostaglandin E1 Injection Recall Due to Sterility Assurance Failure

    Northern VA Compounders has recalled Prostaglandin E1 Injection Solution due to lack of assurance of sterility in the compounding process. The affected lot was distributed nationwide.

    Product
    Prostaglandin (E1) Injection Solution, 10 mcg/ml, 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-0912-2023·2023-01-18

    Medtronic Vanta LT Neurostimulation Programmer Software Anomalies Recall

    Medtronic is recalling 362 units of the Vanta/Seqenita LT Clinician Programmer Application due to software anomalies that display error messages affecting pain therapy neurostimulation system programmer functionality.

    Product
    Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900B
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0122-2023·2023-01-18

    BiMix Injection Recalled for Lack of Assurance of Sterility

    Northern VA Compounders has recalled BiMix Injection due to lack of assurance of sterility. Patients using affected lots should consult their healthcare provider.

    Product
    BiMix Injection (Papaverine HCl/Phentolamine Mesylate) 30mg/0.5mg/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-0925-2023·2023-01-18

    Guarded Luer Connectors Recalled for Compromised Sterility in Blister Packaging

    International Medical Industries recalls 228,000 Prep-Fill Guarded Luer Connectors due to unsealed blister packages compromising product sterility. The Class II recall affects medical devices distributed nationwide.

    Product
    Prep-Fill Guarded Luer Connector (GLC): a. Part Number 57-400, Female Lock - Female Lock Guarded Luer Connector, Sterile; b. Part number 57-400W, Female Lock - Female Lock Guarded Luer Connector, Sterile; c. Part number 57-401, Female Lock - Male Lock Guarded Luer…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0125-2023·2023-01-18

    Compounded Injectable Drug Recalled for Lack of Sterility Assurance

    Northern VA Compounders PLLC is recalling 1,200 vials of BiMix STD 001 injectable nationwide due to lack of assurance of sterility. The compounded drug cannot be verified as sterile.

    Product
    BiMix STD 001 (Papaverine HCl/Phentolamine Mesylate) 30mg/1mg/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-0259-2023·2023-01-18

    Sweet Potato Biscuits Recalled Due to Unlabeled Milk and Wheat Allergens

    Hippos and Hashbrowns is recalling Take & Bake Sweet Potato Biscuits due to missing allergen labels for milk and wheat. Approximately 158 units were distributed in Texas.

    Product
    Take & Bake Sweet Potato Biscuits 44216-26522 packaged in metal tin with clear plastic nonflexible lid
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0935-2023·2023-01-18

    PICC Kit Recall: Outer Bag Pinhole Leaks May Compromise Sterility

    Stradis Healthcare is recalling PICC Kits due to potential pinhole leaks in the outer bag that may compromise kit sterility. No illnesses or injuries have been reported.

    Product
    PICC KIT, 10/CS, ACCESS MEDICAL LABEL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0260-2023·2023-01-18

    Take & Bake Maple Pecan Biscuits recalled for missing allergen labels

    Hippos and Hashbrowns is recalling Take & Bake Maple Pecan Biscuits sold in Texas because the product labels fail to declare milk and wheat allergens. Consumers with allergies should not consume this product.

    Product
    Take & Bake Maple Pecan Biscuits no UPC packaged in metal tin with clear plastic nonflexible lid
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0945-2023·2023-01-18

    Fluid Filter Transfer Kit Recalled Over Potential Sterility Breaches

    Stradis Healthcare is recalling approximately 1,175 Tacy Medical fluid filter transfer kits due to potential pinhole leaks in the outer bag that may compromise sterility. The kits were distributed nationwide in nine states.

    Product
    Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0932-2023·2023-01-18

    PHS Lacertaion Tray Sterile Kit Recall Due to Seal Leakage Risk

    Stradis Healthcare recalls PHS Lacertaion Tray sterile surgical kits due to potential pinhole leaks in outer packaging near the seal that could compromise sterility. 300 units affected across 10 US states.

    Product
    PHS Lacertaion Tray, Sterile, 20 per case, Manufactured for Professional Hosptial Supply, Inc.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0258-2023·2023-01-18

    Take & Bake Cinnabiscuits Recalled: Missing Allergen Labels for Milk and Wheat

    Hippos and Hashbrowns is recalling Take & Bake Cinnabiscuits because the product label fails to list milk and wheat as allergens. Consumers with these allergies may unknowingly consume the product.

    Product
    Take & Bake Cinnabiscuits UPC 44216-26552 packaged in metal tin with clear plastic nonflexible lid
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0112-2023·2023-01-18

    Prostaglandin E1 Injection Vials Recalled for Sterility Issues

    Northern VA Compounders PLLC is recalling Prostaglandin E1 Injection Solution vials nationwide due to lack of assurance of sterility. Patients should contact their healthcare provider.

    Product
    Prostaglandin (E1) Injection Solution, 40mcg/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-0919-2023·2023-01-18

    Anspach Adult Rotating Craniotome Attachment ball bearings may detach during surgery

    The Anspach Adult Rotating Craniotome Attachment (CRANI-A-R) may have ball bearings that detach during surgical use. The FDA recommends users follow inspection intervals to prevent potential serious patient injury.

    Product
    6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-A-R intended for cutting and shaping bone including the spine and cranium
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0930-2023·2023-01-18

    Medline CISION Sterile Surgical Blades Recalled for Sterile Packaging Breach Risk

    Medline Industries is recalling CISION Sterile Blades used in surgical procedures due to potential for the blade to puncture the sterile outer packaging, breaching sterility. No injuries reported.

    Product
    Medline CISION Sterile Blades. Labeled as follows with corresponding Item Number. a. STERILE BLADE NO. 10 CARBON STEEL, Item Number: CISION10CS; b. STERILE BLADE NO. 10 CARBON STEEL RIB, Item Number: CISION10CSR; c. STERILE BLADE NO. 11 CARBON STEEL, Item Number…
    Category
    Medical Device
    Distribution
    Distributed nationwide

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