Vereinigte Staaten Recalls

Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count Bag, Product Number MSC351450BG4

Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration may compromise the effectiveness of disinfection, potentially allowing for the survival and persistence of pathogenic microorganisms.

Grade A White In-shell Chicken eggs packaged in the following configurations: 1. Kroger, Medium, 12 Eggs, Net Wt 21 oz (1lb 5oz) 596g, UPC 0 11110-60902 1. Distributed by The Kroger Co., Cincinnati, OH 45202. 2. Kroger, Medium, 30 Eggs, Net Wt 52.5 oz (3lb 4.5oz) 596g, UPC 0 11110-60980 9. Distributed by The Kroger Co., Cincinnati, OH 45202. 3. Kroger, Large 12 Eggs, Net Wt 24 oz (1lb 8oz) 681g, UPC 0 11110-60903 8. Distributed by The Kroger Co., Cincinnati, OH 45202. 4. Kroger, Large 18 Eggs, Net Wt 36 oz (2lb 4oz) 1.03kg, UPC 0 11110-60933 5. Distributed by The Kroger Co., Cincinnati, OH 45202. 5. Kroger, Large 60 Eggs, Net Wt 7lb 8oz (3.40kg), UPC 0 11110-60933 5. Distributed by The Kroger Co., Cincinnati, OH 45202. 6. Kroger, Extra Large 12 Eggs, Net Wt 27 oz (1lb 11oz) 766g, UPC 0 11110-60904 5. Distributed by The Kroger Co., Cincinnati, OH 45202. 7. Kroger, Jumbo 12 Eggs, Net Wt 30 oz (1lb 14oz) 851g, UPC 0 11110-60905 2. Distributed by The Kroger Co., Cincinnati, OH 45202. Packed by Tx Lic #613171, 800 Wabash Rd, N. Manchester, IN 46962. 8. Brookshire's farm fresh, Large 6 Eggs, Net Wt 12 oz (341g), UPC 0 92825-09564 4. Distributed by: Brookshire Grocery Company, P.O. Box 1411, Tyler, TX 75710-1411. 9. Brookshire's farm fresh, Large 12 Eggs, Net Wt 24 oz (1lb 8oz) 681g, UPC 0 92825-09555 2. Distributed by: Brookshire Grocery Company, P.O. Box 1411, Tyler, TX 75710-1411. 10. Brookshire's farm fresh, Large 18 Eggs, Net Wt 36 oz (2lb 4oz) 1.03kg, UPC 0 92825-09556 9. Distributed by: Brookshire Grocery Company, P.O. Box 1411, Tyler, TX 75710-1411. 11. Brookshire's farm fresh, Large 36 Total Eggs TWIN PACK (18 Each), Net Wt 36 oz (2lb 4oz) 1.03kg, UPC 0 92825-10980 8. Distributed by: Brookshire Grocery Company, P.O. Box 1411, Tyler, TX 75710-1411. 12. Super 1 Foods Large 60 Eggs, Net Wt 120 oz (7lbs8oz) 3.4kg, UPC 0 92825-09563 7. Distributed by: Brookshire Grocery Company, P.O. Box 1411, Tyler, TX 75710-1411. 13. Brookshire's farm fresh, Extra Large 18 Eggs, Net Wt 40.5 oz (2lb 8.5oz) 1.15kg, UPC 0 92825-09560 6. Distributed by: Brookshire Grocery Company, P.O. Box 1411, Tyler, TX 75710-1411. 14. Brookshire's farm fresh, Jumbo 12 Eggs, Net Wt 30 oz (1lb 14oz) 851g, UPC 0 92825-09558 3. Distributed by: Brookshire Grocery Company, P.O. Box 1411, Tyler, TX 75710-1411. Packed by MPS Egg Farms, 14374 E State Hwy 21, Byran, TX 77808. 15. Country Morning Medium 12 Eggs, Net Wt 21 oz (1lb 5oz) 596g, UPC 0 78566-00104 5. 16. Country Morning Large 12 Eggs, Net Wt 24 oz (1lb 8oz) 681g, UPC 0 78566-20000 4. 17. Country Morning Large 18 Eggs, Net Wt 36 oz (2lb 4oz) 1.03kg, UPC 0 78566-00503 6. 18. Country Morning Large 2 1/2 Dozen Eggs, UPC 0 79307-00516 2. 19. Country Morning Extra Large 12 Eggs, Net Wt 27 oz (1lb 11oz) 766g, UPC 0 78566-00102 1. 20. Country Morning Jumbo 12 Eggs, Net Wt 30 oz (1lb 14oz) 851g, UPC 0 78566-00101 4. 21. Cal-Maine Sunups 2 1/2 Dozen Eggs, UPC 0 28621-30498 7. Packed by Tx Lic #s. 0840962, 0840961 MPS Egg Farms, 2750 County Road 1011, Center, TX 75935. Bulk Product packaged as follows: 22. Medium Grade A JD 183, 15 dozen, MPS Egg Farms TX Lic. No. 0840961, 14374 E Hwy 21, Byran, TX 77808. 23. Medium Grade A JD 158, 30 dozen, MPS Egg Farms TX Lic. No. 0840961, 14374 E Hwy 21, Byran, TX 77808. 24. Large Grade A JD 193, 15 dozen, MPS Egg Farms TX Lic. No. 0840961, 14374 E Hwy 21, Byran, TX 77808. 25. Large Grade A JD 193, 30 dozen MPS Egg Farms TX Lic. No. 0840961, 14374 E Hwy 21, Byran, TX 77808. 26. Grade A Large Egg JD 208, 900 dozen, Distributed by MPS Egg Farms, 14374 E Hwy 21, Byran, TX 77808. 27. Extra Large Grade A, JD 193, 15 dozen, MPS Egg Farms TX Lic. No. 0840961, 14374 E Hwy 21, Byran, TX 77808. 28. Jumbo Grade A, JD 175, 16.67 Dozen, MPS Egg Farms TX Lic. No. 0840961, 14374 E Hwy 21, Byran, TX 77808. Keep Refrigerated at or Below 45-Degrees F.

Possible Salmonella Enteritidis

BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic

Due to increase in false negative results

Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0 BLU 75CM C14 88861799-31

Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.

E-One Incorporated - Hydraulic Valve May Fail and Prevent Outrigger Operation

The inability to extend or retract the outriggers can delay emergency response, increasing the risk of injury.

Cardinal Health Presource Kits: 1) BASIC PACK , Catalog Number: SBA73BPGCA; 2) SPINE PACK , Catalog Number: SNE11SPHKC; 3) SPINE PACK , Catalog Number: SNE11SPHKD; 4) CRANIOTOMY PACK , Catalog Number: SNE12BS01B

Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.

Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system.

Firmware issue potentially leading to loss of geometry movements.

BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US MV-BGA01095 For use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems.

Due to an increase rate of balloon pinhole defects.

V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY PASS FINAL BOX07405V1 BOX BYPASS CARDON BOX01056V2 BOX BYPASS DR LAGAE BOX01482V2 BOX BYPASS KIT DEZEMBER 2025 BOX09222V1 BOX BYPASS KIT NEU BOX 003 BOX08767V1 BOX GASTRIC BYPASS JAWBYPASS2 BOX GASTRIC BYPASS SIGNIA BOX02191V11 BOX GASTRICBYPASS KIT V4 BOX06863V4 BOX GB BOX MET LHOOK PST04884V3 BOX GB ZONDER ENDOHERNIA EGIA PST04884V6 BOX GBP SIGNIA BOX08506V2 BOX KIT COLON IHS KIT00625V1 BOX KIT HERNIA HIATO IHS KIT01026V1 BOX LAP HERNIE INGUNIAL RIGHT BOX00051V4 BOX NEW GBP KIT PST03130V2 BOX ZESTAW DO BARIATRII GB UCKGB5 BOX ZESTAW DO RYGB WEJRYGB3 VLOCL0013 V-LOC* 180 4-0 CLR 30CM P12 VLOCL0013 VLOCL0014 V-LOC* 180 3-0 CLR 30CM P12 VLOCL0014 VLOCL0023 V-LOC* 180 4-0 CLR 45CM P12 VLOCL0023 VLOCL0024 V-LOC* 180 3-0 CLR 45CM P12 VLOCL0024 VLOCL0306 V-LOC 180 DEVICE 0 15CM GS-21 VLOCL0306 VLOCL0316 V-LOC* 180 0 GRN 30CM GS21X12 VLOCL0316 VLOCL0345 V-LOC* 180 2-0 GRN 23CM GS21 VLOCL0345 VLOCL0436 V-LOC* 180 0 GRN 60CM GS25X12 VLOCL0436 VLOCL0604 V-LOC* 180 3-0 GRN 15CM V20 VLOCL0604 VLOCL0615 V-LOC* 180 2-0 GRN 30CM V20 VLOCL0615 VLOCL0625 V-LOC* 180 2-0 GRN 45CM V20 VLOCL0625 VLOCL0644 V-LOC* 180 3-0 GRN 23CM V20 VLOCL0644 VLOCL0804 V-LOC 180 3-0 GRN 15CM CV23 VLOCL0804 VLOCL2105 V-LOC* 180 2-0 GRN 15CM GS22 VLOCL2105 VLOCL2145 V-LOC* 180 2-0 GRN 23CM GS22 VLOCL2145 VLOCL2246 VLOC180 0 GRN 9 GS-22 VLOCL2246

Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.

Vodka Tomato Sauce, NET WT. 24 oz / 680g, glass jar packed 12 jars in a carton.

Label declares cream and cheese, but Milk is not declared

Prince Bakery Inc Issues Allergy Alert on Undeclared Milk and Sesame in Prince Bakery Breads

Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCC

Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.

SUBWAY SHRED LETTUCE 1/4" 4/5# Iceberg only products.

Potential Cyclospora contamination.

OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF: C020130-1

There is a potential for vaginal speculums to contain a burr on the proximal plastic blade, which may introduce a sharp edge in the contact regions for both the patient and the healthcare provider.

GM Helix Implant, Endosseous Dental Implant Article No. 109.984

There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the incorrect implant is installed, the issue could cause bone compression or difficulty during installation in situations where there is sufficient bone volume

ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.

The use of a non-validated rework process for assay reagents which could lead to missed diagnosis of renal disease, inappropriate treatment decisions, or inappropriate monitoring of renal disease in intended users.

Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726A; 2) KIT,SINUS , Catalog Number: PE13SPAJA; 3) KIT,SINUS , Catalog Number: PE13SPAJB; 4) KIT, SINUS , Catalog Number: PE13SPAJC; 5) KIT,NASAL SEPTOPLASTY,F, Catalog Number: PE13SPAJC; 6) KIT,NASAL SEPTOPLASTY,F, Catalog Number: PE29NSFGP; 7) KIT, HEAD AND NECK , Catalog Number: PE33HNCR1; 8) KIT, HEAD AND NECK , Catalog Number: PE33HNCR2; 9) KIT, HEAD AND NECK , Catalog Number: PE33HNCR3; 10) KIT, HEAD AND NECK , Catalog Number: PE33HNCR4; 11) KIT, HEAD AND NECK , Catalog Number: PE33HNCRA; 12) KIT, HEAD AND NECK , Catalog Number: PE33HNCRB; 13) KIT, NASAL , Catalog Number: PE35NSB23; 14) KIT, NASAL , Catalog Number: PE35NSBLG; 15) KIT, EENT , Catalog Number: PE44EMKW8;

Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.

Optimal Balance Pharmacy Issues Voluntary Nationwide Recall of Certain Lots of Compounded Glutathione 200 mg/mL Multi-Dose Vials Due to Elevated Endotoxin Levels

Cardinal Health Presource Kits: 1) SEPTO RHINO PACK , Catalog Number: SEN73NSKCF; 2) PACK NEURO MINOR CRANIOTOMY , Catalog Number: SNE30CNOHE; 3) NEURO MAJOR 2 PACK , Catalog Number: SNE30CRJGY; 4) NEURO PACK , Catalog Number: SNE43NEE13; 5) LAMINECTOMY PACK , Catalog Number: SNE43NEE13; 7) LAMINECTOMY PACK , Catalog Number: SNE5CLPB13; 8) PEDI SPINE R , Catalog Number: SNE69PSKR4; 9) SHUNT PACK , Catalog Number: SNE7CSHY15; 10) SHUNT PACK , Catalog Number: SNE7CSHY16; 11) ENS ORTHO FUSION POSTERIEURE 3, Catalog Number: SOP30ODSCL

Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.

GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed.

10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).

SEMAGLUTIDE 5mg (1mg/mL), Glycine 25 mg (5mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202.NDC 71170-712-03

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

SILDENAFIL CITRATE USP, 1.00KG, 1.00KG-bag Net Wt. Rx only " For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO. 171599-83-0) NDC 85702-001-08.

CGMP Deviations:Noted during FDA inspection

TADALAFIL USP, 1.00 KG, 1KG(1000gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 171596-29-5), NDC 85702-001-08

CGMP Deviations:Noted during FDA inspection

GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The Glidesheath Slender is used to facilitate placing a catheter through the skin into the radial artery.

Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.