États-Unis Recalls

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

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.

MIDWEST POULTRY SERVC C/O H & LELECTRIC

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.

Aug 19, 2026MIDWEST POULTRY SERVC C/O H & LELECTRIC

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

Spacelabs Healthcare, Inc.

Brand Name: Xhibit Product Name: Xhibit Central Station Model/Catalog Number: 96102 Software Version: N/A Product Description: The Spacelabs Healthcare (Spacelabs) Xhibit Central Station, Model 96102. Xhibit offers remote surveillance of patient data for those patients connected to a Spacelabs Healthcare bedside monitors and telemetry systems. The DisplayPort audio/video splitter allows users to extend the audio/video source from the Xhibit to additional external displays or monitors. This extension of audio/video is for viewing only and does not allow interaction with the Xhibit. Component: The DisplayPort audio/video splitter is a 3rd party external accessory to Xhibit.

Aug 19, 2026Spacelabs Healthcare, Inc.

Brand Name: Xhibit Product Name: Xhibit Central Station Model/Catalog Number: 96102 Software Version: N/A Product Description: The Spacelabs Healthcare (Spacelabs) Xhibit Central Station, Model 96102. Xhibit offers remote surveillance of patient data for those patients connected to a Spacelabs Healthcare bedside monitors and telemetry systems. The DisplayPort audio/video splitter allows users to extend the audio/video source from the Xhibit to additional external displays or monitors. This extension of audio/video is for viewing only and does not allow interaction with the Xhibit. Component: The DisplayPort audio/video splitter is a 3rd party external accessory to Xhibit.

Due to off-the-shelf display port component that has audio/video failures

60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235 MaxPlus Ext Set w/Needleless and Y-Site REF MPX5305-C UDI-DI code: 10885403274619 9 IN Extension Set w/Max Y REF MPX5300-C UDI-DI code: 10885403237218 Intravascular Administration Set and Extension Set used to administer fluids.

BD SWITZERLAND SARL

Aug 19, 2026BD SWITZERLAND SARL

60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235 MaxPlus Ext Set w/Needleless and Y-Site REF MPX5305-C UDI-DI code: 10885403274619 9 IN Extension Set w/Max Y REF MPX5300-C UDI-DI code: 10885403237218 Intravascular Administration Set and Extension Set used to administer fluids.

Products may not have received adequate sterilization processing.

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

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.

Waldemar Link GmbH & Co. KG (Mfg Site)

Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16

Aug 19, 2026Waldemar Link GmbH & Co. KG (Mfg Site)

Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16

The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a prolonged or modified surgery as the plateau cannot be inserted and an alternative product would be needed. If the incorrect plateau were to be implanted, this is associated with increased risk of wear, which could result in a reduced standing time of the implant.

ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000

Erbe USA Inc

ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000

A strong pull on the high-pressure transfer hose of cryosurgical unit may lead to pneumatic short circuit between he gas inlet and the connector resulting in CO2 leaking into the return path, leading to excessive pressure causing the cryoprobe to rupture.

Aug 19, 2026Erbe USA Inc

V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22 GS-25 VLOCM0436 VLOCM0436 VLOCM0003 V-LOC* 90 4-0 CLR 15CM P12X12 VLOCM0003 VLOCM0013 V-LOC* 90 4-0 CLR 30CM P12X12 VLOCM0013 VLOCM0024 V-LOC* 90 3-0 CLR 45CM P12X12 VLOCM0024 VLOCM0123 V-LOC* 90 4-0 CLR 45CM P14X12 VLOCM0123 VLOCM0315 V-LOC* 90 2-0 VIO 30CM GS21 VLOCM0315 VLOCM0603 V-LOC* 90 4-0 VIO 15CM V20X12 VLOCM0603 VLOCM0604 V-LOC* 90 3-0 VIO 15CM V20X12 VLOCM0604 VLOCM1203 V-LOC* 90 4-0 VIO 15CM CV15 VLOCM1203 VLOCM2115 V-LOC* 90 2-0 VIO 30CM GS22 VLOCM2115

Covidien, LP

V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22 GS-25 VLOCM0436 VLOCM0436 VLOCM0003 V-LOC* 90 4-0 CLR 15CM P12X12 VLOCM0003 VLOCM0013 V-LOC* 90 4-0 CLR 30CM P12X12 VLOCM0013 VLOCM0024 V-LOC* 90 3-0 CLR 45CM P12X12 VLOCM0024 VLOCM0123 V-LOC* 90 4-0 CLR 45CM P14X12 VLOCM0123 VLOCM0315 V-LOC* 90 2-0 VIO 30CM GS21 VLOCM0315 VLOCM0603 V-LOC* 90 4-0 VIO 15CM V20X12 VLOCM0603 VLOCM0604 V-LOC* 90 3-0 VIO 15CM V20X12 VLOCM0604 VLOCM1203 V-LOC* 90 4-0 VIO 15CM CV15 VLOCM1203 VLOCM2115 V-LOC* 90 2-0 VIO 30CM GS22 VLOCM2115

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.

Aug 19, 2026Covidien, LP

Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form

Straumann USA LLC

Aug 19, 2026Straumann USA LLC

Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form

Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently contain implants that are 12mm in length instead of 14mm as the labeling would suggest.

Taylor Farms de Mexico S. de R.L. de C.V.

Jack in the Box 1/8" SHRED LETTUCE 4/5# Iceberg only products.

Aug 19, 2026Taylor Farms de Mexico S. de R.L. de C.V.

Jack in the Box 1/8" SHRED LETTUCE 4/5# Iceberg only products.

Potential Cyclospora contamination.

Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMB

Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMB

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

Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics

Remel Europe Ltd.

Aug 19, 2026Remel Europe Ltd.

Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics

Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not positive to ATCC13102 within 60 Seconds.

Taylor Farms de Mexico S. de R.L. de C.V.

Cross Valley Farms BLEND LETT/ROM 80/20 WITH SEP BAGGIES 4/5# Iceberg, Romaine, Carrots, Red Cabbage products.

Aug 19, 2026Taylor Farms de Mexico S. de R.L. de C.V.

Cross Valley Farms BLEND LETT/ROM 80/20 WITH SEP BAGGIES 4/5# Iceberg, Romaine, Carrots, Red Cabbage products.

Potential Cyclospora contamination.

Taylor Farms de Mexico S. de R.L. de C.V.

SYSCO LETTUCE SALAD MIX 4/5# SYSCO LETTUCE SALAD WITH SEP BAG 4/5# Iceberg, Carrots, Red Cabbage products.

Aug 19, 2026Taylor Farms de Mexico S. de R.L. de C.V.

SYSCO LETTUCE SALAD MIX 4/5# SYSCO LETTUCE SALAD WITH SEP BAG 4/5# Iceberg, Carrots, Red Cabbage products.

Potential Cyclospora contamination.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Version Numbers: R3.0 and R3.1; Interventional fluoroscopic x-ray system

Aug 19, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Version Numbers: R3.0 and R3.1; Interventional fluoroscopic x-ray system

Two software related issues: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications

W L Gore & Associates, Inc.

GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed.

Aug 19, 2026W L Gore & Associates, Inc.

GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006. 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).

Medline Micro-Kill Bleach Germicidal Bleach Wipes,7" x 8", 150 count, 150 count, Product Number MSC351400AN

Medline Industries, LP

Aug 19, 2026Medline Industries, LP

Medline Micro-Kill Bleach Germicidal Bleach Wipes,7" x 8", 150 count, 150 count, Product Number MSC351400AN

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.

Ventana Medical Systems, Inc.

navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5. Material Number 09453733001 UDI-DI Code: 761333602095AQ In the United States, navify Digital Pathology software (previously known as uPath Enterprise Software) is a component of the Roche Digital Pathology Dx device cleared by the US FDA for Whole Slide Imaging purposes. Roche Digital Pathology Dx is an automated digital slide creation, viewing, and management system.

Aug 19, 2026Ventana Medical Systems, Inc.

navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5. Material Number 09453733001 UDI-DI Code: 761333602095AQ In the United States, navify Digital Pathology software (previously known as uPath Enterprise Software) is a component of the Roche Digital Pathology Dx device cleared by the US FDA for Whole Slide Imaging purposes. Roche Digital Pathology Dx is an automated digital slide creation, viewing, and management system.

Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window

Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Number: 21-4720B; 2) TRAY FAT GRAFT ADD , Catalog Number: 21-4720C; 3) KIT,BOSC MICROLARYNGOSCOPY , Catalog Number: PECGMLBOB; 4) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAU8; 5) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAU8; 6) KIT, TRIPOINT SPINE , Catalog Number: PN1DTSLH9; 7) KIT, TRIPOINT SPINE , Catalog Number: PN1DTSLHC; 8) KIT, TRIPOINT SPINE , Catalog Number: PN1DTSLHD; 9) KIT, TRIPOINT SPINE , Catalog Number: PN1DTSLHE; 10) KIT,NEURO , Catalog Number: PN21OTMC6; 11) KIT,NEURO , Catalog Number: PN21OTMC7; 12) KIT,NEURO , Catalog Number: PN21OTMCC; 13) KIT,NEURO , Catalog Number: PN21OTMCD; 14) KIT, MER CRANI , Catalog Number: PN33CRMYB; 15) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCHB; 16) KIT, CRANIOTOMY , Catalog Number: PN40CKC27; 17) KIT, CRANIOTOMY , Catalog Number: PN40CKC28; 18) KIT, CRANIOTOMY , Catalog Number: PN40CKC29; 19) KIT, CRANIOTOMY , Catalog Number: PN40CKCFC; 20) KIT, BAL LUMBAR LAMINECTOMY , Catalog Number: PNCGLLBMB; 21) KIT, BAL LUMBAR LAMINECTOMY , Catalog Number: PNCGLLBMC; 22) BASIC PACK , Catalog Number: SBA73BPGCA; 23) FACIAL FEMINIZATION PACK , Catalog Number: SBA73FFKW9; 24) E BASIC MILLER PACK , Catalog Number: SBA95BMHH6; 25) E BASIC MILLER PACK , Catalog Number: SBA95BMHH7; 26) E BASIC MILLER PACK , Catalog Number: SBA95BMHH8; 27) E BASIC MILLER PACK , Catalog Number: SBA95BMHHF; 28) E BASIC MILLER PACK , Catalog Number: SBA95BMHHG; 29) E BASIC MILLER PACK , Catalog Number: SBA95BMHHH; 30) TRAM PACK , Catalog Number: SBA95TPD10; 31) TRAM PACK , Catalog Number: SBA95TPD11; 32) TRAM PACK , Catalog Number: SBA95TPDU6; 33) TRAM PACK , Catalog Number: SBA95TPDU7; 34) TRAM PACK , Catalog Number: SBA95TPDU8; 35) TRAM PACK , Catalog Number: SBA95TPDU9; 36) TRAM PACK , Catalog Number: SBA95TPDUP; 37) TRAM PACK , Catalog Number: SBA95TPDUQ; 38) PLASTIC SURGERY PACK ,

Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Number: 21-4720B; 2) TRAY FAT GRAFT ADD , Catalog Number: 21-4720C; 3) KIT,BOSC MICROLARYNGOSCOPY , Catalog Number: PECGMLBOB; 4) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAU8; 5) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAU8; 6) KIT, TRIPOINT SPINE , Catalog Number: PN1DTSLH9; 7) KIT, TRIPOINT SPINE , Catalog Number: PN1DTSLHC; 8) KIT, TRIPOINT SPINE , Catalog Number: PN1DTSLHD; 9) KIT, TRIPOINT SPINE , Catalog Number: PN1DTSLHE; 10) KIT,NEURO , Catalog Number: PN21OTMC6; 11) KIT,NEURO , Catalog Number: PN21OTMC7; 12) KIT,NEURO , Catalog Number: PN21OTMCC; 13) KIT,NEURO , Catalog Number: PN21OTMCD; 14) KIT, MER CRANI , Catalog Number: PN33CRMYB; 15) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCHB; 16) KIT, CRANIOTOMY , Catalog Number: PN40CKC27; 17) KIT, CRANIOTOMY , Catalog Number: PN40CKC28; 18) KIT, CRANIOTOMY , Catalog Number: PN40CKC29; 19) KIT, CRANIOTOMY , Catalog Number: PN40CKCFC; 20) KIT, BAL LUMBAR LAMINECTOMY , Catalog Number: PNCGLLBMB; 21) KIT, BAL LUMBAR LAMINECTOMY , Catalog Number: PNCGLLBMC; 22) BASIC PACK , Catalog Number: SBA73BPGCA; 23) FACIAL FEMINIZATION PACK , Catalog Number: SBA73FFKW9; 24) E BASIC MILLER PACK , Catalog Number: SBA95BMHH6; 25) E BASIC MILLER PACK , Catalog Number: SBA95BMHH7; 26) E BASIC MILLER PACK , Catalog Number: SBA95BMHH8; 27) E BASIC MILLER PACK , Catalog Number: SBA95BMHHF; 28) E BASIC MILLER PACK , Catalog Number: SBA95BMHHG; 29) E BASIC MILLER PACK , Catalog Number: SBA95BMHHH; 30) TRAM PACK , Catalog Number: SBA95TPD10; 31) TRAM PACK , Catalog Number: SBA95TPD11; 32) TRAM PACK , Catalog Number: SBA95TPDU6; 33) TRAM PACK , Catalog Number: SBA95TPDU7; 34) TRAM PACK , Catalog Number: SBA95TPDU8; 35) TRAM PACK , Catalog Number: SBA95TPDU9; 36) TRAM PACK , Catalog Number: SBA95TPDUP; 37) TRAM PACK , Catalog Number: SBA95TPDUQ; 38) PLASTIC SURGERY PACK ,

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

Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC27; 2) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC28; 3) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC2C; 4) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC2D; 5) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC2D; 6) KIT, IUS NASAL , Catalog Number: PECGNSBOA; 7) KIT,NASAL FENS, SW , Catalog Number: PEMHNFMHB; 8) KIT,ENT , Catalog Number: PEMIEPHP2; 9) KIT,ENT , Catalog Number: PEMIEPHP3; 10) KIT,ENT , Catalog Number: PEMIEPHPB; 11) KIT, NASAL SINUS P, Catalog Number: PEV2CL016; 12) KIT, ENT FESS , Catalog Number: PEV2FSNYC;

Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC27; 2) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC28; 3) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC2C; 4) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC2D; 5) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC2D; 6) KIT, IUS NASAL , Catalog Number: PECGNSBOA; 7) KIT,NASAL FENS, SW , Catalog Number: PEMHNFMHB; 8) KIT,ENT , Catalog Number: PEMIEPHP2; 9) KIT,ENT , Catalog Number: PEMIEPHP3; 10) KIT,ENT , Catalog Number: PEMIEPHPB; 11) KIT, NASAL SINUS P, Catalog Number: PEV2CL016; 12) KIT, ENT FESS , Catalog Number: PEV2FSNYC;

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

Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP (Kit-075-03) Sheath with Dilator , Stiffen Dilator, Nitinol Mandrel Wire w/ Radiopaque Tip [Au}, Needle, Extension Tube with Stopcock

Galt Medical Corporation

Aug 19, 2026Galt Medical Corporation

Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP (Kit-075-03) Sheath with Dilator , Stiffen Dilator, Nitinol Mandrel Wire w/ Radiopaque Tip [Au}, Needle, Extension Tube with Stopcock

Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits.

Baxter Healthcare Corporation

Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration Sets

FDA DevicesClass I

Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration Sets

Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed at the fully open position.

Aug 19, 2026Baxter Healthcare Corporation

Spectra Medical Devices, Llc

Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Catalog Number: AMPUL10MLK. Sodium Chloride Flush for IV tubing systems and indwelling intravascular access devices.

FDA DevicesClass I

Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Catalog Number: AMPUL10MLK. Sodium Chloride Flush for IV tubing systems and indwelling intravascular access devices.

Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matter. This may trigger inflammatory responses, infections, micro-clots, and organ failure.

Aug 19, 2026Spectra Medical Devices, Llc

Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX

Covidien, LP