Safety Recall Directory
Browse and filter the latest official safety alerts globally.
Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, 722225, 722226, 722227, 722228, 722280*, 722281*, and 722282* (*These models are distributed only in China), with Software Version Number R2.2.10 and R2.1.10* (*This software version is distributed only in China); Interventional Fluoroscopic X-Ray System
Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, 722225, 722226, 722227, 722228, 722280*, 722281*, and 722282* (*These models are distributed only in China), with Software Version Number R2.2.10 and R2.1.10* (*This software version is distributed only in China); Interventional Fluoroscopic X-Ray System
Two software related issues affecting Azurion R2.2.10 Systems: 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
Avride Inc. - ADS Software May Cause Unexpected Vehicle Movement
Avride Inc. - ADS Software May Cause Unexpected Vehicle Movement
Unexpected vehicle movement may increase the risk of a crash.
SEMAGLUTIDE 7.5mg (5mg/mL), Glycine 7.5 mg (5mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-721-01
SEMAGLUTIDE 7.5mg (5mg/mL), Glycine 7.5 mg (5mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-721-01
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
SYSCO LETTUCE SALAD MIX 4/5# SYSCO LETTUCE SALAD WITH SEP BAG 4/5# Iceberg, Carrots, Red Cabbage products.
SYSCO LETTUCE SALAD MIX 4/5# SYSCO LETTUCE SALAD WITH SEP BAG 4/5# Iceberg, Carrots, Red Cabbage products.
Potential Cyclospora contamination.
Cibus Fresh, Sprig & Sprout, and Jack & Olive brand Garden Salad, 7.75oz clear plastic container, UPC 810028250253
Cibus Fresh, Sprig & Sprout, and Jack & Olive brand Garden Salad, 7.75oz clear plastic container, UPC 810028250253
Possible Cyclospora Contamination
Vodka Tomato Sauce, NET WT. 24 oz / 680g, glass jar packed 12 jars in a carton.
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
Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0 BLU 75CM C14 88861799-31
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.
SEMAGLUTIDE 0.9mg (0.9 mg/mL), 1 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-810-01
SEMAGLUTIDE 0.9mg (0.9 mg/mL), 1 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-810-01
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per dropper bottle, Sterile, Dist. by Medtech Products Inc., Tarrytown, NY 10591, a Prestige Consumer Healthcare Company. NDC: 67172-999-01 UPC 6 78112 65920 3
CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per dropper bottle, Sterile, Dist. by Medtech Products Inc., Tarrytown, NY 10591, a Prestige Consumer Healthcare Company. NDC: 67172-999-01 UPC 6 78112 65920 3
Lack of assurance of sterility. The recall is due to potential contamination
OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF: C020130-1
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.
MARKON BLEND LETT/ROM 80/20 WITH SEP BAGGIES 4/5# Iceberg, Romaine, Carrots, Red Cabbage products.
MARKON BLEND LETT/ROM 80/20 WITH SEP BAGGIES 4/5# Iceberg, Romaine, Carrots, Red Cabbage products.
Potential Cyclospora contamination.
ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000
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.
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
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.
Kian Pee Wan Capsules, 30-count bottles
Kian Pee Wan Capsules, 30-count bottles
Marketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone and cyproheptadine.
Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics
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.
Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form
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.
Grade A Brown In-shell Chicken eggs packaged in the following configurations: 1. Simple Truth, Natural Cage Free Grain Fed, Medium, 12 Eggs, Net Wt 21 oz (1lb 5oz) 596g, UPC 0 11110-87032 0. Distributed by The Kroger Co., Cincinnati, OH 45202. 2. Simple Truth, Natural Cage Free Grain Fed, Large, 12 Eggs, Net Wt 24 oz (1lb 8oz) 681g, UPC 0 11110-79770 4. Distributed by The Kroger Co., Cincinnati, OH 45202. 3. Simple Truth, Natural Cage Free Grain Fed, Large, 18 Eggs, Net Wt 36 oz (2lb 4oz) 1,031g, UPC 0 11110-89310 9. Distributed by The Kroger Co., Cincinnati, OH 45202. 4. Simple Truth, Natural Cage Free Grain Fed, Large, 24 Eggs, Net Wt 48 oz (3lb) 1,360g, UPC 0 11110-15097 4. Distributed by The Kroger Co., Cincinnati, OH 45202. 5. Grade A CFB Large Egg, Bulk - BROWN, TICTAC, 900 doz, Distributed by MPS Egg Farms 14374 E State Hwy 21, Byran, TX 77808. Keep Refrigerated.
Grade A Brown In-shell Chicken eggs packaged in the following configurations: 1. Simple Truth, Natural Cage Free Grain Fed, Medium, 12 Eggs, Net Wt 21 oz (1lb 5oz) 596g, UPC 0 11110-87032 0. Distributed by The Kroger Co., Cincinnati, OH 45202. 2. Simple Truth, Natural Cage Free Grain Fed, Large, 12 Eggs, Net Wt 24 oz (1lb 8oz) 681g, UPC 0 11110-79770 4. Distributed by The Kroger Co., Cincinnati, OH 45202. 3. Simple Truth, Natural Cage Free Grain Fed, Large, 18 Eggs, Net Wt 36 oz (2lb 4oz) 1,031g, UPC 0 11110-89310 9. Distributed by The Kroger Co., Cincinnati, OH 45202. 4. Simple Truth, Natural Cage Free Grain Fed, Large, 24 Eggs, Net Wt 48 oz (3lb) 1,360g, UPC 0 11110-15097 4. Distributed by The Kroger Co., Cincinnati, OH 45202. 5. Grade A CFB Large Egg, Bulk - BROWN, TICTAC, 900 doz, Distributed by MPS Egg Farms 14374 E State Hwy 21, Byran, TX 77808. Keep Refrigerated.
Possible Salmonella Enteritidis
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.
SYSCO LETTUCE CHOP 4/5# SYSCO LETTUCE SHRED 1/8" 4/5# Iceberg only products.
SYSCO LETTUCE CHOP 4/5# SYSCO LETTUCE SHRED 1/8" 4/5# Iceberg only products.
Potential Cyclospora contamination.
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.
Cefazolin in Dextrose, Injection, USP, 2g / 100mL (20mg / mL) Single-Dose Infusion Bag in 100mL GALAXY Plastic Container, Frozen Premix, Sterile, Rx only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-3508-41.
Cefazolin in Dextrose, Injection, USP, 2g / 100mL (20mg / mL) Single-Dose Infusion Bag in 100mL GALAXY Plastic Container, Frozen Premix, Sterile, Rx only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-3508-41.
Presence of Particulate Matter
SYSCO BLEND LETT/ROM 50/50 NOCLR 4/5# SYSCO BLEND LETT/ROM 70/30 NOCOLR 4/5# SYSCO BLEND LETT/ROM 80/20 4/5# Iceberg, Romaine products.
SYSCO BLEND LETT/ROM 50/50 NOCLR 4/5# SYSCO BLEND LETT/ROM 70/30 NOCOLR 4/5# SYSCO BLEND LETT/ROM 80/20 4/5# Iceberg, Romaine products.
Potential Cyclospora contamination.
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.
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
PEAK LETTUCE SHRED 1/8" 4/5# Iceberg only products.
PEAK LETTUCE SHRED 1/8" 4/5# Iceberg only products.
Potential Cyclospora contamination.