|
|
FDA
Z-2916-2026
|
Medical Device |
High |
Aug 19, 2026
Recall: Jun 4, 2026
|
Details |
|
|
FDA
Z-2915-2026
|
Medical Device |
High |
Aug 19, 2026
Recall: May 22, 2026
|
Details |
|
|
FDA
Z-2944-2026
|
Medical Device |
High |
Aug 19, 2026
Recall: Jul 14, 2026
|
Details |
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.
|
FDA
Z-2935-2026
|
Medical Device |
High |
Aug 19, 2026
Recall: Jul 16, 2026
|
Details |
|
|
FDA
Z-2918-2026
|
Medical Device |
High |
Aug 19, 2026
Recall: Jun 24, 2026
|
Details |
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.
|
FDA
Z-2938-2026
|
Medical Device |
High |
Aug 19, 2026
Recall: Jun 26, 2026
|
Details |
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
|
FDA
Z-2932-2026
|
Medical Device |
High |
Aug 19, 2026
Recall: Jul 16, 2026
|
Details |
|
|
FDA
Z-2927-2026
|
Medical Device |
High |
Aug 19, 2026
Recall: Jul 17, 2026
|
Details |
|
|
FDA
Z-2923-2026
|
Medical Device |
High |
Aug 19, 2026
Recall: Jun 30, 2026
|
Details |
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)
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
|
FDA
Z-2947-2026
|
Medical Device |
High |
Aug 19, 2026
Recall: Jul 14, 2026
|
Details |
|
|
FDA
Z-2913-2026
|
Medical Device |
High |
Aug 19, 2026
Recall: Apr 20, 2026
|
Details |
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,NE
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
|
FDA
Z-2942-2026
|
Medical Device |
High |
Aug 19, 2026
Recall: Jul 14, 2026
|
Details |
Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX
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.
|
FDA
Z-2922-2026
|
Medical Device |
High |
Aug 19, 2026
Recall: Jun 24, 2026
|
Details |
|
|
FDA
Z-2917-2026
|
Medical Device |
High |
Aug 19, 2026
Recall: Jun 26, 2026
|
Details |
|
|
FDA
Z-2766-2026
|
Medical Device |
High |
Aug 19, 2026
Recall: Jun 30, 2026
|
Details |
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.
|
FDA
Z-2873-2026
|
Medical Device |
High |
Aug 19, 2026
Recall: Jul 6, 2026
|
Details |
|
|
FDA
Z-2924-2026
|
Medical Device |
High |
Aug 19, 2026
Recall: Jun 30, 2026
|
Details |
|
|
FDA
Z-2925-2026
|
Medical Device |
High |
Aug 19, 2026
Recall: Jun 30, 2026
|
Details |
|
|
FDA
Z-2930-2026
|
Medical Device |
High |
Aug 19, 2026
Recall: Jun 15, 2026
|
Details |
|
|
FDA
Z-2928-2026
|
Medical Device |
High |
Aug 19, 2026
Recall: Jun 29, 2026
|
Details |
Cardinal Health Presource Kits: 1) KIT, MER NEURO BACK , Catalog Number: PN33NBMYD; 2) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCH4; 3) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCH5; 4) KIT, ANT CERVICAL DISC , Catalog Number: PN41ACLA9; 5) KIT, ANT CERVICAL DISC , Catalog Number: PN41ACLA9; 6) KIT, ANT CERVICAL DISC , Catalog Number: PN41ACLAI; 7) KIT, LAMINECTOMY , Catalog Number: PN41LMB10; 8) KIT, LAMINECTOMY , Catalog Number: PN41LMB11; 9) KIT, LAMINECTOMY , Catalog Number: PN41LMB12; 10) KIT, NEURO LAMINECTOMY , Catalog Number: PN41LMBLC; 11) KIT, BAL CRANIOTOMY , Catalog Number: PN
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
|
FDA
Z-2948-2026
|
Medical Device |
High |
Aug 19, 2026
Recall: Jul 14, 2026
|
Details |
|
|
FDA
Z-2926-2026
|
Medical Device |
High |
Aug 19, 2026
Recall: Jun 30, 2026
|
Details |
|
|
FDA
Z-2943-2026
|
Medical Device |
High |
Aug 19, 2026
Recall: Jul 14, 2026
|
Details |
|
|
FDA
Z-2912-2026
|
Medical Device |
High |
Aug 19, 2026
Recall: Apr 30, 2026
|
Details |
|
|
FDA
Z-2919-2026
|
Medical Device |
High |
Aug 19, 2026
Recall: Jun 24, 2026
|
Details |