ClearanceBrief

Latest device recalls

Newest first, 50 per page. Open a recall to see the 510(k) clearances it names.

DateFirm and productCodeLinked 510(k)
Nov 5, 2026Luminex Corporation
LIAISON PLEX Gram-Negative Blood Culture Assay Catalog No. 20-005-303
Open, Classified
NSUK243013
Nov 5, 2026AVID Medical, Inc.
Halyard ARTHROSCOPY PACK. Model/Catalog Number: SAMM014-21.
Open, Classified
LRONone listed
Nov 4, 2026GE Medical Systems, LLC
Senographe Pristina 3D
Open, Classified
OTENone listed
Nov 4, 2026GE Medical Systems, LLC
Senographe Pristina
Open, Classified
MUEK162268
Nov 4, 2026GE Medical Systems, LLC
Senographe Pristina
Open, Classified
MUEK260087
Nov 4, 2026INTELERAD MEDICAL SYSTEMS INCORPORATED
intelerad IntelePACS software
Open, Classified
LLZK192176
Nov 3, 2026Remel, Inc
Yeastone Broth, 11ML, 10/BOX, used in antibiotic susceptibility testing of mycological clinical specimens
Open, Classified
NGZK090968
Nov 3, 2026Baxter Healthcare Corporation
TruSystem 7500 Hybrid Plus (FC), Fixed-Installation Operating Table Column, Model/Catalog Number: 1854087
Open, Classified
GDCNone listed
Nov 3, 2026Baxter Healthcare Corporation
Operating Table TruSystem 7000 U (dV), Model/Catalog Number: 1723633
Open, Classified
GDCNone listed
Nov 3, 2026Baxter Healthcare Corporation
Operating Table TruSystem 7000 U, Surgical table, universal, Model/Catalog Number: 1604788
Open, Classified
GDCNone listed
Nov 3, 2026Baxter Healthcare Corporation
Operating table column TS7500 MOBIUS, Hybrid operating table column, Model/Catalog Number: 1704695
Open, Classified
GDCNone listed
Nov 3, 2026Baxter Healthcare Corporation
TruSystem 7500 surgical table, Model/Catalog Number: 4091000
Open, Classified
GDCNone listed
Nov 3, 2026Cochlear Limited
Cochlear Nucleus Nexa cochlear implant with Contour Advance electrode REF P1979576 Model Number: CI1000 UDI-DI codes: 9321502069847 Cochlear Nucleus CI1000 Series implants are prescription only, sing
Open, Classified
MCMNone listed
Nov 3, 2026Baxter Healthcare Corporation
Mobile column TruSystem 7500 U, Product Code 1730720
Open, Classified
GDCNone listed
Nov 3, 2026restor3d Inc.
Veritas Reverse Total Shoulder Replacement, Model/Catalog Number: 3500-140C3, 3500-140U3, 3500-140C1, 3500-140U1, size 1 -2, 40mm Polymer Liner
Open, Classified
PHXK243643
Nov 3, 2026SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Trinias Opera Smart (C16s, F12s)/Opera Grand(C12s,C16s, F12s)/Smart OBL Interventional Fluoroscopic X-Ray System containing C-arm support (MH-500, MH-60),
Open, Classified
OWBK203535
K221922
Nov 3, 2026Henry Schein Inc.
Generic Name: Perma Sharp Sutures; Generic Name: Polypropylene Nonabsorbable Surgical Suture; Model/Catalog Number: PSN8695P (HSI Item No. 600-9795); Product Description: Sterile, synthetic, nonabsorb
Open, Classified
GAWNone listed
Nov 3, 2026Henry Schein Inc.
Generic Name: Perma Sharp Sutures; Generic Name: PGA Absorbable Surgical Suture; Model/Catalog Number: PSN387V (HSI Item No. 600-9683); Product Description: Sterile, synthetic, absorbable, braided 6-0
Open, Classified
GAMNone listed
Nov 3, 2026Henry Schein Inc.
Generic Name: Perma Sharp Sutures; Generic Name: PGA Absorbable Surgical Suture; Model/Catalog Number: PSN392V (HSI Item No. 600-9613); Product Description: Sterile, synthetic, absorbable, braided 4-0
Open, Classified
GAMNone listed
Nov 3, 2026Henry Schein Inc.
Generic Name: Perma Sharp Sutures; Generic Name: PGA Absorbable Surgical Suture; Model/Catalog Number: PSN388V (HSI Item No. 600-8803); Product Description: Sterile, synthetic, absorbable, braided 5-0
Open, Classified
GAMNone listed
Nov 3, 2026Henry Schein Inc.
Generic Name: Perma Sharp Sutures; Generic Name: Polypropylene Nonabsorbable Surgical Suture; Model/Catalog Number: PSN8384P (HSI Item No. 600-7664); Product Description: Sterile, synthetic, nonabsorb
Open, Classified
GAWNone listed
Nov 3, 2026Henry Schein Inc.
Generic Name: Perma Sharp Sutures; Generic Name: Polypropylene Nonabsorbable Surgical Suture; Model/Catalog Number: PSN8660P (HSI Item No. 600-7193); Product Description: Sterile, synthetic, nonabsorb
Open, Classified
GAWNone listed
Nov 3, 2026Henry Schein Inc.
Generic Name: Perma Sharp Sutures; Generic Name: PGA Absorbable Surgical Suture; Model/Catalog Number: PSN421V (HSI Item No. 600-6870); Product Description: Sterile, synthetic, absorbable, braided 5-0
Open, Classified
GAMNone listed
Nov 3, 2026Henry Schein Inc.
Generic Name: Perma Sharp Sutures; Generic Name: Silk Nonabsorbable Surgical Suture; Model/Catalog Number: PSN683S (HSI Item No. 600-6411); Product Description: Sterile, natural, nonabsorbable, braide
Open, Classified
GAPNone listed
Nov 3, 2026Henry Schein Inc.
Generic Name: Perma Sharp Sutures; Generic Name: Polypropylene Nonabsorbable Surgical Suture; Model/Catalog Number: PSN8698P (HSI Item No. 600-5659); Product Description: Sterile, synthetic, nonabsorb
Open, Classified
GAWNone listed
Nov 3, 2026Henry Schein Inc.
Generic Name: Perma Sharp Sutures; Generic Name: Silk Nonabsorbable Surgical Suture; Model/Catalog Number: PSN632S (HSI Item No. 600-3506); Product Description: Sterile, natural, nonabsorbable, braide
Open, Classified
GAPNone listed
Nov 3, 2026Henry Schein Inc.
Generic Name: Perma Sharp Sutures; Generic Name: Silk Nonabsorbable Surgical Suture; Model/Catalog Number: PSN7772S (HSI Item No. 600-3090); Product Description: Sterile, natural, nonabsorbable, braid
Open, Classified
GAPNone listed
Nov 3, 2026Henry Schein Inc.
Generic Name: Perma Sharp Sutures; Generic Name: PGA Absorbable Surgical Suture; Model/Catalog Number: PSN397V (Henry Schein Item No. 600-0331); Product Description: Sterile, synthetic, absorbable, br
Open, Classified
GAMNone listed
Nov 3, 2026Henry Schein Inc.
Generic Name: Perma Sharp Sutures; Generic Name: Polypropylene Suture; Model/Catalog Number: PSN8696P (Henry Schein Item No. 600-0115); Product Description: Sterile, non-absorbable 7-0 blue polypropyl
Open, Classified
GAWNone listed
Nov 3, 2026Baxter Healthcare Corporation
TruSystem 7000 U Operating Table (dV), Product Code 1723633
Open, Classified
GDCNone listed
Nov 3, 2026AVID Medical, Inc.
Halyard MINOR PACK. Model/Catalog Number: VASF105-08.
Open, Classified
LRONone listed
Nov 3, 2026CORIN MEDICAL, LTD.
Unity Knee ASC Modular Handle included in the Corin UNITY ASC INSTRUMENT SYSTEM. Part Number: 1232040.
Open, Classified
JWHK113060
Nov 2, 2026Cardinal Health 200, LLC
Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as: KIT EMERGENCY BASKET GENERAL, CATALOG # RES307732A
Open, Classified
OKINone listed
Nov 2, 2026Cardinal Health 200, LLC
Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as: 1) C SECTION, ADM, KIT , CATALOG #MA3HD0326B; 2) C SEC
Open, Classified
OHMNone listed
Nov 2, 2026Cardinal Health 200, LLC
Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as: 1) KIT,LABOR KIT, , CATALOG # MA1JV8300C; 2) KIT,LABOR KIT,
Open, Classified
MLSNone listed
Nov 2, 2026Edwards Lifesciences, LLC
Generic Name: Edwards Commander M Delivery System Generic Name: Edwards Commander M Delivery System Model/Catalog Number: 9880CM29A Software Version: Not applicable. Product Description: Prosthesis, m
Open, Classified
NPUNone listed
Nov 2, 2026Cardinal Health 200, LLC
Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as: SWAN GANZ, KIT, CATALOG # PC37SGPHA
Open, Classified
OKENone listed
Nov 2, 2026Cardinal Health 200, LLC
Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as: 1) IV START LD KIT , CATALOG # IVS5342277; 2) IV S
Open, Classified
LRSNone listed
Nov 2, 2026Cardinal Health 200, LLC
Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as: 1) KIT, ANTEPARTUM IV , CATALOG # MA1DH7533C; 2) KIT,
Open, Classified
LRPNone listed
Nov 2, 2026Cardinal Health 200, LLC
Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as: 1) KIT,C SECTION ADMIT,, CATALOG # MATJV8300D; 2) KIT,C SECTION
Open, Classified
LRONone listed
Nov 2, 2026Cardinal Health 200, LLC
Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as: 1) KIT, CABG, , CATALOG # PCOCCG3A12; 2) KIT, CABG,
Open, Classified
OEZNone listed
Nov 2, 2026Cardinal Health 200, LLC
Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as: KIT, CATH LAB ADMIT, CATALOG # ADMMH2133A.
Open, Classified
OESNone listed
Nov 2, 2026Cardinal Health 200, LLC
Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as: 1) STR CATH ANGIO PEDIATRIC PACK , CATALOG #SAN68PAVU3; 2) CATH A
Open, Classified
OEQNone listed
Nov 2, 2026Cardinal Health 200, LLC
Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as: 1) KIT, ANESTHESIA, CATALOG # IVSVM41612; 2) KIT, ANESTHESIA, CAT
Open, Classified
OFQNone listed
Oct 30, 2026Artivion, Inc
CryoPatch SynerGraft (SG) Pulmonary Human Cardiac Patch, Model: SGP010
Open, Classified
DXZK101866
Oct 30, 2026Illumina, Inc.
VeriSeq Onsite Server V2 REF: 20047000
Open, Classified
PFFNone listed
Oct 30, 2026Illumina, Inc.
Illumina DRAGEN Server for NextSeq 550Dx REF: 20086130,
Open, Classified
PFFNone listed
Oct 30, 2026Illumina, Inc.
NovaSeq 6000Dx Instrument REF: 20068232, FOR IN VITRO DIAGNOSTIC USE
Open, Classified
PFFNone listed
Oct 30, 2026Illumina, Inc.
MiSeq Dx Instrument REF: DX-410-1001 / 15036706, FOR IN VITRO DIAGNOSTIC USE
Open, Classified
PFFNone listed
Oct 30, 2026Illumina, Inc.
Nextseq 550Dx Instrument REF: 20005715, FOR IN VITRO DIAGNOSTIC USE
Open, Classified
PFFNone listed