Latest device recalls
Newest first, 50 per page. Open a recall to see the 510(k) clearances it names.
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 5, 2026 | Luminex Corporation LIAISON PLEX Gram-Negative Blood Culture Assay
Catalog No. 20-005-303 Open, Classified |
NSU | K243013 |
| Nov 5, 2026 | AVID Medical, Inc. Halyard ARTHROSCOPY PACK. Model/Catalog Number: SAMM014-21. Open, Classified |
LRO | None listed |
| Nov 4, 2026 | GE Medical Systems, LLC Senographe Pristina 3D Open, Classified |
OTE | None listed |
| Nov 4, 2026 | GE Medical Systems, LLC Senographe Pristina Open, Classified |
MUE | K162268 |
| Nov 4, 2026 | GE Medical Systems, LLC Senographe Pristina Open, Classified |
MUE | K260087 |
| Nov 4, 2026 | INTELERAD MEDICAL SYSTEMS INCORPORATED intelerad IntelePACS software Open, Classified |
LLZ | K192176 |
| Nov 3, 2026 | Remel, Inc Yeastone Broth, 11ML, 10/BOX, used in antibiotic susceptibility testing of mycological clinical specimens Open, Classified |
NGZ | K090968 |
| Nov 3, 2026 | Baxter Healthcare Corporation TruSystem 7500 Hybrid Plus (FC), Fixed-Installation Operating Table Column, Model/Catalog Number: 1854087 Open, Classified |
GDC | None listed |
| Nov 3, 2026 | Baxter Healthcare Corporation Operating Table TruSystem 7000 U (dV), Model/Catalog Number: 1723633 Open, Classified |
GDC | None listed |
| Nov 3, 2026 | Baxter Healthcare Corporation Operating Table TruSystem 7000 U, Surgical table, universal, Model/Catalog Number: 1604788 Open, Classified |
GDC | None listed |
| Nov 3, 2026 | Baxter Healthcare Corporation Operating table column TS7500 MOBIUS, Hybrid operating table column, Model/Catalog Number: 1704695 Open, Classified |
GDC | None listed |
| Nov 3, 2026 | Baxter Healthcare Corporation TruSystem 7500 surgical table, Model/Catalog Number: 4091000 Open, Classified |
GDC | None listed |
| Nov 3, 2026 | Cochlear 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 |
MCM | None listed |
| Nov 3, 2026 | Baxter Healthcare Corporation Mobile column TruSystem 7500 U, Product Code 1730720 Open, Classified |
GDC | None listed |
| Nov 3, 2026 | restor3d 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 |
PHX | K243643 |
| Nov 3, 2026 | SHIMADZU 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 |
OWB | K203535 K221922 |
| Nov 3, 2026 | Henry 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 |
GAW | None listed |
| Nov 3, 2026 | Henry 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 |
GAM | None listed |
| Nov 3, 2026 | Henry 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 |
GAM | None listed |
| Nov 3, 2026 | Henry 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 |
GAM | None listed |
| Nov 3, 2026 | Henry 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 |
GAW | None listed |
| Nov 3, 2026 | Henry 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 |
GAW | None listed |
| Nov 3, 2026 | Henry 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 |
GAM | None listed |
| Nov 3, 2026 | Henry 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 |
GAP | None listed |
| Nov 3, 2026 | Henry 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 |
GAW | None listed |
| Nov 3, 2026 | Henry 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 |
GAP | None listed |
| Nov 3, 2026 | Henry 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 |
GAP | None listed |
| Nov 3, 2026 | Henry 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 |
GAM | None listed |
| Nov 3, 2026 | Henry 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 |
GAW | None listed |
| Nov 3, 2026 | Baxter Healthcare Corporation TruSystem 7000 U Operating Table (dV), Product Code 1723633 Open, Classified |
GDC | None listed |
| Nov 3, 2026 | AVID Medical, Inc. Halyard MINOR PACK. Model/Catalog Number: VASF105-08. Open, Classified |
LRO | None listed |
| Nov 3, 2026 | CORIN MEDICAL, LTD. Unity Knee ASC Modular Handle included in the Corin UNITY ASC INSTRUMENT SYSTEM. Part Number: 1232040. Open, Classified |
JWH | K113060 |
| Nov 2, 2026 | Cardinal 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 |
OKI | None listed |
| Nov 2, 2026 | Cardinal 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 |
OHM | None listed |
| Nov 2, 2026 | Cardinal 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 |
MLS | None listed |
| Nov 2, 2026 | Edwards 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 |
NPU | None listed |
| Nov 2, 2026 | Cardinal 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 |
OKE | None listed |
| Nov 2, 2026 | Cardinal 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 |
LRS | None listed |
| Nov 2, 2026 | Cardinal 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 |
LRP | None listed |
| Nov 2, 2026 | Cardinal 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 |
LRO | None listed |
| Nov 2, 2026 | Cardinal 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 |
OEZ | None listed |
| Nov 2, 2026 | Cardinal 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 |
OES | None listed |
| Nov 2, 2026 | Cardinal 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 |
OEQ | None listed |
| Nov 2, 2026 | Cardinal 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 |
OFQ | None listed |
| Oct 30, 2026 | Artivion, Inc CryoPatch SynerGraft (SG) Pulmonary Human Cardiac Patch, Model: SGP010 Open, Classified |
DXZ | K101866 |
| Oct 30, 2026 | Illumina, Inc. VeriSeq Onsite Server V2
REF: 20047000 Open, Classified |
PFF | None listed |
| Oct 30, 2026 | Illumina, Inc. Illumina DRAGEN Server for NextSeq 550Dx
REF: 20086130, Open, Classified |
PFF | None listed |
| Oct 30, 2026 | Illumina, Inc. NovaSeq 6000Dx Instrument
REF: 20068232, FOR IN VITRO DIAGNOSTIC USE Open, Classified |
PFF | None listed |
| Oct 30, 2026 | Illumina, Inc. MiSeq Dx Instrument
REF: DX-410-1001 / 15036706, FOR IN VITRO DIAGNOSTIC USE Open, Classified |
PFF | None listed |
| Oct 30, 2026 | Illumina, Inc. Nextseq 550Dx Instrument
REF: 20005715, FOR IN VITRO DIAGNOSTIC USE Open, Classified |
PFF | None listed |