Latest recalls of Class II devices
The 100 newest FDA recalls of Class II device types, by product code, with the 510(k)s they name.
Device class is the FDA risk class of the product code (I lowest, III highest). It is not the recall's own severity class, which the openFDA recall file does not carry.
| 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 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 | 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 | 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 | 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,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 |
| Oct 30, 2026 | NATUS MEDICAL INCORPORATED Embletta MPR PG Multi Parameter Recorder Sleep Monitor, Model/Catalog Number: 2003011 Open, Classified |
MNR | K122516 |
| Oct 30, 2026 | Smith & Nephew, Inc. EVOS 3.5MM LATERAL PROXIMAL TIBIA PLATE 6 HOLE LEFT 91MM
REF72463106 Open, Classified |
HRS | K170457 K210837 +1 |
| Oct 30, 2026 | Accriva Diagnostics, Inc. Hemochron Jr., Whole Blood Microcoagulation System, Activated Partial Thromboplastin Time (APTT) Test Cuvette, REF: J103 Open, Classified |
JPA | K940401 |
| Oct 30, 2026 | Tandem Diabetes Care, Inc. Tandem Mobi Insulin Pump, Models: 1004004, 1010750, 1012676, 1012719, 1013655, 1013656, 1013501, 1013700, 1014081, 1014801, 1014811, 1014813, 1014936, 1016911, 1016912, 1016913, 1016914, 1018075, 1018 Open, Classified |
QFG | K223213 K233044 +3 |
| Oct 29, 2026 | Stryker Leibinger GmbH & Co. KG Precision Pointer Electromagnetic (8000-050-001) Open, Classified |
HAW | K212194 |
| Oct 29, 2026 | Boston Scientific Neuromodulation Corporation Nalu TD2 Therapy Disc with firmware, REF: 34014-001, and TD2 Patient Kit, REF: 74011, part of the Nalu Neurostimulation System Open, Classified |
GZB | K233801 |
| Oct 28, 2026 | Pentax of America Inc PENTAX Medical Water bottle assembly. Model Number. OS-H5. Open, Classified |
PEA | K191282 |
| Oct 28, 2026 | Pentax of America Inc PENTAX Medical Ultrasound Endoscope. Model Number. EG-3270UK. Open, Classified |
ODG | K182004 |
| Oct 28, 2026 | Pentax of America Inc PENTAX Medical Ultrasound Endoscope. Model Numbers. EG-3870UTK, EG-3670URK. Open, Classified |
ODG | K182004 |
| Oct 28, 2026 | Pentax of America Inc PENTAX Medical Ultrasound Endoscope. Model Numbers. EG38-J10UT, EG34-J10U. Open, Classified |
ODG | K200090 |
| Oct 28, 2026 | Pentax of America Inc PENTAX Medical Ultrasound Endoscope. Model Number. EG36-J10UR. Open, Classified |
ODG | K200090 |
| Oct 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion S. Model Number: 722285. Open, Classified |
OWB | K172822 K181830 +1 |
| Oct 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 7 M20. Model Numbers: 722079, 722224, 722282. Open, Classified |
OWB | K172822 K181830 +1 |
| Oct 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 7 M12. Model Numbers: 722078, 722223. Open, Classified |
OWB | K172822 K181830 +1 |
| Oct 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 7 B20. Model Numbers: 722068, 722226. Open, Classified |
OWB | K172822 K181830 +1 |
| Oct 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 7 B12. Model Numbers: 722067, 722225. Open, Classified |
OWB | K172822 K181830 +1 |
| Oct 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 5 M20. Model Numbers: 722228, 722281. Open, Classified |
OWB | K172822 K181830 +1 |
| Oct 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 5 M12. Model Number: 722227. Open, Classified |
OWB | K172822 K181830 +1 |
| Oct 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 3 M15. Model Number: 722064, 722222, 722280. Open, Classified |
OWB | K172822 K181830 +1 |
| Oct 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 3 M12. Model Numbers: 722063, 722221. Open, Classified |
OWB | K172822 K181830 +1 |
| Oct 27, 2026 | Canon Medical System, USA, INC. ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM
REF: INFX-8000V Open, Classified |
OWB | K203551 K233107 |
| Oct 27, 2026 | Canon Medical System, USA, INC. ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM
REF: INFX-8000F Open, Classified |
OWB | K182415 |
| Oct 27, 2026 | Canon Medical System, USA, INC. ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM
REF: INFX-8000C Open, Classified |
OWB | K210900 |
| Oct 26, 2026 | Philips North America Model Number: 712010. Open, Classified |
IZL | K233678 |
| Oct 23, 2026 | ZIEHM-ORTHOSCAN INC Orthoscan VERSA Accessory Cart, REF: 1000-0021 and Versa Mini C-Arm System, REF: 1000-0020 Open, Classified |
OXO | K243452 |
| Oct 23, 2026 | Ethicon, LLC ETHILON Nylon Suture, Product Code 697G Open, Classified |
GAQ | K946173 |
| Oct 22, 2026 | AVID Medical, Inc. Halyard ANTERIOR HIP PACK. Model/Catalog Number: SOAH30. Open, Classified |
LRO | None listed |
| Oct 22, 2026 | AVID Medical, Inc. Halyard ANTERIOR HIP PACK. Model/Catalog Number: SOAH31. Open, Classified |
LRO | None listed |
| Oct 22, 2026 | Medline Industries, LP MEDLINE medical convenience kits labeled as:
1) HIP SCOPE PACK, Medline Kit Number/SKU DYNJ64103C;
2) HIP SCOPE PACK, Medline Kit Number/SKU DYNJ64155B. Open, Classified |
PUI | None listed |
| Oct 22, 2026 | Medline Industries, LP MEDLINE medical convenience kits labeled as: C-SECTION TRAY-LF, Medline Kit Number/SKU OBN471K Open, Classified |
PUI | None listed |
| Oct 22, 2026 | Medline Industries, LP MEDLINE medical convenience kits labeled as: TUBAL LIGATION RFD, Medline Product Number/SKU DYNJ906291G Open, Classified |
PUI | None listed |
| Oct 22, 2026 | Medline Industries, LP MEDLINE medical convenience kits labeled as:
(list truncated) Open, Classified |
PUI | None listed |
| Oct 22, 2026 | Medline Industries, LP MEDLINE medical convenience kits labeled as:
1) LAPAROTOMY GYN CDS, Medline Kit Number/SKU CDS983529O;
2) GYN ROBOTIC PK-LF, Medline Kit Number/SKU DYNJ52432M;
3) TAH PACK, Medline Kit Number/SKU Open, Classified |
PUI | None listed |
| Oct 22, 2026 | Medline Industries, LP MEDLINE medical convenience kits labeled as:
1) BIRTHDAY KIT-DOUBLE BASIN-LF, Medline Kit Number/SKU DYNJ16127N;
2) NYGH-DELIVERY PACK-LF, Medline Kit Number/SKU DYNJ27206D;
3) OB/GYN, Medline Kit Open, Classified |
PUI | None listed |
| Oct 22, 2026 | Medline Industries, LP MEDLINE medical convenience kits labeled as (list truncated) Open, Classified |
PUI | None listed |
| Oct 22, 2026 | Medline Industries, LP MEDLINE medical convenience kits labeled as: 1) FETAL SURGERY CDS-LF, Medline Kit Number/SKUCDS840214R;
2) MAJOR, Medline Kit Number/SKUDYNJ904851I;
3) ABDOMINAL TRANSPLANT, Medline Kit Number/SKUD Open, Classified |
PUI | None listed |
| Oct 22, 2026 | Medline Industries, LP MEDLINE medical convenience kits labeled as: C-SECTION PACK, Medline Product Number/SKU DYNJ48455A Open, Classified |
PUI | None listed |
| Oct 22, 2026 | Medline Industries, LP MEDLINE medical convenience kits labeled as: FETOSCOPY CDS-LF, Medline Product Number/SKU CDS840215P Open, Classified |
PUI | None listed |
| Oct 22, 2026 | Medline Industries, LP MEDLINE DRAPE C-SECTION FEN CLR SCREEN W, Medline Product Number/SKU DYNJP6108 Open, Classified |
PUI | None listed |
| Oct 22, 2026 | Medline Industries, LP MEDLINE DRAPE C-SEC FEN CLEAR SCRN WIRE, Medline Product Number/SKU DYNJP6106 Open, Classified |
PUI | None listed |
| Oct 22, 2026 | Medline Industries, LP MEDLINE DRAPE C-SECTION W/POUCH ST 7/CS, Medline Product Number/SKU DYNJP6101 Open, Classified |
PUI | None listed |
| Oct 22, 2026 | Medtronic MiniMed, Inc. Generic Name: MiniMed Go App
Generic Name: MiniMed Go App
Model/Catalog Number: MMT-8600 (iOS), MMT-8601 (Android)
Software Version: Software version 1.2.1
Product Description: The MiniMed Go app for Open, Classified |
NDC | K253512 |
| Oct 22, 2026 | restor3d Inc. Generic Name: restor3d MTP Implant
Generic Name: MTP Implant
Model/Catalog Number: 1103-161620
Software Version: None
Product Description: The restor3d Metatarsophalangeal (MTP) Implant is a sterile, Open, Classified |
KWD | K201393 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/TRANSEND/027/BERN/1RO/130;
Material Number: M001195940 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/TRANSEND/027/STRAIGHT/1RO/130;
Material Number: M001195910 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/BERN/1RO/155;
Material Number: M001195850 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/BERN/1RO/130;
Material Number: M001195840 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/STRAIGHT/1RO/130;
Material Number: M001195810 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/FATHOM/027/BERN/1RO/155;
Material Number: M001195750 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/FATHOM/027/BERN/1RO/130;
Material Number: M001195740 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/FATHOM/027/STRAIGHT/1RO/155;
Material Number: M001195720 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/FATHOM/027/STRAIGHT/1RO/130;
Material Number: M001195710 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/2RO/130;
Material Number: M001195670 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/2RO/130;
Material Number: M001195660 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/1RO/155;
Material Number: M001195650 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/1RO/130;
Material Number: M001195640 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/1RO/155;
Material Number: M001195620 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/1RO/130;
Material Number: M001195610 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/SWAN/1RO/155;
Material Number: M001195510 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/SWAN/1RO/130;
Material Number: M001195500 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/J/1RO/155;
Material Number: M001195480 Open, Classified |
KRA | K163701 |
More: Medical device recalls by FDA device class · Recalls within a year of 510(k) clearance · Most recalled device types by review panel · Top 510(k) applicants in the last 12 months · Latest recalls of Class III devices · Latest recalls of Class I devices · Companies with the most medical device recalls