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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.

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
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, 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, 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, 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,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
Oct 30, 2026NATUS MEDICAL INCORPORATED
Embletta MPR PG Multi Parameter Recorder Sleep Monitor, Model/Catalog Number: 2003011
Open, Classified
MNRK122516
Oct 30, 2026Smith & Nephew, Inc.
EVOS 3.5MM LATERAL PROXIMAL TIBIA PLATE 6 HOLE LEFT 91MM REF72463106
Open, Classified
HRSK170457
K210837 +1
Oct 30, 2026Accriva Diagnostics, Inc.
Hemochron Jr., Whole Blood Microcoagulation System, Activated Partial Thromboplastin Time (APTT) Test Cuvette, REF: J103
Open, Classified
JPAK940401
Oct 30, 2026Tandem 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
QFGK223213
K233044 +3
Oct 29, 2026Stryker Leibinger GmbH & Co. KG
Precision Pointer Electromagnetic (8000-050-001)
Open, Classified
HAWK212194
Oct 29, 2026Boston 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
GZBK233801
Oct 28, 2026Pentax of America Inc
PENTAX Medical Water bottle assembly. Model Number. OS-H5.
Open, Classified
PEAK191282
Oct 28, 2026Pentax of America Inc
PENTAX Medical Ultrasound Endoscope. Model Number. EG-3270UK.
Open, Classified
ODGK182004
Oct 28, 2026Pentax of America Inc
PENTAX Medical Ultrasound Endoscope. Model Numbers. EG-3870UTK, EG-3670URK.
Open, Classified
ODGK182004
Oct 28, 2026Pentax of America Inc
PENTAX Medical Ultrasound Endoscope. Model Numbers. EG38-J10UT, EG34-J10U.
Open, Classified
ODGK200090
Oct 28, 2026Pentax of America Inc
PENTAX Medical Ultrasound Endoscope. Model Number. EG36-J10UR.
Open, Classified
ODGK200090
Oct 27, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion S. Model Number: 722285.
Open, Classified
OWBK172822
K181830 +1
Oct 27, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion 7 M20. Model Numbers: 722079, 722224, 722282.
Open, Classified
OWBK172822
K181830 +1
Oct 27, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion 7 M12. Model Numbers: 722078, 722223.
Open, Classified
OWBK172822
K181830 +1
Oct 27, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion 7 B20. Model Numbers: 722068, 722226.
Open, Classified
OWBK172822
K181830 +1
Oct 27, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion 7 B12. Model Numbers: 722067, 722225.
Open, Classified
OWBK172822
K181830 +1
Oct 27, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion 5 M20. Model Numbers: 722228, 722281.
Open, Classified
OWBK172822
K181830 +1
Oct 27, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion 5 M12. Model Number: 722227.
Open, Classified
OWBK172822
K181830 +1
Oct 27, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion 3 M15. Model Number: 722064, 722222, 722280.
Open, Classified
OWBK172822
K181830 +1
Oct 27, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion 3 M12. Model Numbers: 722063, 722221.
Open, Classified
OWBK172822
K181830 +1
Oct 27, 2026Canon Medical System, USA, INC.
ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM REF: INFX-8000V
Open, Classified
OWBK203551
K233107
Oct 27, 2026Canon Medical System, USA, INC.
ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM REF: INFX-8000F
Open, Classified
OWBK182415
Oct 27, 2026Canon Medical System, USA, INC.
ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM REF: INFX-8000C
Open, Classified
OWBK210900
Oct 26, 2026Philips North America
Model Number: 712010.
Open, Classified
IZLK233678
Oct 23, 2026ZIEHM-ORTHOSCAN INC
Orthoscan VERSA Accessory Cart, REF: 1000-0021 and Versa Mini C-Arm System, REF: 1000-0020
Open, Classified
OXOK243452
Oct 23, 2026Ethicon, LLC
ETHILON Nylon Suture, Product Code 697G
Open, Classified
GAQK946173
Oct 22, 2026AVID Medical, Inc.
Halyard ANTERIOR HIP PACK. Model/Catalog Number: SOAH30.
Open, Classified
LRONone listed
Oct 22, 2026AVID Medical, Inc.
Halyard ANTERIOR HIP PACK. Model/Catalog Number: SOAH31.
Open, Classified
LRONone listed
Oct 22, 2026Medline 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
PUINone listed
Oct 22, 2026Medline Industries, LP
MEDLINE medical convenience kits labeled as: C-SECTION TRAY-LF, Medline Kit Number/SKU OBN471K
Open, Classified
PUINone listed
Oct 22, 2026Medline Industries, LP
MEDLINE medical convenience kits labeled as: TUBAL LIGATION RFD, Medline Product Number/SKU DYNJ906291G
Open, Classified
PUINone listed
Oct 22, 2026Medline Industries, LP
MEDLINE medical convenience kits labeled as: (list truncated)
Open, Classified
PUINone listed
Oct 22, 2026Medline 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
PUINone listed
Oct 22, 2026Medline 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
PUINone listed
Oct 22, 2026Medline Industries, LP
MEDLINE medical convenience kits labeled as (list truncated)
Open, Classified
PUINone listed
Oct 22, 2026Medline 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
PUINone listed
Oct 22, 2026Medline Industries, LP
MEDLINE medical convenience kits labeled as: C-SECTION PACK, Medline Product Number/SKU DYNJ48455A
Open, Classified
PUINone listed
Oct 22, 2026Medline Industries, LP
MEDLINE medical convenience kits labeled as: FETOSCOPY CDS-LF, Medline Product Number/SKU CDS840215P
Open, Classified
PUINone listed
Oct 22, 2026Medline Industries, LP
MEDLINE DRAPE C-SECTION FEN CLR SCREEN W, Medline Product Number/SKU DYNJP6108
Open, Classified
PUINone listed
Oct 22, 2026Medline Industries, LP
MEDLINE DRAPE C-SEC FEN CLEAR SCRN WIRE, Medline Product Number/SKU DYNJP6106
Open, Classified
PUINone listed
Oct 22, 2026Medline Industries, LP
MEDLINE DRAPE C-SECTION W/POUCH ST 7/CS, Medline Product Number/SKU DYNJP6101
Open, Classified
PUINone listed
Oct 22, 2026Medtronic 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
NDCK253512
Oct 22, 2026restor3d 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
KWDK201393
Oct 22, 2026Boston Scientific Cork, Ltd.
Direxion Torqueable Microcatheter, NGMC/TRANSEND/027/BERN/1RO/130; Material Number: M001195940
Open, Classified
KRAK163701
Oct 22, 2026Boston Scientific Cork, Ltd.
Direxion Torqueable Microcatheter, NGMC/TRANSEND/027/STRAIGHT/1RO/130; Material Number: M001195910
Open, Classified
KRAK163701
Oct 22, 2026Boston Scientific Cork, Ltd.
Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/BERN/1RO/155; Material Number: M001195850
Open, Classified
KRAK163701
Oct 22, 2026Boston Scientific Cork, Ltd.
Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/BERN/1RO/130; Material Number: M001195840
Open, Classified
KRAK163701
Oct 22, 2026Boston Scientific Cork, Ltd.
Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/STRAIGHT/1RO/130; Material Number: M001195810
Open, Classified
KRAK163701
Oct 22, 2026Boston Scientific Cork, Ltd.
Direxion Torqueable Microcatheter, NGMC/FATHOM/027/BERN/1RO/155; Material Number: M001195750
Open, Classified
KRAK163701
Oct 22, 2026Boston Scientific Cork, Ltd.
Direxion Torqueable Microcatheter, NGMC/FATHOM/027/BERN/1RO/130; Material Number: M001195740
Open, Classified
KRAK163701
Oct 22, 2026Boston Scientific Cork, Ltd.
Direxion Torqueable Microcatheter, NGMC/FATHOM/027/STRAIGHT/1RO/155; Material Number: M001195720
Open, Classified
KRAK163701
Oct 22, 2026Boston Scientific Cork, Ltd.
Direxion Torqueable Microcatheter, NGMC/FATHOM/027/STRAIGHT/1RO/130; Material Number: M001195710
Open, Classified
KRAK163701
Oct 22, 2026Boston Scientific Cork, Ltd.
Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/2RO/130; Material Number: M001195670
Open, Classified
KRAK163701
Oct 22, 2026Boston Scientific Cork, Ltd.
Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/2RO/130; Material Number: M001195660
Open, Classified
KRAK163701
Oct 22, 2026Boston Scientific Cork, Ltd.
Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/1RO/155; Material Number: M001195650
Open, Classified
KRAK163701
Oct 22, 2026Boston Scientific Cork, Ltd.
Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/1RO/130; Material Number: M001195640
Open, Classified
KRAK163701
Oct 22, 2026Boston Scientific Cork, Ltd.
Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/1RO/155; Material Number: M001195620
Open, Classified
KRAK163701
Oct 22, 2026Boston Scientific Cork, Ltd.
Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/1RO/130; Material Number: M001195610
Open, Classified
KRAK163701
Oct 22, 2026Boston Scientific Cork, Ltd.
Direxion Torqueable Microcatheter, NGMC/SINGLE/027/SWAN/1RO/155; Material Number: M001195510
Open, Classified
KRAK163701
Oct 22, 2026Boston Scientific Cork, Ltd.
Direxion Torqueable Microcatheter, NGMC/SINGLE/027/SWAN/1RO/130; Material Number: M001195500
Open, Classified
KRAK163701
Oct 22, 2026Boston Scientific Cork, Ltd.
Direxion Torqueable Microcatheter, NGMC/SINGLE/027/J/1RO/155; Material Number: M001195480
Open, Classified
KRAK163701

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