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)
Sep 18, 2026Philips North America Llc
Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S; Model Numbers (REF): 1. 781315(1.5T), 2. 781341(1.5T), 3. 781396(1.5T), 4. 782101(1.5T), 5. 782115(1.5T), 6. 782140(1.5T), 7. 781261(1.5T CX), 8. 7812
Open, Classified
LNHK183063
K193215 +1
Sep 18, 2026Philips North America Llc
Evolution upgrade 1.5T and Evolution upgrade 3.0T; Model Numbers (REF): 1. 782116 (1.5T), 2. 782148 (1.5T), 3. 782117 (3.0T), 4. 782143 (3.0T);
Open, Classified
LNHK213583
K251808
Sep 18, 2026Philips North America Llc
Achieva XR; Model Numbers (REF): 1. 781153, 2. 781253;
Open, Classified
LNHK052078
Sep 18, 2026Philips North America Llc
Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 781344, 5. 781345;
Open, Classified
LNHK052013
K052078 +1
Sep 18, 2026Philips North America Llc
Achieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T Initial system; Model Numbers (REF): 1. 781196 (Achieva 1.5T), 2. 781343 (Achieva 1.5T), 3. 781283 (Achieva 1.5T Conversion), 4. 781346 (Achieva
Open, Classified
LNHK052013
K052078 +3
Sep 18, 2026CooperVision, Inc.
Brand Name: Pearle Vision 1 day Product Name: (somofilcon A) Contact Lens Model/Catalog Number: Pearle Vision 1 day
Open, Classified
MVNK130331
Sep 18, 2026Biomerieux Inc
VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811
Open, Classified
LONNone listed
Sep 18, 2026Medline Industries, LP
Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and SINUS PACK DYNJ48258F.
Open, Classified
OGRNone listed
Sep 18, 2026Medline Industries, LP
Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and Sinus Pack DYNJ48258F.
Open, Classified
LROK213481
Sep 18, 2026Philips Ultrasound, LLC
Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234
Open, Classified
IYNK260123
K260680
Sep 18, 2026Fresenius Medical Care Renal Therapies Group, LLC
CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors; Model Number: 03-2522-1;
Open, Classified
FJKK213992
Sep 18, 2026Maquet SAS
PowerLED 300 Concealed Lighting System (PWD30+SF W K3 SPRING ARM A2 FC3 50-100nm) Model Numbers: 1. ARD568474114A, 2. ARD567501286;
Open, Classified
FSYK070442
Sep 18, 2026SEASPINE ORTHOPEDICS CORPORATION
SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12
Open, Classified
NKBK211606
Sep 18, 2026Midmark Corporation
Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients
Open, Classified
MWIK161909
Sep 18, 2026Midmark Corporation
Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients
Open, Classified
MWIK161909
Sep 18, 2026Midmark Corporation
Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients
Open, Classified
MWIK161909
Sep 18, 2026Ventec Life Systems, Inc.
REF: HF2POSTD HomeFill Oxygen System HomeFill cylinder D with CGA870 Compatible Post Valve
Open, Classified
ECXNone listed
Sep 18, 2026Ventec Life Systems, Inc.
REF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 with Integrated Conserver
Open, Classified
ECXNone listed
Sep 18, 2026Ventec Life Systems, Inc.
HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 with CGA870 Compatible Post Valve
Open, Classified
ECXNone listed
Sep 18, 2026CooperSurgical, Inc.
INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-0712, 44-0707, 44-0709, 44-0715.
Open, Classified
BZDK911780
Sep 18, 2026CooperSurgical, Inc.
INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-2707, 44-2709, 44-2710, 44-2712, 44-2715.
Open, Classified
BZDK911780
Sep 18, 2026Midmark Corporation
Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients
Open, Classified
MWIK161909
Sep 18, 2026Olympus Corporation of the Americas
Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.
Open, Classified
FGENone listed
Sep 18, 2026Olympus Corporation of the Americas
Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA.
Open, Classified
KNSK123319
Sep 18, 2026Olympus Corporation of the Americas
Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector. Model/Catalog Number: CD-B620LA.
Open, Classified
KNSK123319
Sep 18, 2026Olympus Corporation of the Americas
Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector. Model/Catalog Number: CD-B612LA.
Open, Classified
KNSK123319
Sep 18, 2026Olympus Corporation of the Americas
Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector. Model/Catalog Number: CD-B610LA.
Open, Classified
KNSK123319
Sep 18, 2026Heidelberg Engineering GmbH
Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Module Model/Catalog Number: S3610, S2610, S2000, S1610 multimodal imaging platform optimized for the posterior segment of t
Open, Classified
OBOK181594
Sep 17, 2026PI CARDIA LTD
Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US
Open, Classified
SCZNone listed
Sep 17, 2026ICU Medical, Inc.
CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes: 21-7600-24, 21-7609-24 OUS Product Codes: 21-7609-24 21-7600-24 21-7600-24 21-7600-24 21-7609-24 21-7609-24 21-7600-2
Open, Classified
LHIK162219
Sep 17, 2026F & A Foundation
Reign Medical Clench Staple System (Compression), Description/REF: 9mm x 7mm/152-30907; 11mm x 10mm/152-31110; 15mm x 12mm/152-31512; 18mm x 18mm/152-31818; 20mm x 20mm/152-32020; 9mm x 7mm/152-4090
Open, Classified
JDRNone listed
Sep 16, 2026AVID Medical, Inc.
Haylard UNIV IMAGING BIOPSY TRUCUSTOM; Model/Item Number (Kit): VARV042-03;
Open, Classified
OESNone listed
Sep 16, 2026AVID Medical, Inc.
Haylard BASIC BIOPSY TRAY; Model/Item Number (Kit): PM415;
Open, Classified
LRONone listed
Sep 16, 2026AVID Medical, Inc.
Haylard CONTINUOUS NERVE BLOCK TRAY; Model/Item Number (Kit): BMCN001-05;
Open, Classified
OGDNone listed
Sep 16, 2026AVID Medical, Inc.
Haylard 18G SINGLE SHOT EPI TRAY; Model/Item Number (Kit): DPGE002-02;
Open, Classified
OGDNone listed
Sep 16, 2026Mirion Technologies (Capintec), Inc.
Captus 4000e Thyroid Uptake System, Models: 1. 5430-30151, 2. 5430-30152, 3. 5430-30154;
Open, Classified
IZDNone listed
Sep 16, 2026Abiomed, Inc.
Impella Optical Controller, Automated Impella Controller, Impella Connect Package with the below product descriptions and corresponding Product Codes. 1. Optical, AIC, Impella Connect, Packaged, AU; P
Open, Classified
OZDNone listed
Sep 16, 2026Abiomed, Inc.
Impella Optical Controller with the below product descriptions and corresponding Product Codes. 1. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 2. Impella Optical Controller,
Open, Classified
OZDNone listed
Sep 16, 2026Abiomed, Inc.
Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged
Open, Classified
OZDNone listed
Sep 16, 2026Medline Industries, LP
Convenience kits CATARACT PACK DYNJ59881A
Open, Classified
OJKNone listed
Sep 16, 2026Medline Industries, LP
Convenience kits MYRINGOTOMY PACK-LF DYNJ59097A
Open, Classified
LROK213481
Sep 16, 2026Medline Industries, LP
Convenience kits MINOR PACK DYNJ58421A SPRINGHILL MINOR PACK DYNJ40734F
Open, Classified
FDENone listed
Sep 16, 2026Medline Industries, LP
Convenience kits ANESTHESIA PAIN PK LEAGUE DYNJ67925A
Open, Classified
OFTNone listed
Sep 16, 2026Datex-Ohmeda, Inc.
Et Control, Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents, Field replaceable unit (FRU) part numbers: 1011-8000-000-S, 5700665
Open, Classified
BSZK172045
Sep 16, 2026Datex-Ohmeda, Inc.
Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000
Open, Classified
BSZK172045
Sep 16, 2026Datex-Ohmeda, Inc.
Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000
Open, Classified
BSZK172045
Sep 16, 2026Datex-Ohmeda, Inc.
Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000
Open, Classified
BSZK172045
Sep 16, 2026Boston Scientific Corporation
Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord, (1) Power Adaptor, (1)DVI Cable, (1) DVI to HDMI Cable, (1) DisplayPort Cable REF: M0067933000, M006793300H0, M006793
Open, Classified
FGBK233645
Sep 16, 2026Stryker Sustainability Solutions
REF:B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X75MM
Open, Classified
NLMK201511
Sep 16, 2026Stryker Sustainability Solutions
REF:B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X100MM
Open, Classified
NLMK201511