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) |
|---|---|---|---|
| Sep 18, 2026 | Philips 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 |
LNH | K183063 K193215 +1 |
| Sep 18, 2026 | Philips 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 |
LNH | K213583 K251808 |
| Sep 18, 2026 | Philips North America Llc Achieva XR;
Model Numbers (REF): 1. 781153, 2. 781253; Open, Classified |
LNH | K052078 |
| Sep 18, 2026 | Philips North America Llc Achieva 3.0T;
Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 781344, 5. 781345; Open, Classified |
LNH | K052013 K052078 +1 |
| Sep 18, 2026 | Philips 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 |
LNH | K052013 K052078 +3 |
| Sep 18, 2026 | CooperVision, Inc. Brand Name: Pearle Vision 1 day
Product Name: (somofilcon A) Contact Lens
Model/Catalog Number: Pearle Vision 1 day Open, Classified |
MVN | K130331 |
| Sep 18, 2026 | Biomerieux Inc VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811 Open, Classified |
LON | None listed |
| Sep 18, 2026 | Medline Industries, LP Medline convenience kits containing Healthmark Instrument Channel Brushes.
SINUS PACK DYNJ48258D and SINUS PACK DYNJ48258F. Open, Classified |
OGR | None listed |
| Sep 18, 2026 | Medline Industries, LP Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and Sinus Pack DYNJ48258F. Open, Classified |
LRO | K213481 |
| Sep 18, 2026 | Philips Ultrasound, LLC Philips EPIQ Elite Diagnostic Ultrasound System
Model # 795234 Open, Classified |
IYN | K260123 K260680 |
| Sep 18, 2026 | Fresenius 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 |
FJK | K213992 |
| Sep 18, 2026 | Maquet SAS PowerLED 300 Concealed Lighting System (PWD30+SF W K3 SPRING ARM A2 FC3 50-100nm)
Model Numbers: 1. ARD568474114A, 2. ARD567501286; Open, Classified |
FSY | K070442 |
| Sep 18, 2026 | SEASPINE ORTHOPEDICS CORPORATION SeaSpine Mariner Deformity
Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm
REF: MD1-300010-12 Open, Classified |
NKB | K211606 |
| Sep 18, 2026 | Midmark 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 |
MWI | K161909 |
| Sep 18, 2026 | Midmark 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 |
MWI | K161909 |
| Sep 18, 2026 | Midmark 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 |
MWI | K161909 |
| Sep 18, 2026 | Ventec Life Systems, Inc. REF: HF2POSTD
HomeFill Oxygen System
HomeFill cylinder D with CGA870 Compatible Post Valve Open, Classified |
ECX | None listed |
| Sep 18, 2026 | Ventec Life Systems, Inc. REF:HF2PC9
HomeFill Oxygen System, HomeFill Cylinder M9 with Integrated Conserver Open, Classified |
ECX | None listed |
| Sep 18, 2026 | Ventec Life Systems, Inc. HF2P0ST9
HomeFill Oxygen System
HomeFill Cylinder M9 with CGA870 Compatible Post Valve Open, Classified |
ECX | None listed |
| Sep 18, 2026 | CooperSurgical, 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 |
BZD | K911780 |
| Sep 18, 2026 | CooperSurgical, 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 |
BZD | K911780 |
| Sep 18, 2026 | Midmark 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 |
MWI | K161909 |
| Sep 18, 2026 | Olympus Corporation of the Americas Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355. Open, Classified |
FGE | None listed |
| Sep 18, 2026 | Olympus Corporation of the Americas Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA. Open, Classified |
KNS | K123319 |
| Sep 18, 2026 | Olympus Corporation of the Americas Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector. Model/Catalog Number: CD-B620LA. Open, Classified |
KNS | K123319 |
| Sep 18, 2026 | Olympus Corporation of the Americas Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector. Model/Catalog Number: CD-B612LA. Open, Classified |
KNS | K123319 |
| Sep 18, 2026 | Olympus Corporation of the Americas Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector. Model/Catalog Number: CD-B610LA. Open, Classified |
KNS | K123319 |
| Sep 18, 2026 | Heidelberg 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 |
OBO | K181594 |
| Sep 17, 2026 | PI CARDIA LTD Pi-Cardia Inc.
ShortCut
REF: Z-A-20.003-US Open, Classified |
SCZ | None listed |
| Sep 17, 2026 | ICU 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 |
LHI | K162219 |
| Sep 17, 2026 | F & 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 |
JDR | None listed |
| Sep 16, 2026 | AVID Medical, Inc. Haylard UNIV IMAGING BIOPSY TRUCUSTOM;
Model/Item Number (Kit): VARV042-03; Open, Classified |
OES | None listed |
| Sep 16, 2026 | AVID Medical, Inc. Haylard BASIC BIOPSY TRAY;
Model/Item Number (Kit): PM415; Open, Classified |
LRO | None listed |
| Sep 16, 2026 | AVID Medical, Inc. Haylard CONTINUOUS NERVE BLOCK TRAY;
Model/Item Number (Kit): BMCN001-05; Open, Classified |
OGD | None listed |
| Sep 16, 2026 | AVID Medical, Inc. Haylard 18G SINGLE SHOT EPI TRAY;
Model/Item Number (Kit): DPGE002-02; Open, Classified |
OGD | None listed |
| Sep 16, 2026 | Mirion Technologies (Capintec), Inc. Captus 4000e Thyroid Uptake System, Models: 1. 5430-30151, 2. 5430-30152, 3. 5430-30154; Open, Classified |
IZD | None listed |
| Sep 16, 2026 | Abiomed, 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 |
OZD | None listed |
| Sep 16, 2026 | Abiomed, 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 |
OZD | None listed |
| Sep 16, 2026 | Abiomed, 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 |
OZD | None listed |
| Sep 16, 2026 | Medline Industries, LP Convenience kits
CATARACT PACK
DYNJ59881A Open, Classified |
OJK | None listed |
| Sep 16, 2026 | Medline Industries, LP Convenience kits
MYRINGOTOMY PACK-LF
DYNJ59097A Open, Classified |
LRO | K213481 |
| Sep 16, 2026 | Medline Industries, LP Convenience kits
MINOR PACK
DYNJ58421A
SPRINGHILL MINOR PACK
DYNJ40734F Open, Classified |
FDE | None listed |
| Sep 16, 2026 | Medline Industries, LP Convenience kits
ANESTHESIA PAIN PK LEAGUE
DYNJ67925A Open, Classified |
OFT | None listed |
| Sep 16, 2026 | Datex-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 |
BSZ | K172045 |
| Sep 16, 2026 | Datex-Ohmeda, Inc. Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000 Open, Classified |
BSZ | K172045 |
| Sep 16, 2026 | Datex-Ohmeda, Inc. Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000 Open, Classified |
BSZ | K172045 |
| Sep 16, 2026 | Datex-Ohmeda, Inc. Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000 Open, Classified |
BSZ | K172045 |
| Sep 16, 2026 | Boston 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 |
FGB | K233645 |
| Sep 16, 2026 | Stryker Sustainability Solutions REF:B5ST
Ethicon Endo-Surgery, Inc.
XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X75MM Open, Classified |
NLM | K201511 |
| Sep 16, 2026 | Stryker Sustainability Solutions REF:B5LT
Ethicon Endo-Surgery, Inc.
XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X100MM Open, Classified |
NLM | K201511 |