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 25, 2026 | American Nitrile Operations Llc Brand Name: Opportunity Flex
Product Name: Opportunity Flex
Model/Catalog Number: 72-50900, 72-50901, 72-50902, 72-50903, 72-50904
Product Description: Blue Nitrile Patient examination gloves Open, Classified |
LZA | K220825 |
| Sep 25, 2026 | American Nitrile Operations Llc Brand Name: Performance Pro
Product Name: Performance Pro
Model/Catalog Number: 72-RM50601,72-RM50602, 72-RM50603,72-RM50604
Product Description: Blue Nitrile Patient examination gloves Open, Classified |
LZA | K220825 |
| Sep 25, 2026 | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo S with software Open, Classified |
KPS | K251839 |
| Sep 25, 2026 | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo with software Open, Classified |
KPS | K241596 K243538 +1 |
| Sep 25, 2026 | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama GS with software Open, Classified |
KPS | K231572 K241585 |
| Sep 25, 2026 | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama 35 with software Open, Classified |
KPS | K223325 K232712 |
| Sep 25, 2026 | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System, Model: uMI 550 with software Open, Classified |
KPS | K182237 K193241 |
| Sep 25, 2026 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model: uCT ATLAS Astound with software Open, Classified |
JAK | K203448 K231482 +1 |
| Sep 25, 2026 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model: uCT ATLAS with software Open, Classified |
JAK | K203448 K231482 +1 |
| Sep 25, 2026 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model: uCT 780 with software Open, Classified |
JAK | K172135 K230162 +2 |
| Sep 25, 2026 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model: uCT 760 with software Open, Classified |
JAK | K172135 K230162 |
| Sep 25, 2026 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model: uCT 550 with software Open, Classified |
JAK | K181414 K200016 +1 |
| Sep 25, 2026 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model: uCT 530 with software Open, Classified |
JAK | K181414 K200016 |
| Sep 25, 2026 | Volcano Corp Philips IntraSight Plus
REF: 797423 and 797417
100-120v-220-240v,50/60hZ, 1000 VA Open, Classified |
IYO | K253714 |
| Sep 25, 2026 | Heraeus Medical GmbH (Dental Division) PALACOS MV pro 40; PALACOS MV pro 80. Model/Catalog Number: 5150633; 5150635.
Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitabl Open, Classified |
LOD | K213812 |
| Sep 25, 2026 | Heraeus Medical GmbH (Dental Division) PALACOS MV+G pro 40; PALACOS MV+G pro 80. Model/Catalog Number: 5081290; 5081291.
Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suit Open, Classified |
MBB | K210607 |
| Sep 25, 2026 | Heraeus Medical GmbH (Dental Division) PALACOS R+G pro 40; PALACOS R+G pro 80. Model/Catalog Number: 5081288; 5081289.
Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suita Open, Classified |
MBB | K210607 |
| Sep 25, 2026 | Heraeus Medical GmbH (Dental Division) PALACOS R pro 40; PALACOS R pro 80. Model/Catalog Numbers: 5081286; 5081287.
Radiopaque, poly (methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable Open, Classified |
LOD | K210607 |
| Sep 25, 2026 | Bard Peripheral Vascular Inc EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model number: ENCPDRIVER) with software Open, Classified |
KNW | K252681 |
| Sep 25, 2026 | Merit Medical Systems, Inc. Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF:
S420GH/EUA, S620GH/EUA;
Embosphere 700-900 micrometer 2 mL Syringe Sterile Steam, REF: S820GH/CAB;
Embosphere 900-1200 micrometer 2 mL Open, Classified |
KRD | K181300 |
| Sep 25, 2026 | Alere San Diego, Inc. McKesson CONSULT hCG Urine Cassette, Model/ Part: FHC-A102/5001;
Alere hCG Cassette (20 mIU/mL) in Urine, Model/ Part: FHC-A102/92210;
Fisher Scientific Sure-Vue Serum/UrinehCG-STAT, Model/ Part: FHC- Open, Classified |
JHI | K062361 |
| Sep 25, 2026 | HeartSine Technologies Ltd HeartSine samaritan PAD (Public Access Defibrillator);
HeartSine SAM 350P
350P US Device, US English - 2 Min CPR
UDI-DI codes: 0506016712067
350P US Device, US English (American Airlines) - 2 Min Open, Classified |
MKJ | None listed |
| Sep 24, 2026 | Medline Industries, LP Medline Convenience Kits:
1) ANTERIOR SPINE PACK, Catalog Number: DYNJT10197;
2) CRANIOTOMY #IMF 56646-LF, Catalog Number: DYNJVB91001;
3) CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348O;
4) SLUH Open, Classified |
OJH | None listed |
| Sep 24, 2026 | Medline Industries, LP Medline Convenience Kits:
1) MAJOR NEURO VCH, Catalog Number: DYNJ39218I;
2) NEURO PACK-LF, Catalog Number: DYNJ41246F;
3) CRANIOTOMY PACK (CRSJE)227-LF, Catalog Number: DYNJ47487A;
4) MAJOR NEURO Open, Classified |
OJG | None listed |
| Sep 24, 2026 | Medline Industries, LP Medline Convenience Kits:
1) MFC CRANIOTOMY PACK, Catalog Number: DYNJT8784;
2) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348Q;
3) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348R;
4) S Open, Classified |
LRO | K213481 |
| Sep 24, 2026 | Medline Industries, LP Medline Convenience Kits:
1) MAJOR PACK, Catalog Number: DYNJ81325A Open, Classified |
FDE | None listed |
| Sep 24, 2026 | Medline Industries, LP Medline Convenience Kits:
1) PEDS SINUS PACK, Catalog Number: DYNJ02516G;
2) SINUS PACK-LF, Catalog Number: DYNJ0342705J;
3) NASAL-LF, Catalog Number: DYNJ40094G;
4) ENT PACK, Catalog Number: DYNJ5 Open, Classified |
OGR | None listed |
| Sep 24, 2026 | Baxter Healthcare Corporation PRO+ 40" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide weight-based pressure redistribution whenever a patient move Open, Classified |
IOQ | None listed |
| Sep 24, 2026 | Baxter Healthcare Corporation PRO+ 36" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide weight-based pressure redistribution whenever a patient move Open, Classified |
IOQ | None listed |
| Sep 24, 2026 | Baxter Healthcare Corporation PRO+ MRS SURFACE FOR VERSACARE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide weight-based pressure redistribution whenever a pa Open, Classified |
IOQ | None listed |
| Sep 23, 2026 | AVID Medical, Inc. Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-01 Open, Classified |
LRO | None listed |
| Sep 23, 2026 | AVID Medical, Inc. Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-02 Open, Classified |
LRO | None listed |
| Sep 23, 2026 | AVID Medical, Inc. Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator.
Kit Model Number: KRIV26-02. Open, Classified |
LRO | None listed |
| Sep 23, 2026 | New York Embroidery Studio, Inc. New York Embroidery Studio Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large. Model Number: NYES100-2.
Packaged in inner packs of 10 and 100 gowns per shipping case. Open, Classified |
OEA | None listed |
| Sep 23, 2026 | INTERVASCULAR, SAS Cardioroot Woven Collagen Coated Vascular Graft;
Model Numbers: 1. HEWROOT0024, 2. HEWROOT0026, 3. HEWROOT0028, 4. HEWROOT0030, 5. HEWROOT0032, 6. HEWROOT0034; Open, Classified |
DSY | K103347 |
| Sep 23, 2026 | Boston Scientific Corporation Imager II Angiographic Catheters
M001314001
IMAGER II/5/ST/65/038 BX5;
M001314011
IMAGER II/5/ST/100/038 BX5;
M001314021
IMAGER II/5/ST/65/035 BX 5;
M001314031
IMAGER II/5/ST/100/035 BX 5;
M00131 Open, Classified |
DQO | K121694 |
| Sep 23, 2026 | Baxter Healthcare Corporation Brand Name: VOLARA System
Product Name: VOLARA, HC, NA A
Model/Catalog Number: M08594A
Software Version: N/A
Product Description: VOLARA, HOMECARE, NORTH AMERICA
Component: No Open, Classified |
NHJ | K200988 |
| Sep 22, 2026 | DeRoyal Industries Inc REF: 81-030415
Myocardial Probe Non-Pyrogenic , 400 Series Open, Classified |
FLL | K925792 |
| Sep 22, 2026 | Cardinal Health 200, LLC Presource Convenience Kits:
1) KIT, USGPIV , Catalog Number: PVMHIVMHD;
2) KIT, USGPIV , Catalog Number: PVMHIVM14;
3) KIT, USGPIV , Catalog Num Open, Classified |
OWL | None listed |
| Sep 22, 2026 | Cardinal Health 200, LLC Presource Convenience Kits:
1) KIT, PRE OP , Catalog Number: AMN548616A;
2) KIT, NICU ADMIT NEW HAN , Catalog Number: BA1DH0116B;
3) KIT, PRE PROCEDURE , Catalog N Open, Classified |
LRP | None listed |
| Sep 22, 2026 | Criticare Technologies, Inc. nGenuity Patient Monitor with Capnography (ETCO2)
CAT 8100E1-ST-US, CAT 8100E1-US, CAT 8100EP1, CAT 8100EP1-ST, CAT 8100EP1-ST-US, CAT 8100EP1-US, CAT 8100EP1R Open, Classified |
MHX | K030613 |
| Sep 21, 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, Pack Open, Classified |
OZD | None listed |
| Sep 21, 2026 | Becton, Dickinson and Company ForeSight Elite Tissue Oximetry Cable REF HEMFSM10
UDI-DI code: 00690103210927
The non-invasive ForeSight oximeter cable is intended for use as an adjunct monitor of absolute regional hemoglobin oxyg Open, Classified |
MUD | K243781 |
| Sep 18, 2026 | Philips North America Llc SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, SmartPath to Ingenia Elition X;
Model Numbers (REF): 1. 781260 (1.5T), 2. 782112 (1.5T), 3. 782146 ( Open, Classified |
LNH | K110151 K193215 +4 |
| Sep 18, 2026 | Philips North America Llc MR 7700 and Upgrade to MR 7700;
Model Number (REF): 1. 782120, 2. 782153, 3. 782130 (Upgrade); Open, Classified |
LNH | K213516 K230972 |
| Sep 18, 2026 | Philips North America Llc MR 5300
Model Number (REF): 1. 782110, 2. 782152; Open, Classified |
LNH | K193215 K223442 +1 |
| Sep 18, 2026 | Philips North America Llc Name (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T (781295), 3. Intera 1.5T Achieva IT Nova (781175), 4. Intera 1.5T Achieva Nova (781172), 5. Intera 1.5T Achieva Nova-Dual (781173), 6. Inte Open, Classified |
LNH | K030520 K052013 +1 |
| Sep 18, 2026 | Philips North America Llc Ingenia Elition S and Ingenia Elition X;
Model Numbers (REF): 1. 781357(S), 2. 782106(S), 3. 782137(S), 4. 781358(X), 5. 782107(X), 6. 782119(X), 7. 782136(X), 8. 782158(X); Open, Classified |
LNH | K183063 K193215 +4 |
| Sep 18, 2026 | Philips North America Llc Ingenia 3.0T and Ingenia 3.0T CX;
Model Numbers (REF): 1. 781342(3.0T), 2. 781377(3.0T), 3. 782103(3.0T), 4. 781271(3.0T CX), 5. 782105(3.0T CX); Open, Classified |
LNH | K183063 K193215 +1 |
| Sep 18, 2026 | Philips North America Llc Ingenia Ambition S and Ingenia Ambition X;
Model Numbers (REF): 1. 781359 (S), 2. 782108 (S), 3. 782139 (S), 4. 781356 (X), 5. 782109 (X), 6. 782138 (X); Open, Classified |
LNH | K183063 K193215 +2 |