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 25, 2026American 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
LZAK220825
Sep 25, 2026American 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
LZAK220825
Sep 25, 2026Shanghai United Imaging Healthcare Co., Ltd.
Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo S with software
Open, Classified
KPSK251839
Sep 25, 2026Shanghai United Imaging Healthcare Co., Ltd.
Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo with software
Open, Classified
KPSK241596
K243538 +1
Sep 25, 2026Shanghai United Imaging Healthcare Co., Ltd.
Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama GS with software
Open, Classified
KPSK231572
K241585
Sep 25, 2026Shanghai United Imaging Healthcare Co., Ltd.
Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama 35 with software
Open, Classified
KPSK223325
K232712
Sep 25, 2026Shanghai United Imaging Healthcare Co., Ltd.
Positron Emission Tomography and Computed Tomography System, Model: uMI 550 with software
Open, Classified
KPSK182237
K193241
Sep 25, 2026Shanghai United Imaging Healthcare Co., Ltd.
Computed Tomography X-ray System, Model: uCT ATLAS Astound with software
Open, Classified
JAKK203448
K231482 +1
Sep 25, 2026Shanghai United Imaging Healthcare Co., Ltd.
Computed Tomography X-ray System, Model: uCT ATLAS with software
Open, Classified
JAKK203448
K231482 +1
Sep 25, 2026Shanghai United Imaging Healthcare Co., Ltd.
Computed Tomography X-ray System, Model: uCT 780 with software
Open, Classified
JAKK172135
K230162 +2
Sep 25, 2026Shanghai United Imaging Healthcare Co., Ltd.
Computed Tomography X-ray System, Model: uCT 760 with software
Open, Classified
JAKK172135
K230162
Sep 25, 2026Shanghai United Imaging Healthcare Co., Ltd.
Computed Tomography X-ray System, Model: uCT 550 with software
Open, Classified
JAKK181414
K200016 +1
Sep 25, 2026Shanghai United Imaging Healthcare Co., Ltd.
Computed Tomography X-ray System, Model: uCT 530 with software
Open, Classified
JAKK181414
K200016
Sep 25, 2026Volcano Corp
Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
Open, Classified
IYOK253714
Sep 25, 2026Heraeus 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
LODK213812
Sep 25, 2026Heraeus 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
MBBK210607
Sep 25, 2026Heraeus 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
MBBK210607
Sep 25, 2026Heraeus 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
LODK210607
Sep 25, 2026Bard Peripheral Vascular Inc
EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model number: ENCPDRIVER) with software
Open, Classified
KNWK252681
Sep 25, 2026Merit 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
KRDK181300
Sep 25, 2026Alere 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
JHIK062361
Sep 25, 2026HeartSine 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
MKJNone listed
Sep 24, 2026Medline 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
OJHNone listed
Sep 24, 2026Medline 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
OJGNone listed
Sep 24, 2026Medline 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
LROK213481
Sep 24, 2026Medline Industries, LP
Medline Convenience Kits: 1) MAJOR PACK, Catalog Number: DYNJ81325A
Open, Classified
FDENone listed
Sep 24, 2026Medline 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
OGRNone listed
Sep 24, 2026Baxter 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
IOQNone listed
Sep 24, 2026Baxter 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
IOQNone listed
Sep 24, 2026Baxter 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
IOQNone listed
Sep 23, 2026AVID 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
LRONone listed
Sep 23, 2026AVID 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
LRONone listed
Sep 23, 2026AVID 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
LRONone listed
Sep 23, 2026New 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
OEANone listed
Sep 23, 2026INTERVASCULAR, SAS
Cardioroot Woven Collagen Coated Vascular Graft; Model Numbers: 1. HEWROOT0024, 2. HEWROOT0026, 3. HEWROOT0028, 4. HEWROOT0030, 5. HEWROOT0032, 6. HEWROOT0034;
Open, Classified
DSYK103347
Sep 23, 2026Boston 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
DQOK121694
Sep 23, 2026Baxter 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
NHJK200988
Sep 22, 2026DeRoyal Industries Inc
REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series
Open, Classified
FLLK925792
Sep 22, 2026Cardinal 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
OWLNone listed
Sep 22, 2026Cardinal 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
LRPNone listed
Sep 22, 2026Criticare 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
MHXK030613
Sep 21, 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, Pack
Open, Classified
OZDNone listed
Sep 21, 2026Becton, 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
MUDK243781
Sep 18, 2026Philips 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
LNHK110151
K193215 +4
Sep 18, 2026Philips North America Llc
MR 7700 and Upgrade to MR 7700; Model Number (REF): 1. 782120, 2. 782153, 3. 782130 (Upgrade);
Open, Classified
LNHK213516
K230972
Sep 18, 2026Philips North America Llc
MR 5300 Model Number (REF): 1. 782110, 2. 782152;
Open, Classified
LNHK193215
K223442 +1
Sep 18, 2026Philips 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
LNHK030520
K052013 +1
Sep 18, 2026Philips 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
LNHK183063
K193215 +4
Sep 18, 2026Philips 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
LNHK183063
K193215 +1
Sep 18, 2026Philips 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
LNHK183063
K193215 +2