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)
Aug 12, 2026Erbe USA Inc
ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000
Open, Classified
GEHK190651
Aug 12, 2026Bioporto Diagnostics A/S
ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
Open, Classified
PIGK232761
Aug 12, 2026BioFire Diagnostics, LLC
BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic
Open, Classified
QOFNone listed
Aug 11, 2026Straumann USA LLC
Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form
Open, Classified
DZEK140878
Aug 11, 2026Waldemar Link GmbH & Co. KG (Mfg Site)
Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16
Open, Classified
KROK143179
Aug 11, 2026Baxter Healthcare Corporation
Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration Sets
Open, Classified
FPAK243529
Aug 11, 2026Spectra Medical Devices, Llc
Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Catalog Number: AMPUL10MLK. Sodium Chloride Flush for IV tubing systems and indwel
Open, Classified
NGTK082689
K103740
Aug 10, 2026OBP Medical Corporation
OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF: C020130-1
Open, Classified
HIBK091937
Aug 10, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Version Numbers: R3.0 and R3.1; Interventional fluoroscopic x-ray system
Open, Classified
OWBK200917
Aug 10, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, 722225, 722226, 722227, 722228, 722280*, 722281*, and 722282* (*These models ar
Open, Classified
OWBK163715
K172822 +1
Aug 10, 2026Straumann USA LLC
GM Helix Implant, Endosseous Dental Implant Article No. 109.984
Open, Classified
NHAK163194
Aug 10, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system.
Open, Classified
OWBK133292
K141979 +2
Aug 10, 2026Terumo Medical Corporation
GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The Glidesheath Slender is used to facilitate placing a catheter through the skin into the radial artery.
Open, Classified
DYBK173831
Aug 7, 2026Remel Europe Ltd.
Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics
Open, Classified
GTJNone listed
Aug 7, 2026Medline Industries, LP
Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count Bag, Product Number MSC351450BG4
Open, Classified
LRJNone listed
Aug 7, 2026Medline Industries, LP
Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count, Product Number MSC351450AN
Open, Classified
LRJNone listed
Aug 7, 2026Medline Industries, LP
Medline Micro-Kill Bleach Germicidal Bleach Wipes, 6" x 5", 150 count, Product Number MSC351410AN
Open, Classified
LRJNone listed
Aug 7, 2026Medline Industries, LP
Medline Micro-Kill Bleach Germicidal Bleach Wipes,7" x 8", 150 count, 150 count, Product Number MSC351400AN
Open, Classified
LRJNone listed
Aug 7, 2026Covidien, LP
Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX
Open, Classified
GAWK050947
Aug 7, 2026Covidien, LP
Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623
Open, Classified
GAWNone listed
Aug 7, 2026Covidien, LP
Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0 BLU 75CM C14 88861799-31
Open, Classified
GARK981582
Aug 7, 2026Covidien, LP
V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY PASS FINAL BOX07405V1 BOX BYPASS CARDON BOX01056V2 BOX BYPASS DR LAGAE BOX01482V2 BOX BYPASS
Open, Classified
GAMK091087
K093408
Aug 7, 2026Covidien, LP
V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22 GS-25 VLOCM0436 VLOCM0436 VLOCM0003 V-LOC* 90 4-0 CLR 15CM P12X12 VLOCM0003 VLOCM0013 V-LOC* 90 4-
Open, Classified
GAMK100257
Aug 7, 2026Galt Medical Corporation
Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP (Kit-075-03) Sheath with Dilator , Stiffen Dilator, Nitinol Mandrel Wire w/ Radiopaque Tip [Au}, Needle, Extension Tube
Open, Classified
DQXK000737
K021990
Aug 7, 2026Spacelabs Healthcare, Inc.
Brand Name: Xhibit Product Name: Xhibit Central Station Model/Catalog Number: 96102 Software Version: N/A Product Description: The Spacelabs Healthcare (Spacelabs) Xhibit Central Station, Model 96102.
Open, Classified
MHXK122146
Aug 7, 2026W L Gore & Associates, Inc.
GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed.
Open, Classified
FGEK170740
Aug 7, 2026W L Gore & Associates, Inc.
GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed.
Open, Classified
FGEK170740
Aug 7, 2026Ventana Medical Systems, Inc.
navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5. Material Number 09453733001 UDI-DI Code: 761333602095AQ In the United States, navify Dig
Open, Classified
PSYK232879
K242783
Aug 7, 2026MICROVENTION INC.
BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US MV-BGA01095 For use in facilitating the insertion and guidance of an intravascular catheter into a selected blood
Open, Classified
DQYK193607
Aug 6, 2026United Orthopedic Corp.
Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 2mm and 6mm Model/Catalog Number: 9323-5312 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Comp
Open, Classified
LXHNone listed
Aug 6, 2026Contego Medical, Inc
Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System), REF: NG-0630-140-2, NG-0640-140-2, NG-0730-140-2, NG-0740-140-2, NG-NV-
Open, Classified
NIMNone listed
Aug 6, 2026TISSIUM SA
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO6010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Open, Classified
SFDNone listed
Aug 6, 2026TISSIUM SA
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO5010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Open, Classified
SFDNone listed
Aug 6, 2026TISSIUM SA
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO4010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Open, Classified
SFDNone listed
Aug 6, 2026TISSIUM SA
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO3010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Open, Classified
SFDNone listed
Aug 6, 2026TISSIUM SA
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2075 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Open, Classified
SFDNone listed
Aug 6, 2026TISSIUM SA
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Open, Classified
SFDNone listed
Aug 6, 2026TISSIUM SA
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO1575 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Open, Classified
SFDNone listed
Aug 6, 2026TISSIUM SA
Brand Name: COAPTIUM Connect Product Name: COAPTIUM Connect Model/Catalog Number: NCOCO1510 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: N/
Open, Classified
SFDNone listed
Aug 6, 2026Freudenberg Medical, LLC
Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF
Open, Classified
EWLK932120
Aug 6, 2026Freudenberg Medical, LLC
Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF
Open, Classified
EWLK932120
Aug 6, 2026Instrumentation Laboratory
GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011 00055445010 00055445011 00055360010.A
Open, Classified
CHLK203790
Aug 6, 2026Instrumentation Laboratory
GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 00077415008 00077415010 00077430010 Product Description: The GEM Premier 7000 with iQM3 is a portable critical care sys
Open, Classified
CHLK223608
Aug 6, 2026United Orthopedic Corp.
Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 0mm and 4mm Model/Catalog Number: 9323-5310 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Comp
Open, Classified
LWHNone listed
Aug 5, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional Fluoroscopic X-Ray System.
Open, Classified
OWBK102005
K130638 +4
Aug 5, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion under the following System Descriptions and corresponding model numbers: 1. Azurion 3 M12; Model Numbers: 722063, 722221. 2. Azurion 3 M15; Model Numbers: 722064, 722222, 722280.
Open, Classified
OWBK172822
K181830 +1
Aug 5, 2026United Orthopedic Corp.
Brand Name: U2 Total Knee System Product Name: Femoral valgus offset adaptor, 2mm, 4mm, 6mm, left and Femoral valgus offset adaptor, 2mm, 4mm, 6mm, right Model/Catalog Number: 9323-5335, 9323-5337, 93
Open, Classified
LXHNone listed
Aug 5, 2026Siemens Healthcare Diagnostics, Inc.
Atellica CH Urine Albumin REF: 11537225
Open, Classified
JIRNone listed
Aug 5, 2026Beckman Coulter Inc.
REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the following instruments: - B1018-280 MicroScan autoSCAN-4 Instrument - B1018-283 MicroScan WalkAway-40 plus Instrument - B1018-2
Open, Classified
LONK201405
Aug 5, 2026Beckman Coulter Inc.
REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the following instruments: - B1018-280 MicroScan autoSCAN-4 Instrument - B1018-283 MicroScan WalkAway-40 plus Instr
Open, Classified
LONK201405