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) |
|---|---|---|---|
| Aug 12, 2026 | Erbe USA Inc ERBECRYO 2 Cryosurgical Unit
Model/Catalog Number: 10402-000 Open, Classified |
GEH | K190651 |
| Aug 12, 2026 | Bioporto Diagnostics A/S ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System. Open, Classified |
PIG | K232761 |
| Aug 12, 2026 | BioFire 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 |
QOF | None listed |
| Aug 11, 2026 | Straumann 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 |
DZE | K140878 |
| Aug 11, 2026 | Waldemar 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 |
KRO | K143179 |
| Aug 11, 2026 | Baxter Healthcare Corporation Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration Sets Open, Classified |
FPA | K243529 |
| Aug 11, 2026 | Spectra 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 |
NGT | K082689 K103740 |
| Aug 10, 2026 | OBP Medical Corporation OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small
REF: C020130-1 Open, Classified |
HIB | K091937 |
| Aug 10, 2026 | PHILIPS 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 |
OWB | K200917 |
| Aug 10, 2026 | PHILIPS 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 |
OWB | K163715 K172822 +1 |
| Aug 10, 2026 | Straumann USA LLC GM Helix Implant, Endosseous Dental Implant
Article No. 109.984 Open, Classified |
NHA | K163194 |
| Aug 10, 2026 | PHILIPS 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 |
OWB | K133292 K141979 +2 |
| Aug 10, 2026 | Terumo 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 |
DYB | K173831 |
| Aug 7, 2026 | Remel Europe Ltd. Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics Open, Classified |
GTJ | None listed |
| Aug 7, 2026 | Medline Industries, LP Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count Bag, Product Number MSC351450BG4 Open, Classified |
LRJ | None listed |
| Aug 7, 2026 | Medline Industries, LP Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count, Product Number MSC351450AN Open, Classified |
LRJ | None listed |
| Aug 7, 2026 | Medline Industries, LP Medline Micro-Kill Bleach Germicidal Bleach Wipes, 6" x 5", 150 count, Product Number MSC351410AN Open, Classified |
LRJ | None listed |
| Aug 7, 2026 | Medline Industries, LP Medline Micro-Kill Bleach Germicidal Bleach Wipes,7" x 8", 150 count, 150 count, Product Number MSC351400AN Open, Classified |
LRJ | None listed |
| Aug 7, 2026 | Covidien, LP Surgipro II
S8698GX SURGIPRO II BL 5/0 18 P-13
S8698GX Open, Classified |
GAW | K050947 |
| Aug 7, 2026 | Covidien, LP Surgipro
SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36
SP-623 Open, Classified |
GAW | None listed |
| Aug 7, 2026 | Covidien, LP Dermalon
88861757-31 DERMALON* 4-0 BLU 75CM C13
88861757-31
88861799-31 DERMALON* 4-0 BLU 75CM C14
88861799-31 Open, Classified |
GAR | K981582 |
| Aug 7, 2026 | Covidien, 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 |
GAM | K091087 K093408 |
| Aug 7, 2026 | Covidien, 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 |
GAM | K100257 |
| Aug 7, 2026 | Galt 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 |
DQX | K000737 K021990 |
| Aug 7, 2026 | Spacelabs 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 |
MHX | K122146 |
| Aug 7, 2026 | W 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 |
FGE | K170740 |
| Aug 7, 2026 | W 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 |
FGE | K170740 |
| Aug 7, 2026 | Ventana 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 |
PSY | K232879 K242783 |
| Aug 7, 2026 | MICROVENTION 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 |
DQY | K193607 |
| Aug 6, 2026 | United 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 |
LXH | None listed |
| Aug 6, 2026 | Contego 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 |
NIM | None listed |
| Aug 6, 2026 | TISSIUM 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 |
SFD | None listed |
| Aug 6, 2026 | TISSIUM 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 |
SFD | None listed |
| Aug 6, 2026 | TISSIUM 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 |
SFD | None listed |
| Aug 6, 2026 | TISSIUM 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 |
SFD | None listed |
| Aug 6, 2026 | TISSIUM 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 |
SFD | None listed |
| Aug 6, 2026 | TISSIUM 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 |
SFD | None listed |
| Aug 6, 2026 | TISSIUM 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 |
SFD | None listed |
| Aug 6, 2026 | TISSIUM 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 |
SFD | None listed |
| Aug 6, 2026 | Freudenberg Medical, LLC Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm
REF: 1610-LF Open, Classified |
EWL | K932120 |
| Aug 6, 2026 | Freudenberg Medical, LLC Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm
REF: 1610-LEF Open, Classified |
EWL | K932120 |
| Aug 6, 2026 | Instrumentation Laboratory GEM Premier 5000 PAK
Part Numbers:
00055360010
00055360011
00055407504
00055415010
00055430010
00055430011
00055445010
00055445011
00055360010.A Open, Classified |
CHL | K203790 |
| Aug 6, 2026 | Instrumentation 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 |
CHL | K223608 |
| Aug 6, 2026 | United 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 |
LWH | None listed |
| Aug 5, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400.
Interventional Fluoroscopic X-Ray System. Open, Classified |
OWB | K102005 K130638 +4 |
| Aug 5, 2026 | PHILIPS 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 |
OWB | K172822 K181830 +1 |
| Aug 5, 2026 | United 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 |
LXH | None listed |
| Aug 5, 2026 | Siemens Healthcare Diagnostics, Inc. Atellica CH Urine Albumin
REF: 11537225 Open, Classified |
JIR | None listed |
| Aug 5, 2026 | Beckman 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 |
LON | K201405 |
| Aug 5, 2026 | Beckman 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 |
LON | K201405 |