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)
Oct 7, 2026AVID Medical, Inc.
HEART PREP TRAY; Model/Item Number (Kit): MECV97W;
Open, Classified
LRONone listed
Oct 7, 2026AVID Medical, Inc.
DAVINCI LAP/GYN; Model/Item Number (Kit): WRNM037-16;
Open, Classified
OKVNone listed
Oct 7, 2026AVID Medical, Inc.
PLASTICS TRAY; Model/Item Number (Kit): EURO053;
Open, Classified
LRONone listed
Oct 7, 2026AVID Medical, Inc.
LAPAROSCOPIC PROSTATECTOMY; Model/Item Number (Kit): NIHB0036-07;
Open, Classified
LRONone listed
Oct 7, 2026AVID Medical, Inc.
ROBOTIC PROSTATECTOMY PACK; Model/Item Number (Kit): NAMC423-11;
Open, Classified
OEZNone listed
Oct 7, 2026AVID Medical, Inc.
PACK OPEN HEART CFH; Model/Item Number (Kit): 1. UFCF004-06, 2. UFCF004-07;
Open, Classified
OEZNone listed
Oct 7, 2026AVID Medical, Inc.
CRANIOTOMY PACK; Model/Item Number (Kit): WRNM035-20;
Open, Classified
OJGNone listed
Oct 7, 2026AVID Medical, Inc.
ENDOVASCULAR PACK; Model/Item Number (Kit): VAPX014-04;
Open, Classified
OEZNone listed
Oct 7, 2026AVID Medical, Inc.
ADULT HEART TRAY SHANDS JACKS; Model/Item Number (Kit): SHND419-08;
Open, Classified
OEZNone listed
Oct 7, 2026AVID Medical, Inc.
GYN LAPAROSCOPY/LAPAROTOMY; Model/Item Number (Kit): 1. WRNM002-15, 2. FBCH108-03;
Open, Classified
LRONone listed
Oct 7, 2026AVID Medical, Inc.
DAVINCI TRUCUSTOM BUNDLE; Model/Item Number (Kit): 1. SAMM064-27, 2. SAMM064-28;
Open, Classified
LRONone listed
Oct 7, 2026Canon Medical System, USA, INC.
Alphenix INFX-8000C/B5
Open, Classified
OWBK210900
Oct 7, 2026POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC
SEDIPLAST; Model/Catalog Numbers: S-100 and S-1000;
Open, Classified
JPHK840500
Oct 6, 2026Onkos Surgical, Inc.
Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M
Open, Classified
LPHK212815
K223348
Oct 6, 2026Onkos Surgical, Inc.
Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M
Open, Classified
LPHK212815
K223348
Oct 6, 2026Nihon Kohden America LLC
Product Name: Nihon Kohden CNS-6200 Series Central Nurse Station, Model/Catalog Number: CN-6201 Software Version: software versions: 01-03, 01-04, 01-05, 01-06, 02-10, 02-11, and 02-40 Product Descrip
Open, Classified
MHXK102376
Oct 5, 2026Medtronic MiniMed, Inc.
Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062; MMT-8072 Product Description: The MiniMed Flex pump is an alternate controller enabled (ACE) pump inte
Open, Classified
QFGK253743
Oct 5, 2026Medline Industries, LP
Rollator, Bariatric, Basic Steel, Blue, mechanical walker with four legs and a metal frame intended for medical purposes to provide moderate weight support while walking, Product Number MDS86800XWBS
Open, Classified
ITJNone listed
Oct 5, 2026Medline Industries, LP
Rollator, Bariatric, Basic Steel, Burgundy, mechanical walker with four legs and a metal frame intended for medical purposes to provide moderate weight support while walking, Product Number MDS86800XW
Open, Classified
ITJNone listed
Oct 5, 2026Stryker Sustainability Solutions
BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007
Open, Classified
NLHK030187
Oct 2, 2026Limitless Cryo Spa LLC
Glypto Device, Glypto Cryo Machine;
Open, Classified
GEHNone listed
Oct 2, 2026Cardinal Health 200, LLC
Presource Packs containing Medtronic Microstream Components: Intubation Kit Catalog Numbers AN23366084 AN23366085 AN2336608H AN2336608J Intubating Bag Kit Catalog Number OMSVM4166A Intubation UH K
Open, Classified
LRPNone listed
Oct 2, 2026Safeguard US Operating LLC
Battle Bandage, REF: 32-700; Patrol IFAK Bag, Black - Advanced, REF: 81-125-BL; Patrol IFAK Bag, Multicam - Advanced, REF: 81-125-MC; Patrol IFAK II, Olive Drab, Stocked (Option 1), 81-129-OD; IFAK B
Open, Classified
MHWNone listed
Oct 2, 2026GRI Medical & Electronic Technology Co., Ltd.
HALYARD Laparoscopy Comprehensive Pack II REF: 49332
Open, Classified
FDENone listed
Oct 2, 2026Beckman Coulter Inc.
DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE, Part No. C63519 2. AU w/ISE, Part No. C63520
Open, Classified
JJEK220977
Oct 2, 2026Beckman Coulter Inc.
DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522 2. DxC 500 AU Module, DxC 500i, Part No. C63521 3. Access 2 Module, DxC 500i, Part No. C13252
Open, Classified
JJEK242190
Oct 2, 2026DRG International, Inc.
Sperm Ab ELISA; Model/Catalog Number: EIA-1826; Product Description: Sperm Ab ELISA (96 well plate test);
Open, Classified
DFQNone listed
Oct 2, 2026PHILIPS MEDICAL SYSTEMS
Spectral CT and Spectral CT 7500 RT; Software Version Numbers: 5.2.X (U.S.); 5.0.X, 5.2.X, 5.4.X (Outside U.S.); Model Numbers: 1. 728333 (U.S. and Outside U.S.), 2. 728340 (Outside U.S.), 3. 728344 (
Open, Classified
JAKK244008
Oct 2, 2026Steris Corporation
VERIFY Biological Steam Test Pack Model/Catalog Number: S3069
Open, Classified
FRCK854902
Oct 2, 2026Steris Corporation
VERIFY Biological Steam Test Pack Model/Catalog Number: S3065
Open, Classified
FRCK854902
Oct 2, 2026Steris Corporation
VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3061
Open, Classified
FRCK083665
Oct 2, 2026Steris Corporation
VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3060
Open, Classified
FRCK083665
Oct 2, 2026Steris Corporation
VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB007
Open, Classified
FRCK854902
Oct 2, 2026Steris Corporation
VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB006
Open, Classified
FRCK854902
Oct 2, 2026Medical Action Industries, Inc. 306
Generic Name: Kit, Urine, Clean Catch Trade Name: Kit: Urinary Clean Catch 20/cs Model/Catalog Number: 76769 Lot Number: 333606 UDI-DI: 20809160118228 Software Version: N/A
Open, Classified
OIENone listed
Oct 2, 2026QUANTUM OPS Inc
Brand Name: ADAPTABLE Beach Chair Product Name: Beach Chair surgical patient positioner Model/Catalog Number: 804-33-300 (Enovis); 3105-400-030 (Stryker); internal BC-0001 / BC-0220 Software Version
Open, Classified
BWNNone listed
Oct 1, 2026ASP Global, LLC.
Brand Name: MPR Product Name:DISPOSABLE TOURNIQUET CUFF 18" 2 LINE (10) Model/Catalog Number: DT-7218-02Q Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is u
Open, Classified
KCYNone listed
Oct 1, 2026ASP Global, LLC.
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 15" 2 LINE (10) Model/Catalog Number: DT-7115-02Q Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is u
Open, Classified
KCYNone listed
Oct 1, 2026ASP Global, LLC.
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 15" 1 LINE (10) Model/Catalog Number: DT-7115-01Q Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is us
Open, Classified
KCYNone listed
Oct 1, 2026ASP Global, LLC.
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 12" 2 LINE (10) Model/Catalog Number: DT-7112-02Q Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is us
Open, Classified
KCYNone listed
Oct 1, 2026ASP Global, LLC.
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 12" 1 LINE (10) Model/Catalog Number: DT-7112-01Q Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is us
Open, Classified
KCYNone listed
Oct 1, 2026ASP Global, LLC.
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 8" 2 LINE (10) Model/Catalog Number: DT-7108-02Q Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is use
Open, Classified
KCYNone listed
Oct 1, 2026ASP Global, LLC.
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 44" 2 LINE (10) Model/Catalog Number: DT-7044-02Q Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is us
Open, Classified
KCYNone listed
Oct 1, 2026ASP Global, LLC.
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 44" 1 LINE (10) Model/Catalog Number: DT-7044-01Q Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is us
Open, Classified
KCYNone listed
Oct 1, 2026ASP Global, LLC.
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 34" 2 LINE (10) Model/Catalog Number: DT-7034-02Q Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is us
Open, Classified
KCYNone listed
Oct 1, 2026ASP Global, LLC.
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 34" 1 LINE (10) Model/Catalog Number: DT-7034-01Q Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is us
Open, Classified
KCYNone listed
Oct 1, 2026ASP Global, LLC.
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 30" 2 LINE (10) Model/Catalog Number: DT-7030-02Q Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is us
Open, Classified
KCYNone listed
Oct 1, 2026ASP Global, LLC.
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 30" 1 LINE (10) Model/Catalog Number: DT-7030-01Q Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is us
Open, Classified
KCYNone listed
Oct 1, 2026ASP Global, LLC.
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 24" 2 LINE (10) Model/Catalog Number: DT-7024-02Q Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is us
Open, Classified
KCYNone listed
Oct 1, 2026ASP Global, LLC.
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 24" 1 LINE (10) Model/Catalog Number: DT-7024-01Q Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is us
Open, Classified
KCYNone listed