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) |
|---|---|---|---|
| Oct 7, 2026 | AVID Medical, Inc. HEART PREP TRAY;
Model/Item Number (Kit): MECV97W; Open, Classified |
LRO | None listed |
| Oct 7, 2026 | AVID Medical, Inc. DAVINCI LAP/GYN;
Model/Item Number (Kit): WRNM037-16; Open, Classified |
OKV | None listed |
| Oct 7, 2026 | AVID Medical, Inc. PLASTICS TRAY;
Model/Item Number (Kit): EURO053; Open, Classified |
LRO | None listed |
| Oct 7, 2026 | AVID Medical, Inc. LAPAROSCOPIC PROSTATECTOMY;
Model/Item Number (Kit): NIHB0036-07; Open, Classified |
LRO | None listed |
| Oct 7, 2026 | AVID Medical, Inc. ROBOTIC PROSTATECTOMY PACK;
Model/Item Number (Kit): NAMC423-11; Open, Classified |
OEZ | None listed |
| Oct 7, 2026 | AVID Medical, Inc. PACK OPEN HEART CFH;
Model/Item Number (Kit): 1. UFCF004-06, 2. UFCF004-07; Open, Classified |
OEZ | None listed |
| Oct 7, 2026 | AVID Medical, Inc. CRANIOTOMY PACK;
Model/Item Number (Kit): WRNM035-20; Open, Classified |
OJG | None listed |
| Oct 7, 2026 | AVID Medical, Inc. ENDOVASCULAR PACK;
Model/Item Number (Kit): VAPX014-04; Open, Classified |
OEZ | None listed |
| Oct 7, 2026 | AVID Medical, Inc. ADULT HEART TRAY SHANDS JACKS;
Model/Item Number (Kit): SHND419-08; Open, Classified |
OEZ | None listed |
| Oct 7, 2026 | AVID Medical, Inc. GYN LAPAROSCOPY/LAPAROTOMY;
Model/Item Number (Kit): 1. WRNM002-15, 2. FBCH108-03; Open, Classified |
LRO | None listed |
| Oct 7, 2026 | AVID Medical, Inc. DAVINCI TRUCUSTOM BUNDLE;
Model/Item Number (Kit): 1. SAMM064-27, 2. SAMM064-28; Open, Classified |
LRO | None listed |
| Oct 7, 2026 | Canon Medical System, USA, INC. Alphenix INFX-8000C/B5 Open, Classified |
OWB | K210900 |
| Oct 7, 2026 | POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC SEDIPLAST;
Model/Catalog Numbers: S-100 and S-1000; Open, Classified |
JPH | K840500 |
| Oct 6, 2026 | Onkos Surgical, Inc. Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left
REF PV-ACREC-04M Open, Classified |
LPH | K212815 K223348 |
| Oct 6, 2026 | Onkos Surgical, Inc. Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left
REF PV-ACREC-04M Open, Classified |
LPH | K212815 K223348 |
| Oct 6, 2026 | Nihon 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 |
MHX | K102376 |
| Oct 5, 2026 | Medtronic 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 |
QFG | K253743 |
| Oct 5, 2026 | Medline 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 |
ITJ | None listed |
| Oct 5, 2026 | Medline 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 |
ITJ | None listed |
| Oct 5, 2026 | Stryker Sustainability Solutions BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007 Open, Classified |
NLH | K030187 |
| Oct 2, 2026 | Limitless Cryo Spa LLC Glypto Device, Glypto Cryo Machine; Open, Classified |
GEH | None listed |
| Oct 2, 2026 | Cardinal 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 |
LRP | None listed |
| Oct 2, 2026 | Safeguard 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 |
MHW | None listed |
| Oct 2, 2026 | GRI Medical & Electronic Technology Co., Ltd. HALYARD Laparoscopy Comprehensive Pack II
REF: 49332 Open, Classified |
FDE | None listed |
| Oct 2, 2026 | Beckman 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 |
JJE | K220977 |
| Oct 2, 2026 | Beckman 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 |
JJE | K242190 |
| Oct 2, 2026 | DRG International, Inc. Sperm Ab ELISA;
Model/Catalog Number: EIA-1826;
Product Description: Sperm Ab ELISA (96 well plate test); Open, Classified |
DFQ | None listed |
| Oct 2, 2026 | PHILIPS 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 |
JAK | K244008 |
| Oct 2, 2026 | Steris Corporation VERIFY Biological Steam Test Pack
Model/Catalog Number: S3069 Open, Classified |
FRC | K854902 |
| Oct 2, 2026 | Steris Corporation VERIFY Biological Steam Test Pack
Model/Catalog Number: S3065 Open, Classified |
FRC | K854902 |
| Oct 2, 2026 | Steris Corporation VERIFY Dual Species Self-Contained Biological Indicator
Model/Catalog Number: S3061 Open, Classified |
FRC | K083665 |
| Oct 2, 2026 | Steris Corporation VERIFY Dual Species Self-Contained Biological Indicator
Model/Catalog Number: S3060 Open, Classified |
FRC | K083665 |
| Oct 2, 2026 | Steris Corporation VERIFY Biological/Integrator Challenge Pack
Model/Catalog Number: LCB007 Open, Classified |
FRC | K854902 |
| Oct 2, 2026 | Steris Corporation VERIFY Biological/Integrator Challenge Pack
Model/Catalog Number: LCB006 Open, Classified |
FRC | K854902 |
| Oct 2, 2026 | Medical 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 |
OIE | None listed |
| Oct 2, 2026 | QUANTUM 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 |
BWN | None listed |
| Oct 1, 2026 | ASP 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 |
KCY | None listed |
| Oct 1, 2026 | ASP 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 |
KCY | None listed |
| Oct 1, 2026 | ASP 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 |
KCY | None listed |
| Oct 1, 2026 | ASP 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 |
KCY | None listed |
| Oct 1, 2026 | ASP 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 |
KCY | None listed |
| Oct 1, 2026 | ASP 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 |
KCY | None listed |
| Oct 1, 2026 | ASP 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 |
KCY | None listed |
| Oct 1, 2026 | ASP 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 |
KCY | None listed |
| Oct 1, 2026 | ASP 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 |
KCY | None listed |
| Oct 1, 2026 | ASP 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 |
KCY | None listed |
| Oct 1, 2026 | ASP 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 |
KCY | None listed |
| Oct 1, 2026 | ASP 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 |
KCY | None listed |
| Oct 1, 2026 | ASP 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 |
KCY | None listed |
| Oct 1, 2026 | ASP 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 |
KCY | None listed |