Oct 14, 2026
Z-0079-2027
Presource Packs containing Medtronic Microstream Components: Intubation Kit Catalog Numbers AN23366084 AN23366085 AN2336608H AN2336608J Intubating Bag Kit Cata…
Cardinal Health 200, LLC
- LRP
- Class II
- Ongoing
Device recalls
openFDA device enforcement reports, enriched with the device recall endpoint when a product code or CDRH recall id is available.
779 records
Oct 14, 2026
Z-0078-2027
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…
PHILIPS MEDICAL SYSTEMS
- JAK
- Class II
- Ongoing
Oct 14, 2026
Z-0077-2027
HALYARD Laparoscopy Comprehensive Pack II REF: 49332
GRI Medical & Electronic Technology Co., Ltd.
- FDE
- Class II
- Ongoing
Oct 14, 2026
Z-0076-2027
Brand Name: ADAPTABLE Beach Chair Product Name: Beach Chair surgical patient positioner Model/Catalog Number: 804-33-300 (Enovis); 3105-400-030 (Stryker); inte…
QUANTUM OPS Inc
- BWN
- Class II
- Ongoing
Oct 14, 2026
Z-0075-2027
VERIFY Biological Steam Test Pack Model/Catalog Number: S3069
Steris Corporation
- FRC
- Class II
- Ongoing
Oct 14, 2026
Z-0074-2027
VERIFY Biological Steam Test Pack Model/Catalog Number: S3065
Steris Corporation
- FRC
- Class II
- Ongoing
Oct 14, 2026
Z-0073-2027
VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3061
Steris Corporation
- FRC
- Class II
- Ongoing
Oct 14, 2026
Z-0072-2027
VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3060
Steris Corporation
- FRC
- Class II
- Ongoing
Oct 14, 2026
Z-0071-2027
VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB007
Steris Corporation
- FRC
- Class II
- Ongoing
Oct 14, 2026
Z-0070-2027
VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB006
Steris Corporation
- FRC
- Class II
- Ongoing
Oct 14, 2026
Z-0069-2027
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…
Medical Action Industries, Inc. 306
- OIE
- Class III
- Ongoing
Oct 7, 2026
Z-3335-2026
Atellica CH Revised C-Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223;
Siemens Healthcare Diagnostics, Inc.
- DCN
- Class II
- Ongoing
Oct 7, 2026
Z-3334-2026
CHARLOTTE CLAW Screw, REF: 40122716, intended for use with CLAW II Polyaxial Compression Plating System
Wright Medical Technology, Inc.
- HRS
- Class II
- Ongoing
Oct 7, 2026
Z-3333-2026
HOPKINS Telescope 30¿, 4mm REF 10005BA UDI-DI code: 04048551045121 KARL STORZ HOPKINS¿ and HOPKINS¿ II telescopes are to be used for visualization of the surgi…
Karl Storz Endoscopy
- EOB
- Class II
- Ongoing
Oct 7, 2026
Z-3332-2026
Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER AU480 REF / UDI-DI code: B96692 / 14987666542965 B96693 / 14987666542972 B121…
Beckman Coulter Mishima K.K.
- JJE
- Class II
- Ongoing
Oct 7, 2026
Z-3331-2026
Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra System (RED 62 Reperfusion Catheter) Model/Catalog Number: THNDRRED62SKIT Soft…
Penumbra Inc.
- NRY
- Class II
- Ongoing
Oct 7, 2026
Z-3330-2026
Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS software version 2.13 Software Version: iOS…
Tandem Diabetes Care, Inc.
- QFG
- Class II
- Ongoing
Oct 7, 2026
Z-3329-2026
Olympus Tripp-Lite P580-025 25ft DisplayPort Cable, Model Number P580-025, an accessory used in conjunction wtih OLYSENSE Hub System
Olympus Corporation of the Americas
- Class II
- Ongoing
Oct 7, 2026
Z-3328-2026
Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 Model/Catalog Number: HX55W-S0 Software Version: N/A Product…
SPECTRUM MEDICAL SRL
- DTR
- Class II
- Ongoing
Oct 7, 2026
Z-3327-2026
Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W Model/Catalog Number: HX55V-S0W Software Version: N/A Produ…
SPECTRUM MEDICAL SRL
- DTR
- Class II
- Ongoing
Oct 7, 2026
Z-3326-2026
Pipeline Flex Embolization Device with Shield Technology REF PED2-300-12 UDI-DI code: 00763000448806 he Pipeline Flex Embolization Device with Shield Technolog…
Micro Therapeutics, Inc.
- OUT
- Class II
- Ongoing
Oct 7, 2026
Z-3325-2026
Intrapulmonary Percussive Ventilation, IPV HC, Product Number: S00009; Phasitron, P5-HC
Percussionaire Corporation
- NHJ
- Class II
- Ongoing
Oct 7, 2026
Z-3324-2026
Travel Air, Product Number: S00055; Phasitron 5, Product Number: P5 used with Instruction Manual
Percussionaire Corporation
- NHJ
- Class II
- Ongoing
Oct 7, 2026
Z-3323-2026
Impulsator, Product Number: S00010, Phasitron 5, Product Number: P5 used with Instruction Manual
Percussionaire Corporation
- NHJ
- Class II
- Ongoing
Oct 7, 2026
Z-3322-2026
Intrapulmonary Percussive Ventilation, IPV-2C, Product Number: S00002-C; Phasitron 5, Product Number: P5 used with Instruction Manual
Percussionaire Corporation
- NHJ
- Class II
- Ongoing