PlainRecalls

FDA Medical Devices

U.S. Food and Drug Administration — Medical device recalls

26,000 recalls · Page 22 of 520

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Moderate Sep 3, 2025

PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701

VANTIVE US HEALTHCARE LLC

Moderate Sep 3, 2025

AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) SFCH CRANI PACK (PS 132432), MODEL/ITEM NUMBER UICR10W; 2) SFCH SHUNT…

American Contract Systems Inc

Low Sep 3, 2025

C8-4v Transducer Probe

Philips Ultrasound, Inc

Low Sep 3, 2025

VL13-5 Transducer Probe

Philips Ultrasound, Inc

Low Sep 3, 2025

S4-1 Lumify Transducer Probe

Philips Ultrasound, Inc

Low Sep 3, 2025

S4-2 Transducer Probe

Philips Ultrasound, Inc

Low Sep 3, 2025

OMNI II TEE Transducer Probe

Philips Ultrasound, Inc

Low Sep 3, 2025

C9-2 Transducer Probe

Philips Ultrasound, Inc

Low Sep 3, 2025

Akreos, SKU: AO60P0300. Akreos intraocular lenses

Bausch & Lomb Surgical, Inc.

Low Sep 3, 2025

3D9-3v Transducer Probe

Philips Ultrasound, Inc

Low Sep 3, 2025

L18-5 Transducer Probe

Philips Ultrasound, Inc

Moderate Sep 3, 2025

Brand Name: Atlantis IO FLO Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04S / 6802034 Product Description: The Atlantis intraoral f…

Dentsply IH, Inc.

Moderate Sep 3, 2025

STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite …

Diagnostica Stago, Inc.

Moderate Sep 3, 2025

AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) HEART PACK - 205947, MODEL/ITEM NUMBER ANCV78BC; 2) VASCULAR PACK - 2…

American Contract Systems Inc

Low Sep 3, 2025

D2cwc Transducer Probe

Philips Ultrasound, Inc

Moderate Sep 3, 2025

Orascoptic Superior Visualization Dragonfly Nose Pad Accessory Kit ( nose pad and screw) 1 pk and 20 pk.

Orascoptic Surgical Acuity

Low Sep 3, 2025

mL26-8 Transducer Probe

Philips Ultrasound, Inc

Moderate Sep 3, 2025

AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) A-C SUPPLEMENT PACK - 205946, Model/Item Number ANCV67X; 2) KIDNEY P…

American Contract Systems Inc

Low Sep 3, 2025

C6-3 Transducer Probe

Philips Ultrasound, Inc

Low Sep 3, 2025

eL18-4 Transducer Probe

Philips Ultrasound, Inc

Moderate Sep 3, 2025

STA Satellite. Product Code: All references. All software versions. The STA Satellite is a fully automated benchtop analyzer capable of simultaneo…

Diagnostica Stago, Inc.

Low Sep 3, 2025

mC12-3 Transducer Probe

Philips Ultrasound, Inc

Moderate Sep 3, 2025

TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631

VANTIVE US HEALTHCARE LLC

Low Sep 3, 2025

L15-7io Transducer Probe

Philips Ultrasound, Inc

Low Sep 3, 2025

X5-1c Transducer Probe

Philips Ultrasound, Inc

Low Sep 3, 2025

L12-4 Lumify Transducer Probe

Philips Ultrasound, Inc

Low Sep 3, 2025

S7-3t Transducer Probe

Philips Ultrasound, Inc

Moderate Sep 3, 2025

Brand Name: Atlantis IO FLO-S Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04B / 68020033 Software Version: n/a Product Description…

Dentsply IH, Inc.

Low Sep 3, 2025

S5-2 Transducer Probe

Philips Ultrasound, Inc

Low Sep 3, 2025

3D6-2 Transducer Probe

Philips Ultrasound, Inc

Low Sep 3, 2025

C9-4v Transducer Probe

Philips Ultrasound, Inc

Low Sep 3, 2025

S3-1 Transducer Probe

Philips Ultrasound, Inc

Low Sep 3, 2025

S8-3t Transducer Probe

Philips Ultrasound, Inc

Low Sep 3, 2025

D5cwc Transducer Probe

Philips Ultrasound, Inc

Low Sep 3, 2025

Transducer C10-3v Transducer Probe

Philips Ultrasound, Inc

Low Sep 3, 2025

X11-4t Transducer Probe

Philips Ultrasound, Inc

Moderate Sep 3, 2025

IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC POWEREASE System is indicated for drilling, tapping, and drivin…

Medtronic Xomed, Inc.

Low Sep 3, 2025

L12-3 Transducer Probe

Philips Ultrasound, Inc

Moderate Sep 3, 2025

STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite…

Diagnostica Stago, Inc.

Moderate Sep 3, 2025

AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAP CHOLE PACK, Model/Item Number CILC69L; 2) LAP CHOLE PACK, Model/I…

American Contract Systems Inc

Low Sep 3, 2025

Mini Multi TEE Transducer Probe

Philips Ultrasound, Inc

Moderate Sep 3, 2025

BD PhaSeal Injector Luer (N30C), REF: 515001 BD PhaSeal Injector Luer Lock (N35), REF: 515003 BD PhaSeal Injector Luer Lock (N35C), REF: 515004 BD…

BD SWITZERLAND SARL

Moderate Sep 3, 2025

Brand Name: THOR Product Name: NovoTHOR XL Model/Catalog Number: S2190 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL ar…

THOR Photomedicine Ltd

Moderate Sep 3, 2025

STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 kit is intended for use with the analyzers of the STA-R, STA Compact and …

Diagnostica Stago, Inc.

Low Sep 3, 2025

S4-1 Transducer Probe

Philips Ultrasound, Inc

Moderate Sep 3, 2025

Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2189 Software Version: N/A Product Description: The NovoTHOR and N…

THOR Photomedicine Ltd

Moderate Sep 3, 2025

AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAPAROSCOPY PACK, MODEL/ITEM NUMBER EVLP61I; 2) PELVISCOPY, MODEL/IT…

American Contract Systems Inc

Moderate Sep 3, 2025

Brand Name: THOR Product Name: NovoTHOR Model/Catalog Number: S2188 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are i…

THOR Photomedicine Ltd

Low Sep 3, 2025

c5-1 Transducer Probe

Philips Ultrasound, Inc

Low Sep 3, 2025

V6-2 Transducer Probe

Philips Ultrasound, Inc