Device recalls
Recall records from FDA, newest initiation date first.
Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.
Data as of , the FDA export date. FDA medical device recall database
| Recall number | Class | Product | Recalling firm | Product code | Initiated |
|---|---|---|---|---|---|
| Z-0020-2022 | Class II | OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial... | Exactech, Inc. | HRY | |
| Z-0019-2022 | Class II | OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK... | Exactech, Inc. | JWH | |
| Z-0479-2022 | Class II | Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0... | PTW North America Corporation | IYE | |
| Z-0110-2022 | Class II | United Orthopedics USTAR II Knee System USTAR II Knee System Segment Part, RHS, 25 mm... | UOC USA Inc. | KRO | |
| Z-2583-2021 | Class I | EcoLotion Transmission Lotion, used in ultrasound procedures. Item/Description... | North Coast Medical Inc | ITX | |
| Z-2582-2021 | Class I | Norco Ultrasound Gel, Item/Description: NC70479/Norco Ultrasound Gel, 250 mL... | North Coast Medical Inc | ITX | |
| Z-2520-2021 | Class II | 10 ga ARS Decompression Needle, Part Number ZZ-0298 | North American Rescue LLC. | GAA | |
| Z-0389-2022 | Class II | Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy... | Xstrahl Limited | JAD | |
| Z-0141-2022 | Class II | 1.5T SIGNA HDxt MR System nuclear magnetic resonance imaging system | GE Healthcare | LNH | |
| Z-0140-2022 | Class II | Optima MR450w 1.5T nuclear magnetic resonance imaging system | GE Healthcare | LNH | |
| Z-0139-2022 | Class II | SIGNA Artist nuclear magnetic resonance imaging system | GE Healthcare | LNH | |
| Z-0138-2022 | Class II | SIGNA Voyager nuclear magnetic resonance imaging system | GE Healthcare | LNH | |
| Z-0137-2022 | Class II | SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system | GE Healthcare | LNH | |
| Z-0136-2022 | Class II | Discovery MR750 3.0T nuclear magnetic resonance imaging system | GE Healthcare | LNH | |
| Z-0135-2022 | Class II | Discovery MR750w 3.0T nuclear magnetic resonance imaging system | GE Healthcare | LNH | |
| Z-0134-2022 | Class II | SIGNA Pioneer nuclear magnetic resonance imaging system | GE Healthcare | LNH | |
| Z-0133-2022 | Class II | SIGNA Architect nuclear magnetic resonance imaging system | GE Healthcare | LNH | |
| Z-0132-2022 | Class II | SIGNA Premier nuclear magnetic resonance imaging system | GE Healthcare | LNH | |
| Z-2592-2021 | Class II | Atrium Pneumostat Chest Drain Valve, Part Number 16100 | Atrium Medical Corporation | KDQ | |
| Z-2586-2021 | Class II | Operating room table - Product Usage: intended for use during diagnostic examinations... | IMRIS Imaging, Inc. | KXJ | |
| Z-2585-2021 | Class II | Operating room table - Product Usage: intended for use during diagnostic examinations... | IMRIS Imaging, Inc. | KXJ | |
| Z-2584-2021 | Class II | Operating room table - Product Usage: intended for use during diagnostic examinations... | IMRIS Imaging, Inc. | KXJ | |
| Z-0151-2022 | Class II | HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of... | Instrumentation Laboratory Co. | N/A | |
| Z-0150-2022 | Class II | HemosIL Liquid Anti-Xa- automated chromogenic assay for in vitro diagnostic use by... | Instrumentation Laboratory Co. | QLU | |
| Z-0149-2022 | Class II | HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of... | Instrumentation Laboratory Co. | KFF | |
| Z-2589-2021 | Class II | Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage... | Atrium Medical Corporation | DSY | |
| Z-2518-2021 | Class I | Omnisound Gel, 250 ml bottle and 5 L container; and EcoGel 200, 250 ml bottle... | Accelerated Care Plus Corp. | ITX | |
| Z-0209-2022 | Class II | HENRY SCHEIN Safety Blood Collection Needle 22Gx 1 1/4 Inch, REF 570-2068, 100pcs/box... | Zhejiang Kindly Medical Devices Co., Ltd. | FMI | |
| Z-0208-2022 | Class II | HENRY SCHEIN Safety Blood Collection Needle 21Gx 1 1/4 Inch, REF 570-2067, 100pcs/box... | Zhejiang Kindly Medical Devices Co., Ltd. | FMI | |
| Z-0207-2022 | Class II | McKesson PREVENT HT Safety Winged Blood Collection Needle with Tube Holder, MFR #... | Zhejiang Kindly Medical Devices Co., Ltd. | FMI | |
| Z-0206-2022 | Class II | McKesson PREVENT HT Safety Winged Blood Collection Needle with Tube Holder, MFR #... | Zhejiang Kindly Medical Devices Co., Ltd. | FMI | |
| Z-0205-2022 | Class II | McKesson PREVENT HT Safety Blood Collection Needles, 22G 1 1/4 inch, MFR # 16-NBC22GS | Zhejiang Kindly Medical Devices Co., Ltd. | FMI | |
| Z-0204-2022 | Class II | McKesson PREVENT HT Safety Blood Collection Needles, 21G 1 1/4 inch, MFR # 16-NBC21GS | Zhejiang Kindly Medical Devices Co., Ltd. | FMI | |
| Z-0154-2022 | Class II | Catalog # BEK3411, Ecomomy Jamshidi Bone Marrow Biopsy Tray, 11 G X 4"Biopsy/Aspiration... | Bard Peripheral Vascular Inc | KNW | |
| Z-0153-2022 | Class II | Catalog # BEK4511, Qty: 10, Ecomomy Jamshidi Bone Marrow Biopsy and Aspiration Tray, 11 G... | Bard Peripheral Vascular Inc | KNW | |
| Z-0068-2022 | Class I | ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser Btl | National Distribution & Contracting, Inc | GYB | |
| Z-0067-2022 | Class I | ECO 85CB Lotion Ultrasound 8.5 oz 24/cs ECO 40JBC Gel Ultrasound Transmission Clr 8.5 oz... | National Distribution & Contracting, Inc | ITX | |
| Z-2505-2021 | Class II | DLP Left Heart Vent Catheters, 18 FR. Sterile, Rx Only | Medtronic Perfusion Systems | DRA | |
| Z-2504-2021 | Class II | DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only | Medtronic Perfusion Systems | DRA | |
| Z-0029-2022 | Class I | Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic... | Aesthetics Systems USA Inc | ITX | |
| Z-2487-2021 | Class II | SARS-CoV-2 Process Control (Swab) - Product Usage: intended for use as an external... | Microbiologics, Inc. | OHQ | |
| Z-2486-2021 | Class II | SARS-CoV-2 Process Control (Pellet) - Product Usage: intended for use as an external... | Microbiologics, Inc. | OHQ | |
| Z-2507-2021 | Class II | Greiner Bio-One VACUETTE TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue... | Greiner Bio-One North America, Inc. | GIM | |
| Z-2614-2021 | Class II | DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk) | ConvaTec Limited | NAD | |
| Z-2392-2021 | Class I | LiquaSonic Ultrasound Gel 5L, Model No. 001222 | Athena Medical Products Inc | ITX | |
| Z-2391-2021 | Class I | LiquaSonic Ultrasound Gel 250mL, Model No. 001205 | Athena Medical Products Inc | ITX | |
| Z-0119-2022 | Class I | Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 8881570121 inside the... | Windstone Medical Packaging, Inc. | NGT | |
| Z-0121-2022 | Class II | P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641 | Fort Defiance Industries, LLC | FLE | |
| Z-0071-2022 | Class II | Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795116, 100-240V... | Philips North America LLC | IYN | |
| Z-0070-2022 | Class II | Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795090, 100-240V... | Philips North America LLC | IYN |