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-0126-2020 | Class II | Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline... | Abbott Medical | FRN | |
| Z-0927-2020 | Class II | da Vinci SP Surgical System, SP1098, 00886874114605 Product Usage: used with an... | Intuitive Surgical, Inc. | NAY | |
| Z-0926-2020 | Class II | da Vinci X Surgical System Surgical System, IS4200, 00886874114216 Product Usage: used... | Intuitive Surgical, Inc. | NAY | |
| Z-0925-2020 | Class II | da Vinci Xi Surgical System Surgical System, IS4000, 00886874114216 - Product Usage: used... | Intuitive Surgical, Inc. | NAY | |
| Z-0281-2020 | Class II | Giraffe OmniBed Carestation CS1 - Product Usage: The device can be operated as an... | GE Healthcare | FMZ | |
| Z-2439-2019 | Class II | BD Kiestra InoqulA+ Software Version 20.3. IVD automated specimen processing Catalog... | Becton Dickinson & Co | JTC | |
| Z-2438-2019 | Class II | BD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing Catalog... | Becton Dickinson & Co | JTC | |
| Z-2557-2019 | Class III | Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 - Product Usage: Product is... | Randox Laboratories, Limited | JJW | |
| Z-2440-2019 | Class II | syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomography... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-2276-2019 | Class II | WS80A Diagnostic Ultrasound System Version 1.00.16, 3.00.17, 3.00.18, 3.00.19, 3.01.00... | Samsung HME America, Inc. | IYN | |
| Z-2275-2019 | Class II | HS70A Diagnostic Ultrasound System Version 2.01.00, 2.01.01, 2.01.02, 2.01.03, 2.01.04... | Samsung HME America, Inc. | IYN | |
| Z-2424-2019 | Class II | Endintrak 2 Hook Blade, Angled, Catalog Number 4058A-1 The EPF system is designed for... | Stryker Corp. | HRX | |
| Z-2423-2019 | Class II | Endotrac EPF/EGR Hook Blade, Angled, Catalog Number 3055A-1 The EPF system is designed... | Stryker Corp. | HRX | |
| Z-2422-2019 | Class II | Endotrac EPF/EGR Triangle Blade, Angled, Catalog Number 3054A-1 The EPF system is... | Stryker Corp. | HRX | |
| Z-2421-2019 | Class II | Endotrac ECTR Hook Blade, Angled, Catalog Number 2055A-1 The EPF system is designed for... | Stryker Corp. | HRX | |
| Z-2420-2019 | Class II | Endotrac ECTR Triangle Blade, Angled, Catalog Number 2054A-1 The EPF system is designed... | Stryker Corp. | HRX | |
| Z-2419-2019 | Class II | Endintrak 2 Hook Blade, Catalog Number 4058-1 The EPF system is designed for the... | Stryker Corp. | HRX | |
| Z-2418-2019 | Class II | Endotrac EPF/EGR Hook Blade, Catalog Number 3055-1 The EPF system is designed for the... | Stryker Corp. | HRX | |
| Z-2417-2019 | Class II | Endotrac EPF/EGR Triangle Blade, Catalog Number 3054-1 The EPF system is designed for... | Stryker Corp. | HRX | |
| Z-2416-2019 | Class II | Endotrac EPF/EGR Push Blade, Catalog Number 3053-1 The EPF system is designed for the... | Stryker Corp. | HRX | |
| Z-2415-2019 | Class II | Endotrac ECTR Hook Blade, Catalog Number 2055-1 The EPF system is designed for the... | Stryker Corp. | HRX | |
| Z-2414-2019 | Class II | Endotrac ECTR Triangle Blade, Catalog Number 2054-1 The EPF system is designed for the... | Stryker Corp. | HRX | |
| Z-2413-2019 | Class II | Endotrac ECTR Push Blade, Catalog Number 2053-1 The EPF system is designed for the... | Stryker Corp. | HRX | |
| Z-2412-2019 | Class II | Endotrig ETF Hook Blade, Catalog Number 1052-1 The EPF system is designed for the... | Stryker Corp. | HRX | |
| Z-2465-2019 | Class I | Natrelle 150 Full Height and Short Height Implants, BIOCELL, INTRASHIEL, BioDIMENSIONAL... | Allergan | FTR | |
| Z-2464-2019 | Class I | RITZ PRINCESS, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles RML, RMM, RFL... | Allergan | FTR | |
| Z-2463-2019 | Class I | Komuro, Soft Touch, BIOCELL, INTRASHIEL, BioDIMENSIONAL breast implants, Styles KML, KMM... | Allergan | FTR | |
| Z-2462-2019 | Class I | Natrelle and McGhan Silicone-Filled Breast Implants, TruForm 2 (Soft Touch), BIOCELL... | Allergan | FTR | |
| Z-2461-2019 | Class I | Natrelle 510, TruForm, Dual-Gel, BIOCELL, Styles LX, MX, FX Product Usage: Breast... | Allergan | FTR | |
| Z-2460-2019 | Class I | Natrelle and McGhan 410 TruForm 2 (Soft Touch) BIOCELL breast implant, Styles LL, LM, LF... | Allergan | FTR | |
| Z-2459-2019 | Class I | McGhan BioDIMENSIONAL silicone-Filled Breast Implants, style 153 Product Usage: Breast... | Allergan | FTR | |
| Z-2458-2019 | Class I | McGhan Croissant-Shaped Tissue Expanders, Style 134 Product Usage: intended for... | Allergan | LCJ | |
| Z-2457-2019 | Class I | Natrelle 133 Tissue Expanders w/Suture Tabs BIOCELL Full Height Variable Projection with... | Allergan | LCJ | |
| Z-2448-2019 | Class II | The LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a latex balloon... | LeMaitre Vascular Inc. | MJN | |
| Z-2499-2019 | Class II | Threaded Offset Cup Impactor - Product Usage: To assist the surgeon in the implantation... | Exactech, Inc. | HWA | |
| Z-2456-2019 | Class I | Natrelle133 Plus Tissue Expander With/Without Suture Tabs, BioCell Full Height Variable... | Allergan | LCJ | |
| Z-2455-2019 | Class I | Natrelle 133 Tissue Expanders (also named style 133 BIOSPAN Tissue Expander and Mcghan... | Allergan | LCJ | |
| Z-2454-2019 | Class I | Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile... | Allergan | FTR | |
| Z-2453-2019 | Class I | Natrelle Inspira, Silicone-Filled Breast Implants, Sterile, for the following style... | Allergan | FTR | |
| Z-2452-2019 | Class I | Natrelle 410, Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implant Biocell... | Allergan | FTR | |
| Z-2451-2019 | Class I | Natrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, Sterile, for... | Allergan | FWM | |
| Z-2541-2019 | Class II | Hemospray Endoscopic Hemostat | Wilson-Cook Medical Inc. | QAU | |
| Z-1824-2023 | Class II | 'n'-Hole Post which is a component of the Revolution External Fixation System Catalog... | Fusion Orthopedics USA, LLC | KTT | |
| Z-1639-2022 | Class II | AggreGuide A-100 Instrument | Aggredyne, Inc. | JOZ | |
| Z-2481-2019 | Class II | OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component ApeX-LNK... | Omni Life Science, Inc. | LPH | |
| Z-2480-2019 | Class II | OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual... | Omni Life Science, Inc. | LZO | |
| Z-2479-2019 | Class II | OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual... | Omni Life Science, Inc. | LZO | |
| Z-2487-2019 | Class II | ROTEM ex-tem Rest of the world part No: 503-05 (ROW) | Instrumentation Laboratory Co. | JPA | |
| Z-2486-2019 | Class II | ROTEM ex-tem Canada Part No: 503-05-CA | Instrumentation Laboratory Co. | JPA | |
| Z-2485-2019 | Class II | ROTEM ex-tem; US Part No: 503-05-US | Instrumentation Laboratory Co. | JPA |