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-0870-2015 | Class II | Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating; Part... | Maquet Cardiovascular Us Sales, LLC | DTZ | |
| Z-0818-2015 | Class II | Q-Station Quantification Software. Q-Station 3.0 with a2DQ and/or aCMQ Q-Apps are... | Philips North America LLC | LLZ | |
| Z-0817-2015 | Class II | EPIQ 7 Ultrasound System, EPIQ 7 systems with software versions 1.0.x or 1.1.x with QLAB... | Philips North America LLC | IYN | |
| Z-0816-2015 | Class II | EPIQ 5 Ultrasound System, EPIQ 5 systems with software versions 1.0.x or 1.1.x with QLAB... | Philips North America LLC | IYN | |
| Z-0815-2015 | Class II | Additional devices identified in new FSN MA-FCO 83000190: QLAB versions 10.0 with a2DQ... | Philips North America LLC | LLZ | |
| Z-0490-2015 | Class II | Polyflux Revaclear Max Dialyzer, Model Number 110634. The Polyflux Revaclear and... | Gambro Renal Products | KDI | |
| Z-0489-2015 | Class II | Polyflux Revaclear Dialyzer, Model Number 110633. The Polyflux Revaclear and Polyflux... | Gambro Renal Products | KDI | |
| Z-0471-2015 | Class II | Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software... | Canon Medical Systems USA, Inc. | JAK | |
| Z-0838-2015 | Class II | Dimension Vista 500 Intelligent Lab System or Dimension Vista 1500 Intelligent Lab... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-0470-2015 | Class III | Non-sterile drape | Novadaq Technologies ULC | IZI | |
| Z-0469-2015 | Class III | LUNA Chest, Model No. LU4006 | Novadaq Technologies ULC | IZI | |
| Z-0494-2015 | Class II | McGrath MAC2 Video Laryngoscope Blades Product supplied in box of 50 items, each... | Aircraft Medical Limited | CCW | |
| Z-0864-2015 | Class II | Bausch & Lomb Stellaris PC w/ Laser Upgrade BL14334 (Stellaris PC w v4 Software) with... | Bausch & Lomb Incorporated | HQF | |
| Z-0863-2015 | Class II | Bausch & Lomb Stellaris PC w/ Laser Upgrade BL1433 (Stellaris PC w v3 Software) with... | Bausch & Lomb Incorporated | HQF | |
| Z-0450-2015 | Class II | BrightView product code: 882478 BrightView X product code: 882480 BrightView XCT product... | Philips North America LLC | KPS | |
| Z-1121-2015 | Class II | Pulsiocath PiCCO ProAQT Monitoring Kit, single-use cardiac output (CO) sensor, one unit... | Pulsion Medical Inc | KRB | |
| Z-0591-2015 | Class II | LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 6, LEFT, REF 71426006, QTY 1, Smith &... | Smith & Nephew, Inc. | JWH | |
| Z-0590-2015 | Class II | LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 5, RIGHT, REF 71426005, QTY 1, Smith... | Smith & Nephew, Inc. | JWH | |
| Z-0589-2015 | Class II | LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 4, LEFT, REF 71425004, QTY 1, Smith &... | Smith & Nephew, Inc. | JWH | |
| Z-0524-2015 | Class II | Medtronic MiniMed Silhouette and/or MiniMed Sure-T Infusion Sets; Paradigm Silhouette... | Medtronic, Inc. | FPA | |
| Z-0862-2015 | Class II | Bausch & Lomb Stellaris PC w/ Laser, BL14304 The responsible firm name is Bausch & Lomb... | Bausch & Lomb Incorporated | HQF | |
| Z-0846-2015 | Class II | STERRAD 100NX, Product Code 10144 The STERRAD Cassettes are used on STERRAD... | Advanced Sterilization Products | MLR | |
| Z-0845-2015 | Class II | STERRAD NX, Product Code 10133 The STERRAD Cassettes are used on STERRAD Sterilization... | Advanced Sterilization Products | MLR | |
| Z-0844-2015 | Class II | STERRAD 200, Product Code 10118 The STERRAD Cassettes are used on STERRAD Sterilization... | Advanced Sterilization Products | MLR | |
| Z-0843-2015 | Class II | STERRAD 100S, Product Code 10113. The STERRAD Cassettes are used on STERRAD... | Advanced Sterilization Products | FLF | |
| Z-0842-2015 | Class II | STERRAD 50, Product Code 10114. The STERRAD Cassettes are used on STERRAD Sterilization... | Advanced Sterilization Products | FLF | |
| Z-0493-2015 | Class II | GuardIVa Antimicrobial Hemostatic IV Dressing, REF FP-23-AD008, Manufacturer: Bard Access... | Bard Access Systems, Inc. | FRO | |
| Z-0221-2015 | Class II | MOSAIQ Product Usage: MOSAIQ is an oncology information system used to manage workflows... | Elekta Limited | IYE | |
| Z-0448-2015 | Class II | 8MM, TIP-UP FENESTRATED GRASPER; Intended to assist in the accurate control of Intuitive... | Intuitive Surgical, Inc. | NAY | |
| Z-0447-2015 | Class II | 8MM, CURVED BIPOLAR DISSECTOR; Intended to assist in the accurate control of Intuitive... | Intuitive Surgical, Inc. | NAY | |
| Z-0446-2015 | Class II | 8MM,MEDIUM-LARGE CLIP APPLIER ; Intended to assist in the accurate control of Intuitive... | Intuitive Surgical, Inc. | NAY | |
| Z-0445-2015 | Class II | 8MM, SMALL GRASPING RETRACTOR ; Intended to assist in the accurate control of Intuitive... | Intuitive Surgical, Inc. | NAY | |
| Z-0444-2015 | Class II | 8MM, MEGA SUTURECUT ND; Intended to assist in the accurate control of Intuitive Surgical... | Intuitive Surgical, Inc. | NAY | |
| Z-0443-2015 | Class II | 8MM, DUAL BLADE RETRACTOR; Intended to assist in the accurate control of Intuitive... | Intuitive Surgical, Inc. | NAY | |
| Z-0442-2015 | Class II | 8MM, ATRIAL RETRACTOR SHORT RIGHT ; Intended to assist in the accurate control of... | Intuitive Surgical, Inc. | NAY | |
| Z-0441-2015 | Class II | 8MM, LARGE HEM-O-LOK CLIP APPLIER; Intended to assist in the accurate control of... | Intuitive Surgical, Inc. | NAY | |
| Z-0440-2015 | Class II | 8MM, CARDIAC PROBE GRASPER; Intended to assist in the accurate control of Intuitive... | Intuitive Surgical, Inc. | NAY | |
| Z-0439-2015 | Class II | 8MM, TENACULUM FORCEPS; Intended to assist in the accurate control of Intuitive Surgical... | Intuitive Surgical, Inc. | NAY | |
| Z-0438-2015 | Class II | 8MM FENESTRATED BIPOLAR FORCEPS,; Intended to assist in the accurate control of... | Intuitive Surgical, Inc. | NAY | |
| Z-0437-2015 | Class II | 8MM PERMANENT CAUTERY SPATULA,; Intended to assist in the accurate control of Intuitive... | Intuitive Surgical, Inc. | NAY | |
| Z-0436-2015 | Class II | 8MM PERMANENT CAUTERY HOOK,; Intended to assist in the accurate control of Intuitive... | Intuitive Surgical, Inc. | NAY | |
| Z-0435-2015 | Class II | 8MM RESANO FORCEPS,; Intended to assist in the accurate control of Intuitive Surgical... | Intuitive Surgical, Inc. | NAY | |
| Z-0434-2015 | Class II | 8MM MONOPOLAR CURVED SCISSORS; Intended to assist in the accurate control of Intuitive... | Intuitive Surgical, Inc. | NAY | |
| Z-0433-2015 | Class II | 8MM,MARYLAND BIPOLAR FORCEPS; Intended to assist in the accurate control of Intuitive... | Intuitive Surgical, Inc. | NAY | |
| Z-0432-2015 | Class II | 8MM,PROGRASP FORCEPS; Intended to assist in the accurate control of Intuitive Surgical... | Intuitive Surgical, Inc. | NAY | |
| Z-0431-2015 | Class II | 8MM,MICRO BIPOLAR FORCEPS; Intended to assist in the accurate control of Intuitive... | Intuitive Surgical, Inc. | NAY | |
| Z-0430-2015 | Class II | 8MM,LONG TIP FORCEPS; Intended to assist in the accurate control of Intuitive Surgical... | Intuitive Surgical, Inc. | NAY | |
| Z-0429-2015 | Class II | 8MM,BLACK DIAMOND MICRO FORCEPS; Intended to assist in the accurate control of Intuitive... | Intuitive Surgical, Inc. | NAY | |
| Z-0428-2015 | Class II | 8MM,LARGE NEEDLE DRIVER; Intended to assist in the accurate control of Intuitive... | Intuitive Surgical, Inc. | NAY | |
| Z-0427-2015 | Class II | 8MM,POTTS SCISSORS; Intended to assist in the accurate control of Intuitive Surgical... | Intuitive Surgical, Inc. | NAY |