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-0399-2012 | VARIANT II Link Hemoglobin A1c Program Reorder Pack, 1600 tests, IVD, For the... | Bio-Rad Laboratories Inc. | KRZ | ||
| Z-0937-2012 | GEMINI TF 16 PET/CT System & GEMINI TF 64 PET/CT System, Philips Medical Systems... | Philips North America LLC | KPS | ||
| Z-0597-2012 | Midmark M11 Ultra Steam Sterilizer, Distributed by: Midmark Corporation, 60 Vista Drive... | Midmark Corp | FLE | ||
| Z-0603-2012 | The GSP 2021-0010 (Genetic Screening Processor) instrument is a fully automated, high... | Revvity Health Sciences, Inc. | JLW | ||
| Z-0190-2012 | Step 2, 3000-22000 GPD (Sodium Hydroxide 2.0N) cleaning solution. 4 oz plastic bottle... | Isopure Corp | KPO | ||
| Z-0265-2012 | Stryker Endoscopy 3.55 MM Super 90 S-SERFAS Energy Probe; electrosurgical device. Model... | Stryker Corp. | GEI | ||
| Z-0147-2012 | Medrad(R) Sterile Disposable Stellant Syringe Kit, Catalog # SDS-CTP-SPK, Lot #... | Medrad, Inc. | DXT | ||
| Z-1142-2013 | Class II | GE Healthcare, Innova 2100IQ, Innova 3100IQ, Innova 4100IQ, Cardiovascular and... | GE Healthcare | OWB | |
| Z-0456-2012 | ThermoSuit Manufactured for Life Recovery Systems. HD, LLC, 170 Kinnelon Rd. Kinnelon... | Life Recovery Systems HD, LLC | NZE | ||
| Z-0803-2012 | Salter Labs Bubble humidifier, with 6 PSI safety valve, 350cc, Latex Free; Single Patient... | Salter Labs | BBT | ||
| Z-0324-2012 | ZMR Over the Junction Instruments for Revision, utilized for the following ZMR devices... | Zimmer GmbH | LPH | ||
| Z-0323-2012 | ZMR Crossover Instrumentation, utilized for the following ZMR devices: Porous... | Zimmer GmbH | LPH | ||
| Z-0322-2012 | ZMR Porous Revision Hip Prosthesis Surgical Technique, utilized for the following ZMR... | Zimmer GmbH | LPH | ||
| Z-0321-2012 | Zimmer ZMR Hip System Instructions for Use, utilized for the following ZMR devices... | Zimmer GmbH | LPH | ||
| Z-0303-2012 | Battery Module for Sarns Modular Perfusion System 8000 Product Usage: The Sarns... | Terumo Cardiovascular Systems Corporation | DWB | ||
| Z-0944-2012 | Integra PAC1 Mod 2 Cables used with the Integra MPM, CAM01 Monitors | Integra LifeSciences Corporation | GWM | ||
| Z-0342-2012 | Elekta Synergy XVI X-ray Volume Imaging System To be used as part of radiation therapy... | Elekta Limited | IYE | ||
| Z-0269-2012 | Wolf Medical Supply Inc., WOLF-PAK REDI-FLO ELASTOMERIC INFUSION PUMP, FILL VOLUME 270... | Wolf Medical Supply Inc. | MEB | ||
| Z-0268-2012 | Wolf Medical Supply, Inc., WOLF-PAK REDI-FLO ELASTOMERIC INFUSION PUMP, FILL VOLUME 100... | Wolf Medical Supply Inc. | MEB | ||
| Z-0267-2012 | Wolf Medical Supply, Inc., WOLF-PAK REDI-FLO ELASTOMERIC INFUSION PUMP, FILL VOLUME 60... | Wolf Medical Supply Inc. | MEB | ||
| Z-2650-2017 | Class III | Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two... | Horiba Instruments Incorporated | CGS | |
| Z-0118-2017 | Class II | CADstream software Product Usage: CADstream is an image processing system designed to... | Merge Healthcare Incorporated | LLZ | |
| Z-1538-2012 | Class II | Philips Healthcare Practix Convenio Mobile X-ray system Worldwide Distribution... | Philips North America LLC | IZL | |
| Z-0717-2012 | Model 750 24' MRI Reusable/Disposable Circuit Accessory for use with Model 750 Portable... | ZOLL Medical Corporation | CAI | ||
| Z-0359-2012 | RayStation Version 2.0.0.15 Consult instruction for use. RaySearch Laboratories AB... | RaySearch Laboratories AB (publ) | MUJ | ||
| Z-0199-2012 | Left IBO Blade , for use with Stryker TPS or Core Reciprocating Saw, REF 5100-37-902S2... | Stryker Corp. | DZJ | ||
| Z-0198-2012 | Right IBO Blade , for use with Stryker TPS Reciprocating Saw, REF 5100-37-901S2, Stryker... | Stryker Corp. | DZJ | ||
| Z-0197-2012 | Right/Left IBO Blade Set, for use with Stryker TPS Reciprocating Saw, REF 5100-37-903... | Stryker Corp. | DZJ | ||
| Z-0196-2012 | IBO Blade, Left, for use with Stryker TPS Reciprocating Saw, REF 5100-37-902, Stryker... | Stryker Corp. | DZJ | ||
| Z-0263-2012 | Infinity(R) Acute Care System (IACS) Monitoring Solution (M540) - Physiological Patient... | Draeger, Inc. | MHX | ||
| Z-0311-2012 | Roche Cobas c 111 Analyzer The Roche Cobas c 111 analyzer is an in-vitro diagnostic... | Roche Diagnostics GmbH | JJE | ||
| Z-0195-2012 | IBO Blade, Right, for use with Stryker TPS Reciprocating Saw, REF 5100-37-901, Stryker... | Stryker Corp. | DZJ | ||
| Z-0088-2014 | Class II | da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which contains a... | Intuitive Surgical, Inc. | NAY | |
| Z-2234-2012 | Class II | OPTETRAK LOGIC Proximal Tibial Spacer & Screws (2) 2.5 LT BLUE Size 2.5... | Exactech, Inc. | JWH | |
| Z-2143-2012 | Class II | SoftLab with SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51, and... | SCC Soft Computer | JQP | |
| Z-1106-2012 | Premier Care Recliner Model 5570. Brochure: "***Premier Care Recliner... | Champion Mfg, Inc. | INM | ||
| Z-1105-2012 | Premier LifeCare Recliner 5400. Brochure is labeled in part: "***Premier LifeCare... | Champion Mfg, Inc. | INM | ||
| Z-0939-2012 | Broselow/Hinkle Pediatric Emergency System Vital Signs Inc. 20 Campus Road Totowa, NJ... | Vital Signs, Inc. | OGL | ||
| Z-0279-2012 | STERIS 5085 and 5085SRT Surgical Tables, Catalog Numbers: 5085- ST01-410-1; 5085SRT... | STERIS Corporation | FQO | ||
| Z-0348-2012 | Synthes Oscillating Saw Attachment/Large w/Key for Small Battery Drive. This surgical... | Synthes GmbH | HWE | ||
| Z-1063-2012 | GE SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM ( SENO 2000D). The Senographe... | GE Healthcare | MUE | ||
| Z-1215-2012 | Integra CUSA EXcel Sterile Tips Rx Only Single Use Only Product Usage: For usage in... | Integra LifeSciences Corporation | LFL | ||
| Z-1102-2012 | V Series Monitor Mindray DS USA, Inc. 800 MacArthur Boulevard. Mahwah, NJ 07430 The... | Datascope Corp. | DRT | ||
| Z-0832-2012 | Bassinet Models: BSNT/01; BSNT/02, BSNT/03, BSNT/04 The Nemschoff Perinatal Bassinet... | Nemschoff Chairs, Inc. | NZG | ||
| Z-0512-2012 | Urine Reagent Strips (URS) 11 Parameters URS-11-100G-001 510(K) number: K970250 Devise... | Teco Diagnostics | KQO | ||
| Z-0511-2012 | Urine Reagent Strips (URS) 10 Parameters URS-l0-100W 510(K) number: K970250 Devise... | Teco Diagnostics | KQO | ||
| Z-0358-2012 | Integra Surgical Luxtec MLX Light Source Catalog Numbers: 00MLXEU | Integra LifeSciences Corporation | FCW | ||
| Z-0357-2012 | Integra Surgical Luxtec MLX Light Source Catalog Numbers: 00MLXAU Product Usage: The... | Integra LifeSciences Corporation | FCW | ||
| Z-0356-2012 | Integra Surgical Luxtec MLX Light Source Catalog Numbers: 00MLX Product Usage: The... | Integra LifeSciences Corporation | FCW | ||
| Z-0320-2012 | Elekta Synergy XVI R.4.5 and R4.6 ProducT Usage: To be used as part of radiation... | Elekta Limited | IYE |