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-2299-2013 | Class I | MedStream Programmable Pump; 40ml Pump EMEA 91-4201 Product Usage: The Medstream... | Cerenovus, Inc. | LKK | |
| Z-2298-2013 | Class I | MedStream Refill Kit, U.S (6 units): 91-4288 Product Usage: The Medstream programmable... | Cerenovus, Inc. | LKK | |
| Z-2297-2013 | Class I | MedStream Refill Kit (6 units), EMEA: 91-4290 Product Usage: The Medstream programmable... | Cerenovus, Inc. | LKK | |
| Z-2296-2013 | Class I | MedStream Refill Kit (1 unit), EMEA: 91-4289 Product Usage: The Medstream programmable... | Cerenovus, Inc. | LKK | |
| Z-2214-2013 | Class II | Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054. The Cypher MIS Screw System... | Ebi, LLC | LXH | |
| Z-2199-2013 | Class II | AEQUALIS Reversed II or AEQUALIS Reversed Fracture Impactor. These products are... | TORNIER Inc. | HTZ | |
| Z-2295-2013 | Class I | MedStream Refill Kit, U.S: 91-4287 Product Usage: The Medstream programmable pump is... | Cerenovus, Inc. | LKK | |
| Z-2294-2013 | Class I | MedStream Programmable Pump; 40ml - 91-4201US Usage: The Medstream programmable pump is... | Cerenovus, Inc. | LKK | |
| Z-0114-2014 | Class II | Synthes Application Instrument Sternal Zip Flex System intended for use in primary or... | Synthes GmbH | JDQ | |
| Z-2293-2013 | Class I | MedStream Programmable Pump; 20ml - 91-4200US Product Usage: The Medstream programmable... | Cerenovus, Inc. | LKK | |
| Z-0275-2014 | Class II | DeRoyal (R) Surgical Eye Spears, REF 30-049, Sterile EO, Manufacturer: DeRoyal... | DeRoyal Industries, Inc. | HOZ | |
| Z-2252-2013 | Class II | Central Dressing Change Kit; AMS-8464CP- 6. Vygon Central Dressing Change Kit contains... | Vygon Mfg | FPA | |
| Z-2251-2013 | Class II | Vygon 14 Microbore Extension Set with Bionector, CMS-814-1. The CMS-814-1 is a 14 inch... | Vygon Mfg | FPA | |
| Z-0020-2014 | Class II | Clinical Chemistry Phosphorus Reagent The Phosphorus assay is used for the quantitation... | Abbott Medical | CEO | |
| Z-2159-2013 | Class II | Kirschner-Wire (K-Wire), packed in a clear tube with end caps, tubes packed in a sterile... | MicroAire Surgical Instruments, LLC | HTY | |
| Z-2158-2013 | Class II | Steinmann Pin, packed in a clear tube with end caps, tubes packed in a sterile barrier... | MicroAire Surgical Instruments, LLC | HTY | |
| Z-0003-2014 | Class II | Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of... | Cordis US Corp. | DQY | |
| Z-2200-2013 | Class II | T8 REMOVAL HEAD, REF 8910641, QTY: 1 EA, Product Usage: The non-sterile T8 Removal... | Medtronic Sofamor Danek USA Inc | HXX | |
| Z-0011-2014 | Class II | ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162... | Siemens Healthcare Diagnostics Inc. | GKZ | |
| Z-0065-2014 | Class II | VARISOURCE Breast Template System for high-dose rate Brachytherapy. ***INSTRUCTIONS FOR... | Varian Medical Systems, Inc. | JAQ | |
| Z-0029-2014 | Class II | Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes... | Opti Medical Systems Inc | JJE | |
| Z-2202-2013 | Class II | Sonogage EyeScan, A-Scan Biometer, Product Usage: A-Scan Biometer diagnostic device... | Sonogage, Inc. | IYO | |
| Z-2131-2013 | Class III | WASP (Walk Away Specimen Process). Automatic Planting and Streaking Instrument Catalog... | Copan Italia | JTC | |
| Z-2327-2016 | Class II | Horizon 24 Large Titanium Clips with Adhesive Backing, Ref 004204, Rx Only, Sterile. The... | Teleflex Medical | FZP | |
| Z-2059-2013 | Class II | Philips Easy Upgrade DR, Code No: 712086 This system is used for making X-Ray exposures... | Philips North America LLC | KPR | |
| Z-2135-2014 | Class I | Enhancement Medical expression. model # EXP-150. Injectable Gel 1.5cc Syringe with... | Enhancement Medical, LLC | LMH | |
| Z-0033-2014 | Class II | Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T... | Philips North America LLC | LNH | |
| Z-2097-2013 | Class II | E-Z Clean Disposable Laparoscopic Electrode Model Number 0100L and 0100LS. Expiration... | Megadyne Medical Products, Inc | GEI | |
| Z-2098-2013 | Class II | GE Ultrasound ViewPoint 6. Product Usage: ViewPoint is intended to be used in medical... | GE Healthcare | LLZ | |
| Z-2240-2013 | Class II | TWINFIX Ultra 6.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue... | Smith & Nephew, Inc. | MAI | |
| Z-2239-2013 | Class II | TWINFIX Ultra 5.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue... | Smith & Nephew, Inc. | MAI | |
| Z-2238-2013 | Class II | TWINFIX" Ultra 4.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue... | Smith & Nephew, Inc. | MAI | |
| Z-2237-2013 | Class II | RAPTORMITE" 3.7 mm PLLA with two ULTRABRAID" Sutures Size 0 and Needles; Part Number... | Smith & Nephew, Inc. | MAI | |
| Z-2236-2013 | Class II | TWINFIX Ultra PLLA/HA 6.5 mm with 3 ULTRABRAID Suture; Part Number... | Smith & Nephew, Inc. | MAI | |
| Z-2235-2013 | Class II | TWINFIX" Ultra PLLA/HA 6.5 mm with 2 ULTRABRAID" Suture, White / Black: Part Number... | Smith & Nephew, Inc. | MAI | |
| Z-2234-2013 | Class II | TWINFIX ULTRA PLLA/HA 5.5 mm Suture Anchor with 3 ULTRABRAID Suture: Part Number... | Smith & Nephew, Inc. | MAI | |
| Z-2233-2013 | Class II | TWINFIX Ultra PLLA/HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black: Part... | Smith & Nephew, Inc. | MAI | |
| Z-2232-2013 | Class II | TWINFIX Ultra HA 6.5 mm with 2 ULTRABRAID Suture, Blue / Black; Part Number... | Smith & Nephew, Inc. | MAI | |
| Z-2231-2013 | Class II | TWINFIX Ultra HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Part... | Smith & Nephew, Inc. | MAI | |
| Z-2230-2013 | Class II | TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Part... | Smith & Nephew, Inc. | MAI | |
| Z-2229-2013 | Class II | TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue; Part... | Smith & Nephew, Inc. | MAI | |
| Z-2228-2013 | Class II | OSTEORAPTOR CURVED 2.3 mm Suture Anchor SA ULTRABRAID COBRAID Suture, Blue; Part Number... | Smith & Nephew, Inc. | JDR | |
| Z-2227-2013 | Class II | OSTEORAPTOR CURVED 2.3 mm Suture Anchor ULTRABRAID COBRAID Suture, Black; Part Number... | Smith & Nephew, Inc. | JDR | |
| Z-2226-2013 | Class II | OSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture, White; Part Number... | Smith & Nephew, Inc. | JDR | |
| Z-2225-2013 | Class II | OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black; Part Number... | Smith & Nephew, Inc. | JDR | |
| Z-2224-2013 | Class II | OSTOSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Blue; Part Number... | Smith & Nephew, Inc. | JDR | |
| Z-2223-2013 | Class II | OSTEORAPTOR 2.3 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Black; Part Number... | Smith & Nephew, Inc. | JDR | |
| Z-2222-2013 | Class II | OSTEORAPTOR 2.3 mm with 1 ULTRABRAID Suture, White; Part Number: 72201991 Biodegradable... | Smith & Nephew, Inc. | JDR | |
| Z-2221-2013 | Class II | OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue ; Part Number... | Smith & Nephew, Inc. | JDR | |
| Z-2220-2013 | Class II | OSTEORAPTOR 2.3 mm Suture Anchor with ULTRABRAID COBRAID Suture, Blue; Part Number... | Smith & Nephew, Inc. | JDR |