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-2587-2017 | Class II | Sheridan SHER-I-SLIP and SOFT-TIP Intubating Stylets are intubating stylets manufactured... | Teleflex Medical | BSR | |
| Z-2154-2017 | Class II | Philips DigitalDiagnost 3.1.x X-Ray System | Philips North America LLC | MQB | |
| Z-2252-2017 | Class II | Clear Flashback Needle 7cm x 18G AMC/4; Clear Flashback Needle 2.5 cm x 21G AMC/4; Winged... | Argon Medical Devices, Inc | GDR | |
| Z-2111-2017 | Class II | Normed General Instruments 503004541: Werber Countersink Cannulated for micro CBS Screws... | Zimmer GmbH | HTT | |
| Z-2746-2017 | Class II | Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958. | Medtronic Navigation, Inc | HAW | |
| Z-2245-2017 | Class II | Pediatric, High Conc. Non-Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-ALL Oxygen... | ConvaTec Limited | BYG | |
| Z-2244-2017 | Class II | Non-Rebreather Mask w 7 (2.1 m) No-Crush Tubing, Adult, Product Code 9106-E, Product Code... | ConvaTec Limited | BYG | |
| Z-2243-2017 | Class II | Non-Rebreather Oxygen Mask, Pediatric with Tubing, Product Code 86-3226E, Product Code... | ConvaTec Limited | BYG | |
| Z-2242-2017 | Class II | Oxygen Mask, Standard (Under the Lip) Infant, High Concentration Non-Rebreather, 7 ft... | ConvaTec Limited | BYG | |
| Z-2241-2017 | Class II | Non-Rebreathing Mask, Reservoir Bag, Check Valve, Two Side Valves, with Tubing, Product... | ConvaTec Limited | BYG | |
| Z-2240-2017 | Class II | Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 ft... | ConvaTec Limited | BYG | |
| Z-2239-2017 | Class II | Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 ft... | ConvaTec Limited | BYG | |
| Z-2238-2017 | Class II | Non-Rebreather, Oxygen Mask, Adult 7 (2.1 m) Tubing, Product Code 3108-E, Product Code... | ConvaTec Limited | BYG | |
| Z-2237-2017 | Class II | Oxygen Masks, Elongated (Under Chin) Adult High Conc., Non-Rebreather, 7ft O2 Tubing... | ConvaTec Limited | BYG | |
| Z-2236-2017 | Class II | Rebreather Oxygen Mask, Adult 7 (2.1 m) Tubing, Product Code 3104MM, Product Code 9104-E... | ConvaTec Limited | BYG | |
| Z-2235-2017 | Class II | Oxygen Masks, Elongated (Under Chin), Adult Med Concentration, No Tubing, FITS-All Conn... | ConvaTec Limited | BYG | |
| Z-2234-2017 | Class II | Non-Rebreather Mask, Reservoir Bag, Check Valve, Two Side Valves, No Tubing, Product Code... | ConvaTec Limited | BYG | |
| Z-2233-2017 | Class II | Non-Rebreather Oxygen Mask, Adult High Concentration with 2.1 m (7) Oxygen Tubing... | ConvaTec Limited | BYG | |
| Z-2232-2017 | Class II | Oxygen Masks, Elongated (Under Chin), Adult High Conc., Non-Rebreather, 7ft O2 Tubing... | ConvaTec Limited | BYG | |
| Z-2231-2017 | Class II | Oxygen Mask, Adult High Concentration Non-Rebreather 2.1 m (7) Oxygen Tubing, Product... | ConvaTec Limited | BYG | |
| Z-2230-2017 | Class II | Non-Rebreathing Mask, Reservoir Bag, Check Valve, One Side Valve, with Tubing, Product... | ConvaTec Limited | BYG | |
| Z-2229-2017 | Class II | Rebreathing Mask, Reservoir bag, with Tubing, Product Code 104MM | ConvaTec Limited | BYG | |
| Z-2228-2017 | Class II | Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code 104-E; | ConvaTec Limited | BYG | |
| Z-2318-2017 | Class II | Vitality Spinal Fixation System, Vitality T27 Final Drivers and Vitality Torque Limiting... | Highridge Medical, LLC | LYQ | |
| Z-2539-2017 | Class II | Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in... | Cook Incorporated | GEX | |
| Z-2622-2017 | Class II | Covidien Endo Peanut 5mm Auto Suture Blunt Dissector Item Code: 173019 The instrument has... | Medtronic, Inc. | GCJ | |
| Z-2638-2017 | Class II | Access System-GI Monitor (CA19-9), A83873D, Catalog No. 387687 | Siemens Healthcare Diagnostics Inc. | NIG | |
| Z-2637-2017 | Class II | Access System-Free T4 Assay, B01902E, Catalog No. 33880 | Siemens Healthcare Diagnostics Inc. | CEC | |
| Z-2636-2017 | Class II | Access Thyroglobulin, A34085G, Catalog No. 33860 | Siemens Healthcare Diagnostics Inc. | MSW | |
| Z-2635-2017 | Class II | Access Total T3, A34435H, Catalog No. 33830 | Siemens Healthcare Diagnostics Inc. | CDP | |
| Z-2223-2017 | Class II | Cobas connection module (CCM) - OUTPUT UNIT The module CCM enables a unidirectional... | Roche Diagnostics GmbH | JQP | |
| Z-2338-2017 | Class II | Arrow Pressure Injectable PICC Kit Catheter, Intravascular, Therapeutic, Long-Term... | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-2337-2017 | Class II | ARROWg+ard Blue CVC Kit The ARROWg+ard Blue CVCs are intended to permit venous access to... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2336-2017 | Class II | Arrow Multi-Lumen CVC Kit The Arrow Two-Lumen Central Venous Access device permits venous... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DQY | |
| Z-2335-2017 | Class II | Arrow MAC Two-Lumen Central Venous Access Kit Introducer Catheter The Arrow Two-Lumen... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2334-2017 | Class II | 1) ARROWg+ard Blue You-Blend Two-Lumen Hemodialysis Catheterization Kit for High Volume... | Arrow International LLC (subsidiary of Teleflex Incorporated) | MPB | |
| Z-2333-2017 | Class II | 1) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 2) ARROWg+ard Blue PSI Kit 3)... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2332-2017 | Class II | Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2331-2017 | Class II | 1) Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The Pressure... | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-2330-2017 | Class II | 1) Pressure Injectable Multi-Lumen Central Venous Catheterization Kit 2) Pressure... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2329-2017 | Class II | 1) Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DYB | |
| Z-2328-2017 | Class II | Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, Catheter... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DQY | |
| Z-2327-2017 | Class II | Arterial Catheterization Kit, Arterial Line Kit with Sharps Safety Features wire, guide... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DQX | |
| Z-2251-2017 | Class II | Hudson RCI, Pediatric Nasal Cannula, Non-Flared Prongs, Rx only, | Teleflex Medical | CAT | |
| Z-2309-2017 | Class III | Beekley Medical 0-SPOT Mammography Skin Markers REF 652 | Beekley Corporation | JAC | |
| Z-2591-2017 | Class II | Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed... | Merge Healthcare Incorporated | LLZ | |
| Z-2590-2017 | Class II | Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. | Merge Healthcare Incorporated | LLZ | |
| Z-2198-2017 | Class II | Reusable instruments in the Knee, Hip, Trauma, and Extremities segments. | Zimmer GmbH | N/A | |
| Z-2669-2017 | Class II | Electrophysiology catheter cables are designed as electrode cables with a multi-pin... | Sterilmed Inc | N/A | |
| Z-2605-2017 | Class II | MiniMed 670G Insulin Infusion Pump, Catalog No. MMT-1580, MMT-1780, MMT-1782, MMT-1760. | Medtronic, Inc. | OZP |