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-2251-2018 | Class II | Fabius GS Tiro Anesthesia Machine; Cat. no. 8606000 Product Usage: Inhalation anesthesia... | Draeger, Inc. | BSZ | |
| Z-2250-2018 | Class II | Fabius GS Premium Anesthesia Machine; Cat. no. 8607000 Product Usage: Inhalation... | Draeger, Inc. | BSZ | |
| Z-2158-2018 | Class II | Medline Adult Manual Resuscitator with Medium Adult Mask, Tube Reservoir, PEEP Valve and... | Salter Labs | BTM | |
| Z-2157-2018 | Class II | Medline Adult Manual Resuscitator with Medium Adult Mask, Tube Reservoir, Filter, PEEP... | Salter Labs | BTM | |
| Z-2156-2018 | Class II | Medline Adult Manual Resuscitator with Medium Adult Mask, Tube Reservoir, Filter, PEEP... | Salter Labs | BTM | |
| Z-2155-2018 | Class II | Medline Adult Manual Resuscitator with Large Adult Mask, Tube Reservoir, Filter and 7 Ft... | Salter Labs | BTM | |
| Z-2154-2018 | Class II | Medline Adult Manual Resuscitator with Medium Adult Mask, Tube Reservoir, Filter and 7... | Salter Labs | BTM | |
| Z-2153-2018 | Class II | Medline Adult Manual Resuscitator with Medium Adult Mask, Tube Reservoir, CO2 and 7 Ft... | Salter Labs | BTM | |
| Z-2152-2018 | Class II | Medline Adult Manual Resuscitator with Medium Adult Mask, Tube Reservoir and 7 Ft. Oxygen... | Salter Labs | BTM | |
| Z-2151-2018 | Class II | Medline Adult Manual Resuscitator with Medium Adult Mask 5, Bag Reservoir, PEEP Valve and... | Salter Labs | BTM | |
| Z-2150-2018 | Class II | Medline Adult Manual Resuscitator with Medium Adult Mask, Bag Reservoir, PEEP Valve, CO2... | Salter Labs | BTM | |
| Z-2149-2018 | Class II | Medline Adult Manual Resuscitator with Medium Adult Mask, Bag Reservoir, PEEP Valve and 7... | Salter Labs | BTM | |
| Z-2148-2018 | Class II | Medline Adult Manual Resuscitator with Medium Adult Mask, Bag Reservoir, Filter, CO2 and... | Salter Labs | BTM | |
| Z-2147-2018 | Class II | Medline Adult Manual Resuscitator with Medium Adult Mask, Bag Reservoir, Filter and 7 Ft... | Salter Labs | BTM | |
| Z-2146-2018 | Class II | Medline Adult Manual Resuscitator with Medium Adult Mask, Bag Reservoir and 7 Ft. Oxygen... | Salter Labs | BTM | |
| Z-2145-2018 | Class II | STAT-Check MANUAL RESUSCITATOR / VENTILATOR, REF SC9200MBP-1 | Salter Labs | BTM | |
| Z-2289-2018 | Class II | Vanguard Complete Knee System; E1 Vanguard PS Tibial Bearing; Model Numbers EP-183664... | Zimmer GmbH | JWH | |
| Z-0537-2020 | Class III | Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation studies... | Helena Laboratories, Corp. | GHR | |
| Z-0536-2020 | Class III | Platelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studies... | Helena Laboratories, Corp. | GHR | |
| Z-2889-2018 | Class II | Vertebral Motion Analyzer (VMA), 2.3.250. Product System, image processing, radiological | Wenzel Spine | LLZ | |
| Z-2576-2018 | Class II | Percutaneous Sheath Introducer Kit for use with 7 - 7.5 Fr. Catheters (8 Fr. 10 cm... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DYB | |
| Z-2392-2018 | Class II | Reliance 1227 Cart and Utensil Washer/Disinfector, FW03101, FW03102, FW03S003 Product... | STERIS Corporation | MEC | |
| Z-2516-2018 | Class II | Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling system , Item... | Medtronic, Inc. | GDW | |
| Z-2515-2018 | Class II | Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling system 45 mm... | Medtronic, Inc. | GDW | |
| Z-2514-2018 | Class II | Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling system 30 mm... | Medtronic, Inc. | GDW | |
| Z-2513-2018 | Class II | Tri-Staple 2.0 Intelligent Reload for use with Signia stapling system 30 mm Medium/Thick... | Medtronic, Inc. | GDW | |
| Z-2512-2018 | Class II | Endo GIA 45mm Curved Tip Articulating Vascular/Medium Reload with Tri-Staple Technology... | Medtronic, Inc. | GDW | |
| Z-2511-2018 | Class II | Endo GIA 45 mm Articulating Vascular/Medium Loading Unit with Tri-Staple Technology, Item... | Medtronic, Inc. | GDW | |
| Z-2510-2018 | Class II | Endo GIA 45 mm Extra Thick Black Articulating Reload with Tri-Staple Technology, Item... | Medtronic, Inc. | GDW | |
| Z-2509-2018 | Class II | Endo GIA 45mm Gray Articulating Vascular Reload with Tri-Staple Technology, Item Code... | Medtronic, Inc. | GDW | |
| Z-2508-2018 | Class II | Tri-Staple 2.0 Intelligent Reload for use with Signia stapling system 30... | Medtronic, Inc. | GDW | |
| Z-2507-2018 | Class II | Tri-Staple 2.0 Black Intelligent Reload for use with Signia stapling system 60 mm Extra... | Medtronic, Inc. | GDW | |
| Z-2506-2018 | Class II | Endo GIA 60 mm Articulating Vascular/Medium Loading Unit with Tri-Staple Technology, Item... | Medtronic, Inc. | GDW | |
| Z-2505-2018 | Class II | Endo GIA 60 mm Extra Thick Black Articulating Reload with Tri-Staple Technology, Item... | Medtronic, Inc. | GDW | |
| Z-2504-2018 | Class II | Endo GIA 60 mm Articulating Medium/Thick Reload with Tri-StapleTechnology, Item Code... | Medtronic, Inc. | GDW | |
| Z-2503-2018 | Class II | Endo GIA 45 mm Articulating Medium/Thick Reload with Tri-Staple Technology, Item Code... | Medtronic, Inc. | GDW | |
| Z-2447-2018 | Class II | TIBIAXYS, Model Numbers: 150010S, 150020S, 150030S, 150040S, 150120S, 150110S, 150130S... | NewDeal SA | HRS | |
| Z-2446-2018 | Class II | Large QWIX, Model Numbers: 111740S, 111745S, 111750S, 111755S, 111760S, 111765S... | NewDeal SA | HRS | |
| Z-2445-2018 | Class II | ADVANSYS MLP/DLP, Model Numbers: 181051S, 181052S, 181041S, 181042S, 181031S, 181032S... | NewDeal SA | HRS | |
| Z-2444-2018 | Class II | ADVANSYS TTC, Model Numbers: 181011S, 181012S, 181013S, 181014S, 181001S, 181002S... | NewDeal SA | HRS | |
| Z-2443-2018 | Class II | UNI-CP, Model Numbers: 330021S, 330023S, 330025S, 330030S, 330025S, 30030S, 330217S... | NewDeal SA | HRS | |
| Z-2280-2018 | Class II | Randox Liquid Assayed Specific Protein Control - Level 3 (SP Control 3), Cat. no. PS2684 | Randox Laboratories, Limited | JJY | |
| Z-2279-2018 | Class II | Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat. no. PS2683 | Randox Laboratories, Limited | JJY | |
| Z-2278-2018 | Class II | Randox Liquid Assayed Specific Protein Control - Level 1 (SP Control 1), Cat. no. PS2682 | Randox Laboratories, Limited | JJY | |
| Z-2299-2018 | Class II | LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-236 | Howmedica Osteonics Corp | JDI | |
| Z-2298-2018 | Class II | LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-336 | Howmedica Osteonics Corp | JDI | |
| Z-2297-2018 | Class II | LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-144 | Howmedica Osteonics Corp | JDI | |
| Z-2296-2018 | Class II | LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-140 | Howmedica Osteonics Corp | JDI | |
| Z-2295-2018 | Class II | LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-136 | Howmedica Osteonics Corp | JDI | |
| Z-2294-2018 | Class II | LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-044 | Howmedica Osteonics Corp | JDI |