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-2679-2018 | Class II | rHead Stem Implant Plasma Coated, Size 3. Orthopedic implant for replacement of the... | Howmedica Osteonics Corp | LTF | |
| Z-2678-2018 | Class II | rHead Stem Implant Plasma Coated, Size 2. Orthopedic implant for replacement of the... | Howmedica Osteonics Corp | LTF | |
| Z-2677-2018 | Class II | rHead Stem Implant Plasma Coated, Size 1. Orthopedic implant for replacement of the... | Howmedica Osteonics Corp | LTF | |
| Z-2676-2018 | Class II | Lateral Assembly, Radial Head Impl Assembly, Size 4. Orthopedic implant for replacement... | Howmedica Osteonics Corp | KWI | |
| Z-2675-2018 | Class II | Lateral Assembly, Radial Head Impl Assembly, Size 3. Orthopedic implant for replacement... | Howmedica Osteonics Corp | KWI | |
| Z-2674-2018 | Class II | Lateral Assembly, Radial Head Impl Assembly, Size 2. Orthopedic implant for replacement... | Howmedica Osteonics Corp | KWI | |
| Z-2673-2018 | Class II | Lateral Assembly, Radial Head Implant, Size 4. Orthopedic implant for replacement of the... | Howmedica Osteonics Corp | KWI | |
| Z-2672-2018 | Class II | Lateral Assembly, Radial Head Implant, Size 3. Orthopedic implant for replacement of the... | Howmedica Osteonics Corp | KWI | |
| Z-2671-2018 | Class II | Lateral Assembly, Radial Head Implant, Size 2. Orthopedic implant for replacement of the... | Howmedica Osteonics Corp | KWI | |
| Z-2670-2018 | Class II | Lat Assembly, Rad Stem Implant,Collar 6mm,Size 4. Orthopedic implant for replacement of... | Howmedica Osteonics Corp | KWI | |
| Z-2669-2018 | Class II | Lat Assembly, Rad Stem Implant,Collar 6mm,Size 3. Orthopedic implant for replacement of... | Howmedica Osteonics Corp | KWI | |
| Z-2668-2018 | Class II | Lat Assembly, Rad Stem Implant,Collar 6mm,Size 2. Orthopedic implant for replacement of... | Howmedica Osteonics Corp | KWI | |
| Z-2667-2018 | Class II | Lat Assembly, Rad Stem Implant,Collar 6mm, Size1. Orthopedic implant for replacement of... | Howmedica Osteonics Corp | KWI | |
| Z-2666-2018 | Class II | Lateral Assembly, Radial Stem Implant, Size 4. Orthopedic implant for replacement of the... | Howmedica Osteonics Corp | KWI | |
| Z-2665-2018 | Class II | Lateral Assembly, Radial Stem Implant, Size 3. Orthopedic implant for replacement of the... | Howmedica Osteonics Corp | KWI | |
| Z-2664-2018 | Class II | Lateral Assembly, Radial Stem Implant, Size 2. Orthopedic implant for replacement of the... | Howmedica Osteonics Corp | KWI | |
| Z-2663-2018 | Class II | Lateral Assembly, Radial Implant, Size 1 Orthopedic implant for replacement of the... | Howmedica Osteonics Corp | KWI | |
| Z-1299-2018 | Class II | Pneumothorax Kit | Arrow International LLC (subsidiary of Teleflex Incorporated) | KDD | |
| Z-1298-2018 | Class II | ArrowClarke" PleuraSeal Thoracentesis Kit | Arrow International LLC (subsidiary of Teleflex Incorporated) | KDD | |
| Z-1297-2018 | Class II | Large Volume Abdominal Paracentesis Kit | Arrow International LLC (subsidiary of Teleflex Incorporated) | KDD | |
| Z-0231-2018 | Class II | ABL800 analyzer with FLEXQ module. Device intended for in vitro testing of samples of... | Radiometer America, Inc | CHL | |
| Z-0266-2018 | Class II | The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and... | Medacta USA, Inc. | JWH | |
| Z-0097-2018 | Class II | smith&nephew TRIGEN INTERTAN 10S, REF 71675384, 10 MM X 18 CM NAIL, 130o (degrees), SET... | Smith & Nephew, Inc. | JDS | |
| Z-0069-2018 | Class II | AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO. | Windstone Medical Packaging, Inc. | LRO | |
| Z-1098-2018 | Class II | Wound Closure Tray - Facial | Centurion Medical Products, LP | LRP | |
| Z-1097-2018 | Class II | Wound Care Kit | Centurion Medical Products, LP | LRP | |
| Z-1096-2018 | Class II | Excision Tray | Centurion Medical Products, LP | LRP | |
| Z-1095-2018 | Class II | Neonatal IV Start Kit | Centurion Medical Products, LP | LRP | |
| Z-1094-2018 | Class II | Infant IV Securement Kit | Centurion Medical Products, LP | LRP | |
| Z-1093-2018 | Class II | IV Start Kit | Centurion Medical Products, LP | LRP | |
| Z-1092-2018 | Class II | Pediatric IV & IV Start Kit | Centurion Medical Products, LP | LRP | |
| Z-1091-2018 | Class II | Latex Free IV Start Set | Centurion Medical Products, LP | LRP | |
| Z-1090-2018 | Class II | Neonatal IV Access Set | Centurion Medical Products, LP | LRP | |
| Z-1089-2018 | Class II | Blood Draw Kit | Centurion Medical Products, LP | LRP | |
| Z-1088-2018 | Class II | INCISION & DRAINAGE TRAY or KIT | Centurion Medical Products, LP | LRP | |
| Z-1087-2018 | Class II | Minor Dressing Change Tray | Centurion Medical Products, LP | LRP | |
| Z-1086-2018 | Class II | Tubing Change Kit | Centurion Medical Products, LP | LRP | |
| Z-1085-2018 | Class II | SorbaView Shield Dressing Change Tray | Centurion Medical Products, LP | LRP | |
| Z-1084-2018 | Class II | St. Christopher's Securement Set | Centurion Medical Products, LP | LRP | |
| Z-1083-2018 | Class II | Catheter Securement System | Centurion Medical Products, LP | LRP | |
| Z-1082-2018 | Class II | Circumcision Tray | Centurion Medical Products, LP | LRP | |
| Z-1081-2018 | Class II | Mini Plastics Set | Centurion Medical Products, LP | LRP | |
| Z-1080-2018 | Class II | General Purpose Instrument Tray | Centurion Medical Products, LP | LRP | |
| Z-1079-2018 | Class II | SUTURE REMOVAL TRAY, SET or KIT | Centurion Medical Products, LP | MCZ | |
| Z-1078-2018 | Class II | Skin Staple Remover | Centurion Medical Products, LP | MCZ | |
| Z-0813-2018 | Class II | Surgical punch; sealed pouches packed in punch shelf box Intended for use by trained... | Alto Development Corp | LRY | |
| Z-0672-2018 | Class II | Disposable Curved Circular Staplers Product Usage: Staplers have application throughout... | Ethicon Endo-Surgery Inc | GDW | |
| Z-0162-2018 | Class II | Sensicare Green Surgical Glove, PI, LF, PF. Packaged in a poly/poly peel pouch with... | MEDLINE INDUSTRIES, LP - Northfield | KGO | |
| Z-0406-2018 | Class II | Radial Osteotome Blade, REF 71369314. Used for cutting or preparing bone. | Smith & Nephew, Inc. | MDM | |
| Z-0816-2018 | Class II | Ultrasound Transducer, Model Number: UST-5550-R, is used in conjunction with a diagnostic... | FUJIFILM Healthcare Americas Corporation | ITX |