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-1900-2011 | Siemens brand ACUSON S2000 Ultrasound System with software versions: VA10, VA10A, VA10B... | Siemens Medical Solutions USA, Inc. | GKZ | ||
| Z-1322-2009 | Tri-State Centurion Plastic Laceration Set, sterile, 16 per case, Tri-State Hospital... | Centurion Medical Products, LP | MCZ | ||
| Z-1321-2009 | Tri-State Centurion Incision and Drainage Tray, sterile, 20 per case, Tri-State Hospital... | Centurion Medical Products, LP | KDD | ||
| Z-1320-2009 | Tri-State Centurion Laceration Tray - SnagFree, sterile, 16 per case, Tri-State Hospital... | Centurion Medical Products, LP | MCZ | ||
| Z-1319-2009 | Tri-State Centurion Endoscopy Tray, sterile, 10 per case, Tri-State Hospital Supply... | Centurion Medical Products, LP | LRP | ||
| Z-1087-2009 | HydroSil (Intermittent Catheter) Hydrophilic 14 French Male Length REF#63614 Rochester... | Rochester Medical Corp. | KOD | ||
| Z-1086-2009 | HydroSil (Intermittent Catheter), Hydrophilic 12 French Male Length REF#63612 Rochester... | Rochester Medical Corp. | KOD | ||
| Z-1085-2009 | HydroSil (Intermittent Catheter), Hydrophilic 14 French Male Length Sample Packs... | Rochester Medical Corp. | KOD | ||
| Z-1084-2009 | HydroSil (Intermittent Urethral Catheter), Hydrophilic 12 French Male Length Sample Packs... | Rochester Medical Corp. | KOD | ||
| Z-1083-2009 | Magic3 (Intermittent Catheter), Sterile. Hydrophilic 16 French Male Length REF... | Rochester Medical Corp. | KOD | ||
| Z-1082-2009 | Magic3 (Intermittent Catheter), Sterile. Hydrophilic 14 French Male Length REF... | Rochester Medical Corp. | KOD | ||
| Z-1081-2009 | Magic3 (Intermittent Catheter), Sterile. Hydrophilic 12 French Male Length REF... | Rochester Medical Corp. | KOD | ||
| Z-1080-2009 | Magic3 (Intermittent Catheter), Sterile. Hydrophilic 10 French Pediatric Length REF... | Rochester Medical Corp. | KOD | ||
| Z-1079-2009 | Magic3 (Intermittent Catheter), Sterile. Hydrophilic 8 French Pediatric Length REF... | Rochester Medical Corp. | KOD | ||
| Z-1078-2009 | Magic3 (Intermittent Catheter), Sterile. Uncoated 10 French Male Length REF... | Rochester Medical Corp. | KOD | ||
| Z-1077-2009 | Magic3 (Intermittent Catheter), Sterile. Hydrophilic 6 French Pediatric Length REF... | Rochester Medical Corp. | KOD | ||
| Z-1076-2009 | Magic3 (Intermittent Catheter), Sterile. Uncoated 10 French Pediatric Length REF... | Rochester Medical Corp. | KOD | ||
| Z-1075-2009 | Magic3 (Intermittent Catheter), Sterile, Uncoated 8 French Pediatric Length REF... | Rochester Medical Corp. | KOD | ||
| Z-1074-2009 | Magic3 (Intermittent Catheter), Sterile, Uncoated 6 French Pediatric Length REF #... | Rochester Medical Corp. | KOD | ||
| Z-0557-2010 | Stryker Howmedica Osteonics, Primary Super SecurFit Stems, hip prosthesis, Sterile; Arc... | Howmedica Osteonics Corp | MEH | ||
| Z-0556-2010 | Stryker Howmedica Osteonics, Super SecurFit HA Hip Stem; Sterile Arc Deposited, V40... | Howmedica Osteonics Corp | MEH | ||
| Z-0997-2009 | Shiley PED3.0 Cuffless Pediatric Tracheostomy Tube, REF 3.0 PED, Sterile. Tyco... | Medtronic, Inc. | JOH | ||
| Z-1169-2009 | Tri-State Centurion Umbilical Vessel Tray without catheter, sterile, 5 per tray... | Centurion Medical Products, LP | KGZ | ||
| Z-1162-2009 | Lee Medical Neonatal/Ped PICC Insertion Tray, sterile, 15 per case, Lee Medical, Inc... | Centurion Medical Products, LP | LRS | ||
| Z-1166-2009 | Tri-State Centurion Port Access Tray, sterile, 20 per case, Tri-State Hospital Supply... | Centurion Medical Products, LP | LRS | ||
| Z-1161-2009 | Tri-State Centurion PICC/CVC Insertion Tray, sterile, 15 per case, Tri-State Hospital... | Centurion Medical Products, LP | LRS | ||
| Z-1165-2009 | Tri-State Centurion Port Access Tray, sterile, 20 per case, Tri-State Hospital Supply... | Centurion Medical Products, LP | MCY | ||
| Z-1167-2009 | Tri-State Centurion Implanted Access Port Tray, sterile, 16 per case, Tri-State Hospital... | Centurion Medical Products, LP | MCY | ||
| Z-1164-2009 | Tri-State Centurion Port Access Tray, sterile, 20 per case, Tri-State Hospital Supply... | Centurion Medical Products, LP | MCY | ||
| Z-1163-2009 | Tri-State Centurion Port Access Kit, sterile, 20 per case, Tri-State Hospital Supply... | Centurion Medical Products, LP | LRS | ||
| Z-1168-2009 | Tri-State Centurion Sutureless Multi-Lumen CVC Insertion Kit, sterile, 5 per case... | Centurion Medical Products, LP | LRS | ||
| Z-1159-2009 | Tri-State Centurion PICC Line Tray, sterile, 10 per case, Tri-State Hospital Supply... | Centurion Medical Products, LP | LRS | ||
| Z-1158-2009 | Tri-State Centurion Chest Tube Insertion Tray (Dentry/Bardmoor), sterile, 6 per case... | Centurion Medical Products, LP | FOZ | ||
| Z-1157-2009 | Tri-State Centurion Chest Tube Insertion Tray, sterile, 6 per case, Tri-State Hospital... | Centurion Medical Products, LP | FOZ | ||
| Z-1160-2009 | Tri-State Centurion PICC Insertion Tray, sterile, 15 per case, Tri-State Hospital Supply... | Centurion Medical Products, LP | LRS | ||
| Z-2295-2011 | Newport HT50 Ventilator. Model #HT50 H1-B The device is intended to provide... | Newport Medical Instruments, Inc. | CBK | ||
| Z-0361-2011 | ENDOPATH ETS-FLEX45 Articulating Endoscopic Linear Cutters, Model # ATS45. Manfuactured... | Ethicon Endo-Surgery Inc | GDW | ||
| Z-0973-2009 | Sterile Field Saline Flush; 0.9% Sodium Chloride Injection, USP; Rx Only; Single... | Excelsior Medical LLC | NGT | ||
| Z-1043-2009 | BEC Growth Chek Microbial Suspension - Candida albicans CA1 (100 dose), Product... | Biological & Environmental Control Laboratories | LRF | ||
| Z-2335-2010 | Abbott Spine PathFinder, Cannulated Poly Screwdriver II - MOD, non-sterile, Manufactured... | Zimmer GmbH | MNI | ||
| Z-2314-2009 | Tandem Unipolar, 46 MM CO-CR, REF 126646, Sterile, Smith & Nephew, Memphis TX... | Smith & Nephew, Inc. | LZY | ||
| Z-1570-2009 | Sterrad 50 Sterilizer, Product Code 10050. Low-temperature general-purpose sterilizer... | Advanced Sterilization Products | MLR | ||
| Z-1235-2009 | syngo Imaging, picture archiving and communications system (PACS), Model number 10 014... | Siemens Medical Solutions USA, Inc. | LLZ | ||
| Z-1247-2009 | Ceiling Tube Mount Ceiling Tube Mount (CTM)/Digital Ceiling Tube Mount (DCTM) with 5 inch... | Del Medical, Inc. | IYB | ||
| Z-0969-2009 | GE Centricity PACS RA1000 Workstation (for diagnostic image analysis); GE Healthcare... | GE Healthcare | LLZ | ||
| Z-1224-2009 | Terumo Advanced Perfusion System 1 Central Control Monitor. Terumo Cardiovascular... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0534-2010 | BD Recalled component is labeled: BD 60ml Syringe Luer-Lok Tip, REF 309653... | Biomet Microfixation | KDD | ||
| Z-0533-2010 | BD Recalled component is labeled: BD 60ml Syringe Luer-Lok Tip, REF 309653... | Biomet Microfixation | KDD | ||
| Z-0532-2010 | BD Recalled component is labeled: BD 60ml Syringe Luer-Lok Tip, REF 309653... | Biomet Microfixation | KDD | ||
| Z-0531-2010 | BD Recalled component is labeled: BD 60ml Syringe Luer-Lok Tip, REF 309653... | Biomet Microfixation | KDD |