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-1590-2018 | Class II | StoneBreaker Pneumatic Lithotripter, Catalog number: SBL-KIT1; GPN: G52604... | Cook Incorporated | FFK | |
| Z-0946-2018 | Class II | Ace (Tm) Brand, Deluxe Ankle Brace, 207736, Upc 0 51131 20387 7 | 3M Company | IQI | |
| Z-0945-2018 | Class II | Futuro (Tm) Sport, Quick Strap Ankle Support, Ref 47736Gen, Upc 0 51131 19692 6 | 3M Company | IQI | |
| Z-2063-2018 | Class II | TL-HEX TruLok Hexapod System, Double Row Footplates, TL-HEX Sterile, All Sizes: 120 MM... | Orthofix SRL | KTT | |
| Z-1462-2018 | Class II | Triathlon Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601 The knee system... | Howmedica Osteonics Corp | MBH | |
| Z-1540-2018 | Class II | Dimension Vista Calcium Flex reagent cartridge, Dimension Vista CA, K1023, SMN #... | Siemens Healthcare Diagnostics Inc. | CIC | |
| Z-1241-2018 | Class II | AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 804-06-152... | Encore Medical, LP | PHX | |
| Z-1341-2018 | Class II | AQUIOS CL Flow Cytometer System, Catalog #B30166. The AQUIOS CL Flow Cytometer system is... | Siemens Healthcare Diagnostics Inc. | OYE | |
| Z-1260-2018 | Class II | Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 54mm, REF... | Encore Medical, LP | KWS | |
| Z-1259-2018 | Class II | Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 50mm, REF... | Encore Medical, LP | KWS | |
| Z-1258-2018 | Class II | Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 46mm, REF... | Encore Medical, LP | KWS | |
| Z-1257-2018 | Class II | Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 42mm, REF... | Encore Medical, LP | KWS | |
| Z-0828-2018 | Class II | Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog... | STRYKER Communications, Inc. | FSY | |
| Z-1256-2018 | Class II | Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 38mm, REF... | Encore Medical, LP | KWS | |
| Z-0811-2018 | Class II | NxStage Dialysate Sack: 1) REF SAK-301 UDI-M535SAK3010, 2) REF SAK-302 UDI-M535SAK3020... | NxStage Medical Inc | FKR | |
| Z-0684-2018 | Class II | Philips QCPR Meter - used with MRx Product Usage: The Philips CPR meter is intended for... | Philips North America LLC | LIX | |
| Z-0683-2018 | Class II | Philips QCPR Meter - used with FR3 Product Usage: The Philips CPR meter is intended for... | Philips North America LLC | LIX | |
| Z-2817-2018 | Class I | bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST for... | bioMerieux, Inc. | LON | |
| Z-1597-2018 | Class II | Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-1477-2018 | Class II | Proteus 235, ProteusPLUS or Proteus ONE produces and delivers a proton beam for the... | Ion Beam Applications S.A. | LHN | |
| Z-1275-2018 | Class II | Ray Station 4.9 Ray Station 5, Ray Station 6 and Ray Station 7 Software build numbers... | RaySearch Laboratories AB (publ) | MUJ | |
| Z-1222-2018 | Class II | QUANTA-Lyser 240 EIA, Part #GS0241. The instrument is a fully automated... | Inova Diagnostics, Inc. | JJE | |
| Z-1221-2018 | Class II | QUANTA-Lyser 240 IFA, Part #GS0242. The instrument is a fully automated... | Inova Diagnostics, Inc. | JJE | |
| Z-1065-2018 | Class II | ACUSON SC2000 Ultrasound System Product Usage: The SC2000 ultrasound imaging system is... | Siemens Medical Solutions USA, Inc. | IYN | |
| Z-0692-2018 | Class II | Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of... | STRYKER Communications, Inc. | FSY | |
| Z-2102-2018 | Class II | Centricity Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal... | GE Healthcare | LLZ | |
| Z-2101-2018 | Class II | Centricity PACS-IW with Universal Viewer Product Usage: Usage: Centricity PACS-IW with... | GE Healthcare | LLZ | |
| Z-0928-2018 | Class II | O-arm 1000 mobile image-intensified fluoroscopic x-ray system; (1) Model: BASE OARM... | Medtronic Navigation, Inc | OXO | |
| Z-0974-2018 | Class II | CMI (Collagen Meniscus Implant) device, Ivy Sports Medicine s collagen-based meniscus... | Stryker Corp. | OLC | |
| Z-2572-2018 | Class II | VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2 | LivaNova USA, Inc. | LYJ | |
| Z-1365-2018 | Class II | Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343 Product Usage: The device... | Fresenius Medical Care Renal Therapies Group, LLC | FKX | |
| Z-1443-2018 | Class II | Stage-1 Tissue Punch, Disposable, 4.5mm; catalog number: ISS141K. Intended for use in... | Keystone Dental Inc. | NDP | |
| Z-1289-2018 | Class II | DynaCad software consist of an MR Analysis Server software and the viewer workstation... | Invivo Corporation | LLZ | |
| Z-1321-2018 | Class II | Hematology Diluent M-53D used with BC-5390 Hematology Analyzer; Part Number... | Datascope Corp. | GIF | |
| Z-1320-2018 | Class II | Hematology Diluent M-30D used with BC-3200 and BC-3600 Hematology Analyzer; Part Numbers... | Datascope Corp. | GIF | |
| Z-1239-2018 | Class II | Coonrad/Morrey Elbow Implant System humeral assembly 4IN XSML, Item Number... | Zimmer GmbH | JDC | |
| Z-2874-2018 | Class II | bioMrieux VITEK 2 NH ID Test Kit Product Usage: Is an automated system consisting of... | bioMerieux, Inc. | JST | |
| Z-0599-2018 | Class II | 3M Bair Hugger(M) Normothermia System, Sterile Full Access Underbody, Model 63700 The... | 3M Company | DWJ | |
| Z-0598-2018 | Class II | 3M Bair Hugger(M) Normothermia System, Full Access Underbody Warming Blanket, REF 63500... | 3M Company | DWJ | |
| Z-0539-2018 | Class II | Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform | Implant Direct Sybron Manufacturing LLC | NHA | |
| Z-2430-2018 | Class II | Apollo XT Suture Anchor, 5.5 x 15 Product Usage: Apollo XT Suture Anchors are intended... | Valeris Medical | MBI | |
| Z-1291-2018 | Class II | DS Titanium Ligation Clip Appliers, used in laparoscopic surgery | Aesculap Inc | FZP | |
| Z-1290-2018 | Class II | DS Titanium Ligation Clip, used in laparoscopic surgery | Aesculap Inc | FZP | |
| Z-0637-2018 | Class II | Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B, REF... | DeRoyal Industries, Inc. | LRO | |
| Z-1272-2018 | Class II | The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser The FEMTO LDV(TM)Z8 Femtosecond... | Sie Ag,Surgical Instrument Engineering | OOE | |
| Z-0595-2018 | Class II | Hologic Panther(R) Fusion(TM), Catalog number ASY-09600 Product Usage: The Panther... | Hologic, Inc. | NSU | |
| Z-0266-2023 | Class II | InControl Insulin Syringes, Short Needle, 29 Gauge, 1CC | Allison Medical, Inc. | FMF | |
| Z-2051-2018 | Class II | Restoris MCK Onlay Insert Extractor. | Mako Surgical Corp. | NPJ | |
| Z-1478-2018 | Class II | Flowmeter Module (accessory to Terumo Advanced Perfusion System 1). Provides the... | Terumo Cardiovascular Systems Corporation | DTQ | |
| Z-1168-2018 | Class II | SwishPlus Implant Intended for use in support for fixed bridgework. | Implant Direct Sybron Manufacturing LLC | NHA |