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-2506-2019 | Class II | XP-CR Tibial Tray - Interlok 67mm Item # 195271 | Zimmer GmbH | JWH | |
| Z-2505-2019 | Class II | XP-CR Tibial Tray - Interlok 65mm Item # 195270 | Zimmer GmbH | JWH | |
| Z-2504-2019 | Class II | XP-CR Tibial Tray - Interlok 63mm Item # 195269 | Zimmer GmbH | JWH | |
| Z-2503-2019 | Class II | XP- CR Tibial Tray- Interlok 59mm Item # 195268 | Zimmer GmbH | JWH | |
| Z-1280-2022 | Class II | Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A | Fusion Orthopedics USA, LLC | HXC | |
| Z-0917-2020 | Class II | Bard Conquest 40 PTA Dilation Catheter, 8mm X 20mm x 75cm (CQF7582), 8mm x 40mm x 75cm... | Bard Peripheral Vascular Inc | LIT | |
| Z-2767-2019 | Class II | Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage... | Novanta Medical GmbH | HIG | |
| Z-2754-2019 | Class II | Atellica IM anti-CCP IgG (aCCP) Assay Siemens Material Number: 10732998 (100 Test) Test... | Siemens Healthcare Diagnostics Inc. | NHX | |
| Z-1118-2020 | Class II | VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1000 Generator... | LivaNova USA, Inc. | LYJ | |
| Z-0048-2020 | Class II | STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle Product code: SXPP1B401 suture | Ethicon, Inc | NEW | |
| Z-0047-2020 | Class II | STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle Product code: SXPP1B430 suture | Ethicon, Inc | NEW | |
| Z-0044-2020 | Class II | AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c 8000... | Roche Diagnostics GmbH | JLW | |
| Z-0050-2020 | Class III | EXACTAMED Oral Dispensers, 5mL, AMBER: (a) PHARMACY PACK, REF H9388105, x 100; (b)... | Baxter Healthcare Corporation | N/A | |
| Z-3026-2020 | Class II | ZEUS ELISA Parvovirus B19 IgM Test System, UDI 00845533001755 - Product Usage: intended... | Zeus Scientific LLC | MYM | |
| Z-1899-2020 | Class II | Varian Multileaf Collimator [MLC]; Millenium Multileaf Collimator [52, 80, 120 leaf]... | Varian Medical Systems, Inc. | IYE | |
| Z-1995-2020 | Class I | Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or... | Medtronic Navigation, Inc | HAW | |
| Z-1857-2020 | Class II | Temporary Snap Abutment Engaging CC RP 1.5 mm; Pre-manufactured prosthetic components... | Nobel Biocare USA LLC | NHA | |
| Z-1856-2020 | Class II | Universal Base CC RP 1.5 mm; The Universal Base Abutment in combination with Nobel... | Nobel Biocare USA LLC | DZE | |
| Z-1855-2020 | Class II | Snappy Abutment 5.5 CC RP 3 mm; pre-manufactured prosthetic components directly connected... | Nobel Biocare USA LLC | NHA | |
| Z-1854-2020 | Class II | Esthetic Abutment CC RP 1.5 mm pre-manufactured prosthetic components directly connected... | Nobel Biocare USA LLC | NHA | |
| Z-1853-2020 | Class II | Temporary Abutment Engaging CC RP pre-manufactured prosthetic components directly... | Nobel Biocare USA LLC | NHA | |
| Z-1852-2020 | Class II | Temporary Abutment Non-Engaging CC RP pre-manufactured prosthetic components directly... | Nobel Biocare USA LLC | NHA | |
| Z-0283-2020 | Class II | Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN... | Randox Laboratories, Limited | JIX | |
| Z-0282-2020 | Class II | Rheumatoid Factor Standard (RF CAL) Catalogue Number: RF2301 GTIN: 05055273205039... | Randox Laboratories, Limited | DHR | |
| Z-0364-2020 | Class II | Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD... | Implant Direct Sybron Manufacturing LLC | DZE | |
| Z-2449-2019 | Class II | Proteus XR/a (SlOK : K993090) | GE Healthcare | KPR | |
| Z-2358-2019 | Class II | Medline SYRINGE, PISTON,IRR TRAY,W/.9, REF DYNC2303. Sterile Piston Irrigation Syringe... | MEDLINE INDUSTRIES, LP - Northfield | EYN | |
| Z-1451-2020 | Class II | FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI... | BioFire Diagnostics, LLC | PCH | |
| Z-0864-2020 | Class II | AQURE basic sytem, FLEXLINK, REF 933-599, Version: 2.3.3 (17), CE IVD, Rx Only, UDI... | Radiometer Medical ApS | OUG | |
| Z-0535-2020 | Class II | FoundationOne CDx test report | Foundation Medicine, Inc. | PQP | |
| Z-2497-2019 | Class II | CAIMAN DISP.INSTR.ARTICULAT.D:12/440MM REF: PL731SU- Product Usage: Instrument intended... | Aesculap Inc | GEI | |
| Z-2496-2019 | Class II | CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM REF: PL730SU - Product Usage: Instrument intended... | Aesculap Inc | GEI | |
| Z-0787-2020 | Class II | Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF... | Intersurgical Ltd. | BZA | |
| Z-0786-2020 | Class II | Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF... | Intersurgical Ltd. | BZA | |
| Z-0785-2020 | Class II | Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1996030. Airway... | Intersurgical Ltd. | BZA | |
| Z-0784-2020 | Class II | Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1898000. Airway... | Intersurgical Ltd. | BZA | |
| Z-2435-2019 | Class II | Integra Jarit GEMINI CLAMP 9 1/4 inch - used in vascular and cardiothoracic procedures... | Integra LifeSciences Corporation | DXC | |
| Z-2479-2020 | Class II | BodyGuardian Heart Remote Monitoring Kit, consisting of two BG Heart monitors, either... | Preventice Services, LLC | DSI | |
| Z-2072-2020 | Class II | Kiwi Complete Vacuum Delivery System, Model No. VAC-6000MTE - Product Usage: The Kiwi is... | Clinical Innovations, LLC | HDB | |
| Z-0517-2020 | Class II | ASI 2.0 Calcar Trimmer Shaft for Use with Biomet Rasp, Model Number 110032331 | Zimmer GmbH | LXH | |
| Z-2556-2019 | Class II | Arrow 8.5 Fr. X 16 cm Quad-Lumen Central Venous Catheterization Kit Product... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DYB | |
| Z-2555-2019 | Class II | 8.5 Fr. X 10 cm ARROW+gard Blue PSI Kit Cath-Gard for use with 7.5 - 8... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DYB | |
| Z-2493-2019 | Class II | Medtronic Micra MC1VR01, REF MC1VR01 (OUS only). Cardiac pacemaker. | Medtronic, Inc. | PNJ | |
| Z-2492-2019 | Class II | Medtronic Micra MC1VR01, Single chamber transcatheter pacing system, REF MC1VR01US (US... | Medtronic, Inc. | PNJ | |
| Z-0769-2020 | Class II | LightPod Neo Lasers | Aerolase Corporation | GEX | |
| Z-0768-2020 | Class II | LightPod ERA lasers | Aerolase Corporation | GEX | |
| Z-0838-2020 | Class II | Imactis Navigation Kit, REF 10100, Content Sterile Needle Holder Ref. A10010 CE 0459... | Imactis, SAS | JAK | |
| Z-0512-2020 | Class II | Rocket KCH Fetal Bladder Drainage Catheter Model: R57405 | Rocket Medical | MPR | |
| Z-2411-2019 | Class II | 8 G x 10 CM Jamshidi Crown Bone Marrow biopsy/Aspiration Needle with MAC Catalog Number... | Becton Dickinson & Co | KNW | |
| Z-2446-2019 | Class II | Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of... | STRYKER Communications, Inc. | FSY |