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-1958-2016 | Class II | BioSync Anatomic Cotton Wedge, 16 x 4.5 mm.; Used for internal bone fixation for bone... | Arthrex GmbH | PLF | |
| Z-1829-2016 | Class II | Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve. Spinal... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | KWP | |
| Z-0086-2017 | Class II | 15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415 Intended for the epidural... | Epimed International, Inc. | BSP | |
| Z-1878-2016 | Class II | Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44. Filter Catalogue... | Natus Medical Incorporated | LDS | |
| Z-1720-2016 | Class II | Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot... | Accriva Diagnostics, Inc. | JPA | |
| Z-1831-2016 | Class II | CADD Administration Sets with Flow Stop, Product Reorder No: 21-7321-01, 21-7321-24... | Abbott Medical | FPA | |
| Z-2004-2016 | Class II | Musculoskeletal Transplant Foundation, AFT Diverted Tube (3/4/Filled), indicated for... | Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics | MBP | |
| Z-1957-2016 | Class II | The Red Head 2 Reusable Fat Harvesting Canister, Product # RH-2, Non-Sterile. Intended... | Miami Fat Supply, Inc | MUU | |
| Z-1812-2016 | Class II | Draeger D-Vapor/ D-Vapor 3000 Vaporizers with Baxter Desflurane Agent and Bottles... | Draeger, Inc. | CAD | |
| Z-1631-2016 | Class II | GEM(TM), FLOWCOUPLER(R), 4.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF... | Baxter Healthcare Corporation | DPW | |
| Z-1630-2016 | Class II | GEM(TM), FLOWCOUPLER(R), 3.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF... | Baxter Healthcare Corporation | DPW | |
| Z-1629-2016 | Class II | GEM(TM), FLOWCOUPLER(R), 3.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF... | Baxter Healthcare Corporation | DPW | |
| Z-1628-2016 | Class II | GEM(TM), FLOWCOUPLER(R), 2.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF... | Baxter Healthcare Corporation | DPW | |
| Z-1627-2016 | Class II | GEM(TM), FLOWCOUPLER(R), 2.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF... | Baxter Healthcare Corporation | DPW | |
| Z-0681-2022 | Class II | Acorn 130 Stairlift, Brooks 130 Stairlift, Acorn 180 Stairlift, and Acorn Outdoor... | Acorn Stairlifts, Inc | PCD | |
| Z-0594-2019 | Class II | Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8... | Helena Laboratories, Corp. | JPB | |
| Z-2347-2016 | Class II | MX 16-slice SKD whole body computed tomography X-ray system. Imaging diagnostic tool. | Philips North America LLC | JAK | |
| Z-2346-2016 | Class II | MX 16-slice whole body computed tomography X-ray system. Imaging diagnostic tool. | Philips North America LLC | JAK | |
| Z-1589-2016 | Class II | GE, Revolution CT. The system is intended for head, whole body, cardiac, and vascular... | GE Healthcare | JAK | |
| Z-2804-2016 | Class III | The VITROS Chemistry Products Calibrator Kit 31, Lot 3155 used in conjunction with... | Ortho-Clinical Diagnostics, Inc. | JIT | |
| Z-1925-2016 | Class II | Surgical Table Cushion (HybriGel Pads) HybrGel Pads are an optional accessory to the... | Berchtold Corp. | LWG | |
| Z-1561-2016 | Class II | Radionuclide Radiation Therapy System Product The product is a teletherapy device... | Elekta Limited | IWB | |
| Z-1710-2016 | Class II | 3.2 mm three-fluted Radiolucent Drill Bit/Needle Point/145 mm Sterile Product Usage: The... | Synthes (USA) Products LLC | HTW | |
| Z-1709-2016 | Class II | 3.2 mm Three-fluted drill bit, sterile, Catalog ID # 03.010.060S Product Usage... | Synthes (USA) Products LLC | HTW | |
| Z-2628-2017 | Class II | Merge LIS software. The firm name on the label is Merge Healthcare. Merge LIS system is... | Merge Healthcare Incorporated | JQP | |
| Z-1813-2017 | Class II | Volt Resistance Unisex Rechargeable Heated Slipper (All sizes) Deep penetrating heat... | 2k Innovations Inc. | IRT | |
| Z-1812-2017 | Class II | Volt Resistance Heated Slipper (All sizes) Deep penetrating heat garment and wraps | 2k Innovations Inc. | IRT | |
| Z-1811-2017 | Class II | Volt Resistance Heated Slipper Gray (All sizes) Deep penetrating heat garment and wraps | 2k Innovations Inc. | IRT | |
| Z-1810-2017 | Class II | Volt Resistance Heated Slipper Black (All sizes) Deep penetrating heat garment and wraps | 2k Innovations Inc. | IRT | |
| Z-1809-2017 | Class II | Volt Resistance Heated Socks (All sizes) Deep penetrating heat garment and wraps | 2k Innovations Inc. | IRT | |
| Z-1808-2017 | Class II | Volt Resistance Frostie Heated Gloves (All sizes) Deep penetrating heat garment and wraps | 2k Innovations Inc. | IRT | |
| Z-1807-2017 | Class II | Volt Resistance Heated Elbow Garment Deep penetrating heat garment and wraps | 2k Innovations Inc. | IRT | |
| Z-1806-2017 | Class II | Volt Resistance Heated Therapy Knee Wrap Deep penetrating heat garment and wraps | 2k Innovations Inc. | IRT | |
| Z-1805-2017 | Class II | Volt Resistance Heated Therapy Foot Wrap Deep penetrating heat garment and wraps | 2k Innovations Inc. | IRT | |
| Z-1804-2017 | Class II | Volt Resistance Heated Therapy Shoulder Wrap Deep penetrating heat garment and wraps | 2k Innovations Inc. | IRT | |
| Z-1803-2017 | Class II | Volt Resistance Heated Lower Back Garment Deep penetrating heat garment and wraps | 2k Innovations Inc. | IRT | |
| Z-1802-2017 | Class II | Volt Resistance Heated Neck Garment Deep penetrating heat garment and wraps | 2k Innovations Inc. | IRT | |
| Z-1955-2016 | Class II | 00720504022 Acetab.cupw/sh,0deg,22mmx40mm 00720504222 Acetab.cupw/sh,0deg,22mmx42mm... | Zimmer Trabecular Metal Technology, Inc. | LPH | |
| Z-1954-2016 | Class II | Rev. Shell Liner 0D 28X48 00700504828 Rev. Shell Liner 10D 28X50 00701005028 Rev... | Zimmer Trabecular Metal Technology, Inc. | JDI | |
| Z-2644-2016 | Class II | Ziehm Vision2, Mobile C-arm for Mobile Fluoroscopic Imaging | Ziehm Imaging GmbH | JAA | |
| Z-2643-2016 | Class II | Ziehm Solo, Mobile C-arm for Mobile Fluoroscopic Imaging | Ziehm Imaging GmbH | OWB | |
| Z-2642-2016 | Class II | Ziehm Vision R, Mobile C-arm for Mobile Fluoroscopic Imaging | Ziehm Imaging GmbH | OWB | |
| Z-1953-2016 | Class II | Tm Mono Tib Str Grn Sz 5 - 00588606510 Tm Mono Tib Str Grn Sz 5 12Mm - 00588606512 Tm... | Zimmer Trabecular Metal Technology, Inc. | MBH | |
| Z-2641-2016 | Class II | Ziehm Vision RFD, Mobile C-arm for Mobile Fluoroscopic Imaging | Ziehm Imaging GmbH | OWB | |
| Z-2640-2016 | Class II | Ziehm Vision RFD Mot, Mobile C-arm for Mobile Fluoroscopic Imaging | Ziehm Imaging GmbH | JAA | |
| Z-2639-2016 | Class II | Ziehm Vision RFD 3D Mobile C-arm for Mobile Fluoroscopic Imaging | Ziehm Imaging GmbH | OWB | |
| Z-2623-2016 | Class II | White Lumax Guiding Coaxial Catheter Catheter, Percutaneous Intended for the delivery of... | Cook Incorporated | DQY | |
| Z-2622-2016 | Class II | Transluminal Biliary Biopsy Forceps Set Forceps, Biopsy, Non-Electric Intended for access... | Cook Incorporated | FCL | |
| Z-2621-2016 | Class II | Selective Salpingography Catheter with Beacon Tip Cannula, Manipulator/ Injector... | Cook Incorporated | MOV | |
| Z-2620-2016 | Class II | Aprima Access Nonvascular Introducer Set Accessories, Catheter Intended for... | Cook Incorporated | KGZ |