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-1658-2022 | Class I | Philips OmniLab Advanced+ Intl (Flow Gen), Rx Only. To provide noninvasive ventilation... | Respironics, Inc. | MNS | |
| Z-1657-2022 | Class I | Philips OmniLab Advanced+, Rx Only. To provide noninvasive ventilation support for... | Respironics, Inc. | MNS | |
| Z-1656-2022 | Class I | Philips BiPAP V30 Auto, Rx Only. To provide noninvasive ventilation support for patients... | Respironics, Inc. | MNS | |
| Z-1655-2022 | Class I | Philips BiPAP A40, Rx Only. To provide noninvasive ventilation support for patients with... | Respironics, Inc. | MNS | |
| Z-1654-2022 | Class I | Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with... | Respironics, Inc. | MNS | |
| Z-0007-2023 | Class II | G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E)... | Zimmer GmbH | OQI | |
| Z-0089-2023 | Class II | Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge... | Siemens Healthcare Diagnostics Inc. | JHM | |
| Z-1778-2022 | Class II | Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component. | Howmedica Osteonics Corp | KRQ | |
| Z-0148-2023 | Class II | sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile skin. Used... | Sentec AG | LKD | |
| Z-0202-2023 | Class III | Med-Rx Urological Cysto/bladder Irrigation Set, Ref 10-4001 | Canadian Hospital Specialties Ltd. | LJH | |
| Z-1679-2022 | Class II | Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1.3mL CTRL... | Abbott Molecular, Inc. | QJR | |
| Z-1775-2022 | Class II | Puritan Bennett 560 Ventilator, PB560, CFN 4096600 | Medtronic, Inc. | QOS | |
| Z-1816-2022 | Class II | Dimension Magnesium (MG) Flex reagent cartridge Siemens Material Number (SMN)/REF... | Siemens Healthcare Diagnostics Inc. | JGJ | |
| Z-1774-2022 | Class II | Fungitell STAT- IVD Assay for (1 3)-~-D-Glucan in Serum Ref: FT007 | Associates of Cape Cod, Inc. | NQZ | |
| Z-0130-2023 | Class II | ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400599. For... | ConvaTec Limited | EZQ | |
| Z-0129-2023 | Class II | ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400598. For... | ConvaTec Limited | EZQ | |
| Z-0128-2023 | Class II | ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/4 in., 19-64mm, REF 416975... | ConvaTec Limited | EZQ | |
| Z-0127-2023 | Class II | ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 416976... | ConvaTec Limited | EZQ | |
| Z-1847-2022 | Class II | Movable Core Wire Guide (Tefcor), Guidewire (OUS ONLY) Reference Part... | Cook Incorporated | DQX | |
| Z-1846-2022 | Class II | Movable Core Wire Guide (Tapered Tefcor) (OUS ONLY), Guidewire Reference Part... | Cook Incorporated | DQX | |
| Z-1845-2022 | Class II | Lunderquist -Ring Torque Wire Guide, Guidewire Reference Part... | Cook Incorporated | DQX | |
| Z-1844-2022 | Class II | Vinyl Connecting Tube, Connecting Tube Reference Part Number/GPN CTU14.0-30-ST G02278 CTU1... | Cook Incorporated | GCD | |
| Z-1843-2022 | Class II | Torq-Flex Wire Guide Australian Modification, Guidewire Reference Part... | Cook Incorporated | DQX | |
| Z-1842-2022 | Class II | Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1.5-ROSEN G01623... | Cook Incorporated | DQX | |
| Z-1841-2022 | Class II | Roadrunner PC Wire Guide (The Firm), Guidewire Reference Part... | Cook Incorporated | DQX | |
| Z-1840-2022 | Class II | Roadrunner PC Wire Guide (The Firm LT), Guidewire Reference Part... | Cook Incorporated | DQX | |
| Z-1839-2022 | Class II | Roadrunner PC Wire Guide (Nimble Floppy), Guidewire RFPC-35-145 G07914 | Cook Incorporated | DQX | |
| Z-1838-2022 | Class II | Roadrunner PC Wire Guide (Nimble), Guidewire Reference Part... | Cook Incorporated | DQX | |
| Z-1837-2022 | Class II | Roadrunner PC Hydrophilic Wire Guide, Hydrophilic Guidewire Reference Part... | Cook Incorporated | OCY | |
| Z-1836-2022 | Class II | Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Part... | Cook Incorporated | DQX | |
| Z-1835-2022 | Class II | Heavy Double Flexible Tipped Wire Guide, Guidewire Reference Part... | Cook Incorporated | DQX | |
| Z-1834-2022 | Class II | Fixed Core Wire Guide (Straight), Guidewire Reference Part... | Cook Incorporated | DQX | |
| Z-1833-2022 | Class II | Fixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference Part... | Cook Incorporated | DQX | |
| Z-1832-2022 | Class II | Fixed Core Wire Guide, Guidewire Reference Part Number/GPN THSCF-25-180-3 G02165 TSCF-25-8... | Cook Incorporated | DQX | |
| Z-1831-2022 | Class II | Double Flexible Tipped Wire Guide, Guidewire Reference Part... | Cook Incorporated | DQX | |
| Z-1830-2022 | Class II | Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire Reference Part... | Cook Incorporated | DQX | |
| Z-1829-2022 | Class II | Cope Mandril Wire Guide (Nitinol), Nitinol Guidewire; Reference Part... | Cook Incorporated | DQX | |
| Z-1828-2022 | Class II | Coons Interventional Wire Guide, Guidewire; Reference Part... | Cook Incorporated | DQX | |
| Z-1827-2022 | Class II | Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part... | Cook Incorporated | DQX | |
| Z-1826-2022 | Class II | Bentson Wire Guide, Guidewire (OUS ONLY); Reference Part Number: TSMB-35-145 (GPN G27041) | Cook Incorporated | DQX | |
| Z-1825-2022 | Class II | Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip)... | Cook Incorporated | DQX | |
| Z-1824-2022 | Class II | Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY); Reference Part... | Cook Incorporated | DQX | |
| Z-1741-2022 | Class III | PTS Panels CHOL+GLU Test Strips (REF 1765) | Polymer Technology Systems | CGA | |
| Z-1986-2025 | Class II | SURGIMESH WN, Polymeric Surgical Mesh, 14cm x 15cm Flat Sheet, Model/Catalog Number: T1415 | Chamberlain Technologies LLC | FTL | |
| Z-1985-2025 | Class II | SURGIMESH XB, Polymeric Surgical Mesh, X-Large Ellipse Barrier Mesh, Model/Catalog... | Chamberlain Technologies LLC | FTL | |
| Z-1984-2025 | Class II | SURGIMESH XB, Polymeric Surgical Mesh, 14m x 15cm Flat Sheet with Silicone Barrier... | Chamberlain Technologies LLC | FTL | |
| Z-1983-2025 | Class II | SURGIMESH WN, Polymeric Surgical Mesh, Large Flat Sheet, Model/Catalog Number: T3030 | Chamberlain Technologies LLC | FTL | |
| Z-0126-2023 | Class II | EMPOWER 3D Knee Tibial Insert, REF: 341-14-708. Orthopedic implant component. | Encore Medical, LP | LPH | |
| Z-0125-2023 | Class II | EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Orthopedic... | Encore Medical, LP | LPH | |
| Z-0071-2023 | Class II | COVID Test Kit Nonsterile | American Contract Systems, Inc. | JSM |