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-0934-2023 | Class II | Henry Shein GLOVES, packaged in the following sizes and descriptions: a. Glove 6.5 Pack... | Gyn-Disposables, Inc. | PXC | |
| Z-0933-2023 | Class II | Henry Shein CYSTO SET UP PACK, 20 per case. Distributed by Henry Schein. | Gyn-Disposables, Inc. | FSM | |
| Z-0932-2023 | Class II | PHS Lacertaion Tray, Sterile, 20 per case, Manufactured for Professional Hosptial Supply... | Gyn-Disposables, Inc. | PKD | |
| Z-0931-2023 | Class II | Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter... | Gyn-Disposables, Inc. | PPG | |
| Z-1048-2023 | Class II | GORE CARDIOFORM Septal Occluder, REF: GSX0030A | W. L. Gore & Associates, Inc. | MLV | |
| Z-0994-2023 | Class II | Cardinal Health Jackson-Pratt Channel Drain, 32 Fr, REF JP-2292 | Medtronic, Inc. | GBX | |
| Z-0993-2023 | Class II | Cardinal Health Jackson-Pratt Channel Drain, 28 Fr, REF JP-2290 | Medtronic, Inc. | GBX | |
| Z-0992-2023 | Class II | Cardinal Health Jackson-Pratt Channel Drain, 24 Fr, REF JP-2234 | Medtronic, Inc. | GBX | |
| Z-0991-2023 | Class II | Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2233 | Medtronic, Inc. | GBX | |
| Z-0990-2023 | Class II | Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2232 | Medtronic, Inc. | GBX | |
| Z-0989-2023 | Class II | Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2231 | Medtronic, Inc. | GBX | |
| Z-0988-2023 | Class II | Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2230 | Medtronic, Inc. | GBX | |
| Z-0987-2023 | Class II | Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2229 | Medtronic, Inc. | GBX | |
| Z-0986-2023 | Class II | Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2228 | Medtronic, Inc. | GBX | |
| Z-0985-2023 | Class II | Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2227 | Medtronic, Inc. | GBX | |
| Z-0984-2023 | Class II | Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2226 | Medtronic, Inc. | GBX | |
| Z-0983-2023 | Class II | Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2225 | Medtronic, Inc. | GBX | |
| Z-0982-2023 | Class II | Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2223 | Medtronic, Inc. | GBX | |
| Z-0981-2023 | Class II | Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2221 | Medtronic, Inc. | GBX | |
| Z-0980-2023 | Class II | Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2217 | Medtronic, Inc. | GBX | |
| Z-0979-2023 | Class II | Cardinal Health Jackson-Pratt Channel Drain, 7 mm, REF JP-2216 | Medtronic, Inc. | GBX | |
| Z-0978-2023 | Class II | Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2215 | Medtronic, Inc. | GBX | |
| Z-0977-2023 | Class II | Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2214 | Medtronic, Inc. | GBX | |
| Z-0976-2023 | Class II | Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2213 | Medtronic, Inc. | GBX | |
| Z-0975-2023 | Class II | Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2212 | Medtronic, Inc. | GBX | |
| Z-0974-2023 | Class II | Cardinal Health Jackson-Pratt Channel Drain, 7 mm, REF JP-2211 | Medtronic, Inc. | GBX | |
| Z-0973-2023 | Class II | Cardinal Health Jackson-Pratt Channel Drain, 7 mm, REF JP-2210 | Medtronic, Inc. | GBX | |
| Z-0972-2023 | Class II | Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2191 | Medtronic, Inc. | GBX | |
| Z-0971-2023 | Class II | Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2190 | Medtronic, Inc. | GBX | |
| Z-0970-2023 | Class II | Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2189 | Medtronic, Inc. | GBX | |
| Z-0969-2023 | Class II | Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2188 | Medtronic, Inc. | GBX | |
| Z-0968-2023 | Class II | Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2187 | Medtronic, Inc. | GBX | |
| Z-0967-2023 | Class II | Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2186 | Medtronic, Inc. | GBX | |
| Z-1103-2023 | Class II | SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D) | OLYMPUS Corporation of the Americas | JAK | |
| Z-1215-2023 | Class II | epoc Host 2 as follows: Product SMN epoc NXS Host, US 11413475 epoc... | Siemens Healthcare Diagnostics Inc. | CHL | |
| Z-1214-2023 | Class II | epoc Host 2 as follows: Product SMN epoc Host 10736387 epoc Host 2... | Siemens Healthcare Diagnostics Inc. | CHL | |
| Z-1028-2023 | Class II | Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated... | Medtronic Perfusion Systems | DTZ | |
| Z-1027-2023 | Class II | Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated... | Medtronic Perfusion Systems | DTZ | |
| Z-1026-2023 | Class II | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom... | Medtronic Perfusion Systems | DTZ | |
| Z-1025-2023 | Class II | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom... | Medtronic Perfusion Systems | DTZ | |
| Z-1024-2023 | Class II | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface... | Medtronic Perfusion Systems | DTZ | |
| Z-1023-2023 | Class II | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom... | Medtronic Perfusion Systems | DTZ | |
| Z-0927-2023 | Class II | DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10 | DeRoyal Industries, Inc. | LRO | |
| Z-0781-2023 | Class II | VERIFY Steam Test Pack (20 Tests and 20 controls) Item Number: S3069 Intended for use in... | STERIS Corporation | FRC | |
| Z-0780-2023 | Class II | VERIFY Steam Test Pack (20 Tests and 5 controls) Item Number: S3065 Intended for use in... | STERIS Corporation | FRC | |
| Z-0779-2023 | Class II | VERIFY Dual Species Self-Contained Biological Indicators, 100 per box Item Number... | STERIS Corporation | FRC | |
| Z-0778-2023 | Class II | VERIFY Dual Species Self-Contained Biological Indicators, 50 per box Item Number... | STERIS Corporation | FRC | |
| Z-0952-2023 | Class II | cobas infinity central lab, Material Number 07154003001 | Roche Diagnostics GmbH | JQP | |
| Z-0928-2023 | Class II | BD Pyxis MedBank System - Product Label/labeling pending | CareFusion 303, Inc | BRY | |
| Z-0966-2023 | Class I | CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24, 3) REF... | Abbott Medical | FPA |