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-2447-2019 | Class II | Flexible Intubation Fiberscope, Model # 11301AB1 | Karl Storz Endoscopy-America, Inc. | EOQ | |
| Z-1445-2020 | Class II | Stryker Connected OR Cart,120 V Ref Cat. #240-099-155, Qty 1, Rx Only, Manufactured for... | Stryker Corp. | BZN | |
| Z-1822-2019 | Class II | Arrow PICC with Chlorag+ard Technology Product Code:PR 45552 HPHNM | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-1821-2019 | Class II | Arrow PICC with Chlorag+ard Technology Product Code: PR 45552 HPHNL | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-1820-2019 | Class II | Arrow PICC with Chlorag+ard Technology Product Code:PR 45541 HPHNM | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-1819-2019 | Class II | Arrow PICC with Chlorag+ard Technology Product Code: PR 45541 HPHNL | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-1818-2019 | Class II | Arrowg+ard Blue Advance Midline Product Code: PR 41541 BAS | Arrow International LLC (subsidiary of Teleflex Incorporated) | PND | |
| Z-1817-2019 | Class II | Arrowg+ard Blue Advance JACC Product Code: JRT 43552 HPHNM | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-1816-2019 | Class II | Arrowg+ard Blue Advance JACC Product Code: JRT 43541 HPHNM | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-1815-2019 | Class II | Arrow JACC with Chlorag+ard Technology Product Code:JR 42563 HPHNM | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-1814-2019 | Class II | Arrow JACC with Chlorag+ard Technology Product Code: JR 42541 HPHNM | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-1813-2019 | Class II | Arrow JACC with Chlorag+ard Technology Product Code: JR 42063 HPHNM | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-1812-2019 | Class II | Arrow JACC with Chlorag+ard Technology Product Code: JR 42041 HPHNM | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-1811-2019 | Class II | Arrowg+ard Blue Advance PICC Product Code: CDC45541HPK1A | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-1810-2019 | Class II | Arrowg+ard Blue Advance PICC pre loaded with Arrow VPS" Precision Stylet Product Code... | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-1809-2019 | Class II | Arrowg+ard Blue Advance PICC pre loaded with Arrow VPS" Precision Stylet Product Code... | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-1808-2019 | Class II | Arrowg+ard Blue Advance" PICC pre loaded with Arrow VPS" Precision Stylet Product Code... | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-1807-2019 | Class II | Arrowg+ard Blue Advance PICC pre loaded with Arrow VPS" Precision Stylet Product... | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-1806-2019 | Class II | Arrowg+ard Blue Advance PICC pre loaded with Arrow VPS" Precision... | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-1805-2019 | Class II | Arrow PICC with Chlorag+ard Technology Product Code: CDC 44052 HPK1A | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-1804-2019 | Class II | Arrow JACC with Chlorag+ard Technology Jugular Axillosubclavian Central... | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-1803-2019 | Class II | Arrow JACC with Chlorag+ard Technology Jugular Axillo subclavian Central... | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-1802-2019 | Class II | Arrow JACC with Chlorag+ard Technology Jugular Axillo subclavian Central... | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-1801-2019 | Class II | Arrowg+ard Blue Advance JACC Product Code: CDC 42063 JX1A | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-1800-2019 | Class II | Arrowg+ard Blue Advance JACC Product Code:CDC 42052 JX1A | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-1799-2019 | Class II | Arrowg+ard Blue Advance JACC Product Code: CDC 42041 JX1A | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-1798-2019 | Class II | Arrowg+ard Blue Advance JACC Product Code: CDC 41552 JX1A | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-1797-2019 | Class II | Arrowg+ard Blue Advance JACC Product Code: CDC 41541 JX1A | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-1796-2019 | Class II | Arrow PICC with Chlorag+ard Technology Product Code: CDA 45552 VPS2 | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-1795-2019 | Class II | Arrow PICC with Chlorag+ard Technology Product Code: CDA 45541 HPK1A | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-1794-2019 | Class II | Arrow PICC with Chlorag+ard Technology Product Code: CDA 45052 HPK1A | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-1793-2019 | Class II | Arrow PICC with Chlorag+ard Technology Product Code: CDA 45041 HPK1A | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-1792-2019 | Class II | Arrow PICC with Chlorag+ard Technology Product Code: CDA 44052 HPK1A | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-1791-2019 | Class II | Arrow PICC Kit Product Code: ASK 45552 RWJ4 | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-1790-2019 | Class II | Arrow PICC Kit pre loaded with Arrow VPS Precision Stylet Product Code: ASK 45552 CRM | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-1789-2019 | Class II | Arrow PICC Kit Product Code: ASK 45541 RWJ4 | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-1788-2019 | Class II | Arrow PICC Kit Product Code: ASK 45541 LVH1 | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-1787-2019 | Class II | Arrow PICC powered by Arrow VPS Stylet Product Code: ASK45041JHVA | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-1840-2019 | Class II | LEEP Precision Integrated System 120V, Model LP-10-120 Product Usage: The LEEP PRECISION... | CooperSurgical, Inc. | HGI | |
| Z-0920-2022 | Class II | Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R | Luminex Corporation | NSU | |
| Z-1370-2019 | Class II | Cook Salle Intraoperative Pyeloplasty Stent Set PRODUCT/CATALOG NUMBER/GPN: 4.0 Fr... | Cook Incorporated | KOB | |
| Z-1369-2019 | Class II | Cook Kwart Retro-Inject Ureteral Stent Set: PRODUCT/CATALOG NUMBER/GPN: 4.7 Fr 003500... | Cook Incorporated | KOB | |
| Z-2338-2020 | Class II | IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be used by... | Philips North America LLC | LLZ | |
| Z-0823-2020 | Class II | Finish Thompson Centrifugal Pump Model #110192-3 (sold as spare part) | Isopure Corp | N/A | |
| Z-0822-2020 | Class II | Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish... | Isopure Corp | FIN | |
| Z-0821-2020 | Class II | Acidified Concentrate Distribution and Storage System (ACDS System) with a Finish... | Isopure Corp | KPO | |
| Z-1842-2019 | Class II | ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX Product Code... | Ethicon, Inc | GAQ | |
| Z-1841-2019 | Class II | ETHIBOND EXCEL Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code... | Ethicon, Inc | GAQ | |
| Z-0025-2020 | Class II | Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120 | Auris Health, Inc | EOQ | |
| Z-1324-2019 | Class II | SureSigns VS4 Government Bundle, Product Number 863286. For monitoring the physiological... | Philips North America LLC | MHX |