Browse Device Recalls
2,057 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,057 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 2,057 FDA device recalls in NJ.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 27, 2020 | Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 40cc IAB (... | Potential Endotoxin Contamination | Class II | Datascope Corporation |
| Jul 27, 2020 | Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 7.5Fr 30cc IAB, P/N: 0... | Potential Endotoxin Contamination | Class II | Datascope Corporation |
| Jul 27, 2020 | Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 35cc IAB (... | Potential Endotoxin Contamination | Class II | Datascope Corporation |
| Jul 27, 2020 | Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 25cc IAB Kit P/... | Potential Endotoxin Contamination | Class II | Datascope Corporation |
| Jul 27, 2020 | Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 8Fr 50cc IAB Ki... | Potential Endotoxin Contamination | Class II | Datascope Corporation |
| Jul 27, 2020 | Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 8Fr 50cc IAB Kit P/N: 068... | Potential Endotoxin Contamination | Class II | Datascope Corporation |
| Jul 27, 2020 | Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 35cc IAB ... | Potential Endotoxin Contamination | Class II | Datascope Corporation |
| Jul 27, 2020 | Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan)... | Potential Endotoxin Contamination | Class II | Datascope Corporation |
| Jul 27, 2020 | Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 34cc IAB Kit P/N:... | Potential Endotoxin Contamination | Class II | Datascope Corporation |
| Jul 14, 2020 | Wuxi Nest, model numbers 202115, 202117, 202017, 202018 - Product Usage: Pati... | The firm is replacing all tubes that were manufactured and distributed prior to Enforcement Discr... | Class II | Thomas Scientific |
| Jun 19, 2020 | SafeStep Huber Needle Set; Catalog Numbers LH-0029 (UDI 00801741066160), LH-... | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... | Class II | Becton Dickinson & Company |
| Jun 19, 2020 | PowerLoc MAX Power Injectable Infusion Set with GuardIVa Antimicrobial Hemost... | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... | Class II | Becton Dickinson & Company |
| Jun 19, 2020 | SafeStep Huber Needle Set AllPoints Port Access System; Catalog Numbers AN152... | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... | Class II | Becton Dickinson & Company |
| Jun 19, 2020 | SafeStep Huber Needle Set myPICK Port Access Kit; Catalog Numbers CPA00020A (... | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... | Class II | Becton Dickinson & Company |
| Jun 19, 2020 | SafeStep Huber Needle Set with Y Injection Site and Medegen Needleless Inject... | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... | Class II | Becton Dickinson & Company |
| Jun 19, 2020 | PowerLoc MAX Power Injectable Infusion Set AllPoints Port Access System; Cata... | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... | Class II | Becton Dickinson & Company |
| Jun 19, 2020 | PowerLoc MAX Power-Injectable Infusion Set myPICK Port Access Kit; Catalog Nu... | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... | Class II | Becton Dickinson & Company |
| Jun 19, 2020 | SafeStep Huber Needle Set Port Access Kit; Catalog Numbers PA-0029 (UDI 00801... | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... | Class II | Becton Dickinson & Company |
| Jun 19, 2020 | SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing Por... | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... | Class II | Becton Dickinson & Company |
| Jun 19, 2020 | PowerLoc MAX Power Injectable Infusion Set; Catalog Numbers 0131910 (UDI 0080... | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... | Class II | Becton Dickinson & Company |
| Jun 19, 2020 | SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing; Ca... | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... | Class II | Becton Dickinson & Company |
| Jun 19, 2020 | PowerLoc MAX Power Injectable Infusion Port Access Kit; Catalog Numbers 21319... | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... | Class II | Becton Dickinson & Company |
| Jun 18, 2020 | Holder HKHZ 19 for use with Quadrox-i and Quadrox-iD Neonatal / Pediatric Oxy... | Removal for a specific lot, lot number 70128207, of Holder HKHZ 19 for use with QUADROX iD Pediat... | Class II | Maquet Cardiovascular Us Sales, Llc |
| Jun 10, 2020 | PERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes EH7457G EH7... | Lots of size 8-0 Blue twisted Silk Suture may not meet the stringent full shelf life of 5 years | Class II | Ethicon, Inc. |
| Jun 3, 2020 | MagNA Pure 96 Instrument, clinical sample concentrator, Material number 06541... | When using Sample Transfer protocol version 3.0, the drop catcher is not activated on the MagNA P... | Class II | Roche Molecular Systems, Inc. |
| May 15, 2020 | Siemens IMMULITE 2000 XPi Immunoassay System - In vitro Chemistry Analyzer SM... | Flexible tubing connected to the liquid waste bottle can crack during routine customer maintenanc... | Class II | Siemens Healthcare Diagnostics Inc. |
| May 15, 2020 | Siemens IMMULITE 2000 Immunoassay System - In vitro Chemistry Analyzer SMN #1... | Flexible tubing connected to the liquid waste bottle can crack during routine customer maintenanc... | Class II | Siemens Healthcare Diagnostics Inc. |
| Apr 16, 2020 | Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 68 right,... | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... | Class II | Howmedica Osteonics Corp. |
| Apr 16, 2020 | Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 66 left, ... | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... | Class II | Howmedica Osteonics Corp. |
| Apr 16, 2020 | Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 68 left, ... | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... | Class II | Howmedica Osteonics Corp. |
| Apr 16, 2020 | Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 66 right,... | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... | Class II | Howmedica Osteonics Corp. |
| Apr 16, 2020 | Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Right,... | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... | Class II | Howmedica Osteonics Corp. |
| Apr 16, 2020 | Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Left, ... | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... | Class II | Howmedica Osteonics Corp. |
| Apr 16, 2020 | Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 right,... | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... | Class II | Howmedica Osteonics Corp. |
| Apr 16, 2020 | Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 62 left, ... | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... | Class II | Howmedica Osteonics Corp. |
| Apr 16, 2020 | BD Posiflush SF Saline Flush Syringe (US Distributed Catalog 306553), UDI 503... | This product has been confirmed to exhibit holes in the packaging, which impacts package integrit... | Class II | Becton Dickinson & Company |
| Apr 16, 2020 | Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Left, ... | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... | Class II | Howmedica Osteonics Corp. |
| Apr 16, 2020 | Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 Left, ... | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... | Class II | Howmedica Osteonics Corp. |
| Apr 16, 2020 | Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 62 right,... | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... | Class II | Howmedica Osteonics Corp. |
| Apr 16, 2020 | Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 right,... | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... | Class II | Howmedica Osteonics Corp. |
| Apr 16, 2020 | Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Left, ... | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... | Class II | Howmedica Osteonics Corp. |
| Apr 16, 2020 | Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Right,... | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... | Class II | Howmedica Osteonics Corp. |
| Apr 16, 2020 | Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 left, ... | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... | Class II | Howmedica Osteonics Corp. |
| Apr 16, 2020 | Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Right,... | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... | Class II | Howmedica Osteonics Corp. |
| Apr 7, 2020 | Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemora... | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... | Class II | Maquet Cardiovascular, LLC |
| Apr 7, 2020 | HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Branch, Product Code... | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... | Class II | Maquet Cardiovascular, LLC |
| Apr 7, 2020 | HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Cod... | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... | Class II | Maquet Cardiovascular, LLC |
| Apr 7, 2020 | HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Cod... | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... | Class II | Maquet Cardiovascular, LLC |
| Apr 7, 2020 | HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Angled 4 Branch, Produ... | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... | Class II | Maquet Cardiovascular, LLC |
| Apr 7, 2020 | HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code... | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... | Class II | Maquet Cardiovascular, LLC |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.