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Browse Device Recalls

2,036 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,036 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 2,036 FDA device recalls in NJ.

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DateProductReasonClassFirm
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
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-Thoracoabdominal, Prod... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
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-4 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- 4 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- 4 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-Thoracoabdominal, Prod... 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
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
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 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 Graft01 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-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 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- 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 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-4 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-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 1, 2020 Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010 Shipments were transported outside of the required refrigerated temperature conditions. Potential... Class II Howmedica Osteonics Corp.
Mar 26, 2020 CareFusion Safe-T-Centesis Catheter Drainage Tray, Sterile, For Single Use On... The 8 Fr catheter was manufactured with the 6.9 Fr needle instead of the 8 Fr needle. Class II Becton Dickinson & Company
Mar 23, 2020 B. Braun Introcan Safety IV Catheters, Product codes REF 4252500-01 4252519-... Distribution of B.Braun Introcan Safety IV catheters without a 510(k) within the United States by... Class II Janus Trade Group

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.