Browse Device Recalls
2,093 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,093 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 2,093 FDA device recalls in NJ.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 1, 2019 | Rosebud Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00... | NIBP valve assembly board subject to this recall includes enhancements that are not included in t... | Class II | Mindray DS USA, Inc. dba Mindray North America |
| Oct 1, 2019 | Accutorr 3 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679... | NIBP valve assembly board subject to this recall includes enhancements that are not included in t... | Class II | Mindray DS USA, Inc. dba Mindray North America |
| Sep 16, 2019 | 13 Fr. Trialysis Catheter with Alphacurve. Catalog No. 5653150. UDI: 00801741... | A portion of the lot was incorrectly packaged with a 12.5cm catheter instead of a 15cm catheter. | Class II | Becton Dickinson & Company |
| Sep 12, 2019 | Cerelink ICP Monitor, Model Number 826820; intended for use as an interface ... | There is a potential for a progressive decline in observed ICP readings of the monitor during use. | Class II | Integra LifeSciences Corp. |
| Sep 10, 2019 | A&E Medical Thorecon Plating System Kits Model No. 94-1300-04-S. For fractur... | Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding d... | Class II | Alto Development Corp |
| Sep 10, 2019 | A&E Medical Thorecon Plating System Kits Model No. 94-1500-04-S. For fractur... | Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding d... | Class II | Alto Development Corp |
| Sep 10, 2019 | A&E Medical Thorecon Plating System Kits Model No. 94-1200-08. For fracture ... | Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding d... | Class II | Alto Development Corp |
| Sep 10, 2019 | A&E Medical Thorecon Plating System Kits Model No. 94-1700-10. For fracture ... | Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding d... | Class II | Alto Development Corp |
| Sep 10, 2019 | A&E Medical Thorecon Plating System Kits Model No. 94-1400-04. For fracture ... | Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding d... | Class II | Alto Development Corp |
| Aug 28, 2019 | 1 STRATAFIX" Spiral PDS Plus Violet 12" (30 cm) CT-1 Needle, SXPP1B429 | The product do not meet certain internal testing specifications. | Class II | Ethicon, Inc. |
| Aug 28, 2019 | 1 STRATAFIX" Spiral PDS Plus Violet 36" (90cm) CTX Needle, SXPP1B402 | The product do not meet certain internal testing specifications. | Class II | Ethicon, Inc. |
| Aug 28, 2019 | 1 STRATAFIX Spiral PDS Plus Violet 18" (45cm) OS-6 Needle, SXPP1B201 | The product do not meet certain internal testing specifications. | Class II | Ethicon, Inc. |
| Aug 22, 2019 | The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is a woven double ... | Based on an internal incident report, Getinge/Intervascular SAS has identified that the one (1) H... | Class II | GETINGE US SALES LLC |
| Aug 19, 2019 | TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 RIGHT Catalog # 5541-A-202 - ... | Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral com... | Class II | Howmedica Osteonics Corp. |
| Aug 19, 2019 | TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 LEFT Catalog # 5541-A-201 - P... | Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral com... | Class II | Howmedica Osteonics Corp. |
| Aug 19, 2019 | TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 LEFTTriathlon Femoral Distal A... | Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral com... | Class II | Howmedica Osteonics Corp. |
| Aug 19, 2019 | TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 RIGHT Catalog # 5542-A-202 - ... | Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral com... | Class II | Howmedica Osteonics Corp. |
| Aug 15, 2019 | QuickGraft¿ Model # 430PST | Measurement listed on the label is not taken under tension, and this would cause possible extensi... | Class II | Musculoskeletal Transplant Foundation, Inc. |
| Aug 13, 2019 | STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle Product code: SXPP1B... | The product does not meet certain internal strength testing specifications. | Class II | Ethicon, Inc. |
| Aug 13, 2019 | STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle Product code: SXPP1B4... | The product does not meet certain internal strength testing specifications. | Class II | Ethicon, Inc. |
| Aug 12, 2019 | ZEUS ELISA Parvovirus B19 IgM Test System, UDI 00845533001755 - Product Usage... | FDA inspection identified that due to increased positivity (false positives) on the Parvovirus B1... | Class II | Zeus Scientific, Inc. |
| Aug 7, 2019 | Integra Jarit GEMINI CLAMP 9 1/4 inch - used in vascular and cardiothoracic p... | A small crack at the box lock corner may after multiple cleaning and sterilization cycles produce... | Class II | Integra LifeSciences Corp. |
| Aug 1, 2019 | 8 G x 10 CM Jamshidi Crown Bone Marrow biopsy/Aspiration Needle with MAC Cat... | Product Pouches may not be sealed properly and compromise the sterility of the device | Class II | Becton Dickinson & Company |
| Jul 31, 2019 | BD Vacutainer¿ Push Button Blood Collection Set with Pre-Attached Holder Ca... | Separation of front and rear barrels upon activation of the safety feature that retracts the needle | Class II | Becton Dickinson & Company |
| Jul 22, 2019 | Dynex DSX Software-IVD ELISA Assays effected as follows: DSX Assay File Sof... | Assay files used on the open Dynex DSX Instrument to process IVD ELISA samples-programming error ... | Class II | Zeus Scientific, Inc. |
| Jul 22, 2019 | Getinge MCC Flow i Disposable CO2 absorber, used in anesthesia systems. | Reversed expiration and manufacturing date on the label | Class II | GETINGE US SALES LLC |
| Jul 19, 2019 | Codman ISOCOOL Bipolar Forceps-are indicated for cauterizing, coagulating, gr... | Tips have an inadequate product insulation coating, which could result in the tips not coagulatin... | Class II | Integra LifeSciences Corp. |
| Jul 11, 2019 | Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-H... | The sets are configured with quick connectors that have been assembled in reverse on the arterial... | Class II | Maquet Cardiovascular Us Sales, Llc |
| Jun 21, 2019 | A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped... | Updated instructions for use: Ultra-Flex MYO/WIRE Monopolar pacing wire looped electrode (M-21 Se... | Class II | Alto Development Corp |
| Jun 19, 2019 | Alpha Conducting solution product codes:3310-15 ACS - Product Usage: Electrod... | Potential for failed stability antimicrobial effectiveness testing. | Class II | Pharmaceutical Innovations, Inc. |
| Jun 19, 2019 | ElectroMist product codes: 36-3310-04 - Product Usage: Electrode Conductivity... | Potential for failed stability antimicrobial effectiveness testing. | Class II | Pharmaceutical Innovations, Inc. |
| Jun 19, 2019 | ElectroMist product codes: 36-3310-60 - Product Usage: Electrode Conductivity... | Potential for failed stability antimicrobial effectiveness testing. | Class II | Pharmaceutical Innovations, Inc. |
| Jun 19, 2019 | Alpha Conducting solution product codes: 3310-25 ASCR - Product Usage: Electr... | Potential for failed stability antimicrobial effectiveness testing. | Class II | Pharmaceutical Innovations, Inc. |
| Jun 19, 2019 | ElectroMist product codes: 36-3310-25 - Product Usage: Electrode conductivity... | Potential for failed stability antimicrobial effectiveness testing. | Class II | Pharmaceutical Innovations, Inc. |
| Jun 18, 2019 | Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm... | Discrepant length; Lot B88751 90mm screws were manufactured with a 100mm length instead of the re... | Class II | Howmedica Osteonics Corp. |
| Jun 17, 2019 | Cardiosave Rescue IABP, 0998-00-0800-83 Intra-Aortic Balloon Pump For card... | If battery maintenance is not performed appropriately, the battery may provide less than the mini... | Class I | Datascope Corp. |
| Jun 17, 2019 | CS300 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3023-53 For cardiova... | If battery maintenance is not performed per instructions, the battery may provide less than the m... | Class I | Datascope Corp. |
| Jun 17, 2019 | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), 0998-00-0800-53 For card... | Battery short-run times and unanticipated stoppage may be due to user not performing battery main... | Class I | Datascope Corp. |
| Jun 17, 2019 | CS300 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3023-55 For cardiova... | If battery maintenance is not performed per instructions, the battery may provide less than the m... | Class I | Datascope Corp. |
| Jun 17, 2019 | CS100 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3013-53 For cardiova... | If battery maintenance is not performed appropriately, the battery may provide less than the mini... | Class I | Datascope Corp. |
| Jun 17, 2019 | CS100 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3013-55 For cardiova... | If battery maintenance is not performed appropriately, the battery may provide less than the mini... | Class I | Datascope Corp. |
| Jun 12, 2019 | BD Vacutainer PST Gel and Lithium HeparinN (LH) 65 Units Blood Collection Tub... | False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood ga... | Class II | Becton Dickinson & Company |
| Jun 12, 2019 | BD Vacutainer PST Gel and Lithium HeparinN (LH) Blood Collection Tubes, Catal... | False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood ga... | Class II | Becton Dickinson & Company |
| Jun 12, 2019 | BD Vacutainer Lithium HeparinN (LH) 158 USP Units Blood Collection Tubes, Cat... | False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood ga... | Class II | Becton Dickinson & Company |
| Jun 12, 2019 | BD Vacutainer PST Blood Collection Tubes, Catalog Number 368035, 368036 | False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood ga... | Class II | Becton Dickinson & Company |
| Jun 12, 2019 | BD Vacutainer LH (Lithium Heparin) 102 I.U. Plus Blood Collection Tubes, Cata... | False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood ga... | Class II | Becton Dickinson & Company |
| Jun 12, 2019 | BD Vacutainer Lithium HeparinN 75 USP Units Blood Collection Tubes, Catalog N... | False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood ga... | Class II | Becton Dickinson & Company |
| Jun 12, 2019 | BD Vacutainer LH (Lithium Heparin) 68 I.U. Plus Blood Collection Tubes, Catal... | False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood ga... | Class II | Becton Dickinson & Company |
| Jun 12, 2019 | BD Vacutainer PST Gel and Lithium HeparinN (LH) 83 Units Blood Collection Tub... | False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood ga... | Class II | Becton Dickinson & Company |
| Jun 12, 2019 | BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tub... | False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood ga... | Class II | Becton Dickinson & Company |
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.