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 |
|---|---|---|---|---|
| Oct 19, 2017 | BEQ-T 9410 Lurie Chldns Small 1/4, Custom Tubing Kit, Catalog No. 709000430 | The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... | Class II | Datascope Corporation |
| Oct 19, 2017 | BEQ-TOP 24500 ADULT ECC, Custom Tubing Kit, Catalog No. 701050253 | The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... | Class II | Datascope Corporation |
| Oct 19, 2017 | BEQ-TOP 41201 ECC 3/8 PUMP PAC, Custom Tubing Kit, Catalog No. 701064867 | The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... | Class II | Datascope Corporation |
| Oct 19, 2017 | BO-TOP 20705 SMALL PATIENT 1/4, Catalog No. 701053486 | The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... | Class II | Datascope Corporation |
| Oct 19, 2017 | NICU ECC Pack BEQ-TOP 39202, Custom Tubing Kit, Catalog No. 701067313R01 | The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... | Class II | Datascope Corporation |
| Oct 19, 2017 | BEQ-TOP 49101 Childrens Large ECC Pack, Custom Tubing Kit, Catalog No. 701067... | The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... | Class II | Datascope Corporation |
| Oct 19, 2017 | BEQ-T 25502 1/4 Better Bladder , Custom Tubing Kit, Catalog No. 709000434 | The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... | Class II | Datascope Corporation |
| Oct 19, 2017 | BEQ-TOP 38900 ECC PACK, Custom Tubing Kit, Catalog No. 701056368 | The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... | Class II | Datascope Corporation |
| Oct 19, 2017 | BEQ-TOP 22701, Catalog No. 701050790 | The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... | Class II | Datascope Corporation |
| Oct 19, 2017 | BEQ-TOP 5210 ECC Set - Respiratory, Custom Tubing Kit, Catalog No. 701055604R01 | The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... | Class II | Datascope Corporation |
| Oct 19, 2017 | BO-TOP 20700 SMALL PATIENT 3/8, Custom Tubing Kit, Catalog No. 701050966 | The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... | Class II | Datascope Corporation |
| Oct 19, 2017 | ECC Small - Respiratory BEQ-TOP 5210, Custom Tubing Kit, Catalog No. 701055604 | The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... | Class II | Datascope Corporation |
| Oct 19, 2017 | BO-TOP 13901 RAPID RESPONSE, Custom Tubing Kit, Catalog No. 701054874 | The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... | Class II | Datascope Corporation |
| Oct 19, 2017 | Adult ECC Pack BEQ-TOP 22300, Catalog No. 701049504 | The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... | Class II | Datascope Corporation |
| Oct 19, 2017 | BEQ-TOP 33700 ECC 3/8" PACK, Custom Tubing Pack with Bioline Coating, Catalog... | The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... | Class II | Datascope Corporation |
| Oct 19, 2017 | BEQ-TOP 22301, Custom Tubing Kit, Catalog No. 701049513 | The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... | Class II | Datascope Corporation |
| Oct 19, 2017 | BEQ-TOP 27610 ECC PACK 3/8, Custom Tubing Kit, Catalog No. 701065622 | The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... | Class II | Datascope Corporation |
| Oct 19, 2017 | BEQ-TOP 22300, Custom Tubing Kit, Catalog No. 701049504 | The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... | Class II | Datascope Corporation |
| Oct 19, 2017 | BEQ-TOP 22702 ECC W/HMOD 30000, Catalog No. 701051179 | The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... | Class II | Datascope Corporation |
| Sep 26, 2017 | Footswitch accessory to the CUSA Clarity Ultrasonic Tissue Ablation System; C... | A faulty footswitch may result in unintended ultrasonic fragmentation activation. There are two ... | Class II | Integra LifeSciences Corp. |
| Sep 18, 2017 | BD Vacutainer¿ Barricor" Lithium Heparin Plasma Blood Collection Tubes for In... | Increased amount of residual blood present on the top of stopper well after venipuncture | Class II | Becton Dickinson & Company |
| Sep 12, 2017 | i-STAT DE handheld data processing module for clinical use, Software Version ... | Issues resulting from upgrade to software version 2.8: (1) Location, operator, stored patient lis... | Class II | Abbott Point Of Care Inc. |
| Sep 8, 2017 | AccuLIF TL Insertion Handle The AccuLIF Insertion Handle attaches to the ... | When the lever of the Insertion Handle is in the "locked" position, the implant may be able to p... | Class II | Howmedica Osteonics Corp. |
| Aug 29, 2017 | BD Vacutainer¿ K2 EDTA (K2E) 3.6mg Blood Collection Tube (13 x 75 mm x 2.0 mL... | A limited portion of the lot was manufactured with less than the required amount of K2EDTA additi... | Class II | Becton Dickinson & Company |
| Aug 18, 2017 | TCC-EZ, Total Contact Cast System, Model No. TCC2-4051 | A quarantined lot of the devices was released for sale. Devices from this lot may experience incr... | Class II | Integra LifeSciences Corp. |
| Aug 17, 2017 | Coated VICRYL RAPIDETM (Polyglactin 910) Suture | On August 17, 2017, Ethicon had decided to initiate a medical device recall (removal) of the twe... | Class II | Ethicon, Inc. |
| Aug 8, 2017 | REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and t... | Presence of bacterial endotoxins levels above the acceptable limit | Class II | LifeCell Corporation, A Wholly Owned Subsidiary... |
| Jul 27, 2017 | Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part ... | There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flo... | Class II | Datascope Corporation |
| Jul 27, 2017 | Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 4906 PEDIARIC CPB PACK,... | There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flo... | Class II | Datascope Corporation |
| Jul 27, 2017 | Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part ... | There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flo... | Class II | Datascope Corporation |
| Jul 21, 2017 | Accolade and Restoration hip product; Catalog Number: 6021-0030, 6276-1-127, ... | Inner and outer sterile barriers not fully sealed. | Class II | Howmedica Osteonics Corp. |
| Jul 21, 2017 | FUJINON ED-530XT. This device is intended for the visualization of the duo... | An update to the design and labeling was implemented to help reduce patient risk associated with ... | Class II | Fujifilm Medical Systems U.S.A., Inc. |
| Jul 21, 2017 | Accolade and Restoration hip product; Catalog Number: 6720-0837 and 6721-0737 | Inner and outer sterile barriers not fully sealed. | Class II | Howmedica Osteonics Corp. |
| Jul 17, 2017 | CS 300 Intra-Aortic Balloon Pump. It supports the heart's left ventricle b... | False blood back detection alarm and the ingress of fluids into the IABP affecting various electr... | Class I | Maquet Datascope Corp - Cardiac Assist Division |
| Jul 17, 2017 | CS 100i Intra-Aortic Balloon Pump. It supports the heart's left ventricle ... | False blood back detection alarm and the ingress of fluids into the IABP affecting various electr... | Class I | Maquet Datascope Corp - Cardiac Assist Division |
| Jul 17, 2017 | CS 100 Intra-Aortic Balloon Pump. It supports the heart's left ventricle b... | False blood back detection alarm and the ingress of fluids into the IABP affecting various electr... | Class I | Maquet Datascope Corp - Cardiac Assist Division |
| Jul 14, 2017 | TD60 Transmitter battery charger used with the BeneVision Central Station, Pa... | A damaged circuit board in the battery charger can cause the battery to overcharge and the batter... | Class II | Mindray DS USA, Inc. dba Mindray North America |
| Jul 14, 2017 | A-Series A3/A5 Anesthesia Delivery System; Model Numbers: 0633F-01000-0X (A3)... | A software issue may result in the previous settings being applied instead of the default setting... | Class II | Mindray DS USA, Inc. dba Mindray North America |
| Jul 14, 2017 | A-Series A7 Anesthesia Delivery System; Model Number: 0632F-PA0000X (A7) ... | A software issue may result in the previous settings being applied instead of the default setting... | Class II | Mindray DS USA, Inc. dba Mindray North America |
| Jul 13, 2017 | Video Cystoscope models ECY-1570 and ECY-1570K | The video cytoscopes lack 510(k) premarket notification clearance. | Class II | Pentax of America Inc |
| Jul 10, 2017 | VITROS Chemistry Products Performance Verifier is used as an assayed control ... | VITROS Performance Verifier II (PVII) Lot K4852 does not meet long term stability requirements fo... | Class III | Ortho Clinical Diagnostics Inc |
| Jul 5, 2017 | Dial-A-Dose Insulin Delivery Device (Pen-Injector) cartridge holders Produ... | A small number of batches may crack or break if exposed to certain chemicals, like certain cleani... | Class II | Novo Nordisk Inc |
| Jun 16, 2017 | CS 100 Intra-Aortic Balloon Pump | The device failed to pump due to an electrical test failure code #58 (power up vent test fail), m... | Class I | Maquet Datascope Corp - Cardiac Assist Division |
| Jun 16, 2017 | CS 100i Intra-Aortic Balloon Pump | The device failed to pump due to an electrical test failure code #58 (power up vent test fail), m... | Class I | Maquet Datascope Corp - Cardiac Assist Division |
| Jun 16, 2017 | CS 300 Intra-Aortic Balloon Pump | The device failed to pump due to an electrical test failure code #58 (power up vent test fail), m... | Class I | Maquet Datascope Corp - Cardiac Assist Division |
| Jun 13, 2017 | BD Needle 22GA 1-1/2in SafetyGlide(TM) Non Sterile, Bulk, REF 301701 The B... | Presence of loose polypropylene foreign matter above release specification. | Class II | Becton Dickinson & Company |
| Jun 7, 2017 | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021),... | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... | Class II | Terumo Medical Corp |
| Jun 7, 2017 | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021),... | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... | Class II | Terumo Medical Corp |
| Jun 7, 2017 | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021),... | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... | Class II | Terumo Medical Corp |
| Jun 7, 2017 | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 16CM (0.021),... | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... | Class II | Terumo Medical Corp |
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.