Browse Device Recalls
3,010 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,010 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 3,010 FDA device recalls in 2019.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 9, 2019 | Proteus XR/a (SlOK : K993090) | Intermittently not receiving an audible exposure indication upon completion of an exposure on the... | Class II | GE Healthcare, LLC |
| Aug 9, 2019 | Medline SYRINGE, PISTON,IRR TRAY,W/.9, REF DYNC2303. Sterile Piston Irrigati... | Samples in the identified lot were found to have incomplete or open packaging seals. | Class II | Medline Industries Inc |
| Aug 9, 2019 | Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.... | A QA inspection confirmed that a Healing Collar (Part number 8735-15) was packaged instead of the... | Class II | Implant Direct Sybron Manufacturing, LLC |
| Aug 9, 2019 | Temporary Snap Abutment Engaging CC RP 1.5 mm; Pre-manufactured prosthetic co... | Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be ... | Class II | Nobel Biocare Usa Llc |
| Aug 9, 2019 | Universal Base CC RP 1.5 mm; The Universal Base Abutment in combination with ... | Packages of abutments (universal base) may contain an incorrect screw. While the screw will tight... | Class II | Nobel Biocare Usa Llc |
| Aug 9, 2019 | Temporary Abutment Engaging CC RP pre-manufactured prosthetic components dire... | Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be ... | Class II | Nobel Biocare Usa Llc |
| Aug 9, 2019 | Esthetic Abutment CC RP 1.5 mm pre-manufactured prosthetic components directl... | Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be ... | Class II | Nobel Biocare Usa Llc |
| Aug 9, 2019 | Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN: 05... | The assigned value for Rheumatoid Factor over recovers against the reference material RF serum, 1... | Class II | Randox Laboratories Ltd. |
| Aug 8, 2019 | FoundationOne CDx test report | Identified potential false positive MSI-H on the test reports provided to the physicians. | Class II | Foundation Medicine, Inc. |
| Aug 8, 2019 | FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (... | Complaints have been received concerning elevated rates of false negative results while using the... | Class II | BioFire Diagnostics, LLC |
| Aug 8, 2019 | AQURE basic sytem, FLEXLINK, REF 933-599, Version: 2.3.3 (17), CE IVD, Rx On... | The firm has become aware that there is a potential problem relating to the blood gas and immunoa... | Class II | Radiometer Medical ApS |
| Aug 7, 2019 | Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy P... | The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could pos... | Class II | Intersurgical Inc |
| Aug 7, 2019 | CAIMAN DISP.INSTR.ARTICULAT.D:12/440MM REF: PL731SU- Product Usage: Instrume... | possibility of the sterility batch being insufficiently sterilized | Class II | Aesculap Implant Systems LLC |
| 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 7, 2019 | CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM REF: PL730SU - Product Usage: Instrum... | possibility of the sterility batch being insufficiently sterilized | Class II | Aesculap Implant Systems LLC |
| Aug 7, 2019 | Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1996... | The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could pos... | Class II | Intersurgical Inc |
| Aug 7, 2019 | Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1898... | The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could pos... | Class II | Intersurgical Inc |
| Aug 7, 2019 | Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy P... | The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could pos... | Class II | Intersurgical Inc |
| Aug 6, 2019 | BodyGuardian Heart Remote Monitoring Kit, consisting of two BG Heart monitors... | The device data being collected and transferred to the monitoring center may not be accurate due ... | Class II | Preventice Services, LLC |
| Aug 6, 2019 | Medtronic Micra MC1VR01, Single chamber transcatheter pacing system, REF MC1V... | Medtronic is updating the Micra Instructions for Use (IFU) and the Micra Implant Procedure Tip Ca... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Aug 6, 2019 | ASI 2.0 Calcar Trimmer Shaft for Use with Biomet¿ Rasp, Model Number 110032331 | The potential that the end of the shaft could fail to effectively mate with the broach with the C... | Class II | Zimmer Biomet, Inc. |
| Aug 6, 2019 | Medtronic Micra MC1VR01, REF MC1VR01 (OUS only). Cardiac pacemaker. | Medtronic is updating the Micra Instructions for Use (IFU) and the Micra Implant Procedure Tip Ca... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Aug 6, 2019 | Arrow 8.5 Fr. X 16 cm Quad-Lumen Central Venous Catheterization Kit Product ... | Products may contain the incorrect banner card within the kit | Class II | Arrow International Inc |
| Aug 6, 2019 | Kiwi Complete Vacuum Delivery System, Model No. VAC-6000MTE - Product Usage: ... | There is a potential for loss of vacuum or failure to generate vacuum when using the firm's fetal... | Class II | Clinical Innovations, LLC |
| Aug 6, 2019 | 8.5 Fr. X 10 cm ARROW+gard Blue PSI Kit Cath-Gard for use with 7.5 - 8 Fr.Cat... | Products may contain the incorrect banner card within the kit | Class II | Arrow International Inc |
| Aug 1, 2019 | Imactis Navigation Kit, REF 10100, Content Sterile Needle Holder Ref. A10010 ... | The firm has become aware that the sensor cover, a component of the single-use navigation kit ma... | Class II | Imactis |
| Aug 1, 2019 | LightPod Neo Lasers | This relates to the standard 21 CFR 1040.10(f)(3) requiring a readily available remote interlock ... | Class II | Aerolase Corporation |
| Aug 1, 2019 | Gold Cup Leadwire and Snap Leadwire with the following component descriptions... | The electrode lead connector has a protruding conductor beyond insulation of approximately 0.1 mm. | Class II | GN Otometrics |
| Aug 1, 2019 | LightPod ERA lasers | This relates to the standard 21 CFR 1040.10(f)(3) requiring a readily available remote interlock ... | Class II | Aerolase Corporation |
| Aug 1, 2019 | Rocket KCH Fetal Bladder Drainage Catheter Model: R57405 | A complaint was received regarding kinking of the device prior to use. If a device is kinked it c... | Class II | Rocket Medical Plc |
| Aug 1, 2019 | Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a componen... | The mounts on the monitor may have an insufficient weld. | Class II | Stryker Communications |
| 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 | SOMATOM go.All; Models #11061630 Product Usage: This computed tomograph... | The injector holder could potentially fall off together with the injector and the storage box. | Class II | Siemens Medical Solutions USA, Inc |
| Jul 31, 2019 | SOMATOM go.Up; Models ##11061628 Product Usage: This computed tomograph... | The injector holder could potentially fall off together with the injector and the storage box. | Class II | Siemens Medical Solutions USA, Inc |
| Jul 31, 2019 | SOMATOM go.Up; Models #11061620 Product Usage: This computed tomography ... | The injector holder could potentially fall off together with the injector and the storage box. | Class II | Siemens Medical Solutions USA, Inc |
| Jul 31, 2019 | SOMATOM go.All; Models #11061638 Product Usage: This computed tomograph... | The injector holder could potentially fall off together with the injector and the storage box. | Class II | Siemens Medical Solutions USA, Inc |
| Jul 31, 2019 | HS Hi-R NEO 900A Reference # 657 821 Serial # from 101 Product Usage: A... | software error in the central control unit of the floor stand. | Class II | Haag-Streit USA Inc |
| Jul 31, 2019 | SOMATOM go.Now; Models #11061610 & 11061618 Product Usage: This compute... | The injector holder could potentially fall off together with the injector and the storage box. | Class II | Siemens Medical Solutions USA, Inc |
| Jul 31, 2019 | C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usag... | Stryker C2 NerveMonitor's design and instructions may not optimally address usability issues rela... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Jul 31, 2019 | SOMATOM go.Top; Models #11061648 Product Usage: This computed tomograph... | The injector holder could potentially fall off together with the injector and the storage box. | Class II | Siemens Medical Solutions USA, Inc |
| Jul 31, 2019 | HS Hi-R NEO 900 Reference # 657 820 Serial # from 101 Product Usage: A... | software error in the central control unit of the floor stand. | Class II | Haag-Streit USA Inc |
| Jul 31, 2019 | HS Hi-R NEO 900A NIR Reference # 657 822 Serial # from 101 Product Usage... | software error in the central control unit of the floor stand. | Class II | Haag-Streit USA Inc |
| 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 31, 2019 | SOMATOM go.Top; Models #11061640 Product Usage: This computed tomograph... | The injector holder could potentially fall off together with the injector and the storage box. | Class II | Siemens Medical Solutions USA, Inc |
| Jul 31, 2019 | C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usag... | Stryker C2 NerveMonitor's design and instructions may not optimally address usability issues rela... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Jul 30, 2019 | Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h | X-ray imaging system positioning image and protocol label is reversed for Flexion and Extension o... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Jul 30, 2019 | Artis zee and Artis Q/ Q.zen Interventional Fluoroscopic X-Ray System with p... | Artis zee/Q systems patient tables may potentially have cracks in the table mainframe, and cause... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 30, 2019 | Siemens Atellica CH 930 Analyzer. Siemens Material Number (SMN): 11067000 ... | Atellica CH 930 Analyzer - Erroneous Indices for Hemolysis and Lipemia in Software versions 1.19.... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jul 30, 2019 | Sheridan/CF Novaplus 7.0 mm, REF V5-10114 Product Usage: Tracheal tube/ai... | Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connec... | Class I | Teleflex Medical |
| Jul 30, 2019 | Sheridan/HVT Novaplus: a) 7.0 mm, REF V5-10314 b) 7.5 mm, REF V5-10315 c)... | Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connec... | Class I | Teleflex Medical |
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.