Browse Device Recalls
2,447 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,447 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 2,447 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 1, 2018 | 191 cm (75") Appx 2.9 ml, PVC/PUR Smallbore Bifuse Ext Set w/6-Port NanoClave... | ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... | Class II | ICU Medical de Mexico, S.A. de C.V. |
| Mar 1, 2018 | 40 cm (16") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoC... | ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... | Class II | ICU Medical de Mexico, S.A. de C.V. |
| Mar 1, 2018 | PROXIMALE - 18 cm (7") Appx 0.92 ml, PUR Smallbore Ext Set, 6-Port NanoClave ... | ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... | Class II | ICU Medical de Mexico, S.A. de C.V. |
| Mar 1, 2018 | 38 cm (15") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Micro... | ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... | Class II | ICU Medical de Mexico, S.A. de C.V. |
| Feb 5, 2018 | 7" Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer,... | The infusion sets were manufactured with an incorrect spin collar. | Class II | ICU Medical, Inc. |
| Feb 5, 2018 | 6.5" (17 cm) Appx. 0.57 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, NanoClave¿... | The infusion sets were manufactured with an incorrect spin collar. | Class II | ICU Medical, Inc. |
| Feb 5, 2018 | 7" Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouche... | The infusion sets were manufactured with an incorrect spin collar. | Class II | ICU Medical, Inc. |
| Feb 5, 2018 | 5" (13 cm) Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotati... | The infusion sets were manufactured with an incorrect spin collar. | Class II | ICU Medical, Inc. |
| Feb 5, 2018 | 14 cm (5.5") Appx 0.27 ml, Smallbore Ext Set w/SURPLUG¿ Nano T-Connector, Cla... | The infusion sets were manufactured with an incorrect spin collar. | Class II | ICU Medical, Inc. |
| Feb 5, 2018 | 6.5" (17 cm) Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave¿ T-Connect... | The infusion sets were manufactured with an incorrect spin collar. | Class II | ICU Medical, Inc. |
| Feb 2, 2018 | Signature Ceramic Femoral Head. Model Number: 111-152-621. The Signature cer... | This recall has been identified due to the batch being mislabeled, with the packaged component's... | Class II | Signature Orthopedics Pty Limited |
| Jan 22, 2018 | Apollo XT Suture Anchor, 5.5 x 15 Product Usage: Apollo XT Suture Anchors... | The label on Apollo XT 5.5mm Suture Anchor (part # XTS-5515; lots 2358, 2362, and 2363) indicated... | Class II | Valeris Medical, LLC |
| Jan 5, 2018 | Hemodynamic monitoring system (HMS), comprised of a Patient Interface Module ... | When continuous cardiac output monitoring with a pulmonary artery catheter is placed in the Pau... | Class II | ICU Medical, Inc. |
| Jan 2, 2018 | Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas... | The previous version of method sheets for the Acetaminophen assay on the COBAS INTEGRA 400 plus/... | Class II | Roche Diagnostics Corporation |
| Dec 19, 2017 | Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Claria MRI. Label... | Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Dec 19, 2017 | Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Amplia MRI. Label... | Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Dec 19, 2017 | Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Compia MRI. Label... | Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Dec 19, 2017 | Implantable Cardioverter Defibrillators (ICDs), Visia AF MRI. Labeled as the ... | Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Dec 19, 2017 | Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Viva. Labeled as ... | Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Dec 19, 2017 | Implantable Cardioverter Defibrillators (ICDs), Visia AF. Labeled as: a. V... | Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Dec 19, 2017 | Implantable Cardioverter Defibrillators (ICDs), Evera. Labeled as the followi... | Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Dec 19, 2017 | Implantable Cardioverter Defibrillators (ICDs), Evera MRI. Labeled as the fo... | Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Dec 15, 2017 | Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01... | Certain lots of the spinal cement may contain incorrect amounts of contrast medium so that the pr... | Class II | DePuy Spine, Inc. |
| Dec 14, 2017 | DermaPro Waterproof Silicone Tape, SNS57232 | The recalling firm received a customer complaint stating the tape was difficult to peel off the r... | Class II | Safe N Simple, LLC |
| Dec 11, 2017 | Synvisc-One ¿ (hylan G-F 20), 6mL delivered from a 10mL syringe Product Us... | Contamination with Methylbacterium thiocyanatum | Class II | Sanofi Genzyme |
| Dec 4, 2017 | iChem VELOCITY Urine Chemistry Strips, REF 800-7212 Product Usage: The iC... | A subset of Lot 7212154 A of the iChem VELOCITY Urine Chemistry strips has an incorrect pad pla... | Class II | Beckman Coulter Inc. |
| Nov 29, 2017 | BCI Advisor Vital Signs Monitor, Model 9200, Reorder numbers 920654235, 92065... | Some printing modes on the devices may not function properly (tabular data printing, real-time co... | Class II | Smiths Medical ASD Inc. |
| Nov 24, 2017 | U2 Total Knee System Tibial Insert, PSA, #1, 21mm Thick Catalogue number 2303... | UOC received a customer compliant report from our distributor on October 31, 2017 which stated t... | Class II | United Orthopedic Corporation |
| Nov 24, 2017 | U2 Total Knee System Tibial Insert, Posterior Stabilized, #3, 11mm Thick Cat... | UOC received a customer compliant report from our distributor on October 31, 2017 which stated t... | Class II | United Orthopedic Corporation |
| Nov 10, 2017 | MOOG Curlin Infusion Administration Set, Ref 340-4114, Non-DEHP Microbore Tub... | Particulate found on the Curlin spike. | Class II | Zevex Incorporated (dba Moog Medical Medical De... |
| Nov 10, 2017 | MOOG Curlin Infusion Administration Set, Ref 340-4168, Non-DEHP Microbore Tub... | Particulate found on the Curlin spike. | Class II | Zevex Incorporated (dba Moog Medical Medical De... |
| Nov 10, 2017 | MOOG Curlin Infusion Administration Set, Ref 340-4166, Non-DEHP Microbore Tub... | Particulate found on the Curlin spike. | Class II | Zevex Incorporated (dba Moog Medical Medical De... |
| Nov 10, 2017 | MOOG Curlin Infusion Administration Set, Ref 340-4169, Non-DEHP Microbore Tub... | Particulate found on the Curlin spike. | Class II | Zevex Incorporated (dba Moog Medical Medical De... |
| Nov 10, 2017 | MOOG Curlin Infusion Administration Set, Ref 340-4134, Non-DEHP Microbore Tub... | Particulate found on the Curlin spike. | Class II | Zevex Incorporated (dba Moog Medical Medical De... |
| Nov 10, 2017 | MOOG Curlin Infusion Administration Set, Ref 340-4133, Non-DEHP Microbore Tub... | Particulate found on the Curlin spike. | Class II | Zevex Incorporated (dba Moog Medical Medical De... |
| Oct 30, 2017 | Plum 360 Infusion System, List number 30010. | (1) Under certain conditions, if a malfunction alarm occurs while the pump is in the "Paused" sta... | Class II | ICU Medical Inc |
| Oct 30, 2017 | ICU Mednet(TM) Medication Management Suite 6.1 and 6.21, Product Code/List Nu... | Issue 1: The MedNet Meds 6.1 and 6.21 programs, under certain conditions, can change the piggybac... | Class II | ICU Medical Inc |
| 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 16, 2017 | Fukuda Denshi patient monitor model DS-8100M and DS-8100N Product Usage: ... | For the Fukuda Denshi patient monitor model DS-8100, in less than 0.003% (17) of the 6227 devices... | Class II | Fukuda Denshi Co., Ltd. |
| Oct 2, 2017 | Hemosphere System with the following three components: HEM1 Advanced Monitor,... | Pre-procedural issues related to software defects | Class II | Edwards Lifesciences, LLC |
| Sep 15, 2017 | Monarch Airway Clearance System, Model 1000, Product Numbers: PMACS1NA (has b... | Monarch Electromagnetic Interference (EMI) may disrupt the operation of implanted pacemakers or i... | Class II | HILL-ROM MANUFACTURING, INC. |
| Sep 13, 2017 | Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal... | Potential for failure of the device safety interlock. The safety interlock prevents an empty sing... | Class II | Covidien LLC |
| Aug 31, 2017 | SURPLUG MICRO CONNECTOR Item No. 066-C3352; 111" (282 cm) Appx 13.9 ml, 15 ... | ICU Medical has identified certain stopcocks that are incorporated in IV sets may contain a metal... | Class II | ICU Medical, Inc. |
| Aug 28, 2017 | Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: ... | The device may exhibit premature battery depletion. | Class I | St Jude Medical Inc. |
| Aug 28, 2017 | Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Nu... | The device may exhibit premature battery depletion. | Class I | St Jude Medical Inc. |
| Aug 28, 2017 | Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, P... | New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... | Class II | St Jude Medical Inc. |
| Aug 28, 2017 | Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Acce... | New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... | Class II | St Jude Medical Inc. |
| Aug 28, 2017 | Assurity MRI Model Numbers: PM1272, PM2272 Implantation of a single-chamber ... | New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... | Class II | St Jude Medical Inc. |
| Aug 7, 2017 | LCP Drill Sleeve 1.5 Drill Bit 1.1mm Part Number 03.114.001 Used in LCP M... | May have difficulty attaching the drill sleeve to the plate. If the drill sleeve will not connect... | Class II | Synthes, Inc. |
| Aug 1, 2017 | Presource(R) Kits (custom surgical/procedural kits): The standard and custom... | The firm manufactured and distributed Presource(R) kits which contained BD SafetyGlide" 22GA 1¿ i... | Class II | Cardinal Health 200, 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.