Browse Device Recalls
3,013 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,013 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 3,013 FDA device recalls in 2018.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 24, 2018 | MEDLINE O.R. Necessities(R) STERILE R, Needle Counter/Compte-aiguiles/Caja de... | The product packaging seal has the potential to experience seal creep. This may result in gaps to... | Class II | Medline Industries Inc |
| Apr 24, 2018 | Prismaflex System, Product Code 107493 Intended Use: The Prismaflex Contr... | Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the ... | Class II | Baxter Healthcare Corporation |
| Apr 24, 2018 | Medtronic MiniMed Paradigm Veo Insulin Pump Product Catalog Number: MMT-554,... | The MiniMed Paradigm Veo insulin pump has an error that impacts the Arabic language translation.T... | Class II | Medtronic Inc. |
| Apr 24, 2018 | MEDLINE Sterile* Needle Counter, 40Ct. Foam Block / Adhesive, reorder: DYNJNC... | The product packaging seal has the potential to experience seal creep. This may result in gaps to... | Class II | Medline Industries Inc |
| Apr 24, 2018 | Prismaflex 7.20 US, Product Code 955542 Intended Use: The Prismaflex Cont... | Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the ... | Class II | Baxter Healthcare Corporation |
| Apr 23, 2018 | da Vinci Xi EndoWrist Stapler 45 Reload Blue, Model 48645B-03, 12 reloads/box. | Intuitive Surgical, Inc. (ISI) has recently become aware of an issue with the da Vinci Xi Stapler... | Class II | Intuitive Surgical, Inc. |
| Apr 23, 2018 | DeRoyal(R) SURGI MATE(R) Electrosurgical Pencil, Button Switch, with 15 ft (4... | Non-sterile product was packaged inside a case that was labeled as sterile. | Class II | DeRoyal Industries Inc |
| Apr 23, 2018 | da Vinci Xi EndoWrist Stapler 45 Reload Green, Model 48445G-03, 12 reloads/box. | Intuitive Surgical, Inc. (ISI) has recently become aware of an issue with the da Vinci Xi Stapler... | Class II | Intuitive Surgical, Inc. |
| Apr 23, 2018 | t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version: 4.3.4... | The fuel gauge, the component that reads and reports the battery parameters to the pump, could pr... | Class II | Tandem Diabetes Care Inc |
| Apr 20, 2018 | Sorin Stockert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz;... | Firm is notifying customers that the Deep-Cleaning Service is now available in the United States.... | Class II | LivaNova USA |
| Apr 20, 2018 | LINX Reflux Management System, Implant Clasp, 13-17 Bead, 1.5T, Product Code ... | Possible out of specification condition which may allow a bead component to separate from an adja... | Class II | Torax Medical, Inc. |
| Apr 20, 2018 | LINX Reflux Management System, Implant Clasp, 13-16 Bead, 1.5T, Product Code ... | Possible out of specification condition which may allow a bead component to separate from an adja... | Class II | Torax Medical, Inc. |
| Apr 20, 2018 | Alaris Infusion Pump administration sets labeled as: -Infusion Set Alaris P... | Complaints where users were unable to prime the administration set. | Class II | CareFusion 303, Inc. |
| Apr 20, 2018 | LINX Reflux Management System, Implant Suture, 12-17 Bead, 0.7T, Product Code... | Possible out of specification condition which may allow a bead component to separate from an adja... | Class II | Torax Medical, Inc. |
| Apr 20, 2018 | LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code ... | Possible out of specification condition which may allow a bead component to separate from an adja... | Class II | Torax Medical, Inc. |
| Apr 20, 2018 | SOMATOM go.Now, Material Number 11061618 There is a potential for a softw... | There is a potential for a software issue that may cause the need for necessary patient rescans. | Class II | Siemens Medical Solutions USA, Inc |
| Apr 20, 2018 | SOMATOM Go.Up, Material Number 11061628 There is a potential for a softwar... | There is a potential for a software issue that may cause the need for necessary patient rescans. | Class II | Siemens Medical Solutions USA, Inc |
| Apr 20, 2018 | LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code ... | Possible out of specification condition which may allow a bead component to separate from an adja... | Class II | Torax Medical, Inc. |
| Apr 20, 2018 | A warming pad, a component of the PINTLER PEAK & PINTLER SUMMIT Heated OR pad... | Malfunction warming pad. | Class II | Pintler Medical LLC |
| Apr 19, 2018 | VOLISTA StandOP (model 600) surgical lights shipped from October 2012 until J... | Potential keypad failure on VOLISTA StandOP Surgical Lights. | Class II | Maquet SAS |
| Apr 19, 2018 | MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, S... | The Instructions for Use (IFU) is incorrect with regards to sterilization parameters and must be ... | Class II | MicroAire Surgical Instruments, LLC |
| Apr 19, 2018 | Dimension Vista Gentamicin Flex reagent cartridge, DV GENT, gentamicin enzyme... | The affected lots may exhibit inaccuracy for Quality Control and patient samples at the low end o... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Apr 19, 2018 | Dimension Gentamicin Flex reagent cartridge, DM GENT, gentamicin enzyme immu... | The affected lots may exhibit inaccuracy for Quality Control and patient samples at the low end o... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Apr 18, 2018 | DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD) | It was found when an operator performs a radiography using the wireless flat panel detector (FPD)... | Class II | Canon Medical System, USA, INC. |
| Apr 17, 2018 | Amalgatome SD, COAXIAL PNEUMATIC HOSE, SCHRADER, Model X101004 | Improper installation of hand piece may result in a weakening of the internal hose connection whi... | Class II | Exsurco Medical |
| Apr 17, 2018 | BLAST Bandage, sterile. | Blast Bandages (part# BLAST) with Lot# 0617 were not terminally sterilized. | Class II | Tactical Medical Solutions, Inc. |
| Apr 17, 2018 | Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators, Catalog No C6... | There is a potential for the cord to spark and cause a fire. | Class II | Gyrus Acmi, Incorporated |
| Apr 16, 2018 | Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846;... | The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac... | Class II | St Jude Medical Inc. |
| Apr 16, 2018 | Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; ... | The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac... | Class II | St Jude Medical Inc. |
| Apr 16, 2018 | Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195... | The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac... | Class II | St Jude Medical Inc. |
| Apr 16, 2018 | BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.014", 150 cm,... | Device is at risk of having detectable levels of bacterial endotoxin present on the packaging hoo... | Class II | Bard Peripheral Vascular Inc |
| Apr 16, 2018 | BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.035", 150 cm,... | Device is at risk of having detectable levels of bacterial endotoxin present on the packaging hoo... | Class II | Bard Peripheral Vascular Inc |
| Apr 16, 2018 | Merlin PCS Programmer Software: 3330 The Merlin PCS programmer (model 3650... | The firm is advising physicians that exposure to sub-freezing temperatures during the supply chai... | Class II | St Jude Medical Inc. |
| Apr 16, 2018 | Current, Sterile EO, Model #/ Part #: 1207-30/50020236-001, 60010739-207, 6... | The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac... | Class II | St Jude Medical Inc. |
| Apr 16, 2018 | Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100... | The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac... | Class II | St Jude Medical Inc. |
| Apr 16, 2018 | Promote, Sterile EO, Model #/ Part #: 3207-30/60010740-207, 60010740-407; ... | The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac... | Class II | St Jude Medical Inc. |
| Apr 16, 2018 | Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD326... | The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac... | Class II | St Jude Medical Inc. |
| Apr 16, 2018 | Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, ... | The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac... | Class II | St Jude Medical Inc. |
| Apr 16, 2018 | Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623... | The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac... | Class II | St Jude Medical Inc. |
| Apr 16, 2018 | Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041... | The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac... | Class II | St Jude Medical Inc. |
| Apr 16, 2018 | Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 1000419... | The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac... | Class II | St Jude Medical Inc. |
| Apr 16, 2018 | St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: ... | The firm is advising physicians that exposure to sub-freezing temperatures during the supply chai... | Class II | St Jude Medical Inc. |
| Apr 16, 2018 | Advance¿ 35LP Low-Profile PTA Balloon Dilatation Catheter; Catalog numbers: P... | Incorrect product labeling. Product labeled as 6mm x 2cm balloon are packaged with a 4mm x 4 cm b... | Class II | Cook Inc. |
| Apr 16, 2018 | AMENDIA Omega Lumbar Interbody Fusion Device, Part Number 72-00-2-092812-11 ... | Omega LIF interbody implants labeled as having 11 degrees of lordosis was assembled using compone... | Class II | Spinal Elements |
| Apr 16, 2018 | ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral ... | There may be burrs on the extraction hole threads. | Class II | DePuy Orthopaedics, Inc. |
| Apr 16, 2018 | Ulnar Osteotomy Compression Plate, Short Model: UOCP-S Product Usage: Th... | Two instrument holes located on the side of the plate, which act to align the saw guide are locat... | Class II | TriMed Inc. |
| Apr 16, 2018 | ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral ... | There may be burrs on the extraction hole threads. | Class II | DePuy Orthopaedics, Inc. |
| Apr 16, 2018 | Merlin PCS programmer (Model # 3650), Software (Model # 3330) | The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac... | Class II | St Jude Medical Inc. |
| Apr 13, 2018 | Nitinol Staple, Elastic Staple Small-Symmetrical, Sterile R, Model #: a) ES-0... | During a retrospective review of sterilization records, TriMed has determined that evidence of qu... | Class II | TriMed Inc. |
| Apr 13, 2018 | Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model ... | The products are labeled with an incorrect product number. | Class II | Coltene Whaledent Inc |
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.