Browse Device Recalls
2,260 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,260 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 2,260 FDA device recalls in 2021.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 16, 2021 | EXALT Controller - Product Usage: intended for use with a Boston Scientific e... | May have been programmed with a less than optimal brightness setting resulting in a darker than ... | Class III | Boston Scientific Corporation |
| Mar 16, 2021 | REF CH3020 40" (102 cm) Appx. 4.8 ml, 20 Drop Admin Set w/In-Line Chamber, 2 ... | Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... | Class II | ICU Medical, Inc. |
| Mar 16, 2021 | REF 011-H2864-HSR 180 cm (71 IN)APPX 11.5ml, PUR AMBR, Spiros, CAMERA, REG. F... | Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... | Class II | ICU Medical, Inc. |
| Mar 16, 2021 | REF 20120-01 Spiros" Closed Male Luer - Product Usage: provides access for... | Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... | Class II | ICU Medical, Inc. |
| Mar 16, 2021 | REF CL3028T 30" (76 cm) Appx 6.1 ml, 20 Drop Admin Set w/Integrated w/ChemoLo... | Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... | Class II | ICU Medical, Inc. |
| Mar 16, 2021 | REF 20124-01 30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave D... | Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... | Class II | ICU Medical, Inc. |
| Mar 16, 2021 | REF CH3582 5 IN (13cm) APPX 0.57 ml, EXT SET, ANTI-SHIPHON VALVE, Spiros LOT ... | Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... | Class II | ICU Medical, Inc. |
| Mar 16, 2021 | VAPORIZER VICKS 1.5GAL Item Number: 2354942 | Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... | Class II | Cardinal Health Inc. |
| Mar 16, 2021 | Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct pro... | Interference condition between the 10mm Drill Guide Inserter and the inner shaft that mates with ... | Class II | K2M, Inc |
| Mar 16, 2021 | ONETOUCH ULTRA BLUE TEST STRIPS 100 COUNT Item Number: 2990174 | Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... | Class II | Cardinal Health Inc. |
| Mar 16, 2021 | DEXCOM G6 SENSOR 3 PACK Item Number: 5447552 | Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... | Class II | Cardinal Health Inc. |
| Mar 16, 2021 | FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM. Item Number: 5479084 | Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... | Class II | Cardinal Health Inc. |
| Mar 16, 2021 | REF CH3397 Oncology Kit w/Spiros¿, Red Cap, Bag Spike w/Clave Additive Port L... | Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... | Class II | ICU Medical, Inc. |
| Mar 16, 2021 | VIDAS¿ CMV IgM 30 Tests | bioMerieux received complaints about calibration issue observed on several lots of VIDAS¿ CMV IgM... | Class II | Biomerieux Inc |
| Mar 16, 2021 | FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877 | Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... | Class II | Cardinal Health Inc. |
| Mar 16, 2021 | REF CL3960 Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/w/Che... | Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... | Class II | ICU Medical, Inc. |
| Mar 16, 2021 | ACCU-CHEK SMARTVIEW 100 TEST STRIPS Item Number: 4742862 | Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... | Class II | Cardinal Health Inc. |
| Mar 16, 2021 | REF CH3011 30" (76 cm) Appx 3.3 mL, 20 Drop Admin Set w/Integrated ChemoClav... | Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... | Class II | ICU Medical, Inc. |
| Mar 16, 2021 | OPTICHAMBER DIAMOND SPACER WITH LARGE MASK Item Number: 4742326 | Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... | Class II | Cardinal Health Inc. |
| Mar 16, 2021 | REF CH2060 60mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides ... | Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... | Class II | ICU Medical, Inc. |
| Mar 16, 2021 | REF CL3946 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Ve... | Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... | Class II | ICU Medical, Inc. |
| Mar 15, 2021 | ASSURITY Pulse Generator REF PM**** SN ********* ST. JUDE MEDICAL Assur... | Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufact... | Class I | St. Jude Medical, Cardian Rhythm Management Div... |
| Mar 15, 2021 | MiniMed 780G Insulin Pump: Models: PUMP MMT-1885 MM780G 6.5V BLE MMOL;¿ PU... | Due to a software design issue, under certain conditions, a software fault is detected when a lar... | Class II | Medtronic Minimed |
| Mar 15, 2021 | Filtered Triple-Leg Extension Set - Intravascular administration set. Product... | BBMI has identified through complaints the potential for the extension set to become occluded or ... | Class II | B. Braun Medical, Inc. |
| Mar 15, 2021 | ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rh... | Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufact... | Class I | St. Jude Medical, Cardian Rhythm Management Div... |
| Mar 15, 2021 | MiniMed 670G Insulin Pump: Models: PUMP MMT-1740KX 670G V6.3 SF MG CLIN;¿ ... | Due to a software design issue, under certain conditions, a software fault is detected when a lar... | Class II | Medtronic Minimed |
| Mar 15, 2021 | Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the... | Possible false negative or false positive results due to the product being compromised during shi... | Class II | Medline Industries Inc |
| Mar 11, 2021 | Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use ... | It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts. | Class II | Arthrex, Inc. |
| Mar 11, 2021 | Disposable Sampling Tube, REF VSM01, Contents: Transport Media - 50, Nasal Sw... | Verification and validation of the virus transport medium tubes was not provided to FDA prior to ... | Class II | Krishe Inc |
| Mar 11, 2021 | Dasky Disposable Sampling Tube, REF VSM04 (Saliva Collection Kit + VTM), 10 p... | Verification and validation of the virus transport medium tubes was not provided to FDA prior to ... | Class II | Krishe Inc |
| Mar 11, 2021 | Dasky Disposable Sampling Tube, REF VSM03, Contents: Sterile 0.85% Saline - 5... | Verification and validation of the virus transport medium tubes was not provided to FDA prior to ... | Class II | Krishe Inc |
| Mar 11, 2021 | Tritanium X TL Instruments - intervertebral fusion device with bone graft, lu... | Stryker identified non-conforming instruments that are components of the Tritanium X TL sets. The... | Class II | Stryker Spine |
| Mar 11, 2021 | Dasky Disposable Sampling Tube, REF VSM02, Contents: Transport Media - 50, Na... | Verification and validation of the virus transport medium tubes was not provided to FDA prior to ... | Class II | Krishe Inc |
| Mar 11, 2021 | HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW) | Failure to comply with the performance standard for fluoroscopy systems. Per 21 CFR 1020.32(k)(6)... | Class II | LIEBEL-FLARSHEIM COMPANY LLC |
| Mar 10, 2021 | Remel Haemophilus Test Medium (150 mm) 10/PK, REF 04033 Remel Haemophilus ... | When tested with H. influenza ATCC 49247 and ATCC 49766 both organisms may exhibit lighter than n... | Class II | Remel Inc |
| Mar 10, 2021 | AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: in... | Potential for open seal on sterile product | Class II | Oscor, Inc. |
| Mar 10, 2021 | Ysio X.pree, Model Number: 11107464 - Product Usage: A Digital X-Ray System ... | A patient image was assigned to a different patient during image recovery process. In the unlikel... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 10, 2021 | Remel Haemophilus Test Medium(100mm) 10/PK, REF: R01503 Remel Haemophilus... | When tested with H. influenza ATCC 49247 and ATCC 49766 both organisms may exhibit lighter than n... | Class II | Remel Inc |
| Mar 9, 2021 | A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Pr... | There are two issues within this correction action: 1. Cycling Issue: When copying settings fro... | Class II | Medtronic Neuromodulation |
| Mar 8, 2021 | BIOTRONIK ITREVIA 7, VR-T DX DF-1, REF 393037, UDI: 04035479129521 - Product ... | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... | Class II | BIOTRONIK Inc |
| Mar 8, 2021 | BIOTRONIK IPERIA 7, DR-T DF4 ProMRI, REF 392423, UDI: 04035479128913 - Produc... | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... | Class II | BIOTRONIK Inc |
| Mar 8, 2021 | BIOTRONIK INVENTRA 7, VR-T DX DF-1 ProMRI, REF 399436, UDI: 04035479136314 -... | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... | Class II | BIOTRONIK Inc |
| Mar 8, 2021 | BIOTRONIK ILIVIA 7, VR-T DF-1 ProMRI, REF 404625, UDI: 04035479142124 - Prod... | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... | Class II | BIOTRONIK Inc |
| Mar 8, 2021 | BIOTRONIK INTICA NEO 7 VR-T DX DF-1 ProMRI, REF 429559, UDI: 04035479156855 -... | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... | Class II | BIOTRONIK Inc |
| Mar 8, 2021 | BIOTRONIK INVENTRA 7, VR-T DX DF-1, REF 399437, UDI: 04035479136321 - Produc... | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... | Class II | BIOTRONIK Inc |
| Mar 8, 2021 | BIOTRONIK ILIVIA NEO 7 VR-T DF-1 ProMRI, REF 429531, UDI: 04035479156763 - Pr... | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... | Class II | BIOTRONIK Inc |
| Mar 8, 2021 | BIOTRONIK Iperia 7, DR-T, DF-1, ProMRI REF 392409, UDI: 04035479128777 - Prod... | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... | Class II | BIOTRONIK Inc |
| Mar 8, 2021 | BIOTRONIK Iforia 7, vr-T, DX, DF-1,REF 390090, UDI: 04035479127176 - Product ... | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... | Class II | BIOTRONIK Inc |
| Mar 8, 2021 | BIOTRONIK INTICA NEO 7 HF-T DF-1 IS-1 ProMRI, REF 429553, UDI: 04035479156831... | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... | Class II | BIOTRONIK Inc |
| Mar 8, 2021 | BIOTRONIK ILIVIA 7, DR-T DF4 ProMRI, REF 404623, UDI: 04035479142100 - Produ... | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... | Class II | BIOTRONIK 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.