Browse Device Recalls
35,307 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,307 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 35,307 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 14, 2022 | The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Cor... | There is a potential for leaking valves on ports 1 to 4 in certain lots of valve sets. | Class II | Baxter Healthcare Corporation |
| Jul 14, 2022 | cobas e801 Immunoassay Analyzer | Software issue resulting in signals and sample test results of Pre-Wash tests being impacted. The... | Class II | Roche Diagnostics Operations, Inc. |
| Jul 14, 2022 | ARIES SARS-CoV-2 Assay | SARS-CoV-2 assay that detects SARS-CoV-2 ORF1ab and N genes may not detect the ORF1ab gene. A pos... | Class II | Luminex Corporation |
| Jul 14, 2022 | EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System | Update to IFU provides a manual deployment workaround method to help mitigate potential harms rel... | Class II | Medtronic Inc. |
| Jul 14, 2022 | Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Artic... | Application error problems: Rebalance scope message: 1.Rebalancing process 2.Usage of Robot Recov... | Class II | Aesculap Implant Systems LLC |
| Jul 14, 2022 | Philips EPIQ Ultrasound Systems (various models) used in conjunction with th... | Retroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to tra... | Class II | Philips Ultrasound, LLC |
| Jul 13, 2022 | VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only),... | There are 7 reported software anomalies that may affect use of the device. | Class II | bioMerieux, Inc. |
| Jul 13, 2022 | ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number S... | MU22-INA-DUQ case was labeled as MU22-INA-DUQ but was shipped with the Anatomical Model of case ... | Class II | Materialise USA LLC |
| Jul 13, 2022 | Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-... | Suture anchor may break upon insertion, which could lead to potential debris in patient, and dela... | Class II | Paragon 28, Inc. |
| Jul 12, 2022 | Surpria: Software Version V3.11, V3.22 | Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstruc... | Class II | FUJIFILM Healthcare Americas Corporation |
| Jul 12, 2022 | TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Ce... | Some of the devices did not pass fatigue testing. | Class II | Corin Ltd |
| Jul 12, 2022 | Surpria 64: Software Version V3.11, V3.22 | Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstruc... | Class II | FUJIFILM Healthcare Americas Corporation |
| Jul 12, 2022 | SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C | Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstruc... | Class II | FUJIFILM Healthcare Americas Corporation |
| Jul 11, 2022 | SafeControl handset (a component of the Sentida bed which moves and positions... | When the handset is disconnected from the power mains, and mains operation is restored, the hands... | Class II | WISSNER-BOSSERHOFF GMBH |
| Jul 8, 2022 | Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye. | Due to a software issue, IOL calculator printout often does not accurately reflect the alignment ... | Class II | Oculus Optikgeraete GMBH |
| Jul 8, 2022 | Pentacam HR REF 70900. Used to image the anterior segment of the eye. | Due to a software issue, IOL calculator printout often does not accurately reflect the alignment ... | Class II | Oculus Optikgeraete GMBH |
| Jul 8, 2022 | Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior... | Due to a software issue, IOL calculator printout often does not accurately reflect the alignment ... | Class II | Oculus Optikgeraete GMBH |
| Jul 7, 2022 | The PRM is intended to be used as part of the ZOOM LATITUDE Programming Syste... | There is potential for unanticipated software anomalies to occur when using the Model 2868 Applic... | Class II | Boston Scientific Corporation |
| Jul 7, 2022 | AIM-V Medium REF AV.200/500 | Due to equipment failure, affected products were stored at temperatures outside the validated ran... | Class II | OXFORD IMMUNOTEC LTD |
| Jul 7, 2022 | The PRM is intended to be used as part of the ZOOM LATITUDE Programming Syste... | There is potential for unanticipated software anomalies to occur when using the Model 2868 Applic... | Class II | Boston Scientific Corporation |
| Jul 7, 2022 | The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the Z... | There is potential for unanticipated software anomalies to occur when using the Model 2868 Applic... | Class II | Boston Scientific Corporation |
| Jul 7, 2022 | ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S | Mis-wired component-the improperly wired component can result in additional noise on the power su... | Class II | Olympus Corporation of the Americas |
| Jul 7, 2022 | T-Cell Xtend REF TTK.610 US | Due to equipment failure, affected products were stored at temperatures outside the validated ran... | Class II | OXFORD IMMUNOTEC LTD |
| Jul 7, 2022 | T-SPOT.TB REF TB.300 US | Due to equipment failure, affected products were stored at temperatures outside the validated ran... | Class II | OXFORD IMMUNOTEC LTD |
| Jul 5, 2022 | ZAP-X Radiosurgery System | Software issue identified in cases of initial patient setup with large (greater-than-or-equal-to ... | Class II | Zap Surgical Systems |
| Jul 4, 2022 | Medicina Oral Tip Syringe 0.5ml Code: OT005 | Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropyle... | Class II | Medicina Uk Ltd |
| Jul 4, 2022 | Medicina ENFit 1ml Reusable Low Dose Enteral Syringe Code: LHE01LD | Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropyle... | Class II | Medicina Uk Ltd |
| Jul 4, 2022 | Medicina Oral Tip Syringe 2.5ml Code: OT25 | Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropyle... | Class II | Medicina Uk Ltd |
| Jul 4, 2022 | Medicina ENFit 5ml Reusable Enteral Syringe Code: LHE05 | Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropyle... | Class II | Medicina Uk Ltd |
| Jul 4, 2022 | Medicina Reusable Oral syringe 5ml Code: OTH05 | Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropyle... | Class II | Medicina Uk Ltd |
| Jul 4, 2022 | Medicina Oral Tip Syringe 1ml Code: OT01 | Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropyle... | Class II | Medicina Uk Ltd |
| Jul 4, 2022 | Medicina Reusable Oral syringe 2.5ml Code: OTH25 | Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropyle... | Class II | Medicina Uk Ltd |
| Jul 4, 2022 | Medicina Reusable Oral syringe 1ml Code: OTH01 | Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropyle... | Class II | Medicina Uk Ltd |
| Jul 1, 2022 | Da Vinci X/Xi Large Clip Applier, Model 470230 Da Vinci X/Xi Medium-Large Cl... | Due to the potential for unexpected motion caused by the partial disengagement of the instrument ... | Class II | Intuitive Surgical, Inc. |
| Jul 1, 2022 | Da Vinci S/Si Large Clip Applier, Model 420230 Da Vinci S/Si Medium-Large Cl... | Due to the potential for unexpected motion caused by the partial disengagement of the instrument ... | Class II | Intuitive Surgical, Inc. |
| Jun 30, 2022 | Echelon -14 Micro Catheter, REF: 105-5092-150, sterile EO, Rx Only | Outer carton packaging of microcatheters were exposed to wet substance during transport. | Class II | Micro Therapeutics, Inc. |
| Jun 30, 2022 | Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only | Outer carton packaging of microcatheters were exposed to wet substance during transport. | Class II | Micro Therapeutics, Inc. |
| Jun 29, 2022 | Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708 | Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains... | Class II | Trinity Sterile, Inc. |
| Jun 29, 2022 | ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotatio... | Manufactured with a Galvanized High Carbon Steel spring instead of the correct 302 Stainless stee... | Class II | DePuy Orthopaedics, Inc. |
| Jun 29, 2022 | Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5... | Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains... | Class II | Trinity Sterile, Inc. |
| Jun 29, 2022 | SX-One MicroKnife | Potential of dull blade | Class II | SONEX HEALTH LLC |
| Jun 29, 2022 | MEDLINE MICRO-KILL GERMICIDAL BLEACH WIPES, Model numbers MSC351420AN, MSC351... | stability failure | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 29, 2022 | CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to intro... | Outside packaging for a device indicated for introducing cardiovascular catheters into the heart,... | Class II | Biosense Webster, Inc. |
| Jun 29, 2022 | Wolf-Pak Premium Dressing Kit with GuardVA Cs/30 Ref: DC5030LF | Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains... | Class II | Trinity Sterile, Inc. |
| Jun 29, 2022 | Wolf Pak Premium Dressing Change Kit with Statlock CS/30 Ref: DC5040LF | Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains... | Class II | Trinity Sterile, Inc. |
| Jun 29, 2022 | Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN | Manufacturing variance near transition of tip is increasing the likelihood the wire tip may fract... | Class II | OrthoPediatrics Corp |
| Jun 28, 2022 | Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitativ... | Falsely Elevated Atellica CH Microalbumin_2 (¿ALB_2) Results due to Reagent Carryover from the Ir... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 27, 2022 | Product Description/Item: ChemoLock Vial Spike, 20mm/011-CL-80S; ChemoLock B... | Ports have a potential for unintended disconnection, inability to connect to or fully engage with... | Class II | ICU Medical, Inc. |
| Jun 27, 2022 | X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation Syst... | The device may potentially cause a fire, leading to a safety risk. | Class II | Davol, Inc. |
| Jun 27, 2022 | Product Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10; ChemoLock ... | Ports have a potential for unintended disconnection, inability to connect to or fully engage with... | Class II | ICU Medical, 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.