Browse Device Recalls
3,313 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,313 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 3,313 FDA device recalls in 2017.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 28, 2017 | Merlin PCS 3650 Programmer with Model 3330 Software Version 23.1.1 The Merli... | 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 | PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These... | 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 | Merlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models E... | 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 | Persona Partial Knee System Product Usage: The Persona Partial Knee Syste... | Potential for the Persona Partial Knee Impactor Pad to fracture. | Class II | Zimmer Biomet, Inc. |
| Aug 28, 2017 | PM1226 ACCENT ST MRI SR RF and PM2222 ACCENT ST These low voltage (LV) devic... | New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... | Class II | St Jude Medical Inc. |
| Aug 25, 2017 | Stage-1¿ RDS Indexed Abutment for RDS Stage-1¿ Single Stage Implants ... | The recalled units are mislabeled with an incorrect expiration date. The expiration date printed ... | Class II | Keystone Dental Inc |
| Aug 25, 2017 | AGC 2000 LP Patella, labeled as AGC Porous Patellar Med, Model Number 150804.... | The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconfor... | Class II | Zimmer Biomet, Inc. |
| Aug 25, 2017 | AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. ... | The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconfor... | Class II | Zimmer Biomet, Inc. |
| Aug 25, 2017 | G7 DUAL MOBILITY LINER 44MM F Product Usage: Intended for use in hip arth... | The affected products are labeled and etched as F-44 mm liners; however, the physical products co... | Class II | Zimmer Biomet, Inc. |
| Aug 25, 2017 | VITEK(R) 2 GP, REF 21342, IVD, UDI 03573026131920, bioMerieux, Inc. VITEK(R)... | Customer reports have indicated occurrences of atypical negative O129R reactions for Enterococcus... | Class II | Biomerieux Inc |
| Aug 24, 2017 | Graseby 3300 Pump and Graseby 3000 Series Pump Accessories Patient contr... | In certain cases, the lock and key supplied with Graseby 3300 pumps and accessories does not matc... | Class II | Smiths Medical ASD Inc. |
| Aug 24, 2017 | Lyophilized Chemistry Calibrator Level 1 Product Usage: Beckman Coulter ... | Unpaired lots of AU lyophilized chemistry calibrator level 1 and 2 have been distributed. Calibra... | Class II | Beckman Coulter Inc. |
| Aug 24, 2017 | AArtis Q/ Q.Zen biplane Artis zee biplane Product Usage: Artis is a family ... | Within a specific number of Artis zee biplane and Artis Q biplane systems, a connection in the ce... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 24, 2017 | IVEA Product Part Number 16100 Model 500A | The dowel pins (P/N 16082) that fit in the left and right leg pivot castings (P/Ns 16049/16056) c... | Class II | Firefly Medical, Inc. |
| Aug 23, 2017 | North Star Imaging Inc. (NSI) Model X-7000 industrial cabinet x-ray system.... | It was discovered a low-level radiation leak that was found on the NSI X-7000 system. | Class II | North Star Imaging Inc |
| Aug 23, 2017 | Human Alpha-1-Antitrypsin Kit for use on the SPAPlus analyser, Product #NK034... | The high control for the kit is recovering low and may be out of range for assigned values. | Class II | The Binding Site Group, Ltd. |
| Aug 23, 2017 | Syngo.plaza systems with SW VB20A, Model Number - 10863171, 10863172, 1086317... | When a prior study is being replaced in the workflow step, in certain scenarios (based on the Dis... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 23, 2017 | IntelliVue Multi Measurement Server, IntelliVue Multi Measurement Server SLCP... | Distorted ST-Segment when using 12-Lead ECG Monitoring with Philips IntelliVue Patient Monitors | Class II | Philips Electronics North America Corporation |
| Aug 22, 2017 | Artis oneFloor-mounted system for uncompromised imaging; Artis one, Intervent... | The possibility exists for the monitor display of Artis one systems with a DP Transceiver below r... | Class II | Siemens Medical Solutions USA, INC |
| Aug 22, 2017 | Ziptight Ankle Syndesmosis Fixation Device, Titanium Implant Titanium Implant... | Ziptight Ankle Syndesmosis Fixation was packaged without the tip protectors. | Class II | Zimmer Biomet, Inc. |
| Aug 22, 2017 | Medfusion, Syringe Infusion Pump, Software Version 6 (V6), Rx Only, Manufactu... | Potential for the syringe barrel clamp mechanism to loosen, decreasing the pump's ability to accu... | Class II | Smiths Medical ASD Inc. |
| Aug 22, 2017 | Medfusion, Syringe Infusion Pump, Software Version V1.1, Rx Only, Manufacture... | Potential for the syringe barrel clamp mechanism to loosen, decreasing the pump's ability to accu... | Class II | Smiths Medical ASD Inc. |
| Aug 21, 2017 | AQUIOS CL Flow Cytometer System The AQUIOS CL Flow Cytometer is intended f... | Beckman Coulter has identified that an incorrect setting using a proprietary software configurati... | Class II | Beckman Coulter Inc. |
| Aug 18, 2017 | Azurion 3 M12, Azurion 3 M15, Allura R9 7 M12, Allura R9 M20, Azurion 7 M12, ... | When using the downscale option with the Allura R9 system or Azurion R1.1 system, the measurement... | Class II | Philips Electronics North America Corporation |
| Aug 18, 2017 | Xper Flex Cardio Physiomonitoring system. Used to facilitate invasive inve... | Intermittent communication between the host system and the FlexCardio | Class II | Invivo Corporation |
| Aug 18, 2017 | TCC-EZ, Total Contact Cast System, Model No. TCC2-4051 | A quarantined lot of the devices was released for sale. Devices from this lot may experience incr... | Class II | Integra LifeSciences Corp. |
| Aug 18, 2017 | A20975A "Working insert, with ramp, one way" (Lots 13ZW to 172W; A20976A "Bri... | Olympus has received complaints about fragments of adhesive which detached from inside the workin... | Class II | Olympus Corporation of the Americas |
| Aug 18, 2017 | Syngo.plaza Picture Archiving and Communication System (PACS) with software v... | Software update to correct several issues that include (1)Potential data loss, (2) Study mix-up, ... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 17, 2017 | Coated VICRYL RAPIDETM (Polyglactin 910) Suture | On August 17, 2017, Ethicon had decided to initiate a medical device recall (removal) of the twe... | Class II | Ethicon, Inc. |
| Aug 15, 2017 | EasyOne Pro LAB VOS Respiratory Analysis System Pulmonary Function Testing De... | The CO/CO2 sensor cable harness may have lower electromagnetic shielding, which might have result... | Class II | NDDd Medical Technologies, Inc. |
| Aug 15, 2017 | EasyOne Pro Respiratory Analysis System Pulmonary Function Testing Device, Mo... | The CO/CO2 sensor cable harness may have lower electromagnetic shielding, which might have result... | Class II | NDDd Medical Technologies, Inc. |
| Aug 14, 2017 | UniPerc(R) Adjustable Flange Tracheostomy Tube kit, Reorder Number 100/897/08... | Smiths Medical became aware that one lot of the 8.0mm UniPerc(R) Adjustable Flange Tracheostomy T... | Class II | Smiths Medical ASD Inc. |
| Aug 14, 2017 | Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostat... | The US FDA has requested the optional energy treatment settings, "medium" and "low" (Software Pro... | Class II | Edap Technomed Inc. |
| Aug 14, 2017 | ReWalk Personal 6.0. Catalog number: 50-20-0004. | Firm received complaints for ReWalk Personal 6.0 of an injury to tibia and fibula. | Class II | Argo Medical Technologies Ltd |
| Aug 14, 2017 | Merge Unity software, formerly known as DR Systems Unity PACS software. The ... | The software is not identifying the patient as having atypical hyperplasia, resulting in an incor... | Class II | Merge Healthcare, Inc. |
| Aug 14, 2017 | IMRIS DEERFIELD IMAGING, REF 113803, Starburst adaptor thumb screw | incorrect thread on thumbscrews | Class II | Deerfield Imaging |
| Aug 11, 2017 | Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages) | The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconst... | Class III | Randox Laboratories |
| Aug 11, 2017 | Xper Flex Cardio PhysioMonitoring system The Xper Flex Cardio physiomonitor... | Intermittent communication between the host system and the Flex Cardio | Class II | Invivo Corporation |
| Aug 11, 2017 | Immunoassay Premium Controls (3x4x5mL and 12x5mL packages) | The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconst... | Class III | Randox Laboratories |
| Aug 10, 2017 | Norian Drillable Inject | The contract supplier notified DePuy Synthes on June 16, 2017 that the kit expiration dates do no... | Class II | Synthes USA |
| Aug 10, 2017 | NS357R Vega PS Tibia Trial/Preparation Plateau size T4 (Component of the Vega... | The NS357R Vega PS Tibia Trial/Preparation Plateau size T4 may be incorrectly labeled. If the in... | Class II | Aesculap Implant Systems LLC |
| Aug 10, 2017 | CIVCO Arm Support, REF 106047, distributed as: (a) Rigid Arm Support, Large,... | Rigid Arm Supports (PN: 106015 and 106047), which were used as part of the Posiboard-2 and Posir... | Class II | Med Tec Inc |
| Aug 10, 2017 | CIVCO Arm Support, REF 106015, distributed as: (a) Rigid Arm Support, Stan... | Rigid Arm Supports (PN: 106015 and 106047), which were used as part of the Posiboard-2 and Posir... | Class II | Med Tec Inc |
| Aug 10, 2017 | Transfer/Gait Belt, Plastic, Wipeable, packaged in plastic bag, 36 plastic ba... | The locking mechanism on the belt may fail to secure/hold the strap when in locked position poten... | Class II | Medline Industries Inc |
| Aug 10, 2017 | Oncentra Brachy 4.5 radiation therapy software The firm name on the label is... | Incorrect source step size may occur in the software plans | Class II | Nucletron BV |
| Aug 10, 2017 | Norian Drillable Inject | The contract supplier notified DePuy Synthes on June 16, 2017 that the kit expiration dates do no... | Class II | Synthes USA |
| Aug 10, 2017 | Transfer/Gait Belt, Plastic, Wipeable, packaged in plastic bag, 36 plastic ba... | The locking mechanism on the belt may fail to secure/hold the strap when in locked position poten... | Class II | Medline Industries Inc |
| Aug 9, 2017 | Alaris Pump Module model 8100 manufactured between November 2011 and March 20... | The recalling firm has received reports of increased or decreased flows that have occurred in cer... | Class II | CareFusion 303, Inc. |
| Aug 9, 2017 | Medtronic Synchromed II Model 8637 supplied in 20mL and 40 mL reservoir size ... | Medtronic implemented a final design change intended to address the motor stall due to corrosion ... | Class II | Medtronic Neuromodulation |
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.