Browse Device Recalls
3,419 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,419 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 3,419 FDA device recalls in MA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 26, 2017 | Concorde Lift Driver Shaft AO. Used with supplemental internal spinal fixa... | Potential for Intra-operative breakage of driver tips | Class II | DePuy Orthopaedics, Inc. |
| Jul 26, 2017 | Concorde Lift Torque Limiting Handle. Must be used with supplemental int... | Potential for Intra-operative breakage of driver tips | Class II | DePuy Orthopaedics, Inc. |
| Jul 24, 2017 | Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS111111102... | Implant kit mislabeled | Class II | ConforMIS, Inc. |
| Jul 17, 2017 | ECG Out Cable - Heartstart MRx M1783A/M5526A 12-pin Sync cables All units... | Issue with ECG out cables. When a Philips monitor/defibrillator is receiving an ECG signal from ... | Class II | Philips Electronics North America Corporation |
| Jul 14, 2017 | Mobile Detector Holder - Stationary X-ray System (RF System). suitable for po... | If the lock mechanism of the movable camp of the mobile detector holder is not adjusted properly ... | Class II | Philips Electronics North America Corporation |
| Jul 13, 2017 | The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew L... | The heat-shrink insulation tube may split during autoclave sterilization/re-sterilization. If a s... | Class II | Microline Surgical, Inc. |
| Jul 12, 2017 | MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969 ... | Affected units may have a defective component that is intended to protect the internal circuitry ... | Class I | Philips North America, LLC |
| Jul 11, 2017 | Olympus Scientific Solutions Americas Corporation ( OSSA ) Model: VANTA Analy... | Instruments may, under certain specific circumstances listed below, fail to stop when a test is i... | Class II | Olympus Scientific Solutions Americas |
| Jul 5, 2017 | Nitinol TC Reusable Electrodes (TCN), Model Numbers: 1)TCN-10, 2) TCNK-10-R*,... | After multiple reprocessing cycles, the epoxy resin which holds the TCN Electrode in the hub can ... | Class II | Cosman Medical, LLC |
| Jun 30, 2017 | 731 Series Ventilators running software version 05.20.00 The devices in t... | A software anomaly in the 731 software version 05/20/00, was identified, which can lead to a user... | Class II | ZOLL Medical Corporation |
| Jun 22, 2017 | The GC80 Digital X-ray Imaging System | An image was obtained with over exposure during a Thorax examination using the AEC function. | Class II | NeuroLogica Corporation |
| Jun 20, 2017 | Multi-Unit Abutment Angled, 17¿, 4mm Cuff 4.1/4.5mm TiLobe¿ Implants, Catalog... | Abutments are unable to accept the final abutment screw | Class II | Keystone Dental Inc |
| Jun 19, 2017 | Nova Biomedical Stat Profile Prime Analyzer as follows: PN 52855 Stat Profil... | Software- scheduled A-QC analysis could initiate prior to a patient result being released by the... | Class II | Nova Biomedical Corporation |
| Jun 16, 2017 | Max Implant System - Bone Tap for use with 7.0mm diameter Max Implant, Catalo... | An 8mm diameter bone tap was laser marked as 7mm diameter and was packed with a 7mm label. | Class II | Keystone Dental Inc |
| Jun 15, 2017 | Encore(TM) 26 Inflation Device, REF Catalog Nos.: (a) H74904526011, (b) M001... | Boston Scientific (BSC) has received complaints for cracked trays on the Encore device. | Class II | Boston Scientific Corporation |
| Jun 15, 2017 | PriMatrix¿ is an acellular dermal tissue matrix derived from fetal bovine der... | During Final Assembly Operation, it was noticed that some of the PriMatrix Instructions for Use (... | Class II | TEI Biosciences |
| Jun 7, 2017 | ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack. Siemens Materia... | Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur Enhanced Estradiol... | Class II | Siemens Healthcare Diagnostics, Inc |
| Jun 6, 2017 | Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: ... | Cockpits with revision index 06 or higher that contain 4GB RAM modules may not annunciate audio o... | Class II | Draegar Medical Systems, Inc. |
| Jun 1, 2017 | Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 9-12mm Above... | Label on the affected devices incorrectly identifies the injection location as "above" the ball... | Class II | Boston Scientific Corporation |
| Jun 1, 2017 | Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 12-15mm Below... | Label on the affected devices incorrectly identifies the injection location as "above" the ball... | Class II | Boston Scientific Corporation |
| May 31, 2017 | Philips DuraDiagnost X-ray systems: DuraDiagnost (R1.0, Product Number 7122... | Tube arm assembly could fall down due to cracked welding joints | Class II | Philips Electronics North America Corporation |
| May 24, 2017 | Samsung GU60A system- Digital X-ray Imaging Systems are intended for use in ... | When performing the Stitching function on GU60A system, unintended area is exposed to radiation | Class II | NeuroLogica Corporation |
| May 23, 2017 | Magellan Diagnostics LeadCare Ultra and LeadCare Plus test Kits. Product U... | Underestimates the lead concentration of venous blood samples when the sample is analyzed with th... | Class I | Magellan Diagnostics, Inc. |
| May 23, 2017 | Magellan Diagnostics LeadCare and LeadCare II test Kits. Product Usage: ... | Underestimates the lead concentration of venous blood samples when the sample is analyzed with th... | Class I | Magellan Diagnostics, Inc. |
| May 15, 2017 | FFR Link-FFR Signal Processing Module, Material Number H7495551000 It is int... | The device history record (DHR) was missing its test documentation for final HIPOT (high potentia... | Class II | Boston Scientific Corporation |
| May 15, 2017 | Multiphor II Electrophoresis System GE HealthCare Product Number: 18-1018-0... | Potential for electric shock in the case of a failure to install the grommets, supplied with the ... | Class II | Perkinelmer Life Sciences, Inc. |
| May 12, 2017 | DePuy Mitek LATARJET EXPERIENCE Coracoid Top Hat Drill Product Code: 288202 ... | Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operative... | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| May 12, 2017 | DePuy Mitek LATARJET EXPERIENCE-Combo Screw Driver Product Code: 288211 P... | Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operative... | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| May 12, 2017 | Tubing Pack Convenience Kit, Product Code 65217 Product Usage: Intended f... | Kit was labeled with the incorrect Expiration Date of April 30, 2019. | Class II | Terumo Cardiovascular Systems Corp |
| May 12, 2017 | DePuy Mitek LATARJET EXPERIENCE Top Hat Tap Product Code: 288203 Product U... | Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operative... | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| May 12, 2017 | DePuy Mitek LATARJET EXPERIENCE Coracoid Drill Product Code: 288201 Product... | Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operative... | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| May 12, 2017 | DePuy Mitek LATARJET EXPERIENCE Extraction Driver Product Code: 288216 Pro... | Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operative... | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| May 11, 2017 | Philips DigitalDiagnost 3.1.x X-Ray System | During recent evaluations of the Philips DigitalDiagnost 3.1.x, we have identified a potential is... | Class II | Philips Electronics North America Corporation |
| May 4, 2017 | NMT Patient Cable (989803174581) in use with lntelliVue NMT Module (Part# 865... | Manufacturing defect may cause localized heating, which may result in localized skin burn. | Class II | Philips Electronics North America Corporation |
| Apr 11, 2017 | EasyCAL HbA1c Calibrator; REF 10658 Kit is packaged in a paper box containin... | Patient results determined using this calibrator lot might deviate up to 20%. Controls might not ... | Class II | Medica Corporation |
| Apr 10, 2017 | RAPIDPoint¿ 500 Blood Gas Analyzer with v2.4 software for professional use in... | Potential Patient Demographic Error with Blank Patient ID Field | Class II | Siemens Healthcare Diagnostics Inc |
| Apr 5, 2017 | ADVIA Centaur Systems Insulin Calibrator; Test Code: Calibrator IRI; Catalog ... | Current lots of ADVIA Centaur/XP/XPT/CP Insulin (IRI) assay recover approximately 40% higher than... | Class II | Siemens Healthcare Diagnostics, Inc |
| Apr 5, 2017 | ADVIA Centaur Systems Insulin ReadyPack; Test Code: IRI; Catalog Number: 0223... | Current lots of ADVIA Centaur/XP/XPT/CP Insulin (IRI) assay recover approximately 40% higher than... | Class II | Siemens Healthcare Diagnostics, Inc |
| Mar 28, 2017 | Kappa, Catalog Number: MS18853 in combination with Scio, Scio Four, Scio Four... | It was reported that a set low O2 alarm does not go off although the measured O2 level is below t... | Class II | Draegar Medical Systems, Inc. |
| Mar 28, 2017 | Delta XL, Catalog Number: MS18596 in combination with Scio, Scio Four, Scio F... | It was reported that a set low O2 alarm does not go off although the measured O2 level is below t... | Class II | Draegar Medical Systems, Inc. |
| Mar 28, 2017 | Delta, Catalog Number: MS18597 in combination with Scio, Scio Four, Scio Four... | It was reported that a set low O2 alarm does not go off although the measured O2 level is below t... | Class II | Draegar Medical Systems, Inc. |
| Mar 24, 2017 | Dale Medical Stabilock Endotracheal Tube Holder Product # 270 The Dale Sta... | ET Tube Holders contain an adhesive faceplate that may lose its adhesive properties and will not ... | Class II | Dale Medical Products, Inc. |
| Mar 24, 2017 | Dale Medical Stabilock Endotracheal Adhesive Base Product # 273 The Dale S... | ET Tube Holders contain an adhesive faceplate that may lose its adhesive properties and will not ... | Class II | Dale Medical Products, Inc. |
| Mar 22, 2017 | UNIQ: UNIQ FD10 722026; UNIQ FD10/10 722027; UNIQ FD20/10 biplane 722029; UNI... | Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of th... | Class II | Philips Electronics North America Corporation |
| Mar 22, 2017 | The following systems are only affected if a Laird chiller is installed (11NC... | Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of th... | Class II | Philips Electronics North America Corporation |
| Mar 22, 2017 | Allura Xper Release 8.2 (Laird chiller is always installed); Allura Xper FD10... | Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of th... | Class II | Philips Electronics North America Corporation |
| Mar 15, 2017 | Smith & Nephew ACUFEX TRUNAV Retrograde Drill 11.5MM Product Number: 7220404... | Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... | Class II | Smith & Nephew, Inc. |
| Mar 15, 2017 | Smith & Nephew ACUFEX TRUNAV Retrograde Drill 5.5MM Product Number: 72204037... | Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... | Class II | Smith & Nephew, Inc. |
| Mar 15, 2017 | Smith & Nephew ACUFEX TRUNAV Retrograde Drill 6MM Product Number: 72204038 ... | Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... | Class II | Smith & Nephew, Inc. |
| Mar 15, 2017 | Smith & Nephew ACUFEX TRUNAV Retrograde Drill 10.5MM Product Number: 722040... | Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... | Class II | Smith & Nephew, 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.