Browse Device Recalls
3,505 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,505 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 3,505 FDA device recalls in MA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 10, 2013 | IMMULITE Systems Rapid TSH (REF LKRT1 - 100T, LKRT5 - 500 T, L2KRT2 - 200T, L... | A rare variant of TSH, identified in a small cluster of patients, is not detected. | Class II | Siemens Healthcare Diagnostics, Inc |
| May 10, 2013 | Dimension TSH Flex Reagent Cartridge (REF RF412). Intended to quantitative... | A rare variant of TSH, identified in a small cluster of patients, is not detected. | Class II | Siemens Healthcare Diagnostics, Inc |
| May 10, 2013 | Dimension Vista System TSH Flex Reagent Cartridge (REF K6412). Intended to... | A rare variant of TSH, identified in a small cluster of patients, is not detected. | Class II | Siemens Healthcare Diagnostics, Inc |
| May 10, 2013 | Dimension EXL LOCI Module TSHL Flex Reagent Cartridge (REF RF612). Intende... | A rare variant of TSH, identified in a small cluster of patients, is not detected. | Class II | Siemens Healthcare Diagnostics, Inc |
| May 10, 2013 | ADVIA Centaur Systems TSH3 Ultra ReadyPack ((REF 06491072 - 100 Tests, REF 06... | A rare variant of TSH, identified in a small cluster of patients, is not detected. | Class II | Siemens Healthcare Diagnostics, Inc |
| May 10, 2013 | IMMULITE Systems Third Generation TSH (REF LKTS1 - 100T, LKTS5 - 500T, L2KTS2... | A rare variant of TSH, identified in a small cluster of patients, is not detected. | Class II | Siemens Healthcare Diagnostics, Inc |
| May 10, 2013 | Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conju... | Device design. | Class II | SpineFrontier, Inc. |
| May 7, 2013 | MEDITECH Bi-Directional interactive Communication Analyzer Interface; Int... | Incorrect transmission of laboratory results. | Class II | Medical Information Technology, Inc. |
| May 7, 2013 | InSpan Inserter, Right Assembly; InSpan Inserter, Left Assembly Product Us... | Potential for set screw to be come deformed. | Class II | SpineFrontier, Inc. |
| Apr 25, 2013 | Fluoroscan Mini C-arm InSight2, software versions 3.x, 4.0, 4.0.1, 4.0.2 T... | The audible alarm to alert the operator when cumulative irradiation time reaches five minutes is ... | Class II | Hologic, Inc. |
| Apr 25, 2013 | S-LIFT Slap Hammer, Part Number: 11-50204, Revision A The slap hammers are... | Malfunction of slap hammer. | Class II | SpineFrontier, Inc. |
| Apr 25, 2013 | Fluoroscan Mini C-arm InSight, software versions 1.x, 2.x, 3.x The device ... | The audible alarm to alert the operator when cumulative irradiation time reaches five minutes is ... | Class II | Hologic, Inc. |
| Apr 22, 2013 | Case Lid and Base (Inspan, Invue, SLIFT) Caddy Lid (Inspan, Arena-C); Inspan ... | Non-toxic inks, used on the silk screen graphics of the case bases and lids, and caddy lids, were... | Class II | SpineFrontier, Inc. |
| Apr 17, 2013 | CONFIDENCE SPINAL CEMENT SYSTEM 11CC PLUS KIT, Product Code: 2839-10-000 ... | During injection of cement, the water in the hydraulic pump leaks past the piston within the pump... | Class II | DePuy Spine, Inc. |
| Apr 17, 2013 | CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT, Product Code: 2839-05-000 The CON... | During injection of cement, the water in the hydraulic pump leaks past the piston within the pump... | Class II | DePuy Spine, Inc. |
| Apr 17, 2013 | CONFIDENCE SPINAL CEMENT SYSTEM KIT, Product Code: 2839-13-000 The CONFI... | During injection of cement, the water in the hydraulic pump leaks past the piston within the pump... | Class II | DePuy Spine, Inc. |
| Apr 15, 2013 | DePuy Mitek Tissue Liberator -Blade Up Catalog Number: 214623 The Reusab... | Labeled incorrectly as a Blade Up configuration instead of a Blade Down configuration. | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Apr 12, 2013 | Curity Staple Remover Kit; Product Code: 66701. Staple Remover Kit. | On March 26, 2013 Covidien received a recall notice from one of their suppliers CareFusion. Care... | Class III | Covidien LLC |
| Apr 12, 2013 | Curity I.V. Start Kit, Product ID: 80530 and Curity I.V. Start Kit Product ID... | On March 26, 2013 Covidien received a recall notice from one of their suppliers CareFusion. Care... | Class III | Covidien LLC |
| Apr 10, 2013 | Philips HeartStart MRx Monitor/Defibrillator Models: M3536A, M3536J, M3536M,... | Device Operating on Battery Power May Shutdown without Warning if exposed to elevated levels of e... | Class II | Philips Medical Systems, Inc. |
| Apr 9, 2013 | HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is... | Instrumentation Laboratory is recalling HemosIL RecombiPlasTin 2G (RPT2G), Part No. 0020009580 (8... | Class II | Instrumentation Laboratory Co. |
| Apr 8, 2013 | Medi-Trace Cadence Adult Radiotransparent Defibrillation Electrode Product I... | Defibrillation Electrodes may arc/spark result in thermal damage to the leadwire, which could re... | Class II | Covidien LLC |
| Apr 8, 2013 | HeartStart MRx Monitor/Defribillator; Product Codes: M3536A, M3536J, M3536M,... | Device may fail to deliver defibrillation therapy in either Manual Defib or AED mode. | Class II | Philips Healthcare Inc. |
| Apr 8, 2013 | Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode Produ... | Defibrillation Electrodes may arc/spark result in thermal damage to the leadwire, which could re... | Class II | Covidien LLC |
| Apr 4, 2013 | Biosure Driver, Product No: 72201887 For delivery and placement of orthopedic... | Driver does not meet specification, oversized. Driver may not be able to be fully inserted into t... | Class II | Smith & Nephew, Inc., Endoscopy Div. |
| Apr 4, 2013 | Biosure Ratchet Driver, Product No: 72201888 For delivery and placement of or... | Driver does not meet specification, oversized. Driver may not be able to be fully inserted into t... | Class II | Smith & Nephew, Inc., Endoscopy Div. |
| Mar 22, 2013 | ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-7 Taper Ne... | The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 10... | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Mar 22, 2013 | ORTHOCORD ONE VIOLET AND ONE BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Cata... | The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 10... | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Mar 22, 2013 | ORTHOCORD One Violet and One Blue Braided Composite Suture with OS-6 Reverse ... | The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 10... | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Mar 22, 2013 | ORTHOCORD BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number: 223111.... | The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 10... | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Mar 22, 2013 | ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-6 Taper Ne... | The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 10... | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Mar 18, 2013 | Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intend... | If the headphone jack is in use during a surgical procedure with the OCS2 and a non-intended volt... | Class II | Integra Burlington MA, Inc. |
| Mar 18, 2013 | LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 ... | Devices were not sealed correctly during the manufacturing process, and the sterility of these pr... | Class II | LeMaitre Vascular, Inc. |
| Mar 18, 2013 | NxStage PureFlow-B Solution, Model/Catalog Number: RFP-401, packaged in a cas... | Product may be mislabeled. | Class II | NxStage Medical, Inc. |
| Mar 18, 2013 | Glow 'N Tell 20 cm Tape: 1100-00 (100 strips); 1100-50 (50 strips); 1100-20 ... | Devices were not sealed correctly during the manufacturing process, and the sterility of these pr... | Class II | LeMaitre Vascular, Inc. |
| Mar 14, 2013 | Rev E PedFuse Return Screw Inserter, Part Number: 11-80030 Screw inserter... | Inserters have a set screw that fixes a collar to the inserter. The screw set can loosen and fal... | Class II | SpineFrontier, Inc. |
| Mar 13, 2013 | ADVIA Centaur Vitamin D Calibrator 6-pack; Reference Number:10630911. For ... | Negative bias in patient samples for Vitamin D | Class II | Siemens Healthcare Diagnostics, Inc |
| Mar 13, 2013 | ADVIA Centaur Vitamin D Calibrator 2-pack; Reference Number:10493589. For ... | Negative bias in patient samples for Vitamin D | Class II | Siemens Healthcare Diagnostics, Inc |
| Mar 13, 2013 | ADVIA Centaur Vitamin D Assay (500 tests); Reference Number:10631021. For ... | Negative bias in patient samples for Vitamin D | Class II | Siemens Healthcare Diagnostics, Inc |
| Mar 13, 2013 | ADVIA Centaur Vitamin D Assay (100 tests); Reference Number: 10491994. For... | Negative bias in patient samples for Vitamin D | Class II | Siemens Healthcare Diagnostics, Inc |
| Mar 11, 2013 | PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog N... | Mislabeled: Cover screw that was in the package was a WD cover screw and not a SD cover screw as ... | Class II | Keystone Dental Inc |
| Mar 5, 2013 | Philips IntellVue Info Center iX 866023; PIIC iX Upgrade 866024; IntellVue Se... | If a customer creates customized trend scales in the trend review tile and the iX or primary serv... | Class II | Philips Healthcare Inc. |
| Feb 28, 2013 | Allen Traction Boot, Modular, OT 1000 Traction Device Boot Assembly, Fractur... | Some units may have been assembled incorrectly which could result in the boot breaking free from ... | Class II | Allen Medical Systems, Inc. |
| Feb 26, 2013 | Neurotherm Curved Radiofrequency (RF) cannnula 10 cm 18 gauge, 10 mm activ... | Straight needle labeled as a curved needle | Class II | Neurotherm, Inc. |
| Feb 26, 2013 | CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number... | Device with Sample Interference Notes (SIN) enabled not cleared for US marketing. | Class III | Siemens Healthcare Diagnostics Inc |
| Feb 25, 2013 | Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 51493 ... | Glucose test strips reports no result message when tested | Class II | Nova Biomedical Corporation |
| Feb 25, 2013 | Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 42214 | Glucose test strips reports no result message when tested | Class II | Nova Biomedical Corporation |
| Jan 31, 2013 | Medtronic O-arm Imaging System Product Usage: image-intensified fluorosco... | Potential failure of the braking system that controls the O-arm Imaging System gantry movement in... | Class II | Medtronic Navigation, Inc. |
| Jan 28, 2013 | Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290 The He... | Philips HeartStart XL+ Defibrillator/Monitor may become locked out of clinical use | Class II | Philips Healthcare Inc. |
| Jan 16, 2013 | Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 71... | Installation Acceptance Test Document (IATD) non compliant with regulations. Records shows table ... | Class II | Philips Healthcare 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.