Browse Device Recalls
2,093 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,093 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 2,093 FDA device recalls in NJ.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 21, 2015 | Universal Compact Head Ring Adapter Plate (UCHRAP), a component of the Univer... | Integra identified that the UCHRAP component (Arc Adapter Plate) would not assemble properly to t... | Class II | Integra LifeSciences Corp. |
| Aug 17, 2015 | Maquet Getinge Group, Adjustable Positioning Elements (1007.28A0) Manufacture... | Two serious thromboembolic events were reported involving the Adjustable Positioning Elements (Pa... | Class II | Maquet Cardiovascular Us Sales, Llc |
| Aug 17, 2015 | Maquet Getinge Group, Universal Frame for Positioning Patients (1007.24XX) Ma... | Two serious thromboembolic events were reported involving the Adjustable Positioning Elements (Pa... | Class II | Maquet Cardiovascular Us Sales, Llc |
| Jul 27, 2015 | Mindray DPM 7 Monitor, Multi Parameter Patient Monitor (with Arrhythmia Detec... | The DPM 7 Monitors may display a black screen. | Class II | Mindray DS USA, Inc. dba Mindray North America |
| Jul 24, 2015 | cobas Liat Analyzer, for in vitro diagnostic use. | Due to a supplier issue, the incorrect green and amber LED components were used in the manufactur... | Class II | Roche Molecular Systems, Inc. |
| Jul 19, 2015 | Elcam Medical Minimal Residual Volume Luer activated Swabbable stopcock (MRVL... | Punctured blister packages were detected during the packaging process at the manufacturing site. ... | Class II | Elcam Medical, Inc. |
| Jul 19, 2015 | Elcam Medical MANI 3G Plate BLS RAD B.BRAUN; Manifold for pressure monitoring... | Punctured blister packages were detected during the packaging process at the manufacturing site. ... | Class II | Elcam Medical, Inc. |
| Jul 14, 2015 | Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD... | Ortho Solutions Inc is initiating a recall on behalf of UltOS 3.5mm locking screw. The locking th... | Class II | Ortho Solutions Inc |
| Jun 30, 2015 | Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic ... | The EPX-2500 Operation Manual and sales brochure incorrectly identify that the ED-530XT endoscope... | Class II | Fujifilm Medical Systems U.S.A., Inc. |
| Jun 30, 2015 | Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, E... | The suction button on the ED-530XT endoscope may become lodged (stuck) in the active position fol... | Class II | Fujifilm Medical Systems U.S.A., Inc. |
| Jun 30, 2015 | Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). For... | The EPX-2500 Operation Manual and sales brochure incorrectly identify that the ED-530XT endoscope... | Class II | Fujifilm Medical Systems U.S.A., Inc. |
| Jun 25, 2015 | Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip implant compo... | it was discovered that item 623-10-36I Lot 3Y0KHP, although meeting all device specifications, wa... | Class II | Stryker Howmedica Osteonics Corp. |
| Jun 24, 2015 | Radio-Capitellum, Capitellum, Left, Large, Do Not Reuse, Rx Only. Indicated f... | Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging in... | Class II | Stryker Howmedica Osteonics Corp. |
| Jun 24, 2015 | Recon, Radial Implant, Standard Stem, Size 1, Sterile, Do Not Reuse, Rx Only.... | Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging in... | Class II | Stryker Howmedica Osteonics Corp. |
| Jun 24, 2015 | Sigmoid Notch, Radial Plate, Small, Sterile, Do Not Reuse, Rx Only. Intended... | Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging in... | Class II | Stryker Howmedica Osteonics Corp. |
| Jun 24, 2015 | uHead, Ulnar Implant, Standard Stem, Size 1, Sterile, Rx Only. Intended for r... | Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging in... | Class II | Stryker Howmedica Osteonics Corp. |
| Jun 24, 2015 | rHead Lateral Stem, Size 1, Do Not Reuse, Sterile. Intended for replacement o... | Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging in... | Class II | Stryker Howmedica Osteonics Corp. |
| Jun 23, 2015 | BD Vacutainer SST Plus Blood Collection Tubes, 5.0 mL, 13 x 100 mm, Sterile. ... | Some of the tubes were manufactured with stoppers that did not meet current manufacturing specifi... | Class III | Becton Dickinson & Company |
| Jun 15, 2015 | i-Stat PT/INR Cartridges List number 03P89-24 The cartridges are packaged ... | Certain lots of PT/INR cartridges may generate a higher than typical number of PT/INR star outs p... | Class II | Abbott Point Of Care Inc. |
| Jun 10, 2015 | Magnus Hybrid OR Table Column (1180.01B2) used in conjunction with Siemens Ar... | There is a potential issue that could result to collision between the C-arm of the angiography sy... | Class II | Maquet Cardiovascular Us Sales, Llc |
| May 29, 2015 | Stryker Orthopaedics Triathlon X3 Tibial Bearing Insert - CR REF 5530-G-209 ... | Stryker has received a report which identified that a Triathlon Tibial Bearing Insert CS X3 Size ... | Class II | Stryker Howmedica Osteonics Corp. |
| May 29, 2015 | The PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical light syst... | Maquet Suspension Arms used with PowerLED/X-TEN/Volista Surgical Light Systems may grind at the j... | Class II | Maquet Cardiovascular Us Sales, Llc |
| May 29, 2015 | Triathlon PS X3 Tibial Insert; No. 3 Triathlon TS Plus Tibial Insert X3 Poly ... | Stryker Orthopaedics received a report that 5537-G-319 No 3. Triathlon TS Plus Tibial Insert X3 P... | Class II | Stryker Howmedica Osteonics Corp. |
| May 27, 2015 | Integra Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt ... | Integra LifeSciences is recalling the Camino Intracranial Pressure Monitoring Catheters because t... | Class II | Integra LifeSciences Corp. |
| May 27, 2015 | Allofix Insertion Kit, 2.0 mm, Single Drill, Product Usage: MTF Surgical... | Musculoskeletal Transplant Foundation is recalling a certain lot of Allofix Insertion Kits becaus... | Class II | Musculoskeletal Transplant Foundation, Inc. |
| May 27, 2015 | Cortical Pin 2.0 mm,Sterile, FREEZE DRIED: Store at ambient temperature. Do ... | Musculoskeletal Transplant Foundation (MTF) is recalling one lot of MTF's Allograft Cortical Pins... | Class II | Musculoskeletal Transplant Foundation, Inc. |
| May 15, 2015 | Cell Search Circulating Tumor Kit. Intended for the enumeration of circulatin... | Complaints of the presence of artifacts that appears as small bead like structures in the image g... | Class II | Veridex, LLC |
| May 12, 2015 | ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18, Catalog n... | A package labeled as Part #5901-S-4818, Lot MAC7C14, standard humeral head trial, contained part... | Class II | Stryker Howmedica Osteonics Corp. |
| May 8, 2015 | Ethicon Fast Absorbing Plain Gut - MultiPass Needles, Sterile, Absorbable Sur... | Ethicon Fast Absorbing Surgical Gut (Plain) Suture is being recalled because the labeling on the ... | Class II | Ethicon, Inc. |
| Apr 14, 2015 | The Integra Licox Pt02 Monitors are compact, portable device for use with Pre... | Integra LifeSciences Corporation is recalling Integra's Camino ICP Monitor (CAM 02) & Licox PtO2 ... | Class II | Integra LifeSciences Corp. |
| Apr 14, 2015 | The Integra Camino ICP Monitor is a compact, portable device for use with Pre... | Integra LifeSciences Corporation is recalling Integra's Camino ICP Monitor (CAM02) & Licox PtO2 M... | Class II | Integra LifeSciences Corp. |
| Apr 14, 2015 | The Integra Licox Pt02 Monitors are compact, portable device for use with Pre... | Integra LifeSciences Corporation is recalling Integra's Camino ICP Monitor (CAM 02) & Licox PtO2 ... | Class II | Integra LifeSciences Corp. |
| Apr 2, 2015 | FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use ... | In some Flow-i Anesthesia Systems, patient cassette can get dislodged which could result in gas l... | Class I | Maquet Cardiovascular Us Sales, Llc |
| Mar 13, 2015 | Integra¿ Flowable Wound Matrix Size 3cc 1 unit/box single use, sterile dev... | A lot of Flowable Wound Matrix that has been distributed to customers in late 2013 / early 2014 w... | Class II | Integra LifeSciences Corp. |
| Mar 12, 2015 | Polaris 4.75 TI Spinal System, 4.0 x 20 MM, Closed MAS, Closed Head Multiaxia... | Multiaxial screws may not meet internal requirements related to fatigue strength. Compression te... | Class II | Biomet Spine, LLC |
| Mar 12, 2015 | Panorama Patient Monitoring Network, Multi- Parameter Patient Monitor (with A... | Software anomaly in the Panorama System software version 8.9 that manifests when the Panorama is ... | Class II | Mindray DS USA, Inc. dba Mindray North America |
| Mar 9, 2015 | Fujifilm Endoscope Model ED-530XT Product Usage: This product is a me... | Fujifilm is reporting a corrective action due to an FDA inspection. | Class II | Fujifilm Medical Systems U.S.A., Inc. |
| Mar 9, 2015 | Fujifilm Endoscope Models ED-250XL5 ED-250XT5 ED-450XT5 ED-450XL5 ... | Fujifilm is conducting a corrective action due to an FDA inspection. | Class II | Fujifilm Medical Systems U.S.A., Inc. |
| Mar 5, 2015 | Liquid Waste Bottle, Catalog#10291587. The Immulite 2000 systems are conti... | The bottle assemblies were manufactured with a quality issue where in some cases the smaller diam... | Class II | Siemens Medical Solutions Diagnostics |
| Mar 5, 2015 | HLS/HIT Set Advanced with Bioline and/or Softline Coating Console Produc... | A potential issue was detected that could result in blood leakage from the gas outlet port in all... | Class II | Maquet Cardiovascular Us Sales, Llc |
| Mar 5, 2015 | Quadrox-iD Adult Diffusion Membrane Oxygenator Product Usage: The Quadrox... | A potential issue was detected that could result in blood leakage from the gas outlet port in all... | Class II | Maquet Cardiovascular Us Sales, Llc |
| Mar 5, 2015 | Liquid Waste Bottle Kit, Catalog#10386287. The Immulite 2000 and 2000 XPi ... | The bottle assemblies were manufactured with a quality issue where in some cases the smaller diam... | Class II | Siemens Medical Solutions Diagnostics |
| Mar 5, 2015 | Water bottles, Catalog#10380062, #10291586. The Immulite 2000 and 2000 XPi... | The bottle assemblies were manufactured with a quality issue where in some cases the smaller diam... | Class II | Siemens Medical Solutions Diagnostics |
| Mar 5, 2015 | Direct Water feed Kit, Catalog#10373222 | The bottle assemblies were manufactured with a quality issue where in some cases the smaller diam... | Class II | Siemens Medical Solutions Diagnostics |
| Mar 5, 2015 | Water Feed Kit, Catalog#10288216,#10389714. The Immulite 2000 systems are ... | The bottle assemblies were manufactured with a quality issue where in some cases the smaller diam... | Class II | Siemens Medical Solutions Diagnostics |
| Mar 5, 2015 | Accessory Kit, Catalog#10282965, #10373217,#10286080. The Immulite 2000 sy... | The bottle assemblies were manufactured with a quality issue where in some cases the smaller diam... | Class II | Siemens Medical Solutions Diagnostics |
| Mar 2, 2015 | The FLOW-i Anesthesia System Axillary O2 and Suction Module, Device Part numb... | Maquet has identified that in some FLOW-i Anesthesia System Auxiliary O2 and Suction Modules, the... | Class II | Maquet Cardiovascular Us Sales, Llc |
| Feb 27, 2015 | Kinemax Stem Extenders, 80 mm, Product Usage: Kinemax Cemented Stem Extend... | Stryker received four customer complaints reporting that inside the box labeled part #6476-8-260 ... | Class II | Stryker Howmedica Osteonics Corp. |
| Feb 19, 2015 | BD Q-Syte Luer Access Split Septum, 0.16 ml, Sterile, Rx only, Catalog REF #3... | Becton Dickinson received an elevated number of complaints for blood or infusate/medication leaka... | Class II | Becton Dickinson & Company |
| Feb 12, 2015 | Triathlon Distal Capture Assembly Catalog No: 6541-1-723 The Triathlon Dist... | Potential for weld disassociation of the cross pin, which could lead to loose or disassociated tr... | Class II | Stryker Howmedica Osteonics Corp. |
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.