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.

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DateProductReasonClassFirm
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.