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Browse Device Recalls

2,036 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,036 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 2,036 FDA device recalls in NJ.

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DateProductReasonClassFirm
May 18, 2023 QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model ... Product packaging may exhibit small pinholes which may not be visible to the unaided eye, comprom... Class II Maquet Medical Systems USA
May 18, 2023 QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model ... Product packaging may exhibit small pinholes which may not be visible to the unaided eye, comprom... Class II Maquet Medical Systems USA
May 4, 2023 Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-080... The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 inc... Class III Datascope Corp.
May 3, 2023 Exeter V40 Trial Head, 26mm, -3, Catalog Number 6364-8-026 The Exeter V40 Trial Head, catalog number 6364-8-026 (size 26mm, -3) may appear green, when it is... Class II Howmedica Osteonics Corp.
Apr 25, 2023 LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, S... Contains the incorrect implant in the packaging. The packaging incorrectly contains the opposite ... Class II Linkbio Corp.
Apr 17, 2023 VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determi... Potential for both unexpected positive and negative HbA1c results, may result in misdiagnosis Class II Ortho-Clinical Diagnostics, Inc.
Apr 14, 2023 VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 ... Unavailable to calibrate VITROS Chemistry Products VANC Reagent, Generation (GEN) 50, results in ... Class II Ortho-Clinical Diagnostics, Inc.
Apr 13, 2023 TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement... Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM... Class II Howmedica Osteonics Corp.
Apr 13, 2023 TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement... Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM... Class II Howmedica Osteonics Corp.
Apr 11, 2023 Codman Cranial Hand Drill- Indicated when a craniotomy is required for placem... Released with discoloration (rust) on the Drill Chuck and inner chuck of Codman Cranial Hand Dril... Class II Integra LifeSciences Corp.
Apr 10, 2023 Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relinin... The Hard Line Chairside Reline Kit (570-0718) (0921940HS) was labeled as Soft Line Chairside Reli... Class II Keystone Industries
Apr 4, 2023 MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32 The power cord supplied (Type J plug end) for the Cardiosave Hybrid IABP to Brazil is incompati... Class II Datascope Corp.
Mar 31, 2023 PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3... Suture breakage during intra-operative use could result in poor performance of the impacted produ... Class II Ethicon, Inc.
Mar 22, 2023 STA R Max fully automatic clinical instrument designed to perform tests on hu... An internal investigation identified a bug in this firmware version, resulting in the following:I... Class II Diagnostica Stago, Inc.
Mar 22, 2023 STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 an... An internal investigation identified a bug in this firmware version, resulting in the following:I... Class II Diagnostica Stago, Inc.
Mar 22, 2023 STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and ... An internal investigation identified a bug in this firmware version, resulting in the following:I... Class II Diagnostica Stago, Inc.
Mar 21, 2023 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 50MM Item Numbe... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 45MM Item Number:... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 55MM Item Number:... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM Item Number: 15-2... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, LARGE Item Number: ... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9X58MM Item Number: 15-20... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM It... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM Item Nu... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 55MM Item Number:... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM I... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 45MM Item Number:... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM Item Numb... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM It... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM I... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Numb... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM Ite... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM Item Num... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM Item Numbe... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM Item Num... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM Item Num... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 45MM Item Number: 1... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2020/40 Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11X58MM Item Number: 1... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM It... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 55MM Item Number: 1... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM Item Nu... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM Item Number... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item ... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Numb... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 50MM Item Number: 1... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 50MM Item Number:... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM I... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio Corp.
Mar 21, 2023 LINK SLED Knee System: ENDO SLED KNEE FEM COMP, Large Item Number: 15-202... Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product... Class II Linkbio 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.