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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
Feb 27, 2024 TRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision patients a... The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of t... Class II Howmedica Osteonics Corp.
Feb 6, 2024 NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM Potential packaging breaches of inner blister and outer sterile blister. Class II Howmedica Osteonics Corp.
Feb 6, 2024 NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM Potential packaging breaches of inner blister and outer sterile blister. Class II Howmedica Osteonics Corp.
Feb 6, 2024 X3 TRIATHLON CS INSERT NO 6 11 MM Potential packaging breaches of inner blister and outer sterile blister. Class II Howmedica Osteonics Corp.
Feb 6, 2024 X3 TRIATHLON CS INSERT NO 7 9 MM Potential packaging breaches of inner blister and outer sterile blister. Class II Howmedica Osteonics Corp.
Feb 6, 2024 NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM Potential packaging breaches of inner blister and outer sterile blister. Class II Howmedica Osteonics Corp.
Feb 6, 2024 X3 TRIATHLON CS INSERT NO 3 10 MM Potential packaging breaches of inner blister and outer sterile blister. Class II Howmedica Osteonics Corp.
Feb 6, 2024 X3 TRIATHLON CS INSERT NO 6 10 MM Potential packaging breaches of inner blister and outer sterile blister. Class II Howmedica Osteonics Corp.
Feb 6, 2024 NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM Potential packaging breaches of inner blister and outer sterile blister. Class II Howmedica Osteonics Corp.
Jan 22, 2024 Tensive Conductive Adhesive Gel, Product Ref. 22-60. 12, 1 case contains 12 i... Five complaints were received related to viscosity of Tensive Conductive Adhesive Gel Ref 22-60. Class II Parker Laboratories, Inc.
Jan 19, 2024 Ref No: INSHITHRZN / Integra Cranial Access Kit. For access to the subarachno... A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... Class II Integra LifeSciences Corp.
Jan 19, 2024 Ref No: INSHITH / Integra¿ Cranial Access Kit. For access to the subarachnoid... A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... Class II Integra LifeSciences Corp.
Jan 19, 2024 Ref No: HITHSP06 / Integra Cranial Access Kit. For access to the subarachnoid... A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... Class II Integra LifeSciences Corp.
Jan 19, 2024 Ref No: INSHITHND / Integra¿ Cranial access kit (without Prep solutions) Bit ... A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... Class II Integra LifeSciences Corp.
Jan 19, 2024 INS7280 / Integra¿ Cranial Access Kit. For access to the subarachnoid space o... A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... Class II Integra LifeSciences Corp.
Jan 19, 2024 Ref No: 31156 / COMBO KIT CONTAINS INS-8301, INS-4500,INS-HITH. For access t... A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... Class II Integra LifeSciences Corp.
Jan 19, 2024 Ref No: INS7250 / Integra Cranial Access Kit. For access to the subarachnoid ... A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... Class II Integra LifeSciences Corp.
Jan 19, 2024 Ref No: INS7270 / Integra¿ Cranial Access Kit. For access to the subarachnoid... A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... Class II Integra LifeSciences Corp.
Jan 19, 2024 Ref No: INS7260 / Integra¿ Cranial Access Kit. For access to the subarachnoid... A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... Class II Integra LifeSciences Corp.
Jan 19, 2024 Ref No: HITHSP04 / Integra Cranial Access Kit. For access to the subarachnoid... A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... Class II Integra LifeSciences Corp.
Jan 19, 2024 Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and... A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... Class II Integra LifeSciences Corp.
Jan 16, 2024 Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 7... The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier du... Class II Maquet Medical Systems USA
Jan 16, 2024 BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078.... The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier du... Class II Maquet Medical Systems USA
Jan 8, 2024 BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating, Product Code 70... Nonconformities at their seal could potentially compromise the sterile barrier for affected produ... Class II Maquet Medical Systems USA
Jan 8, 2024 BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 70... Nonconformities at their seal could potentially compromise the sterile barrier for affected produ... Class II Maquet Medical Systems USA
Jan 5, 2024 OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Min... OPTIMIZER devices may cease to deliver CCM therapy if the device incorrectly detects a charging e... Class II IMPULSE DYNAMICS (USA) INC
Dec 28, 2023 Bubble Sensor (REF: 70105.5720) The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life support system inclu... Class II Maquet Medical Systems USA
Dec 22, 2023 ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03... Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that ... Class II Onkos Surgical, Inc.
Dec 22, 2023 HRIS ACET CUP CUT TIP 32X140 Part Number: 6210-5-200rker. single-use, st... Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing fo... Class II Howmedica Osteonics Corp.
Dec 22, 2023 ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03... Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that ... Class II Onkos Surgical, Inc.
Dec 22, 2023 AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (... Filling process qualification did not demonstrate adequate process capability. Possible consequen... Class II Musculoskeletal Transplant Foundation, Inc.
Dec 22, 2023 AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (... Filling process qualification did not demonstrate adequate process capability. Possible consequen... Class II Musculoskeletal Transplant Foundation, Inc.
Dec 22, 2023 HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, steri... Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing fo... Class II Howmedica Osteonics Corp.
Dec 13, 2023 Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If th... Class I Maquet Cardiovascular, LLC
Dec 13, 2023 Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If th... Class I Maquet Cardiovascular, LLC
Dec 11, 2023 Flow-i C40 Anesthesia System, model 6677400 Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tamper... Class II Getinge Usa Sales Inc
Dec 11, 2023 Flow-i C30 Anesthesia System, model 6677300 Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tamper... Class II Getinge Usa Sales Inc
Dec 11, 2023 Flow-e Anesthesia System, model 6887900 Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tamper... Class II Getinge Usa Sales Inc
Dec 11, 2023 Flow-i C20 Anesthesia System, model 6677200 Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tamper... Class II Getinge Usa Sales Inc
Dec 11, 2023 Flow-c Anesthesia System, model 6887700 Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tamper... Class II Getinge Usa Sales Inc
Dec 1, 2023 DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement ... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement ... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacem... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 LARGE PRIMARY REV.TIB.INSERT- DURACON Intended for knee replacement ... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SCORPIO TS TIB INSERT -Intended for knee replacment Part Number: 72-4-7516 Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SCORPIO TS TIB INSERT. Intended for knee replacement Part Number: 72-4-7518 Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement ... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #5 -Intended for knee replaceme... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II 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.