Browse Device Recalls

2,057 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,057 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 2,057 FDA device recalls in NJ.

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DateProductReasonClassFirm
Sep 4, 2024 Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable de... Anterior locking tabs on the Triathlon Universal Baseplate are out of specification which may pre... Class II Howmedica Osteonics Corp.
Aug 23, 2024 AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision ... Labeling Correction: Instructions For Use (IFU)-Updated electronic Rev 5, specific language for ... Class II Stryker Spine
Aug 23, 2024 Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of h... This recall was initiated due to customer complaints of false negative of hCG test results when r... Class II Princeton Biomeditech Corp
Aug 8, 2024 CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system ... Firm has developed a software correction (Revision D.01) for outside the US to mitigate product p... Class I Datascope Corp.
Aug 8, 2024 CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system ... Firm has developed a software correction (Revision D.01) for outside the US to mitigate product p... Class I Datascope Corp.
Aug 8, 2024 CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system ... Firm has developed a software correction (Revision D.00) outside the US to mitigate product probl... Class I Datascope Corp.
Aug 8, 2024 CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system ... Firm has developed a software correction (Revision D.00) outside the US to mitigate product probl... Class I Datascope Corp.
Aug 7, 2024 MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063 Stryker has identified an issue with the characterization process that impacted the constant valu... Class II Howmedica Osteonics Corp.
Aug 5, 2024 Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs ... A patient specific, custom-made device was supplied for a surgical procedure that did not match t... Class II Howmedica Osteonics Corp.
Jul 22, 2024 Sevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia System-Used to provi... V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a compo... Class II Mindray DS USA, Inc. dba Mindray North America
Jul 22, 2024 Isoflurane E_Vap.(Safety Filling adapter): used with the A9 Anesthesia System... V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a compo... Class II Mindray DS USA, Inc. dba Mindray North America
Jul 22, 2024 Desflurane E_Vap.(Saf-T-Fill) used with the A9 Anesthesia System-Used to prov... V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a compo... Class II Mindray DS USA, Inc. dba Mindray North America
Jul 22, 2024 Sevoflurane E_Vap.(Safety Filling adapter) used with the A9 Anesthesia System... V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a compo... Class II Mindray DS USA, Inc. dba Mindray North America
Jul 9, 2024 TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV ... Specific lots of TruDi NAV Suction Instruments 0 Degrees were incorrectly calibrated which when u... Class II Integra LifeSciences Corp.
Jul 5, 2024 Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Pr... Invalid Controls. The Low Control is out of range; too high which causes invalid runs that would... Class III DRG International, Inc.
Jun 27, 2024 LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00 The LinkSymphoKnee Patella Sizing Template was incorrectly labeled. The markings on two arms of t... Class II LINK BIO CORP
Jun 19, 2024 UNITRAX Endoprosthesis Head Component - 42mm. Implantable component used in p... Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentia... Class II Howmedica Osteonics Corp.
Jun 19, 2024 UNITRAX Endoprosthesis Head Component - 38mm. Implantable component used in p... Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentia... Class II Howmedica Osteonics Corp.
Jun 19, 2024 UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in p... Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentia... Class II Howmedica Osteonics Corp.
Jun 18, 2024 BD Nano 2nd Gen Pen Needles 32G X 4mm (5-count sample contained in Patient Co... BD Nano 2nd Gen Pen Needle was shipped close to or after the labeled expiration date of February ... Class II Embecta Corp.
Jun 7, 2024 AURORA Surgiscope System. Sterile, single use device that contains a Sheath, ... Potential sheath damage that could lead to tissue damage and/or track hemorrhage. Class II Integra LifeSciences Corp.
May 31, 2024 The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for us... There were 27 complaints between March 22, 2024, and April 30, 2024, related to VH-3500 and VH-40... Class II Maquet Cardiovascular, LLC
May 31, 2024 The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed for use... There were 27 complaints between March 22, 2024, and April 30, 2024, related to VH-3500 and VH-40... Class II Maquet Cardiovascular, LLC
May 29, 2024 CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical proce... Potential for the CUSA Excel 23KHz Straight Handpiece housing to crack, may result in delay of t... Class II Integra LifeSciences Corp.
May 29, 2024 ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B5 The recall is prompted by a defective charger unit (0970.2873) for models 1133.22B4, 1133.22B5, a... Class II Getinge Usa Sales Inc
May 29, 2024 ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322F5 The recall is prompted by a defective charger unit (0970.2873) for models 1133.22B4, 1133.22B5, a... Class II Getinge Usa Sales Inc
May 29, 2024 ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B4 The recall is prompted by a defective charger unit (0970.2873) for models 1133.22B4, 1133.22B5, a... Class II Getinge Usa Sales Inc
May 23, 2024 HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900 The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision... Class II Howmedica Osteonics Corp.
May 23, 2024 Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 621... The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision... Class II Howmedica Osteonics Corp.
May 17, 2024 The VASOVIEW HemoPro Endoscopic Vessel Harvesting Systems are designed for us... Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead ... Class II Maquet Cardiovascular, LLC
May 17, 2024 The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the fo... Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead ... Class II Maquet Cardiovascular, LLC
May 10, 2024 MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in ... Issue on a specific packaging machine resulted in a hole in the primary packaging, product steril... Class II Ethicon, Inc.
May 10, 2024 VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in gen... Issue on a specific packaging machine resulted in a hole in the primary packaging, product steril... Class II Ethicon, Inc.
May 10, 2024 PDS II (polydioxanone) Suture - Intended for use in general soft tissue appro... Issue on a specific packaging machine resulted in a hole in the primary packaging, product steril... Class II Ethicon, Inc.
May 10, 2024 VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue ap... Issue on a specific packaging machine resulted in a hole in the primary packaging, product steril... Class II Ethicon, Inc.
May 10, 2024 MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue... Issue on a specific packaging machine resulted in a hole in the primary packaging, product steril... Class II Ethicon, Inc.
May 10, 2024 PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general s... Issue on a specific packaging machine resulted in a hole in the primary packaging, product steril... Class II Ethicon, Inc.
May 7, 2024 CODMAN EVD BACTISEAL 1.9mm I.D. Catheter Set- indicated for gaining access to... Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may... Class II Integra LifeSciences Corp.
May 7, 2024 CODMAN BACTISEAL Clear EVD Catheter 1.9mm I.D. Catheter Set- indicated for ga... Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may... Class II Integra LifeSciences Corp.
May 7, 2024 CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the vent... Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal tha... Class II Integra LifeSciences Corp.
May 1, 2024 Vaporizer Sevoflurane Maquet Filling, Product code/REF number (6682282), Comp... Sevoflurane used with the vaporizer may degrade to hydrogen fluoride, which could present a risk ... Class I Getinge Usa Sales Inc
Apr 23, 2024 SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979. Some applicator tips from these lots had open seals. Class II Ethicon, Inc.
Apr 22, 2024 Captus 4000e Thyroid Uptake System with Well and 2 inch shielding. Intended t... Complaints of unexpected detachment of the collimator have been reported. Class II Mirion Technologies (Capintec), Inc.
Apr 22, 2024 Captus 4000e Thyroid Uptake System with Well. Intended to be used to perform ... Complaints of unexpected detachment of the collimator have been reported. Class II Mirion Technologies (Capintec), Inc.
Apr 22, 2024 Captus 4000e Thyroid Uptake System. Intended to be used to perform Thyroid Up... Complaints of unexpected detachment of the collimator have been reported. Class II Mirion Technologies (Capintec), Inc.
Apr 17, 2024 Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used duri... Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may com... Class II Integra LifeSciences Corp.
Apr 15, 2024 Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Kn... Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part ... Class II Stryker Orthopaedics
Apr 15, 2024 Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Kn... Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part ... Class II Stryker Orthopaedics
Apr 15, 2024 Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Kn... Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part ... Class II Stryker Orthopaedics
Apr 15, 2024 Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Kn... Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part ... Class II Stryker Orthopaedics

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.