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 |
|---|---|---|---|---|
| Sep 16, 2026 | TS Misc. Instruments Tray, Triathlon. Catalog Number: 6543-6-519. | Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for ... | Class II | Howmedica Osteonics Corp. |
| Sep 16, 2026 | TS Femoral Prep Tray, Triathlon. Catalog Number: 6543-6-507. | Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for ... | Class II | Howmedica Osteonics Corp. |
| Sep 16, 2026 | Triathlon Hinge Femoral Prep Tray. Catalog Number: 6543-6-514. | Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for ... | Class II | Howmedica Osteonics Corp. |
| Sep 16, 2026 | TS Universal Baseplate Finishing Tray, Triathlon. Catalog Number: 6543-6-506. | Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for ... | Class II | Howmedica Osteonics Corp. |
| Aug 31, 2026 | Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / V | Certain monitor operator's manuals contain descriptions that may be insufficient or may require c... | Class III | Mindray DS USA, Inc. |
| Aug 31, 2026 | T1 Patient Monitor. Operator's Manual: T1 Patient Monitor | Certain monitor operator's manuals contain descriptions that may be insufficient or may require c... | Class III | Mindray DS USA, Inc. |
| Aug 31, 2026 | BeneView Series. Operator's Manuals: T5 / T8 | Certain monitor operator's manuals contain descriptions that may be insufficient or may require c... | Class III | Mindray DS USA, Inc. |
| Aug 31, 2026 | cPM Series Patient Monitor. Operator's Manual: cPM 8/cPM 12 | Certain monitor operator's manuals contain descriptions that may be insufficient or may require c... | Class III | Mindray DS USA, Inc. |
| Aug 31, 2026 | BeneVision Series Telemetry Monitor. Operator's Manuals: TM70/TM80 | Certain monitor operator's manuals contain descriptions that may be insufficient or may require c... | Class III | Mindray DS USA, Inc. |
| Aug 31, 2026 | Panorama and Telemetry Monitoring System. Operator's Manuals: TMS-6016/Panora... | Certain monitor operator's manuals contain descriptions that may be insufficient or may require c... | Class III | Mindray DS USA, Inc. |
| Aug 31, 2026 | BeneVision N1 and N-Series Patient Monitor. Patient Monitor: N12/N15/N17/N19/... | Certain monitor operator's manuals contain descriptions that may be insufficient or may require c... | Class III | Mindray DS USA, Inc. |
| Aug 31, 2026 | ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/... | Certain monitor operator's manuals contain descriptions that may be insufficient or may require c... | Class III | Mindray DS USA, Inc. |
| Aug 24, 2026 | Glypto Device, Glypto Cryo Machine; | Lack of 510(k) clearance. | Class II | Limitless Cryo Spa LLC |
| Jul 30, 2026 | AXLE PIN ASSY LARGE ELBOW COBALT CHROME Catalog No. C-M112-2-500 Orthop... | Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw mat... | Class II | Howmedica Osteonics Corp. |
| Jul 30, 2026 | TRIATHLON HINGE INSERT SIZE 4 11MM 5612-P-411 TRIATHLON HINGE INSER... | Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw mat... | Class II | Howmedica Osteonics Corp. |
| Jul 30, 2026 | SCORPIO RECESSED METAL BACKED PATELLA 3045-0026 3045-0028 3045-0030 ... | Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw mat... | Class II | Howmedica Osteonics Corp. |
| Jul 30, 2026 | BEARING AND AXLE BUSHING ASSY STD ELBOW C-M113-1-301 KRH REV TIB INS 1... | Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw mat... | Class II | Howmedica Osteonics Corp. |
| Jul 30, 2026 | SCORPIO + MOBILE BEARING PCS 78-5-0910 SYSTEM ONE BIPOLAR 40MM 6074... | Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw mat... | Class II | Howmedica Osteonics Corp. |
| Jul 30, 2026 | DURACON XL ANGLED TIB INS 11/14MM C-M064-1-300 SELF-PRESSURIZING GLENO... | Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw mat... | Class II | Howmedica Osteonics Corp. |
| Jul 30, 2026 | ALL POLY CONSTRAINED INSERT 54MM 69-2854 NRG KNEE CR 82-2-0512 8... | Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw mat... | Class II | Howmedica Osteonics Corp. |
| Jul 30, 2026 | TRIDENT 0¿ POLY INSERT 28mm ID 620-00-28D Orthopaedic implant compon... | Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw mat... | Class II | Howmedica Osteonics Corp. |
| Jul 30, 2026 | OMNIFIT SERIES I ACET. INSERT 10¿ 22mm ID Catalog No. 2001-2246 Ortho... | Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw mat... | Class II | Howmedica Osteonics Corp. |
| Jul 30, 2026 | ACETABULAR CUP UHMWPE 61-3258 ALL POLY CONSTRAINED INSERT 44MM 69-2... | Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw mat... | Class II | Howmedica Osteonics Corp. |
| Jul 30, 2026 | ABG I ACETABULAR INSERT HOODED 28mm ID X 48mm C-M079-2-801 ARC2F A... | Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw mat... | Class II | Howmedica Osteonics Corp. |
| Jul 30, 2026 | SCORPIO C-DOME PATELLA 73-2710 73-2910 SCORPIO U-DOME PATELLA 73-... | Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw mat... | Class II | Howmedica Osteonics Corp. |
| Jul 29, 2026 | STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074;... | A positive drift in QC values within the reagent's stated 4-hour onboard stability period was ide... | Class II | Diagnostica Stago, Inc. |
| Jul 24, 2026 | Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-AC... | Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers. | Class II | Onkos Surgical, Inc. |
| Jul 24, 2026 | Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-AC... | Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers. | Class II | Onkos Surgical, Inc. |
| Jul 20, 2026 | Captus 4000e Thyroid Uptake System, Models: 1. 5430-30151, 2. 5430-30152, 3. ... | Potential for failure of the tension bolt which would allow the spring arm to unexpectedly fall t... | Class II | Mirion Technologies (Capintec), Inc. |
| Jul 2, 2026 | Sperm Ab ELISA; Model/Catalog Number: EIA-1826; Product Description: Sperm ... | Potential for false negative patient results. | Class II | DRG International, Inc. |
| Jun 5, 2026 | OmniTract Surgical Retractor System, which includes 633 of the firm s product... | The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra Lif... | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Jun 2, 2026 | The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000; UD... | Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-... | Class II | Maquet Cardiovascular, LLC |
| May 19, 2026 | TRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400. | Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in pa... | Class II | Howmedica Osteonics Corp. |
| May 19, 2026 | TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300. | Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in pa... | Class II | Howmedica Osteonics Corp. |
| Apr 27, 2026 | BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 ... | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hyd... | Class I | Becton Dickinson & Company |
| Apr 27, 2026 | BD¿Spinal Tray with BD¿Whitacre Needle 24 G x 3.5 in.; lidocaine HCL (1%), 5 ... | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hyd... | Class I | Becton Dickinson & Company |
| Apr 27, 2026 | BD¿Spinal Tray with BD¿Quincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 m... | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hyd... | Class I | Becton Dickinson & Company |
| Apr 27, 2026 | BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 2 ... | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hyd... | Class I | Becton Dickinson & Company |
| Apr 27, 2026 | BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in., BD¿Quincke Needle 22 G... | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hyd... | Class I | Becton Dickinson & Company |
| Apr 27, 2026 | BD¿Spinal Tray with BD¿Quincke Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 m... | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hyd... | Class I | Becton Dickinson & Company |
| Apr 27, 2026 | BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 ... | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hyd... | Class I | Becton Dickinson & Company |
| Apr 27, 2026 | BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 ... | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hyd... | Class I | Becton Dickinson & Company |
| Apr 27, 2026 | BD¿Spinal Tray with BD¿Quincke Needle 26 G x 3.5 in.; lidocaine HCL (1%), 5 m... | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hyd... | Class I | Becton Dickinson & Company |
| Apr 27, 2026 | BD¿Spinal Tray with BD¿Whitacre Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 ... | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hyd... | Class I | Becton Dickinson & Company |
| Apr 10, 2026 | Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Produ... | Out-of-specification endotoxin result that did not meet the acceptance criteria. | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Apr 1, 2026 | i-STAT EG6+ cartridge; List Number: 03P77-25; | Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (l... | Class II | Abbott Point Of Care Inc. |
| Apr 1, 2026 | i-STAT EG7+ cartridge; List Number: 03P76-25; | Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (l... | Class II | Abbott Point Of Care Inc. |
| Apr 1, 2026 | i-STAT G3+ cartridge; List Number: 03P78-26; | Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (l... | Class II | Abbott Point Of Care Inc. |
| Mar 19, 2026 | Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015. | Increased rate of out-of-specification endotoxin results. | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Mar 19, 2026 | Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710. | Increased rate of out-of-specification endotoxin results. | Class II | Integra LifeSciences Corp. (NeuroSciences) |
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.