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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 9, 2016 | GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stry... | A review of packaging revealed the seal integrity of the pouch may be compromised. More specifica... | Class II | Stryker Howmedica Osteonics Corp. |
| Nov 7, 2016 | BD Spinal Anesthesia Tray The BD Spinal Anesthesia Tray is intended for use ... | BD is conducting a voluntary product recall of the BD Spinal Anesthesia Tray, Cat (Ref) 405671, l... | Class II | Becton Dickinson & Company |
| Oct 24, 2016 | Gammex Non-Latex Sensitive Neoprene Surgical Gloves Ansell Lanka (pvt) Ltd... | Ansell Healthcare Products is initiating a voluntary recall involving 15 cases of Gammex Non Late... | Class II | Ansell Healthcare Products LLC |
| Oct 5, 2016 | Accessory Adapter Part number 600525A0 Product Usage: designed for the mo... | Maquet Inc. is initiating a voluntary field action on the Accessory Adapter part number 600525A0 ... | Class II | Maquet Medical Systems USA |
| Sep 27, 2016 | Heater Cooler Unit Usage: The Heater-Cooler Unit (HCU 30) supplies temper... | There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. ... | Class II | Maquet Cardiovascular Us Sales, Llc |
| Sep 16, 2016 | BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 23G x 1 (0.6mm x ... | BD identified that several lots did not receive the specified dose of irradiation necessary to me... | Class II | Becton Dickinson & Company |
| Sep 16, 2016 | BD SafetyGlide" Injection Needle Catalog #305917 The SafetyGlide " needle i... | BD identified that several lots did not receive the specified dose of irradiation necessary to me... | Class II | Becton Dickinson & Company |
| Sep 16, 2016 | BD 3ml Syringer Luer-Lok Tip Catalog #309604 The BD Single Use, Hypodermic ... | BD identified that several lots did not receive the specified dose of irradiation necessary to me... | Class II | Becton Dickinson & Company |
| Sep 16, 2016 | BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 18G x 1 1/2 (1.2m... | BD identified that several lots did not receive the specified dose of irradiation necessary to me... | Class II | Becton Dickinson & Company |
| Sep 16, 2016 | BD 3ml Syringe Luer-Lok" Tip Catalog 309657 The BD Single Use, Hypodermic S... | BD identified that several lots did not receive the specified dose of irradiation necessary to me... | Class II | Becton Dickinson & Company |
| Sep 16, 2016 | BD 5ml Syringe Luer-Lok" Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40mm... | BD identified that several lots did not receive the specified dose of irradiation necessary to me... | Class II | Becton Dickinson & Company |
| Sep 16, 2016 | BD 10mL Syringe Luer-Lok Tip Catalog number 301997 The BD Single Use, Hypode... | BD identified that several lots did not receive the specified dose of irradiation necessary to me... | Class II | Becton Dickinson & Company |
| Sep 8, 2016 | TD60 display Telemetry Transmitter, SHENZHEN Mindray Bio-Medical Electronics ... | Mindray has become aware that the TD60 Display Telemetry Transmitter used with the BeneVision Cen... | Class II | Mindray DS USA, Inc. dba Mindray North America |
| Aug 29, 2016 | LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm, R... | Stryker received several complaints describing incidence of harm secondary to taper lock failure ... | Class II | Stryker Howmedica Osteonics Corp. |
| Aug 23, 2016 | Integra Lumbar Drainage Set, REF 910120A, Sterile EO, Rx only, primary packag... | During final sampling inspection, one of the lots was discovered with a total incomplete packagin... | Class II | Integra LifeSciences Corp. |
| Aug 23, 2016 | CUSA Dissectron Fingertip Laparoscopic Cannula, REF F75221, Sterile EO, Rx on... | During final sampling inspection, one of the lots was discovered with a total incomplete packagin... | Class II | Integra LifeSciences Corp. |
| Aug 23, 2016 | Integra Straight Ventricular Catheter F8, 25 cm, Sterile EO, Rx only, package... | During final sampling inspection, one of the lots was discovered with a total incomplete packagin... | Class II | Integra LifeSciences Corp. |
| Aug 23, 2016 | Integra Drainage Accessory Kits, REF 910122, Sterile EO, Rx only, packaged in... | During final sampling inspection, one of the lots was discovered with a total incomplete packagin... | Class II | Integra LifeSciences Corp. |
| Aug 23, 2016 | Integra Ventricular Catheter Accessory Kit, REF 951303, Sterile EO, Rx only, ... | During final sampling inspection, one of the lots was discovered with a total incomplete packagin... | Class II | Integra LifeSciences Corp. |
| Aug 23, 2016 | Integral Lumbar Drainage Set, REF 910420, Sterile EO, Rx only, primary packag... | During final sampling inspection, one of the lots was discovered with a total incomplete packagin... | Class II | Integra LifeSciences Corp. |
| Aug 18, 2016 | Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor, REF 2101-0... | Stryker Orthopaedics has received reports of the thread length protruding past the dome of the ac... | Class II | Stryker Howmedica Osteonics Corp. |
| Aug 15, 2016 | Pentax Video Colonoscope is intended to be used with a PENTAX video processor... | Pentax is initiating the product correction of several model numbers of Pentax's Colonoscope that... | Class II | Pentax of America Inc |
| Aug 15, 2016 | Pentax Video Gastroscope is intended to be used with a Pentax video processor... | PENTAX Medical is initiating this field action to provide customers that have purchased the affec... | Class II | Pentax of America Inc |
| Aug 12, 2016 | The Connecting Bracket (Fixture) Device (1002.65A0) is designed as a connecti... | Post Market Surveillance cases reported to Maquet showing instances in which the welded joint bet... | Class II | Maquet Cardiovascular Us Sales, Llc |
| Aug 8, 2016 | BD Vacutainer Push Button Blood Collection Set, Sterile, Rx only, 0.6 x 19 mm... | Becton Dickinson is recalling various lot numbers of BD Vacutainer Push Button Blood Collection S... | Class II | Becton Dickinson & Company |
| Aug 8, 2016 | BD 23 G x .75 in. BD Vacutainer¿ Push Button Blood Collection Set with 12 in... | BD has received multiple reports of units associated with the 23 G x .75 in. BD Vacutainer¿ Push... | Class II | Becton Dickinson & Company |
| Aug 4, 2016 | MISAGO RX Self Expanding Peripheral Stem | During recent routine testing, the MISAGO Peripheral Stent was found not to conform to product sp... | Class II | Terumo Medical Corp |
| Aug 2, 2016 | catalog # 405612 BD Spinal Anesthesia Tray 22G x 3.5 in. BD" Quincke Spinal... | A recall was initiated by Hospira, Inc. for several lots of 5% Lidocaine HCI and 7.5% Dextrose In... | Class II | Becton Dickinson & Company |
| Aug 1, 2016 | Stryker Orthopaedics Patella Assembly Instrument, REF 3182-1000, Non-Sterile,... | Upon failure of the press-fit, the clamping sub components and pins could disassociate from the S... | Class II | Stryker Howmedica Osteonics Corp. |
| Aug 1, 2016 | ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Str... | ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fib... | Class II | Ethicon, Inc. |
| Jul 26, 2016 | AccuLIF PL 6-9mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLI... | Since Stryker acquired the AccuLIF product in March of 2014, there have been Product Inquires (PI... | Class II | Howmedica Osteonics Corp. |
| Jul 26, 2016 | AccuLIF PL 10-16mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The Accu... | Since Stryker acquired the AccuLIF product in March of 2014, there have been Product Inquires (PI... | Class II | Howmedica Osteonics Corp. |
| Jul 26, 2016 | AccuLIF PL 8-12mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuL... | Since Stryker acquired the AccuLIF product in March of 2014, there have been Product Inquires (PI... | Class II | Howmedica Osteonics Corp. |
| Jul 21, 2016 | FPS 35mm x 3.5 mm non-locking screw | Mislabeling of a single batch of FPS 3.5 x 35 mm Locking Screw as being Non-Locking Screws. | Class II | Ortho Solutions Inc |
| Jul 21, 2016 | Large QWIX Compression screw, dia. 7.5 mm L 90 mm, Lot No. FH86, Rx only, ... | Labeling on the Qwix Screw product states that it is a "compression screw" instead of a "position... | Class II | Integra LifeSciences Corp. |
| Jul 20, 2016 | Integra External Fixation System Slotted Post - Small Catalogue #12224228; In... | Through the investigation of reported complaints Integra verified that there have been instances ... | Class II | Integra LifeSciences Corp. |
| Jul 20, 2016 | Integra External Fixation System Universal Wire Fixation Bolt - 17.5 mm Catal... | Through the investigation of reported complaints Integra verified that there have been instances ... | Class II | Integra LifeSciences Corp. |
| Jul 7, 2016 | The TM Ardis Interbody System implant is a convex, straight TLIF or PLIF devi... | This field action is being initiated following the firm's discovery of a procedural error in the ... | Class III | Zimmer Trabecular Metal Technology, Inc. |
| Jul 1, 2016 | Orthopedic manual surgical instrument Usage: Exeter Rasp Handle is a reus... | Malfunctioning of the Exeter Rasp/trial introducer/extractor Handle. | Class II | Stryker Howmedica Osteonics Corp. |
| Jul 1, 2016 | Integra External Fixation System Rocker Bottom Model # 12225400. For use i... | The silicone insert embedded in the rocker bottom has the potential to become dislodged or loose ... | Class II | Integra LifeSciences Corp. |
| Jun 30, 2016 | Femoral Nail, A/R T2 Femur 011x280 mm T2 Femoral Nailing System is one of ... | Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed t... | Class II | Stryker Howmedica Osteonics Corp. |
| Jun 30, 2016 | Supracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System is intend... | Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed t... | Class II | Stryker Howmedica Osteonics Corp. |
| Jun 29, 2016 | TRYX Neuro Absorbable Antibacterial Envelope Product Usage: Indicated for... | TRYX products are being recalled since the processes of spaying, welding, drying oven and polyme... | Class II | TYRX Inc. |
| Jun 29, 2016 | TRYX Absorbable Antibacterial Envelope Product Usage: Indicated for stabi... | TRYX products are being recalled since the processes of spaying, welding, drying oven and polyme... | Class II | TYRX Inc. |
| Jun 29, 2016 | TRYX Antibacterial Envelope Rx Only Product Usage: Indicated for stabiliz... | TRYX products are being recalled since the processes of spaying, welding, drying oven and polyme... | Class II | TYRX Inc. |
| Jun 23, 2016 | Stryker Orthopaedics Modular Handle Triathlon Instruments, Non-Sterile, REF 6... | Stryker Orthopaedic is voluntarily recalling the Triathlon Modular Handle because analysis reveal... | Class II | Stryker Howmedica Osteonics Corp. |
| Jun 23, 2016 | Mindray DS USA Inc., Passport Series Patient Monitor intended for monitoring,... | Mindray has identified a potential leakage issue with the CO2 Module's Dryline II Water Trap used... | Class II | Mindray DS USA, Inc. dba Mindray North America |
| Jun 23, 2016 | Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Seconda... | It was reported that the secondary locking mechanism, and its corresponding components, disassoci... | Class II | Stryker Howmedica Osteonics Corp. |
| Jun 17, 2016 | Achillon Minimally Invasive Device for Achilles Tendon Rupture Treatment The... | Data from internal studies suggests there may be a potential that the secondary package seal inte... | Class II | Integra LifeSciences Corp. |
| Jun 15, 2016 | A7 Anesthesia Delivery System, a device used to administer to a patient, cont... | Potential for a leak to occur on the back-up O2 and air e-size cylinder yokes on the A7 Anesthesi... | Class II | Mindray DS USA, Inc. dba Mindray North America |
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.