Browse Device Recalls
5,543 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,543 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 5,543 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 14, 2019 | S.M.A.R.T. Nitinol Stent System and the S.M.A.R.T. Control Nitinol Stent Syst... | Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI... | Class II | Cardinal Health Inc. |
| Nov 14, 2019 | Cordis Precise Nitinol Stent System. The Cordis PRECISE Nitinol Stent Sys... | Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI... | Class II | Cardinal Health Inc. |
| Nov 11, 2019 | Stratum MDS Screw 3.5x48mm ST Part Number: STRM-MDS-3548ST | Components 2mm shorter than indicated on the package label | Class II | Nextremity Solutions |
| Nov 11, 2019 | CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF... | A manufacturing error caused a single lot of 10mm active tip length Cannulas to be labeled as 5mm... | Class II | Abbott Medical |
| Nov 11, 2019 | Stratum MDS Screw 3.5x46mm ST Part Number: STRM-MDS-3546ST | Components 2mm shorter than indicated on the package label | Class II | Nextremity Solutions |
| Nov 11, 2019 | Stratum MDS Screw 3.5x50mm ST Part Number: STRM-MDS-3550ST | Components 2mm shorter than indicated on the package label | Class II | Nextremity Solutions |
| Nov 4, 2019 | Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple pr... | False positive results due to potential contamination of reagent. | Class II | Immuno-Mycologics, Inc |
| Nov 4, 2019 | Ascension¿ Silicone PIP-Silicone PIP Sz 1, Model Number: SPIP5201WW - Product... | Silicone PIP Implant mislabeled as a size 1 implant on the outer packaging when in fact the packa... | Class II | Integra Lifesciences Sales Llc |
| Oct 30, 2019 | HUDSON RCI SHERIDAN SHERI-BRONCH Endobronchial Tube REF 5-16135 - Product Usa... | The tracheal and brochial swivel connectors are incorrectly labeled. | Class II | Teleflex Medical |
| Oct 30, 2019 | Oral-B, Practitioner Series, 5% Sodium Fluoride Varnish, 500 units (40mL/each... | Product shelf life may be shorter than that indicated on the label. | Class II | Young Dental Manufacturing Co, LLC |
| Oct 28, 2019 | Genius 2 Tympanic Thermometer Private Label Item Code: 3069 | The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manua... | Class II | Cardinal Health 200, LLC |
| Oct 25, 2019 | Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 14MM- Orthopedic ma... | Possible commingle of 13 MM and 14 MM Intramedullary Bone Saw Cam Assembly -an Intramedullary Bo... | Class II | Zimmer Biomet, Inc. |
| Oct 25, 2019 | Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 13MM-Orthopedic manua... | Possible commingle of 13 MM and 14 MM Intramedullary Bone Saw Cam Assembly -an Intramedullary Bo... | Class II | Zimmer Biomet, Inc. |
| Oct 21, 2019 | Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 8cm ... | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... | Class II | Boston Scientific Corporation |
| Oct 21, 2019 | Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 7cm ... | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... | Class II | Boston Scientific Corporation |
| Oct 21, 2019 | Advanix Pancreatic Stent, Straight Leading Barb, 10F x 6cm UPN: M00536640 | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... | Class II | Boston Scientific Corporation |
| Oct 21, 2019 | Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 11cm... | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... | Class II | Boston Scientific Corporation |
| Oct 21, 2019 | Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 18cm... | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... | Class II | Boston Scientific Corporation |
| Oct 21, 2019 | Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 3cm... | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... | Class II | Boston Scientific Corporation |
| Oct 21, 2019 | Boston Advanix Pancreatic Stent, Straight Leading Barb, 10F x 4cm UPN: M00... | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... | Class II | Boston Scientific Corporation |
| Oct 21, 2019 | Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 15cm... | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... | Class II | Boston Scientific Corporation |
| Oct 21, 2019 | Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 10cm... | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... | Class II | Boston Scientific Corporation |
| Oct 21, 2019 | Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 13cm... | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... | Class II | Boston Scientific Corporation |
| Oct 21, 2019 | Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 9cm ... | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... | Class II | Boston Scientific Corporation |
| Oct 21, 2019 | Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 5cm ... | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... | Class II | Boston Scientific Corporation |
| Oct 21, 2019 | Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 12cm... | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... | Class II | Boston Scientific Corporation |
| Oct 14, 2019 | Levo Arm Label: LEVO ARM REF 7887-050 MIZUHO OSI Refurbished Levo Arm Labe... | Due to the potential for fluid ingress into the Arm which could affect the device's electrical sy... | Class II | Mizuho OSI |
| Oct 14, 2019 | BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306547 | Limited number of syringes labeled Posiflush Experimental Product and Not for Human Use being... | Class II | Becton Dickinson & Company |
| Oct 14, 2019 | BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306575 (Canad... | Limited number of syringes labeled Posiflush Experimental Product and Not for Human Use being... | Class II | Becton Dickinson & Company |
| Oct 11, 2019 | ElectroTek Temporal Sensor Cable Gold - Long Length, Single Length - Product ... | Potential for one of the four temporal electrode cables used in with the ElectroTek EEG system ha... | Class II | LIFELINES NEURO COMPANY |
| Oct 11, 2019 | The PolarCath Balloon Catheter consists of a coaxial catheter shaft with two ... | Peripheral Dilation Catheters that were E-Beam Sterilized were inadvertently mislabeled with EO s... | Class II | Nucryo Vascular Inc. |
| Oct 11, 2019 | ElectroTek Temporal Sensor Cable Gold - Long Length, Graduated - Product Usag... | Potential for one of the four temporal electrode cables used in with the ElectroTek EEG system ha... | Class II | LIFELINES NEURO COMPANY |
| Oct 10, 2019 | 4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase... | Firm has identified product has no staining. If used, may result in invalid test results when use... | Class II | Biocare Medical, LLC |
| Oct 10, 2019 | 3.5mm Aresenal Screw Drill Bit , Ref: 330-35-001, Qty. 70, Rx Only, Non-Steri... | Labeling Error; specifically, drill bits from lots # TSL008495A are marked with the lot # of TSL0... | Class II | Trilliant Surgical, LLC |
| Oct 9, 2019 | Encina HA Femoral Stem, Size 11 Coxa Vara Collared, REF 100-30-011, Ti6AI4V A... | The firm has identified that packaging containing components of the hip replacement range are mi... | Class II | Signature Orthopaedics Europe Ltd |
| Oct 9, 2019 | Zimmer Tourniquet Cuff 30" (Blue), PLC Dual Port, Single Bladder, Item Number... | Tourniquet cuffs are potentially mislabeled. If used may lead to (1) Device misuse during procedu... | Class II | Stryker Sustainability Solutions |
| Oct 9, 2019 | Stratum Foot Plating System-NL LP Screw 3.5x50mm ST, sterile. Catalog Number... | Product labeled as STRM-NL-3550ST, NL LP Screw 3.5x50mm ST, lot M1151 may contain the incorrect s... | Class II | Nextremity Solutions |
| Oct 8, 2019 | CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG... | The connector piece to the PEG tube does not pass over the guidewire. | Class II | Avanos Medical, Inc. |
| Oct 8, 2019 | CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG... | The connector piece to the PEG tube does not pass over the guidewire. | Class II | Avanos Medical, Inc. |
| Oct 2, 2019 | Starburst Talon Semi-Flex Electrosurgical Device, Part Number H7877001028451 ... | The devices are not labelled correctly. End users impacted by this issue may experience a proced... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Sep 26, 2019 | TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Use... | Device was shipped without a Unique Device Identification (UDI) label and a separate label identi... | Class III | Theralase Inc. |
| Sep 26, 2019 | TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of k... | Device was shipped without a Unique Device Identification (UDI) label. | Class III | Theralase Inc. |
| Sep 25, 2019 | AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual ... | Needleholder incorrectly labeled as 200MM when the actual instrument size is 150MM. | Class II | Aesculap Implant Systems LLC |
| Sep 24, 2019 | MOSAIQ, oncology information system - Product Usage: MOSAIQ is an oncology in... | The user may inadvertently enter Metric values into Height and Weight fields labeled with US Stan... | Class II | Elekta Impac Software |
| Sep 19, 2019 | Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 18-0904... | The firm has become aware there is a potential problem with its DABRA catheters resulting in high... | Class II | Ra Medical Systems, Inc. |
| Sep 12, 2019 | Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is t... | labeling error: Due to a manufacturing issue, product package was incorrectly labeled with the in... | Class II | Merit Medical Systems, Inc. |
| Sep 12, 2019 | CODAN SWAN-LOCK Swabable Needlefree Connector, Catalog #BC1000N, REF 16.7220,... | Individual packages of connectors may have incomplete or bad seals which would compromise sterility. | Class II | Codan US Corporation |
| Sep 11, 2019 | Respironics RP-Touch Screen, V60/V680 Ventilator Serviced with Touchscreen RP... | Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requ... | Class II | Respironics California, LLC |
| Aug 30, 2019 | SPROTTE Lumbar with Introducer, labeled as the following: 1. Sprotte 22G... | Problem with packaging sealing process which affects sterility. | Class II | Pajunk GmbH |
| Aug 28, 2019 | NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); R... | The top label of article no. 37965, lot 12129104 (immediate packaging of endosseous dental implan... | Class II | Nobel Biocare Usa Llc |
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.