Browse Device Recalls
5,424 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,424 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 5,424 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Aug 22, 2019 | The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is a woven double ... | Based on an internal incident report, Getinge/Intervascular SAS has identified that the one (1) H... | Class II | GETINGE US SALES LLC |
| Aug 21, 2019 | Sidus Stem-Free Shoulder Humeral Head 50-18 Item number: 01.04555.500 orthop... | Incorrect labeling on the products package. The label on the package shows size 50-18 whereas the... | Class II | Zimmer GmbH |
| Aug 21, 2019 | CanGaroo Envelopes labeled as the following: 1. CanGaroo Envelope (Large... | Possible suture brittleness or breakage along the Envelope seam before the expiration date of the... | Class II | AZIYO BIOLOGICS |
| Aug 21, 2019 | Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled a... | Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL)... | Class II | Boston Scientific Corporation |
| Aug 21, 2019 | BioEnvelope, surgical mesh envelope. Labeled as the following: 1. BioEn... | Possible suture brittleness or breakage along the Envelope seam before the expiration date of the... | Class II | AZIYO BIOLOGICS |
| Aug 21, 2019 | Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled a... | Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL)... | Class II | Boston Scientific Corporation |
| Aug 20, 2019 | 20" 2-Needle 26-Gauge 6mm HlgH-Flo Subcutaneous Safety Needle Sets" Product... | Mislabeled needle lengths | Class II | Repro-Med Systems, Inc. |
| Aug 15, 2019 | QuickGraft¿ Model # 430PST | Measurement listed on the label is not taken under tension, and this would cause possible extensi... | Class II | Musculoskeletal Transplant Foundation, Inc. |
| Aug 13, 2019 | VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1... | Firm identified a subset of its generators that were sterilized one additional sterilization cycl... | Class II | LivaNova USA Inc |
| Jul 30, 2019 | Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h | X-ray imaging system positioning image and protocol label is reversed for Flexion and Extension o... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets ... | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... | Class II | ICU Medical Inc |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... | Class II | ICU Medical Inc |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... | Class II | ICU Medical Inc |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... | Class II | ICU Medical Inc |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... | Class II | ICU Medical Inc |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... | Class II | ICU Medical Inc |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... | Class II | ICU Medical Inc |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets ... | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... | Class II | ICU Medical Inc |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets ... | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... | Class II | ICU Medical Inc |
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.