Browse Device Recalls
2,447 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,447 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 2,447 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 5, 2018 | Giraffe Omnibed - Product Usage: The OmniBed is a combination of an infant in... | GE Healthcare has become aware of a potential safety issue that can occur if the canopy seals are... | Class II | Ohmeda Medical |
| Oct 5, 2018 | Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 u... | Potential for leakage due to defect in the thermoset check valve component. | Class II | ICU Medical, Inc. |
| Sep 25, 2018 | PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, S... | Visual particulates within a battery Tyvek pouch. The battery is provided sterile for use with s... | Class II | Pro-Dex Inc |
| Sep 18, 2018 | Puritan Bennett 980 (PB980) ventilator series: Puritan Bennett" 980 Pediatri... | Software Update: External USB Drive performance and its impact on Graphic User Interface (GUI) fu... | Class I | COVIDIEN LLC |
| Sep 12, 2018 | Tritanium TL Steerable Inserter, Cat. No. 48930000, UDI 07613327381900 Pro... | The firm received complaints related to the locking mechanism on the steerable inserter not funct... | Class II | Howmedica Osteonics Corp. |
| Sep 12, 2018 | 3.0mm Headless Compression Screw, Long Thread 18mm, Part Number 04.226.118 ... | The product inside the package does not match the label. The product was labeled as long thread ... | Class II | Synthes (USA) Products LLC |
| Sep 7, 2018 | Codan Filter (Codan catalog number BC 693) used with Medrad Patient Administr... | Bayer has received reports of loose particulate in the filter when the dust cap is removed. Bayer... | Class II | Bayer Medical Care, Inc. |
| Aug 29, 2018 | INSORB SUBCUTICULAR SKIN STAPLER, REF 2030 | Possible compromise of the sterile barrier integrity | Class II | Incisive Surgical Inc |
| Aug 28, 2018 | Hoffman LRF Hexapod Strut, Extra Short 89mm-109mm, Model Number 4935-0-010. P... | The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet... | Class II | Stryker GmbH |
| Aug 28, 2018 | Heart Ware(TM) HVAD(TM) System Controller/Controller Kits, Model Numbers: 14... | Certain HVAD System Controller units may not meet the labeled standard for protection against wat... | Class II | Heartware, Inc. |
| Aug 28, 2018 | Hoffman LRF Hexapod Strut, Extra Short 131mm-191mm, Model Number 4935-0-030. ... | The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet... | Class II | Stryker GmbH |
| Aug 28, 2018 | Hoffman LRF Hexapod Strut, Extra Short 105mm-139mm, Model Number 4935-0-020. ... | The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet... | Class II | Stryker GmbH |
| Aug 28, 2018 | Hoffman LRF Hexapod Strut, Extra Short 183mm-295mm, Model Number 4935-0-040. ... | The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet... | Class II | Stryker GmbH |
| Aug 20, 2018 | ICU Medical 14" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer, REF... | Design change implemented changing the device from a blood set with a filter to a transfer set wi... | Class II | ICU Medical, Inc. |
| Aug 1, 2018 | Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model ... | A software malfunction of the infuser when used with a MedNet Custom Drug Library (CDL). When a ... | Class II | ICU Medical Inc |
| Aug 1, 2018 | Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, ... | Potential for product sterility breach due to a compromised or pinched seal defect | Class II | COVIDIEN LLC |
| Aug 1, 2018 | Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441... | Potential for product sterility breach due to a compromised or pinched seal defect | Class II | COVIDIEN LLC |
| Aug 1, 2018 | Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.... | Potential for product sterility breach due to a compromised or pinched seal defect | Class II | COVIDIEN LLC |
| Aug 1, 2018 | Dermacea Gauze Fluff Roll, 6 Ply, 4 x 4-1/8 yd (10.2 cm x 3.7 m), REF 441106 ... | Potential for product sterility breach due to a compromised or pinched seal defect | Class II | COVIDIEN LLC |
| Aug 1, 2018 | Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), ... | Potential for product sterility breach due to a compromised or pinched seal defect | Class II | COVIDIEN LLC |
| Jul 31, 2018 | Capnostream20 M NICU (CPM), CS08654RN | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac... | Class II | Oridion Medical 1987 Ltd. |
| Jul 31, 2018 | Capnostream20 M ADULT ICU (CPM), CS08654RA | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac... | Class II | Oridion Medical 1987 Ltd. |
| Jul 17, 2018 | Abbott ARCHITECT c8000 Processing Module, List No. 01G06 - Product Usage: The... | There is a potential to generate incorrect results on the instrument if particular error codes ar... | Class II | Abbott Laboratories, Inc |
| Jul 17, 2018 | Abbott ARCHITECT c16000 Processing Module, List No. 03L77 - Product Usage: Th... | There is a potential to generate incorrect results on the instrument if particular error codes ar... | Class II | Abbott Laboratories, Inc |
| Jul 17, 2018 | Abbott ARCHITECT c4000 Processing Module, List No. 02P24 - Product Usage: The... | There is a potential to generate incorrect results on the instrument if particular error codes ar... | Class II | Abbott Laboratories, Inc |
| Jul 12, 2018 | Peg Fully Threaded, Locking, 2.5mm x 10mm, Item Number 131212610 Orthopedic d... | A size 22mm threaded peg was found in the package of a 10mm unit. | Class II | Zimmer Biomet, Inc. |
| Jun 21, 2018 | Medtronic EnTrust Escudo D144VRC (OUS distribution) Product Usage: The imp... | Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 21, 2018 | Percepta CRT-P MRI SureScan, REF W1TR04 Product Usage: The CRT-P models a... | Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 21, 2018 | Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with A... | Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 21, 2018 | Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with At... | Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 21, 2018 | Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with A... | Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 21, 2018 | Medtronic EnTrust Escudo D144DRG (OUS distribution) Product Usage: The imp... | Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 21, 2018 | Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with At... | Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 21, 2018 | Percepta Quad CRT-P MRI SureScan, REF W4TR01 Product Usage: The CRT-P mod... | Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 21, 2018 | Percepta Quad CRT-P MRI SureScan, REF W4TR04 Product Usage: The CRT-P mod... | Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 21, 2018 | Percepta CRT-P MRI SureScan, REF W1TR01 Product Usage: The CRT-P models a... | Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 31, 2018 | VentriClear Ventricular Drainage Catheter Set, Cat. No. N-VVDC-01-ABRM Pro... | This lot of VentriClear failed endotoxin testing. Potential adverse events include immune respon... | Class II | Cook Inc. |
| May 25, 2018 | Vectris(TM) Sure Scan(R) MRI Lead Kit for Spinal Cord Stimulation, Models: (... | This voluntary recall is being conducted due to the curved tip introducer needle which is include... | Class II | Medtronic Neuromodulation |
| May 25, 2018 | Vectris(TM) Trial Screening Lead Kit for Spinal Cord Stimulation, Models: (a... | This voluntary recall is being conducted due to the curved tip introducer needle which is include... | Class II | Medtronic Neuromodulation |
| May 24, 2018 | Fabius GS MRI Anesthesia Machine; Cat. no. 8607300 Product Usage: Inhalat... | The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC mo... | Class II | Draeger Medical, Inc. |
| May 24, 2018 | Fabius GS Premium Anesthesia Machine; Cat. no. 8607000 Product Usage: Inh... | The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC mo... | Class II | Draeger Medical, Inc. |
| May 24, 2018 | Fabius GS Tiro Anesthesia Machine; Cat. no. 8606000 Product Usage: Inhala... | The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC mo... | Class II | Draeger Medical, Inc. |
| May 23, 2018 | Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation st... | Through an investigation, it has been determined that vials of Collagen packaged within the Colla... | Class III | Helena Laboratories, Corp. |
| May 23, 2018 | Platelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studi... | Through an investigation, it has been determined that vials of Collagen packaged within the Colla... | Class III | Helena Laboratories, Corp. |
| May 22, 2018 | Endo GIA 45mm Curved Tip Articulating Vascular/Medium Reload with Tri-Staple ... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| May 22, 2018 | Endo GIA 45 mm Extra Thick Black Articulating Reload with Tri-Staple Technolo... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| May 22, 2018 | Endo GIA 60 mm Extra Thick Black Articulating Reload with Tri-Staple Technolo... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| May 22, 2018 | Endo GIA 60 mm Articulating Vascular/Medium Loading Unit with Tri-Staple Tec... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| May 22, 2018 | Endo GIA 60 mm Articulating Medium/Thick Reload with Tri-StapleTechnology, It... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| May 22, 2018 | Endo GIA 45 mm Articulating Vascular/Medium Loading Unit with Tri-Staple Tech... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
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.