Browse Device Recalls
5,428 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,428 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 5,428 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 3, 2014 | Rotoprone Therapy System. The Rotoprone Therapy System is an advanced pati... | The recalled devices labeling and instructions for use contain unapproved medical claims. | Class II | Arjo Hospital Equipment AB |
| Dec 3, 2014 | RotoRest Delta Advanced Therapy System. The RotoRest Delta Advanced Kineti... | The recalled devices labeling and instructions for use contain unapproved medical claims. | Class II | Arjo Hospital Equipment AB |
| Dec 3, 2014 | WECK Hemoclip¿ Traditional Medium Tantalum Ligating Clips. Weck Ligating C... | The manufacturing dates and expiration dates were transposed on the Tyvek label. | Class II | Teleflex Medical |
| Dec 3, 2014 | TriaDyne Proventa Critical Care Therapy System. The TriaDyne Proventa Crit... | The recalled devices labeling and instructions for use contain unapproved medical claims. | Class II | Arjo Hospital Equipment AB |
| Nov 20, 2014 | Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Ther... | The recalled product was distributed with an incorrect serial number printed on the device's label. | Class II | Cyberonics, Inc |
| Nov 20, 2014 | UniStrip1, Blood Glucose Test Strips, 50 count box. The test strips are in... | Failure to submit a 510(k) for device labeling changes. | Class II | Unistrip Technologies LLC |
| Nov 17, 2014 | Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 80... | Through in-house routine real time stability monitoring of Trinity's Captia Syphilis IgM Capture ... | Class III | Clark Laboratories, Inc. (dba,Trinity Biotech USA) |
| Nov 12, 2014 | Sheridan/CF Cuffed Tracheal Tube, Sterile, Rx only, Teleflex Medical, Researc... | Product Labeling; Units from the affected lot indicates that it contains a size 8mm tracheal tube... | Class II | Teleflex Medical |
| Nov 11, 2014 | Alcon Single-Use Curved Jewelers/Iris Bipolar Forceps REF 8065129101 Sterile ... | The product is sold and labeled as EO sterilized, however the units were not sterilized prior to ... | Class II | Alcon Research, Ltd. |
| Nov 11, 2014 | Aesculap Miethke Shunt System, miniNAV Valve: The Miethke Shunt System is int... | Aesculap Inc. (AIC (USA)) initiated a recall of Miethke Shunt System accessories due to missing p... | Class III | Aesculap, Inc. |
| Nov 11, 2014 | Pediatric, 10Fr, Intermittent Urinary Catheters Model: P10 Pouch Label UPC ... | Some of the intermediate boxes within lot 140417-3, were labeled as P8, a French Size 8 pediatric... | Class II | Cure Medical LLC |
| Nov 10, 2014 | Arrow Nerve Block Component, Product Code: AB-18040-N: Permits placement of c... | Arrow is recalling certain lots of the Continuous Nerve Block Component, Product Code: AB-18040-... | Class II | Arrow International Inc |
| Nov 5, 2014 | Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coatin... | Maquet has confirmed through a customer complaint that while the oxygenators and the pouches for ... | Class II | Maquet Cardiovascular Us Sales, Llc |
| Nov 4, 2014 | Non-sterile drape | Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label. | Class III | Novadaq Technologies, Inc. |
| Nov 4, 2014 | LUNA Chest, Model No. LU4006 | Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label. | Class III | Novadaq Technologies, Inc. |
| Oct 27, 2014 | CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D, 12 cm shaft... | Outer box is mislabeled as P/N R2010- Large Radius Loop Electrode instead of P/N R1010- Medium Ra... | Class II | CooperSurgical, Inc. |
| Oct 24, 2014 | The Dual Switch Valve is used for fluid drainage from the ventricles into the... | Aesculap Inc. (AIC (USA)) initiated a recall of Miethke Shunt System, Dual Switch Valve, due to i... | Class II | Aesculap, Inc. |
| Oct 24, 2014 | GE Discovery MR950 MRI system | The alignment lasers are missing the labels required by radiation safety regulations. | Class II | GE Healthcare |
| Oct 23, 2014 | Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box co... | A reagent within the test may return false negative results. | Class II | Remel Inc |
| Oct 19, 2014 | ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D13... | The recall was initiated because Biosense Webster is providing additional labeling for the safe a... | Class II | Biosense Webster, Inc. |
| Oct 17, 2014 | The Synthes Mandible External Fixator; all lots of part nos.: 04.305.003 ... | Under new testing protocols for MR Environment safety and compatibility, metal devices are no lon... | Class II | Synthes, Inc. |
| Oct 17, 2014 | Tenaxis Medical ArterX(TM) Surgical Sealant, (a) 4mL, REF 9002, and (b) 5mL R... | Product was improperly labeled leading to improper storage. | Class II | Mallinckrodt Manufacturing LLC |
| Oct 16, 2014 | Etest¿ Ceftaroline (CPT32) US B30. Etest¿ (Antimicrobial Susceptibility Te... | The products have a wrong expiration date on their labeling, 5 years instead of 2 years. | Class III | Biomerieux |
| Oct 16, 2014 | Etest¿ Ceftaroline (CPT32) WWB100. Etest¿ (Antimicrobial Susceptibility Te... | The products have a wrong expiration date on their labeling, 5 years instead of 2 years. | Class III | Biomerieux |
| Oct 16, 2014 | Etest¿ Ceftaroline (CPT32) US B30. Etest¿ (Antimicrobial Susceptibility Te... | The products have a wrong expiration date on their labeling, 5 years instead of 2 years. | Class III | Biomerieux |
| Oct 16, 2014 | Etest¿ Ceftaroline (CPT32) WW B30. Etest¿ (Antimicrobial Susceptibility Te... | The products have a wrong expiration date on their labeling, 5 years instead of 2 years. | Class III | Biomerieux |
| Oct 16, 2014 | Etest¿ Ceftaroline (CPT32) US B100. Etest¿ (Antimicrobial Susceptibility T... | The products have a wrong expiration date on their labeling, 5 years instead of 2 years. | Class III | Biomerieux |
| Oct 14, 2014 | St Jude Medical, 10F Fast-Cath Trio" Hemostasis Introducer, REF # 406308, St... | St. Jude Medical is conducting a voluntary recall of SMJ Batch # 4641580 of the Fast-Cath Trio" H... | Class II | St Jude Medical |
| Oct 13, 2014 | Medtronic Launcher Coronary Guide Catheter; MODEL: LA6JR40K | Two reports have been received on the 6F launcher Guide Catheter lot (Model Number LA6JR40K; lot ... | Class II | Medtronic Vascular |
| Oct 9, 2014 | Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, C... | Mislabeled | Class II | Exactech, Inc. |
| Oct 8, 2014 | Bard¿ PerFix Light Plug The Bard¿ PerFix Light Plug is indicated for rei... | The patient record peel-off label product code and size did not match the other labeling and actu... | Class II | Davol, Inc., Subs. C. R. Bard, Inc. |
| Oct 8, 2014 | Box Label: 3 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-3KDINX . ... | The recall has been initiated due to concerns that the applicator wand may malfunction potentiall... | Class II | Ad-Tech Medical Instrument Corporation |
| Oct 6, 2014 | Alliance Tech Medical, Inc. All Flow Pulmonary Function Filters, 100 filters ... | Patients have experienced a bad taste associated with the filters. | Class II | Alliance Tech Medical, Inc |
| Oct 6, 2014 | ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative deter... | Siemens Healthcare Diagnostics has confirmed that approximately 2000 ReadyPacks from the ADVIA Ce... | Class III | Siemens Healthcare Diagnostics, Inc |
| Oct 6, 2014 | UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric hand... | Non-injury complaints from Europe identified a malfunction that made it possible for a handpiece ... | Class II | Zimmer Surgical Inc |
| Sep 29, 2014 | VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemis... | Calibration may not occur when using calibrator barcode labels supplied with VITROS Chemisty Prod... | Class III | Ortho-Clinical Diagnostics |
| Sep 29, 2014 | ASTS-LG1212: Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic ... | Product is mislabeled. | Class II | 4-Web Inc. |
| Sep 26, 2014 | Merit Maestro Microcatheter, 2.4F 130cm Straight, REF28MC24130ST, Rx Only, No... | These microcatheters were packaged with a 2.8 F distal tip, rather than the labeled 2.4 F. | Class II | Merit Medical Systems, Inc. |
| Sep 23, 2014 | ArcPoint Labs 5 Panel Dip Drug Screen, Part No. APD-5M. The ArcPoint Labs ... | Ameditech is recalling the ArcPoint Labs Dip Drug Screen Dip Card because the positive interpreta... | Class II | Ameditech Inc |
| Sep 23, 2014 | ArcPoint Labs 10 Panel Dip Screen (OXY), Part No. APD-10MO. The ArcPoint L... | Ameditech is recalling the ArcPoint Labs Dip Drug Screen Dip Card because the positive interpreta... | Class II | Ameditech Inc |
| Sep 23, 2014 | ArcPoint Labs 10 Panel Dip Screen (BAR), Part No. APD-10M. The ArcPoint La... | Ameditech is recalling the ArcPoint Labs Dip Drug Screen Dip Card because the positive interpreta... | Class II | Ameditech Inc |
| Sep 22, 2014 | Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture; ... | CP Medical Inc. is recalling five lots of Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorb... | Class II | C P Medical, Inc. |
| Sep 19, 2014 | MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag... | Incorrect sizing was being laser etched on the MaxLock Extreme Mod-Foot Concave Reamer | Class II | Orthohelix Surgical Designs Inc |
| Sep 18, 2014 | Multi-Lumen Central Venous Catheterization Kit | Arrow International, Inc. has initiated a voluntary recall for product code AK- 12703, lot numbe... | Class II | Arrow International Inc |
| Sep 18, 2014 | V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration an... | A portion of the V.A.C. GranuFoam Silver Dressing M8275099/10 lot 50775977 was incorrectly manufa... | Class II | KCI USA, Inc. |
| Sep 17, 2014 | nordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic... | An error was discovered in the interpretation of certain DICOM header tags that may lead to incor... | Class II | NordicNeuroLab AS |
| Sep 17, 2014 | EndoWrist One Vessel Sealer used in conjunction with the da Vinci Si Surgical... | Intuitive Surgical is initiating a voluntary correction relating to the labeling and software ass... | Class II | Intuitive Surgical, Inc. |
| Sep 15, 2014 | GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Product Used for general surgica... | mA Accuracy may exceed the design and labeling specification of+ 10%. Per 1020.32(f): Deviation o... | Class II | GE OEC Medical Systems, Inc |
| Sep 15, 2014 | GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product Used for general surgical... | mA Accuracy may exceed the design and labeling specification of+ 10%. Per 1020.32(f): Deviation o... | Class II | GE OEC Medical Systems, Inc |
| Sep 12, 2014 | nordicICE 2.3.14 Image processing software package used by trained profess... | An error was discovered in the interpretation of certain DICOM header tags that may lead to incor... | Class II | NordicNeuroLab AS |
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.