Browse Device Recalls

2,437 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,437 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 2,437 FDA device recalls in 2013.

Date	Product	Reason	Class	Firm
Dec 24, 2013	103" (262 cm) Appx 3.9 ml, Smallbore Bifuse Ext Set w/NanoClave", Anti-Sipho...	ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ...	Class II	ICU Medical, Inc.
Dec 24, 2013	6" (15 cm) Appx 0.58 ml, Smallbore Trifuse Ext Set w/3 NanoClave¿, 3 Clamps,...	ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ...	Class II	ICU Medical, Inc.
Dec 24, 2013	78" Ext Set w/2 BCV-Clave¿, Remv 2-Gang 4-Way Stopcocks, NanoClave" T-Connec...	ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ...	Class II	ICU Medical, Inc.
Dec 24, 2013	5" Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Luer Slip, Item # B330...	ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ...	Class II	ICU Medical, Inc.
Dec 24, 2013	5" Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Rotating Luer, Item #...	ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ...	Class II	ICU Medical, Inc.
Dec 24, 2013	7" (18 cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoCla...	ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ...	Class II	ICU Medical, Inc.
Dec 23, 2013	Horizon Medical Imaging, Picture Archive Communication System (PACS).	Images may be archived to an incorrect or invalid archive location resulting in incorrect images ...	Class II	Mckesson Information Solutions LLC
Dec 23, 2013	Aesculap proSA Adjustment Disc Size Large (L) The Miethke proSA Adjustment...	The accuracy is out of specification for the Aesculap proSA Adjustment Disc Size L.	Class II	Aesculap, Inc.
Dec 22, 2013	ACUSON SC2000 Ultrasound System; Power Input: 100-240VAC, 1600W Max, 50/60 H...	The user interface assembly on the ACUSON SC2000 may become loose with the potential for the ent...	Class II	Siemens Medical Solutions USA, Inc.
Dec 22, 2013	ACUSON SC2000 Power Input: 100-240VAC, 1600 Max 50/60Hz; Siemens Medical ...	The locking mechanism that is intended to hold the control panel in a fixed position can become l...	Class II	Siemens Medical Solutions USA, Inc.
Dec 20, 2013	IMMULITE 2000/2000 XPi Systems Androstenedione (Test Code AND), REF L2KAO2, S...	Siemens Healthcare Diagnostics confirmed over-recovery of samples with concentrations greater tha...	Class II	Siemens Healthcare Diagnostics
Dec 20, 2013	IMMULITE 2000 /IMMULITE 2000 XPi Systems TIE Total IgE, REF L2KIE2, SMN 10380...	Siemens confirmed an overall average positive bias of 23% against the WHO 2nd IRP 75/502 with the...	Class II	Siemens Healthcare Diagnostics
Dec 20, 2013	CARESCAPE Monitor B850, a multi-parameter high acuity patient monitor intende...	There is a potential for communication loss associated with the F5-01 Frame when connected to CAR...	Class II	GE Healthcare, LLC
Dec 20, 2013	Catalys Precision Laser System (United States) - Catalys-U: Catalys Precisio...	Potential for unexpected heating of the transformer mounting bolt located within the system chass...	Class II	Optimedica Corporation
Dec 20, 2013	Compensator Slider Lambda 6x20 component (part number 473704-0000-000) utiliz...	Carl Zeiss Microscopy, LLC has recalled the Compensator Slider Lamda 6x20 component utilized on S...	Class II	Zeiss, Carl Inc
Dec 20, 2013	IMMULITE/IMMULITE 1000 Systems Androstenedione (Test Code AND), REF LKAO1, SM...	Siemens Healthcare Diagnostics confirmed over-recovery of samples with concentrations greater tha...	Class II	Siemens Healthcare Diagnostics
Dec 20, 2013	Orbit soft Infusion sets, 9 mm soft cannula, P10 (42") tubing; Single-Use Set...	Perrigo was notified by our supplier, Ypsomed AG, that they are recalling these batches due to be...	Class II	Perrigo Diabetes Care
Dec 20, 2013	IMMULITE /IMMULITE 1000 Systems TIE Total IgE, REF LKIE1, SMN 10380867, IVD -...	Siemens confirmed an overall average positive bias of 23% against the WHO 2nd IRP 75/502 with the...	Class II	Siemens Healthcare Diagnostics
Dec 19, 2013	Weck, Electrosurgical Coagulation Suction Tube 6 (15.2cm), 11 French, with S...	Sterility cannot be guaranteed.	Class II	Teleflex Medical
Dec 19, 2013	Single and Dual use Emission Computer Tomography gamma cameras (BrightView XC...	Three problems were reported to the firm: When positioning for a relative 180 degree non circu...	Class II	Philips Medical Systems (Cleveland) Inc
Dec 19, 2013	ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 962...	The AriaTele Model 96281 with SpO2 monitoring Option C is recalled because the AriaTele (transmit...	Class II	Spacelabs Healthcare, Llc
Dec 19, 2013	Locking Cortical Screw 3.5mmX38mm REF 8161-35-038	3.5mmx38mm Locking Cortical Screw, implants are being recalled since an investigation identified ...	Class II	Biomet, Inc.
Dec 19, 2013	Zimmer Segmental Systems; Polyethylene Inserts, Size C. Knee replacement.	After evaluation of 13 complaints(0.4% rate) for hyper-extension of the Zimmer Segmental System, ...	Class II	Zimmer, Inc.
Dec 19, 2013	Brilliance CT Big Bore Oncology Whole Body Computed Tomography X-Ray System ...	During internal testing, the Brilliance CT Big Bore was found to be out of tolerance for radio fr...	Class II	Philips Medical Systems (Cleveland) Inc
Dec 19, 2013	Zimmer Segmental Systems; Polyethylene Inserts, Size B. Designed to addres...	After evaluation of 13 complaints(0.4% rate) for hyper-extension of the Zimmer Segmental System, ...	Class II	Zimmer, Inc.
Dec 19, 2013	Weck, Electrosurgical Coagulation Suction Tube 8 (20.0cm), 11 French, with S...	Sterility cannot be guaranteed.	Class II	Teleflex Medical
Dec 19, 2013	VERIFY¿ SixCess 270FP Challenge Pack, STERIS Corporation, 5960 Heisley Road, ...	STERIS has identified that the outer shipping package for one lot (Lot #024552A) of VERIFY¿ SixCe...	Class II	Steris Corporation
Dec 19, 2013	Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulati...	ITC has determined that some Citrate APTT cuvettes may recover higher than expected results in n...	Class II	ITC-Nexus Dx
Dec 19, 2013	On Site Gas Systems POGS 33C Portable Oxygen Generation System	Heat exchanger hose becomes weak and may fail.	Class II	On Site Gas Systems Inc.
Dec 18, 2013	ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled ele...	Possible break in the connector of the Force Sensor.	Class II	Zimmer Biomet, Inc.
Dec 18, 2013	Radial Assist RAD BOARD, used to support the weight of a patient's arm and s...	Merit Medical Systems, Inc. is voluntarily recalling one lot (B507171) of RAD BOARD RB 100 device...	Class II	Merit Medical Systems, Inc.
Dec 18, 2013	ABX PENTRA Urine Control L/H. The ABX PENTRA Urine Control L/H is a two-le...	HORIBA Medical is informing all ABX PENTRA Urine Control L/H customers running the Creatinine ass...	Class III	Horiba Instruments, Inc dba Horiba Medical
Dec 18, 2013	Specialty Straight Static Inserter Assembly Product Usage: This instru...	Stryker has received complaints from customers relating to fracture along the weld that binds the...	Class II	Stryker Spine
Dec 18, 2013	ADVIA Centaur¿ Systems Phenytoin Calibrator N ( PHTN) 6-pack SMN 10314977 ...	ADVIA Centaur¿ Systems Phenytoin Calibrator N, lots CN58 and higher, change in recovery observe...	Class II	Siemens Healthcare Diagnostics, Inc
Dec 18, 2013	ADVIA Centaur¿ Systems Phenytoin Calibrator N ( PHTN) 2-pack SMN 10311391 ...	ADVIA Centaur¿ Systems Phenytoin Calibrator N, lots CN58 and higher, change in recovery observe...	Class II	Siemens Healthcare Diagnostics, Inc
Dec 18, 2013	TopCare Clifford THE BIG RED DOG power toothbrush for kids!	Ranir, LLC is recalling all lots of Up & Up brand Kid's Power Toothbrush and TopCare brand Cliffo...	Class II	Ranir Corporation
Dec 18, 2013	Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Inject...	Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloo...	Class II	Boston Scientific Corporation
Dec 18, 2013	Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injec...	Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloo...	Class II	Boston Scientific Corporation
Dec 18, 2013	Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm Injects...	Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloo...	Class II	Boston Scientific Corporation
Dec 18, 2013	UP & UP kids' power toothbrush	Ranir, LLC is recalling all lots of UP & UP brand Kid's Power Toothbrush and TopCare brand Cliffo...	Class II	Ranir Corporation
Dec 17, 2013	Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems. Automated, clinical c...	An overflow flag //// is displayed in the result column for a test when the algorithm for the tes...	Class II	Siemens Healthcare Diagnostics, Inc.
Dec 17, 2013	Anspach Carbide Cutting Burrs & Drums: 2MM Carbide Fluted Ball, Extended par...	Some carbide cutting burr fractured during use.	Class II	The Anspach Effort, Inc.
Dec 17, 2013	Anspach Carbide Cutting Burrs: 1.5MMx7.5MM Cylindrical Carbide Drum part # S...	Some carbide cutting burr fractured during use.	Class II	The Anspach Effort, Inc.
Dec 17, 2013	Anspach Carbide Cutting Burrs & Drums: 1.5MM x 7.5MM Cylindrical Carbide Dru...	Some carbide cutting burr fractured during use.	Class II	The Anspach Effort, Inc.
Dec 17, 2013	Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine Pa...	Bicarbonate Jug Adapter distributed prior to 510(k) approval	Class II	Fresenius Medical Care Holdings, Inc.
Dec 17, 2013	Anspach Carbide Cutting Burrs: 2MM Carbide Fluted Ball, Standard, 8 Flutes -...	Some carbide cutting burr fractured during use.	Class II	The Anspach Effort, Inc.
Dec 16, 2013	STERRAD 50 Sterilization System, Product Code: 10050 The STERRAD 50 Steriliz...	Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S S...	Class II	Advanced Sterilization Products
Dec 16, 2013	Puritan Bennett 840 ventilator systems software part number 4-070212-85, revi...	Covidien is conducting a voluntary field corrective action on Puritan Bennett 840 ventilator syst...	Class I	Covidien
Dec 16, 2013	SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthc...	GE Healthcare has recently become aware of a potential safety issue which affects all Patient Da...	Class II	GE Healthcare, LLC
Dec 16, 2013	STERRAD NX Sterilization System, Product Code: 10033 The STERRAD NX Steril...	Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S S...	Class II	Advanced Sterilization Products

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.