Browse Device Recalls

3,013 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,013 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 3,013 FDA device recalls in 2018.

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DateProductReasonClassFirm
Mar 9, 2018 Hamilton-C3 Ventilator Unit Product Usage: The HAMILTON-C3 ventilator is ... An out of specification component on the control board may cause the ventilator to open the inspi... Class II Hamilton Medical AG
Mar 9, 2018 6381 M-1 Cot Fastener, catalog no. 6381000000 The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect i... Class II Stryker Medical Division of Stryker Corporation
Mar 9, 2018 Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD.... The product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the... Class II The Binding Site Group, Ltd.
Mar 8, 2018 SOUTHERN IMPLANTS REF IBR12d-13, Implant, Ext. Hex, tapered 12o Co-Axis(TM) i... The UDI label correctly reads IBR12d-13, however, the inner label incorrectly read IBNT12d-13. Class II Southern Implants, (Pty.) Ltd.
Mar 7, 2018 Edwards Lifesciences Femoral Venous Cannula, 20F X 55CM, resterilized. The expiration date on the device labeling exceeds its actual validated shelf life because the st... Class II SPS Sterilization, Inc
Mar 7, 2018 Edwards Lifesciences Aortic Perfusion Cannula, 24F x 30CM, resterilized. The expiration date on the device labeling exceeds its actual validated shelf life because the st... Class II SPS Sterilization, Inc
Mar 7, 2018 Edwards Lifesciences Optisite Arterial Perfusion Cannula, 22F X 24CM, resteri... The expiration date on the device labeling exceeds its actual validated shelf life because the st... Class II SPS Sterilization, Inc
Mar 7, 2018 Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Self-Expanding... The expiration date on the device labeling exceeds its actual validated shelf life because the st... Class II SPS Sterilization, Inc
Mar 7, 2018 Edwards Lifesciences Femoral Venous Cannula, 18FR, resterilized. The expiration date on the device labeling exceeds its actual validated shelf life because the st... Class II SPS Sterilization, Inc
Mar 7, 2018 Edwards Lifesciences EZ Glide Aortic Cannula, 24F x 37.6CM, resterilized. The expiration date on the device labeling exceeds its actual validated shelf life because the st... Class II SPS Sterilization, Inc
Mar 7, 2018 Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding St... The expiration date on the device labeling exceeds its actual validated shelf life because the st... Class II SPS Sterilization, Inc
Mar 7, 2018 Vascular Solutions Venture Rx Catheter, 6F, resterilized. The expiration date on the device labeling exceeds its actual validated shelf life because the st... Class II SPS Sterilization, Inc
Mar 7, 2018 Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Transhepatic B... The expiration date on the device labeling exceeds its actual validated shelf life because the st... Class II SPS Sterilization, Inc
Mar 7, 2018 Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding St... The expiration date on the device labeling exceeds its actual validated shelf life because the st... Class II SPS Sterilization, Inc
Mar 7, 2018 Product: Milford Smartbase Model # 9934105 Pride SmartBase Pride product ... Recalling firm was informed that as a result of combination of a weak spring and incorrect alignm... Class II Autochair
Mar 7, 2018 Boston Scientific Wallstent Enteral Endoprosthesis Colonic/Duodenal Stent, 22... The expiration date on the device labeling exceeds its actual validated shelf life because the st... Class II SPS Sterilization, Inc
Mar 7, 2018 Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 38FRX40C... The expiration date on the device labeling exceeds its actual validated shelf life because the st... Class II SPS Sterilization, Inc
Mar 7, 2018 Boston Scientific Wallstent Endoprosthesis Tracheobronchial Transhepatic Bili... The expiration date on the device labeling exceeds its actual validated shelf life because the st... Class II SPS Sterilization, Inc
Mar 7, 2018 D-RAD Self-Tapping Locking Screw intended for the fixation of fractures invol... One lot of D-RAD Self-Taping Locking Screws used with the Distal Radius Fracture Kit were machine... Class II Smith & Nephew, Inc.
Mar 7, 2018 Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 34F (11.... The expiration date on the device labeling exceeds its actual validated shelf life because the st... Class II SPS Sterilization, Inc
Mar 7, 2018 Edwards Lifesciences Avid Dual Stage Venous Drainage Cannula, 29/37F (9.6/12.... The expiration date on the device labeling exceeds its actual validated shelf life because the st... Class II SPS Sterilization, Inc
Mar 7, 2018 da Vinci X Surgical System, Model IS4200. Product Usage: The Intuitive Su... Specific da Vinci X Surgical Systems (IS4200) were shipped with defective Arm Controller Joint (A... Class II Intuitive Surgical, Inc.
Mar 7, 2018 Evicel Accessory Device - 45 cm Flexible Tip (SET OF 3), Product Code EVT45. ... Products labeled for distribution outside the United States may have been distributed to customer... Class II Ethicon, Inc.
Mar 6, 2018 Manuka Honey Wound Gel Catalogue No: 716597 Product Usage: Helps maintai... Incorrect gel part number listed in a master manufacturing record Class II Integra LifeSciences Corp.
Mar 5, 2018 ST-AIA PACK IRI; Part Number: 025260 Assay, Diabetes Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 Part no. 690.375, Graphic Case F/6.5mm & 7.3mm Combined Cannulated Screw Set Affected screw gauges incorrectly measure screws 5.41mm shorter than the actual overall screw len... Class II Synthes (USA) Products LLC
Mar 5, 2018 ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medic... The ECG signal may flatline due to electromagnetic interference during the use of electrosurgical... Class II Siemens Medical Solutions USA, Inc.
Mar 5, 2018 AIA-PACK TSH 3rd Generation; Part Number: 020294 Assay, Thyroid Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 ST-AIA PACK SHBG; Part Number: 025238 Assay, Reproductive Hormone Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 Tosoh ST AIA-PACK HbA1c Pretreatment Solution, HbA1c Pretreatment Solution, P... The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient re... Class II Tosoh Bioscience Inc
Mar 5, 2018 ST-AIA PACK Myoglobin; Part Number: 025297 Assay, Cardiac Marker Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 ST-AIA PACK HCG; Part Number: 025256 Assay, Reproductive Hormone Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 ST-AIA PACK C-Peptide II; Part Number: 025283 Assay, Diabetes Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 ST-AIA PACK BMG; Part Number:025259 Assay, Tumor Marker Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 ST-AIA PACK PAP; Part Number: 025262 Assay, Prostate Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 ST-AIA PACK Estradiol; Part Number: 025274 Assay, Reproductive Hormone Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 ST-AIA PACK cTnI 2nd Gen; Part Number: 025205 Assay, Cardiac Marker Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 ST-AIA PACK TT3; Part Number: 025282 Assay, Thyroid Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 ST-AIA PACK FT3; Part Number: 025286 Assay, Thyroid Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 Tosoh ST AIA-PACK HbA1c Calibrator, HbA1c Calibrator, PN 025318 The produc... The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient re... Class II Tosoh Bioscience Inc
Mar 5, 2018 ST-AIA PACK hsE2; Part Number: 025225 Assay, Reproductive Hormone Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 Part no. 690.380, Graphic Case F/7.3mm Cannulated Screw Set Affected screw gauges incorrectly measure screws 5.41mm shorter than the actual overall screw len... Class II Synthes (USA) Products LLC
Mar 5, 2018 ST-AIA PACK C-Peptide; Part Number: 025284 Assay, Diabetes Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 ST-AIA PACK AFP; Part Number: 025252 Assay, Tumor Marker Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 ST-AIA PACK HGH; Part Number: 025266 Assay, Metabolic Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 ST-AIA PACK TU; Part Number: 025270 Assay, Thyroid Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 ST-AIA PACK Cystatin C; Part Number: 025217 Assay, Kidney Marker Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 Tosoh ST AIA-PACK HbA1c, HbA1c Reagent, Pt. No. 025218 The device is desig... The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient re... Class II Tosoh Bioscience Inc
Mar 5, 2018 ST-AIA PACK FT4; Part Number: 025268 Assay, Thyroid Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 ST-AIA DHEA-S; Part Number: 025222 Assay, Reproductive Hormone Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience 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.