Browse Device Recalls

2,276 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,276 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 2,276 FDA device recalls in 2022.

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DateProductReasonClassFirm
Jun 16, 2022 Various convenience packs Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class II American Contract Systems, Inc.
Jun 16, 2022 Various convenience packs Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class II American Contract Systems, Inc.
Jun 16, 2022 Various C-section packs Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class II American Contract Systems, Inc.
Jun 16, 2022 Breast Abdominoplasty Pack Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class II American Contract Systems, Inc.
Jun 16, 2022 Various Angiography packs/trays Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class II American Contract Systems, Inc.
Jun 16, 2022 AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic P... Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised... Class II Fresenius Medical Care Holdings, Inc.
Jun 15, 2022 Sensis Vibe Combo with software version VD12A. A diagnostic and administrati... Sensis/Sensis Vibe SoftwareVD12A, the ComboBox may encounter a disconnect of its communication du... Class II Siemens Medical Solutions USA, Inc
Jun 15, 2022 SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral... Various brands of SARS CoV 2 Antigen Rapid Test kits were offered for sale and distribution to c... Class I North American Diagnostics
Jun 15, 2022 Sensis with software version VD12A. A diagnostic and administrative tool su... Sensis/Sensis Vibe SoftwareVD12A, the ComboBox may encounter a disconnect of its communication du... Class II Siemens Medical Solutions USA, Inc
Jun 15, 2022 SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-... When scanning sponges out after a surgical procedure, an error may allow for a duplicate sponge t... Class II Stryker Instruments Div. of Stryker Corporation
Jun 14, 2022 Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative co... The Instructions for Use (IFU, Part Number 750095) provided with the affected lots by the firm co... Class III R & D Systems, Inc.
Jun 14, 2022 Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1 The default reference ranges for MCH, MCHC, and RDW for age group "Child 2-11y" are mixed up and ... Class II SIGHT DIAGNOSTICS LTD
Jun 14, 2022 Wright EVOLVE TRIAD Plate Cutter, REF 49510120 The plate cutter is unable to meet sterilization requirements when it is sterilized in a double-w... Class II Wright Medical Technology, Inc.
Jun 14, 2022 Centricity PACS Software Version 7.0 SP0.0.4.7 The Event Notification Manager (ENM) functionality for certain products does not process notifica... Class II GE Healthcare, LLC
Jun 13, 2022 Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobiliz... Some of the rods in this lot were observed to have discoloration, later confirmed to be indicatio... Class II K2M, Inc.
Jun 13, 2022 LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055 There was translation error in the Spanish version of the IFU where the Spanish version instructs... Class II CooperSurgical, Inc.
Jun 10, 2022 HAIOU Needle retractable safety syringe with needle-(1ml syringe with 25G x 1... Complaints received in which needle and needle holder have detached from the syringe after inject... Class II Guangdong Haiou Medical Apparatus Co., Ltd
Jun 10, 2022 RayStation 11B This notice concerns two issues found related to the display of Linear Energy Transfer (LET) in R... Class II RAYSEARCH LABORATORIES AB
Jun 10, 2022 Haiou Needle Retractable Safety Syringe with Needle-1ML 23G x 1 (0.6x25mm). ... Complaints received in which needle and needle holder have detached from the syringe after inject... Class II Guangdong Haiou Medical Apparatus Co., Ltd
Jun 10, 2022 Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Ca... Between March 2, 2021 and December 31, 2021, the product label used in production did not contain... Class III Invacare Corporation
Jun 10, 2022 Artis Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000 A video signal from one of the transceivers of the Large Display may be lost. In very rare cases,... Class II Siemens Medical Solutions USA, Inc
Jun 9, 2022 Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ... When connected to the EnSite Precision Navigation System, an affected TactiCath Contact Force Abl... Class II Abbott
Jun 9, 2022 CoolCore ZELTIQ Vacuum Applicator REF BRZ-AP1-063-000 Executing a voluntary discontinuation and removal of parallel plate applicators due to an increas... Class II Zeltiq Aesthetics, Inc
Jun 9, 2022 Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4 P... Due to latex gloves being include in Custom Pak. Kits are supposed to include non-latex gloves. Class II Alcon Research, LLC
Jun 9, 2022 REF: 08P4320, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2... There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be genera... Class II Abbott Laboratories
Jun 9, 2022 CoolCurve+ ZELTIQ Vacuum Applicator REF BRZ-AP1-064-000 Executing a voluntary discontinuation and removal of parallel plate applicators due to an increas... Class II Zeltiq Aesthetics, Inc
Jun 9, 2022 Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF... A customer reported a problem with the reagent and calibrator. Randox Laboratories carried out an... Class III Randox Laboratories Ltd.
Jun 9, 2022 CoolCurve ZELTIQ Vaccum Applicator REF BRZ-AP1-062-000 Executing a voluntary discontinuation and removal of parallel plate applicators due to an increas... Class II Zeltiq Aesthetics, Inc
Jun 9, 2022 CoolFit ZELTIQ Vacuum Applicator REF BRZ-AP1-066-000 Executing a voluntary discontinuation and removal of parallel plate applicators due to an increas... Class II Zeltiq Aesthetics, Inc
Jun 9, 2022 CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000 Executing a voluntary discontinuation and removal of parallel plate applicators due to an increas... Class II Zeltiq Aesthetics, Inc
Jun 9, 2022 REF: 4P52-20 Hemoglobin A1c for use with Architect, IVD, CE, R1 1 x 52 mL, R2... There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be genera... Class II Abbott Laboratories
Jun 9, 2022 Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use On... A customer reported a problem with the reagent and calibrator. Randox Laboratories carried out an... Class III Randox Laboratories Ltd.
Jun 9, 2022 REF: 08P4377, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2... There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be genera... Class II Abbott Laboratories
Jun 8, 2022 Palindrome HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and ... There is a potential leaking condition within the hub of specific chronic dialysis catheters, due... Class I Covidien Llc
Jun 8, 2022 Palindrome Precision SI Chronic Catheter, Sterile, Single Use, Rx Only. For v... There is a potential leaking condition within the hub of specific chronic dialysis catheters, due... Class I Covidien Llc
Jun 8, 2022 Palindrome Precision H Chronic Catheter, Sterile, Single Use, Rx Only. For va... There is a potential leaking condition within the hub of specific chronic dialysis catheters, due... Class I Covidien Llc
Jun 8, 2022 Palindrome Chronic Catheter, Sterile, Single Use, Rx Only. For vascular acces... There is a potential leaking condition within the hub of specific chronic dialysis catheters, due... Class I Covidien Llc
Jun 8, 2022 Mahurkar Chronic Carbothane (Maxid) Catheter, Sterile, Single Use, Rx Only. F... There is a potential leaking condition within the hub of specific chronic dialysis catheters, due... Class I Covidien Llc
Jun 8, 2022 Palindrome SI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and c... There is a potential leaking condition within the hub of specific chronic dialysis catheters, due... Class I Covidien Llc
Jun 8, 2022 Palindrome H Chronic Catheter, Sterile, Single Use, Rx Only. For acute and ch... There is a potential leaking condition within the hub of specific chronic dialysis catheters, due... Class I Covidien Llc
Jun 8, 2022 Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For ... There is a potential leaking condition within the hub of specific chronic dialysis catheters, due... Class I Covidien Llc
Jun 8, 2022 Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vasc... There is a potential leaking condition within the hub of specific chronic dialysis catheters, due... Class I Covidien Llc
Jun 8, 2022 GE Centricity Universal Viewer Zero Footprint. To view, communicate, proces... Potential to display inaccurate measurements on images in Centricity Universal Viewer Zero Footpr... Class II GE Healthcare, LLC
Jun 7, 2022 TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet t... Electrical component failure within the control unit. The observed failure mode is a loss of func... Class II Covidien Llc
Jun 7, 2022 HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Va... The product is not able to provide irrigation. Class II Davol, Inc.
Jun 7, 2022 HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Va... The product is not able to provide irrigation. Class II Davol, Inc.
Jun 6, 2022 Medline convenience kits labeled as: a. MIDDLE EAR PACK-LF, Model DYNJ068909... Kits contain leaking bottles of isopropyl alcohol Class II MEDLINE INDUSTRIES, LP - SPT
Jun 6, 2022 Brand Name: Medline Product Name: convenience kits labeled as: LAP CHOLE M... Kits contain leaking bottles of isopropyl alcohol Class II MEDLINE INDUSTRIES, LP - SPT
Jun 6, 2022 Medline Convenience kits labeled as: a. MAJOR VASCULAR CDS, b. POST OP KIT, ... Kits contain leaking bottles of isopropyl alcohol Class II MEDLINE INDUSTRIES, LP - SPT
Jun 6, 2022 Kits contain leaking bottles of isopropyl alcohol Class II MEDLINE INDUSTRIES, LP - SPT

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.