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Browse Device Recalls

709 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 709 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 709 FDA device recalls in CT.

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DateProductReasonClassFirm
Jul 29, 2022 Hobbs Medical Cytology Brush Catalog Number: 4204 Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, Inc.
Jul 29, 2022 Hobbs Biliary Pigtail Stent Kits (contains 3412) Catalog Number: 6027 Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, Inc.
Jul 29, 2022 Freeman Pancreatic Flexi-Stent Kit (containing 6568) Catalog Number: 6529 Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, Inc.
Jul 29, 2022 Hobbs Medical Polypectomy Snare Catalog Number: 4565-OLY Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, Inc.
Jul 29, 2022 Hobbs Medical Grasping Forceps Catalog Number:5004 Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, Inc.
Jul 29, 2022 Hobbs Posi-Stop Injection Needle Catalog Number: 4722 Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, Inc.
Jul 29, 2022 Hobbs Transbronchial Aspiration Needle Catalog Number: 4621 Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, Inc.
Jul 29, 2022 Freeman Pancreatic Flexi-Stent Kits: Single Pigtail Catalog Number: 6501 Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, Inc.
Jul 29, 2022 Freeman Pancreatic Flexi-Stent Kit (containing 6533) Catalog Number: 6507 Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, Inc.
Jul 29, 2022 Hobbs Medical Polypectomy Snare Catalog Number: 4575-OLY Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, 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 3, 2022 Hobbs Medical Polypectomy Snare, Catalog No. 7202 During use, the sheath of the device may accordion at the proximal end where the sheath meets the... Class II Hobbs Medical, Inc.
May 13, 2022 EEA Autosuture Circular Stapler with DST Series Technology, 25mm. Model Numbe... The affected staplers have the potential for the staple guide to not be securely attached to the ... Class II Covidien, LP
Apr 1, 2022 VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a... Products in this lot may have compromised barrier seals, introducing a risk to sterility. Class II CooperSurgical, Inc.
Mar 31, 2022 CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model: 61-4005S ... Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment o... Class II CooperSurgical, Inc.
Mar 31, 2022 Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-For administering contrast me... Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment o... Class II CooperSurgical, Inc.
Mar 31, 2022 Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media... Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment o... Class II CooperSurgical, Inc.
Mar 18, 2022 Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl... Wrong compression material - Template Ultra Quick matrix Material was packaged instead of the Hea... Class II Clinician's Choice Dental Products Inc.
Dec 28, 2021 Bronchial Microbiology Brush, Catalog Number 4310 and 4320. Microbial samplin... The labeling for the Microbiology Brush identifies the device as a Bronchial Microbiology Brush. ... Class II Hobbs Medical, Inc.
Dec 22, 2021 SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code A... Prior to use on a patient, the device alarm speaker failed to annunciate on power up and the devi... Class II Covidien, LP
Sep 29, 2021 LEEP PRECISION Generator 120V Cooper Surgical Part Number: LP-20-120 Coagulate function may not operate with the use of the Hand Switch, failure of the device to coag... Class II CooperSurgical, Inc.
Sep 29, 2021 Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05 Coagulate function may not operate with the use of the Hand Switch, failure of the device to coag... Class II CooperSurgical, Inc.
Sep 29, 2021 LEEP PRECISION Integrated System, 120V CooperSurgical part number: LP-10-120 Coagulate function may not operate with the use of the Hand Switch, failure of the device to coag... Class II CooperSurgical, Inc.
Sep 29, 2021 LEEP PRECISION Generator 220V Cooper Surgical Part Number: LP-20-220 Coagulate function may not operate with the use of the Hand Switch, failure of the device to coag... Class II CooperSurgical, Inc.
Sep 29, 2021 Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05W XXX Class II CooperSurgical, Inc.
Sep 29, 2021 LEEP PRECISION Integrated System, 220V CooperSurgical part numbers: LP-10-220 Coagulate function may not operate with the use of the Hand Switch, failure of the device to coag... Class II CooperSurgical, Inc.
Sep 29, 2021 Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075 Coagulate function may not operate with the use of the Hand Switch, failure of the device to coag... Class II CooperSurgical, Inc.
Sep 22, 2021 QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleedin... Lack of Packaging seal integrity may result in a sterile barrier breach. Class II Z-Medica, LLC
Jun 30, 2021 Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Wo... Units are displaying output readings that differ from the measurements taken using a Gas Analyzer... Class II CooperSurgical, Inc.
May 28, 2021 Palindrome RT Repair Kit 15 FR TAL 28cm, Sterile, Item Code 8888541128 This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... Class II Covidien, LP
May 28, 2021 Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunnele... This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... Class II Covidien, LP
May 28, 2021 Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch... This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... Class II Covidien, LP
May 28, 2021 Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch... This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... Class II Covidien, LP
May 28, 2021 Palindrome RT Repair Kit 15 FR TAL 19cm, Sterile, Item Code 8888541119 This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... Class II Covidien, LP
May 28, 2021 Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch... This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... Class II Covidien, LP
May 28, 2021 Palindrome RT Repair Kit 15 FR TAL 23cm, Sterile, Item Code 8888541123 This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... Class II Covidien, LP
May 28, 2021 Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunnele... This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... Class II Covidien, LP
May 28, 2021 Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch... This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... Class II Covidien, LP
May 28, 2021 Palindrome RT Repair Kit 15 FR TAL 33cm, Sterile, Item Code 8888541133 This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... Class II Covidien, LP
May 28, 2021 Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch... This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... Class II Covidien, LP
May 28, 2021 Palindrome RT Repair Kit 15 FR TAL 44cm, Sterile, Item Code 8888541144 This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... Class II Covidien, LP
May 28, 2021 Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunnele... This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... Class II Covidien, LP
May 28, 2021 Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch... This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... Class II Covidien, LP
May 28, 2021 Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunnele... This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... Class II Covidien, LP
May 28, 2021 Palindrome RT Repair Kit 15 FR TAL 55cm, Sterile, Item Code 8888541155 This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... Class II Covidien, LP
May 28, 2021 Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunnele... This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... Class II Covidien, LP
May 28, 2021 Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunnele... This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... Class II Covidien, LP
Apr 30, 2021 CooperSurgical Wallach Loop Electrode 10mm x 10mm Square P/N: 909131. Dispo... The affected Wallach LOOP Electrodes were incorrectly packaged with a Round Electrode inside a pa... Class II CooperSurgical, Inc.
Apr 29, 2021 HME for Tracheostomized Patients, Item Code 353S13046 - Product Usage: indica... The company was notified by their supplier of sterilization services for airway products in Italy... Class II Covidien, LP
Apr 29, 2021 Electrostatic Filter Angled, Item Code 350S19006 - Product Usage: indicated f... The company was notified by their supplier of sterilization services for airway products in Italy... Class II Covidien, LP

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.