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.

Clear

Date	Product	Reason	Class	Firm
Aug 6, 2015	Mahurkar Acute Dual Lumen Catheter Tray, High Flow¿ Pre-Curved with IC* Safet...	Sterility may be compromised	Class II	Covidien LLC
Aug 6, 2015	MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16cm, Curve...	Sterility may be compromised	Class II	Covidien LLC
Aug 6, 2015	Monoject 0.9% Saline Flush Prefill Double Pouch Item Code: 8881570129 Produ...	Sterility may be compromised	Class II	Covidien LLC
Aug 5, 2015	Villa Sistemi Rotograph EVO 3D X-ray	It has been discovered that due to lack of information accompanying documents the product fails t...	Class II	Villa Radiology Systems LLC
Aug 5, 2015	Owandy Radiology I -MAX Touch 3D X-ray	It has been discovered that due to lack of information accompanying documents the product fails t...	Class II	Villa Radiology Systems LLC
Jul 31, 2015	Covidien Argyle Infant Heel Warmers (no tab) Item Code: MH00002N Product ...	Infant Heel warmers may break during activation resulting in spillage of the contents on patients...	Class II	Covidien LLC
Jul 31, 2015	Covidien Argyle Infant Heel Warmers (with tab) Item Code: MH00002T Produc...	Infant Heel warmers may break during activation resulting in spillage of the contents on patients...	Class II	Covidien LLC
Jul 6, 2015	Infant Heel Warmer and Infant Gel Warmer, sold under the brand names CooperSu...	Product marketed without a 510(k)	Class II	CooperSurgical, Inc.
Jun 19, 2015	Milex Vaginal-Hymenal Silicone Dilators Set of 4 P/N MX20 Product Usage...	Incorrect expiration date on outer carton kit label	Class II	CooperSurgical, Inc.
May 20, 2015	MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80	A diaphragm size 80 labeled box was incorrectly packaged with a size 85.	Class II	CooperSurgical, Inc.
May 18, 2015	Ally Uterine Positioning System (Ally UPS) used in the mounting and position...	Design of device may expose user to injury to fingers or body parts	Class II	CooperSurgical, Inc.
May 4, 2015	Spine Wave Access Kit, Catalog Number 10-1530 Package contents: RLSP494-Rhyt...	Mislabeled outer carton: Monopolar Probe is listed as 200 x 1.5mm when it should be listed as 28...	Class II	Spine Wave, Inc.
Apr 27, 2015	Dr. Sheffield's LUBRI GEL 3 oz (85 g) Non sterile over-the-counter persona...	Recovery of high count of gram positive rods including single colonies of B. cepacia.	Class II	Sheffield Pharmaceuticals, LLC
Apr 23, 2015	Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33c...	Catheters may not meet antimicrobial specification	Class II	Covidien LLC
Apr 23, 2015	Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item C...	Catheters may not meet antimicrobial specification	Class II	Covidien LLC
Apr 23, 2015	Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr...	Catheters may not meet antimicrobial specification	Class II	Covidien LLC
Apr 23, 2015	Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm Item Code: 8888245064	Catheters may not meet antimicrobial specification	Class II	Covidien LLC
Apr 23, 2015	Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 88881...	Catheters may not meet antimicrobial specification	Class II	Covidien LLC
Apr 23, 2015	Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Cod...	Catheters may not meet antimicrobial specification	Class II	Covidien LLC
Apr 23, 2015	Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Cod...	Catheters may not meet antimicrobial specification	Class II	Covidien LLC
Apr 23, 2015	Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm I...	Catheters may not meet antimicrobial specification	Class II	Covidien LLC
Apr 23, 2015	Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item C...	Catheters may not meet antimicrobial specification	Class II	Covidien LLC
Apr 23, 2015	Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Co...	Catheters may not meet antimicrobial specification	Class II	Covidien LLC
Apr 23, 2015	Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Cod...	Catheters may not meet antimicrobial specification	Class II	Covidien LLC
Apr 23, 2015	Palindrome SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066C	Catheters may not meet antimicrobial specification	Class II	Covidien LLC
Apr 23, 2015	Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 28 cm Item Code:8888228458	Catheters may not meet antimicrobial specification	Class II	Covidien LLC
Apr 23, 2015	Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 88881...	Catheters may not meet antimicrobial specification	Class II	Covidien LLC
Apr 23, 2015	Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Cod...	Catheters may not meet antimicrobial specification	Class II	Covidien LLC
Apr 23, 2015	Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm...	Catheters may not meet antimicrobial specification	Class II	Covidien LLC
Apr 23, 2015	Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm ...	Catheters may not meet antimicrobial specification	Class II	Covidien LLC
Apr 23, 2015	Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm...	Catheters may not meet antimicrobial specification	Class II	Covidien LLC
Apr 23, 2015	Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Co...	Catheters may not meet antimicrobial specification	Class II	Covidien LLC
Apr 23, 2015	Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 44cm Item Code: 88881...	Catheters may not meet antimicrobial specification	Class II	Covidien LLC
Apr 23, 2015	Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item C...	Catheters may not meet antimicrobial specification	Class II	Covidien LLC
Apr 23, 2015	Palindrome SI Chronic Catheter Kit 14.5 Fr x 23cm Item Code: 8888245063	Catheters may not meet antimicrobial specification	Class II	Covidien LLC
Apr 23, 2015	Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm ...	Catheters may not meet antimicrobial specification	Class II	Covidien LLC
Apr 23, 2015	Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 44cm Item Code: 88881...	Catheters may not meet antimicrobial specification	Class II	Covidien LLC
Apr 23, 2015	Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm...	Catheters may not meet antimicrobial specification	Class II	Covidien LLC
Apr 23, 2015	Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23c...	Catheters may not meet antimicrobial specification	Class II	Covidien LLC
Apr 23, 2015	Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Co...	Catheters may not meet antimicrobial specification	Class II	Covidien LLC
Apr 23, 2015	Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 F...	Catheters may not meet antimicrobial specification	Class II	Covidien LLC
Apr 23, 2015	Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28c...	Catheters may not meet antimicrobial specification	Class II	Covidien LLC
Apr 23, 2015	Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm Item Code: 8888245064	Catheters may not meet antimicrobial specification	Class II	Covidien LLC
Apr 23, 2015	Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 F...	Catheters may not meet antimicrobial specification	Class II	Covidien LLC
Apr 23, 2015	Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm I...	Catheters may not meet antimicrobial specification	Class II	Covidien LLC
Apr 23, 2015	Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm...	Catheters may not meet antimicrobial specification	Class II	Covidien LLC
Apr 23, 2015	Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item C...	Catheters may not meet antimicrobial specification	Class II	Covidien LLC
Apr 23, 2015	Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19c...	Catheters may not meet antimicrobial specification	Class II	Covidien LLC
Apr 23, 2015	Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm I...	Catheters may not meet antimicrobial specification	Class II	Covidien LLC
Apr 23, 2015	Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Co...	Catheters may not meet antimicrobial specification	Class II	Covidien LLC

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.