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
Dec 18, 2019	Polysorb Braided Absorbable Suture 4/0 30 VIO SC-2 124K, Item Code SL654 - Pr...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 2 36" VIOLET GS-24, Item Code CL911 - Prod...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 0 30" UNDYED HOS-11, Item Code CL537 - Pro...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 6-0 18" UNDYED SS-24 D/A, Item Code L2752K...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 6/0 18" UNDYED P-10, Item Code SL1625G - P...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 13, 2019	ADVANCED ENDOSEE System CANNULA, Cooper Surgical Product Code/Model Number: E...	Potential for unsealed pouches in two (2) lots of the Endosee Advance Cannula (P/N: ESPX5).	Class II	CooperSurgical, Inc.
Nov 21, 2019	The products involved are DeWALT laser distance measurers, model numbers DW01...	The products are labeled as Class II lasers. However, the level of laser radiation emitted by the...	Class II	STANLEY BLACK & DECKER INC.
Oct 16, 2019	Quantam 2000 Electrosurgical Generator, Part number 909075-05.	Potential for the Quantum 2000 Electrosurgery Generator, part numbers 909075, 909075-05 and 90907...	Class II	CooperSurgical, Inc.
Oct 16, 2019	Quantam 2000 Electrosurgical Generator, Part number 909075.	Potential for the Quantum 2000 Electrosurgery Generator, part numbers 909075, 909075-05 and 90907...	Class II	CooperSurgical, Inc.
Oct 16, 2019	Quantam 2000 Electrosurgical Generator, Part number 909075-05W.	Potential for the Quantum 2000 Electrosurgery Generator, part numbers 909075, 909075-05 and 90907...	Class II	CooperSurgical, Inc.
Sep 5, 2019	Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-8...	The touchpad may not work properly after cleaning.	Class III	CooperSurgical, Inc.
Aug 19, 2019	LEEP Return Patient Pads (10/ box) Model # 6050Pl used in electrosurgical ...	Discrepancy between the correct expiration dates on the individual pouches inside the boxes and i...	Class III	CooperSurgical, Inc.
Jul 8, 2019	TransWarmer Warming Infant Transport Mattress, Model no. 20421 Product Us...	The firm updated the IFU in April 2019 to clarify that use of the TRANSWARMER Mattress with other...	Class II	CooperSurgical, Inc.
Jun 18, 2019	LEEP Precision Integrated System 120V & LEEP Precision Generator, Model Nos. ...	The products' cut, coagulate, or blend function may not operate with the use of the Foot Pedal.	Class II	CooperSurgical, Inc.
Jun 14, 2019	Advincula Delineator with Ultem Plastic Soft Cup size 2.5 cm; Part No. AD750S...	The soft, flexible cup of the Advincula Delineator may be unvalidated and could potentiall crack ...	Class II	CooperSurgical, Inc.
Jun 14, 2019	Advincula Delineator with Ultem Plastic Soft Cup size 3.0 cm; Part No. AD750S...	The soft, flexible cup of the Advincula Delineator may be unvalidated and could potentiall crack ...	Class II	CooperSurgical, Inc.
May 17, 2019	EGIA45 CT AR MD THK REL, EGIA45CTAMT	The device may be missing one of two pin components that maintain alignment of the device jaws, r...	Class II	Covidien LLC
May 17, 2019	EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT	The device may be missing one of two pin components that maintain alignment of the device jaws, r...	Class II	Covidien LLC
May 17, 2019	SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT	The device may be missing one of two pin components that maintain alignment of the device jaws, r...	Class II	Covidien LLC
May 17, 2019	SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT	The device may be missing one of two pin components that maintain alignment of the device jaws, r...	Class II	Covidien LLC
May 17, 2019	EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT	The device may be missing one of two pin components that maintain alignment of the device jaws, r...	Class II	Covidien LLC
May 17, 2019	EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT	The device may be missing one of two pin components that maintain alignment of the device jaws, r...	Class II	Covidien LLC
May 17, 2019	SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT	The device may be missing one of two pin components that maintain alignment of the device jaws, r...	Class II	Covidien LLC
May 17, 2019	EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT	The device may be missing one of two pin components that maintain alignment of the device jaws, r...	Class II	Covidien LLC
May 17, 2019	EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT	The device may be missing one of two pin components that maintain alignment of the device jaws, r...	Class II	Covidien LLC
May 17, 2019	SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT	The device may be missing one of two pin components that maintain alignment of the device jaws, r...	Class II	Covidien LLC
May 17, 2019	SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT	The device may be missing one of two pin components that maintain alignment of the device jaws, r...	Class II	Covidien LLC
May 17, 2019	EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT	The device may be missing one of two pin components that maintain alignment of the device jaws, r...	Class II	Covidien LLC
May 8, 2019	Draco Enzymatic Deep-Cleaning Pad with Ready-to-Use Enzymatic Detergent, Prod...	This product has been contaminated with Stenotrophomonas lactiubi.	Class II	Madison Polymeric Engineering
May 8, 2019	First Step Draco Pad, Product Number EP-4D	This product has been contaminated with Stenotrophomonas lactiubi.	Class II	Madison Polymeric Engineering
Apr 23, 2019	LEEP Precision Integrated System 120V, Model LP-10-120 Product Usage: The...	2.5A slow blow fuses may have been installed in the LEEP RPECISION Generator rather than the appr...	Class II	CooperSurgical, Inc.
Mar 27, 2019	ICSI MICROPIPETTE CooperSurgical part number: MICC001-30-B1.0	ICSI CUSTOM MICROPIPETTES the thirty-degree bend is absent	Class II	CooperSurgical, Inc.
Feb 18, 2019	Avitus¿ Bone Harvester w/ Filter Insert - 5mm intended to harvest cancellous...	Breach in the sterile barrier pouch may compromise sterility of the device.	Class II	Avitus Orthopaedics, Inc.
Feb 18, 2019	Avitus¿ Bone Harvester w/ Filter Insert - 8mm intended to harvest cancellou...	Breach in the sterile barrier pouch may compromise sterility of the device.	Class II	Avitus Orthopaedics, Inc.
Dec 14, 2018	Draco Enzymatic Deep-Cleaning Pads, Product Number HY0305Z Product Usage: ...	The product is contaminated with Pseudomonas.	Class II	Madison Polymeric Engineering
Dec 6, 2018	I-View¿ Contrast Enhanced Digital Mammography, ASY-08109	Calibration issue not possible to visualize contrast uptake in the subtracted mammography images	Class II	Hologic, Inc.
Nov 15, 2018	Covidien Emprint Short Percutaneous Antenna with Thermosphere Technology, Mat...	The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna dise...	Class II	Covidien LLC
Nov 15, 2018	Covidien Emprint Long Percutaneous Antenna with Thermosphere Technology, Mate...	The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna dise...	Class II	Covidien LLC
Nov 15, 2018	Covidien Emprint Standard Percutaneous Antenna with Thermosphere Technology, ...	The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna dise...	Class II	Covidien LLC
Oct 5, 2018	Parietex Composite Parastomal Mesh (Product Number PCOPM15 / PCOPM20) Prod...	The firm is issuing this voluntary removal following receipt of reports of parastomal mesh failur...	Class II	Covidien LLC
Oct 1, 2018	YXLON Cheetah cabinet X-Ray System Product Usage: The products are genera...	Failure to meet the requirement of the performance standard for cabinet x-ray systems (21 CFR 102...	Class II	Comet Technologies Usa Inc
Oct 1, 2018	YXLON Cougar Cabinet X-Ray System Product Usage: The products are general...	Failure to meet the requirement of the performance standard for cabinet x-ray systems (21 CFR 102...	Class II	Comet Technologies Usa Inc
Sep 4, 2018	Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) Product Us...	There is a possibility that the seal of the sterile pouch may be compromised, thereby increasing ...	Class II	CooperSurgical, Inc.
Sep 4, 2018	Colpo-Pneumo Occluder, Part CPO-6	The seal of the sterile pouch may be compromised, thereby increasing the risk of infection.	Class II	CooperSurgical, Inc.
Jul 26, 2018	Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems. Prod...	Revised replacement instructions for the Li-ion battery packs used in BIS Vista and BIS View Moni...	Class II	Covidien LLC
Jun 15, 2018	Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number ...	Potential proplylene glycol contamination	Class II	Covidien LLC
Jun 13, 2018	O-SPOT REF 791, 791S Adhere to skin for marking and identifying moles in ...	There is a potential for imaging artifact to mimic calcifications on patient's mammograms	Class II	Beekley Corporation
Jun 13, 2018	TomoSPOT REF 782, 782S, 783, 783S, 784, 784S, 785 & 785S Adhere to skin f...	There is a potential for imaging artifact to mimic calcifications on patient's mammograms	Class II	Beekley Corporation
Jun 13, 2018	S-SPOT REF 777, 777S Adhere to skin for marking and identifying moles in ...	There is a potential for imaging artifact to mimic calcifications on patient's mammograms	Class II	Beekley Corporation
May 22, 2018	Tri-Staple 2.0 Black Intelligent Reload for use with Signia stapling system 6...	Device may be missing a sled component. The sled component is responsible for staple deployment. ...	Class II	COVIDIEN MEDTRONIC

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.