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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Date	Product	Reason	Class	Firm
Apr 26, 2018	BOX KIT00713 KIT BY PASS Product Usage: The Endo GIA universal and Endo ...	Device may be missing a sled component. The sled component is responsible for staple deployment. ...	Class II	COVIDIEN MEDTRONIC
Apr 26, 2018	(1) BOX LAPZD ZESTAW DO SG (2) BOX LAPISG1 ZESTAW DO SG (3) BOX LAPISGW...	Device may be missing a sled component. The sled component is responsible for staple deployment. ...	Class II	COVIDIEN MEDTRONIC
Apr 26, 2018	(1)BOX HEMIGX1 ZESTAW DO HEMICOLECTOMII (Item Number HEMIGX1 ZESTAW DO HE...	Device may be missing a sled component. The sled component is responsible for staple deployment. ...	Class II	COVIDIEN MEDTRONIC
Apr 26, 2018	BOX TGGLOGOWX1 DO TOTAL GASTRECTOMIII Product Usage: The Endo GIA univer...	Device may be missing a sled component. The sled component is responsible for staple deployment. ...	Class II	COVIDIEN MEDTRONIC
Apr 9, 2018	EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 4.8MM, P...	There is a potential for improper welding of the yellow staple guide to the instrument. Use of a ...	Class II	Covidien LLC
Apr 9, 2018	EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 3.5MM, P...	There is a potential for improper welding of the yellow staple guide to the instrument. Use of a ...	Class II	Covidien LLC
Mar 21, 2018	Draco Enzymatic Deep-Cleaning Pad, Draco Pad infused with Simple2 Enzymatic D...	The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.	Class II	Madison Polymeric Engineering
Mar 21, 2018	First Step Endoscopic Cleaning Pad with 4" Button Brush, 200ml, Flexible Endo...	The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.	Class II	Madison Polymeric Engineering
Mar 21, 2018	First Step Endoscopic Cleaning Pad, 500ml, Flexible Endoscope Bedside Pre-Cle...	The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.	Class II	Madison Polymeric Engineering
Mar 21, 2018	First Step Endoscopic Cleaning Pad, 200ml, Flexible Endoscope Bedside Pre-Cle...	The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.	Class II	Madison Polymeric Engineering
Mar 21, 2018	Travel Kit, First Step EP-4 Kit (200 mL) and 1 Soiled Scope Bag (White), Flex...	The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.	Class II	Madison Polymeric Engineering
Mar 21, 2018	First Step Endoscopic Cleaning Pad, 100ml, Flexible Endoscope Bedside Pre-Cle...	The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.	Class II	Madison Polymeric Engineering
Mar 15, 2018	LigaSure" Exact Dissector Nano Coated 20.6mm-21cm Product Usage: A bipola...	Devices were found with a sterile breach (puncture) in the pouch from a sort of 8,064 packaged de...	Class II	Covidien LLC
Mar 12, 2018	5 mm Apple-Hunt Secondary Cannula/Pyramidal Tip Trocar - extended length (5 c...	Products have been packaged with the wrong Trocar length type.	Class II	CooperSurgical, Inc.
Mar 12, 2018	Fischer Cone Biopsy Excisor, Medium (5/Box); Model Number: 900-151	Products have been packaged with an incorrect product size.	Class II	CooperSurgical, Inc.
Feb 2, 2018	Philips Avent Smart Ear Thermometer (SCH740), Philips Ear Thermometer (DL8740)	Device may provide inaccurate measurements.	Class II	Philips Consumer Lifestyle
Dec 13, 2017	Signia" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits) The Signia...	Product reportedly shutting down during use.	Class II	Covidien LLC
Nov 21, 2017	Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series Ventilato...	Rechargeable lithium-ion batteries with incorrect firmware that are used in certain Puritan Benne...	Class II	Covidien LLC
Nov 17, 2017	QuikClot TraumaPad, Part# 460 a topical dressing for local management of blee...	A customer complained that one of the pouches in a box of 10 had "QuikClot Roll" pouch instead of...	Class II	Z-Medica, LLC
Nov 3, 2017	First Step Flexible Endoscope Bedside Pre-Clean Kit, EP-4. Intended for pre-c...	Affected lots may have exceeded its microbial limits.	Class II	Madison Polymeric Engineering
Oct 12, 2017	Situate Gauze RF and X-Ray detectable. Product Number: G0804-16P02CN-1 Si...	This voluntary recall is being conducted due to the potential for failure to detect the affected...	Class II	Covidien LLC
Oct 6, 2017	Cooper Surgical 2 MHZ Waterproof OB Probe Product The CooperSurgical 2 MHz...	The 2MHZ prove was incorrectlhttp://cts.fda.gov/division-tracking/images/trash.pngy labeled as a ...	Class II	CooperSurgical, Inc.
Sep 21, 2017	GastriSail" Gastric Positioning Device Product Usage: The GastriSail gastr...	Reports of gastric or esophageal perforation occurring in procedures where the GastriSail" Gastri...	Class II	Covidien LLC
Sep 15, 2017	Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA radial r...	The device cartridge disengaged during use due to manufacturing error.	Class II	Covidien LLC
Sep 13, 2017	Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal...	Potential for failure of the device safety interlock. The safety interlock prevents an empty sing...	Class II	Covidien LLC
Aug 7, 2017	Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm (rei...	The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna dise...	Class II	Covidien LLC
Aug 7, 2017	Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm, Mat...	The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna dise...	Class II	Covidien LLC
Aug 7, 2017	Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm, Mat...	The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna dise...	Class II	Covidien LLC
Aug 7, 2017	Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm (rei...	The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna dise...	Class II	Covidien LLC
Aug 7, 2017	Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm (rei...	The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna dise...	Class II	Covidien LLC
Aug 7, 2017	Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm, Mat...	The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna dise...	Class II	Covidien LLC
Aug 4, 2017	Aspire HD (for FDR-1000AWS) The Fujifilm Digital Mammography System, Aspir...	FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography ...	Class II	Fujifilm Medical Systems U.S.A., Inc.
Aug 4, 2017	Aspire HD Plus, Aspire HD-s (for FDR-2000AWS) The Fujifilm Digital Mammog...	FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography ...	Class II	Fujifilm Medical Systems U.S.A., Inc.
Aug 4, 2017	ASPIRE Cristalle (for FDR-3000AWS) The Fujifilm Digital Mammography Syste...	FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography ...	Class II	Fujifilm Medical Systems U.S.A., Inc.
Aug 4, 2017	Fuji Computed Radiography Mammography Suite, FCRMS (for CR-IR363AWS) The ...	FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography ...	Class II	Fujifilm Medical Systems U.S.A., Inc.
Jul 14, 2017	Aspire HD Plus (FDR MS-2500), also known as Aspire HD Plus F and Aspire HD-s...	There was a case that the swivel arm went down unintentionally when it was moved up/down.	Class II	Fujifilm Medical Systems U.S.A., Inc.
Jul 14, 2017	ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital M...	There was a case that the swivel arm went down unintentionally when it was moved up/down.	Class II	Fujifilm Medical Systems U.S.A., Inc.
Jul 7, 2017	Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880	The firm is implementing a product correction involving its Affirm¿ Lateral Arm Upright Biopsy Ac...	Class II	Hologic, Inc.
Jun 15, 2017	FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary ...	A potential issue in the X-ray tube ceiling unit CH-200 which constitutes the Digital Radiography...	Class II	Fujifilm Medical Systems U.S.A., Inc.
Jun 10, 2017	Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1002	Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing press...	Class II	Kelyniam Global, Inc.
Jun 10, 2017	Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1001 (Small)	Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing press...	Class II	Kelyniam Global, Inc.
Jun 10, 2017	Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004	Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing press...	Class II	Kelyniam Global, Inc.
Jun 10, 2017	Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003	Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing press...	Class II	Kelyniam Global, Inc.
May 17, 2017	QuikClot TraumaPad, , sterile, soft, white, X-ray detectable hemostatic dres...	Packaging breach may compromise sterility	Class II	Z-Medica, LLC
May 9, 2017	Covidien Endo Peanut 5mm Auto Suture Blunt Dissector Item Code: 173019 The ...	Cotton tip of the device may disengage due to insufficient adhesive	Class II	Covidien LLC
May 8, 2017	Beekley Medical 0-SPOT Mammography Skin Markers REF 652	Mammography Skin Marker 0 -SPOT (REF 652) product was mis-labeled with A-SPOT (REF 651) labels	Class III	Beekley Corporation
May 3, 2017	Sutures. POLYSORB: POLSORB 0 18 U/D PRECUT 126R, Item Number: L4; POLSORB 0 ...	Potential for an incomplete seal on the inner package, which may result in premature degradation ...	Class II	Medtronic
May 3, 2017	Sutures. MAXON: MAXON 4/0 5X18" GREEN CV-24 D-TACH; Item Number: 8886621933;...	Potential for an incomplete seal on the inner package, which may result in premature degradation ...	Class II	Medtronic
May 3, 2017	USPACK-SUTURE KIT; Item Number: US1672	Potential for an incomplete seal on the inner package, which may result in premature degradation ...	Class II	Medtronic
May 3, 2017	Best Practice Kit, Item Numbers: 00Z2064, 00Z2150, 00Z2190, 00Z2192, 00Z2211,...	Potential for an incomplete seal on the inner package, which may result in premature degradation ...	Class II	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.