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
Dec 14, 2014	Juno DFR X-ray system	The system does not provide the appropriate audible signal, permanent activation, and manual over...	Class II	Villa Radiology Systems LLC
Oct 27, 2014	CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D, 12 cm shaft...	Outer box is mislabeled as P/N R2010- Large Radius Loop Electrode instead of P/N R1010- Medium Ra...	Class II	CooperSurgical, Inc.
Oct 27, 2014	Cooper Surgical CANNULA-CURETTE 12MM; Model Number: MX562 The CooperSurgic...	The product has been identified to contain an incorrect curette type.	Class III	CooperSurgical, Inc.
Sep 30, 2014	CooperSurgical MILEX PESSARY KITS-Ring w/Support Folding Pessary- #1 Model: ...	Incorrect expiration date printed on the MILEX PESSARY KIT packaging	Class III	CooperSurgical, Inc.
Sep 30, 2014	CooperSurgical MILEX PESSARY KITS- Hodge w/Support Folding Pessary- #1 Mode...	Incorrect expiration date printed on the MILEX PESSARY KIT packaging	Class III	CooperSurgical, Inc.
Jul 3, 2014	CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonograph...	Unsealed pouches.	Class II	CooperSurgical, Inc.
Jun 11, 2014	Prosound F75 or F75 The Hitachi Aloka Medical, Ltd. Prosound F75 is intended...	Loosened monitor arm.	Class II	Hitachi Aloka Medical, Ltd.
May 13, 2014	Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, ...	Selenia Full Field Digital Mammography System defective relay switch, if there is a need to use t...	Class II	Hologic, Inc.
May 13, 2014	Hologic M-IV Mammography System; Model M4--00001. Intended to produce radi...	Selenia Full Field Digital Mammography System defective relay switch, if there is a need to use t...	Class II	Hologic, Inc.
May 13, 2014	Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonograph...	Sterility of the device may be compromised due to unsealed pouch	Class II	CooperSurgical, Inc.
Mar 18, 2014	Playtex Nurser Deluxe Double Electric Breast Pump, Model X06578AO, powered by...	Some of the power adapters outer casings may become loose and separate, resulting in a potential ...	Class II	Energizer Personal Care
Dec 19, 2013	On Site Gas Systems POGS 33C Portable Oxygen Generation System	Heat exchanger hose becomes weak and may fail.	Class II	On Site Gas Systems Inc.
Sep 6, 2013	Selenia Full Field Digital Mammography System with software versions 5.0.x an...	Software: When the Selenia upon meeting the hard drive threshold of 4,000 images, may delete the ...	Class II	Hologic, Inc.
Aug 2, 2013	Juno DRF System. Mobile X-ray system These are general, multi-function x-r...	It has been discovered that the Air Kerma rate information is inconsistent in Continuous Fluoro m...	Class II	Villa Radiology Systems LLC
Jun 19, 2013	Beekley Spots Light Image O-Spots for Mammography Catalog Number: 252 Pro...	Light Image O-Spots Dispenser mislabeled as Soft n' Stretchy Light Image S-Spots	Class III	Beekley Corporation
May 14, 2013	StaXx¿ IB Convex Expandable Implant (25 x 12 x 9 mm), Intervertebral Fusion D...	A component Superior endplate manufactured from a different polymer than specified	Class II	Spine Wave, Inc.
May 6, 2013	Versaport Bladeless Optical Fixation Cannula - 5mm Product Code: ONBFCA5ST ...	Seals may disengage from the cannula which may result in a component inadvertently disengaging in...	Class II	Covidien LP
May 6, 2013	Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Product Code:...	Seals may disengage from the cannula which may result in a component inadvertently disengaging in...	Class II	Covidien LP
May 6, 2013	Versaport Bladeless Optical Fixation Cannula - 5mm Short Product Code: ONB...	Seals may disengage from the cannula which may result in a component inadvertently disengaging in...	Class II	Covidien LP
May 6, 2013	Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Short Produ...	Seals may disengage from the cannula which may result in a component inadvertently disengaging in...	Class II	Covidien LP
May 6, 2013	Versaport Bladeless Optical Trocar With (2) Fixation Cannulae - 5mm Produc...	Seals may disengage from the cannula which may result in a component inadvertently disengaging in...	Class II	Covidien LP
May 6, 2013	Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Long Product...	Seals may disengage from the cannula which may result in a component inadvertently disengaging in...	Class II	Covidien LP
May 1, 2013	CooperSurgical TransWarmer Infant Transport Mattress with WarmGel P/N 20421...	Trans Warmer Infant and Transport Mattress not labeled with exp.date may not meet specification	Class II	CooperSurgical, Inc.
Feb 26, 2013	Cooper Surgical Incontinence Dish w/ Support Pessary #5, 80mm. Milex :Part N...	Pessary mislabeled outer package may not reflect the size of the product contained in the package	Class III	Cooper Surgical, Inc.
Feb 26, 2013	Cooper Surgical Gellhorn Flexible Pessary -2 3/4", 70mm. Milex Part Number: ...	Pessary mislabeled outer package may not reflect the size of the product contained in the package	Class III	Cooper Surgical, Inc.
Feb 26, 2013	Cooper Surgical Incontinence Ring Flexible Pessary #4, 2 3/4", 70mm. Milex P...	Pessary mislabeled outer package may not reflect the size of the product contained in the package	Class III	Cooper Surgical, Inc.
Feb 26, 2013	Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. Milex Part Numbe...	Pessary mislabeled outer package may not reflect the size of the product contained in the package	Class III	Cooper Surgical, Inc.
Feb 26, 2013	Cooper Surgical Cube Pessary 1 5/8"", 41mm. Milex Part Number: MXKPEC04 ...	Pessary mislabeled outer package may not reflect the size of the product contained in the package	Class III	Cooper Surgical, Inc.
Feb 26, 2013	Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Mod...	Incorrect size was printed on the outer product packaging.	Class II	Cooper Surgical, Inc.
Feb 26, 2013	Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. Milex Part Numbe...	Pessary mislabeled outer package may not reflect the size of the product contained in the package	Class III	Cooper Surgical, Inc.
Feb 26, 2013	Cooper Surgical Cube Pessary w/Drainage Holes #0"1", 25mm. Milex Part Number...	Pessary mislabeled outer package may not reflect the size of the product contained in the package	Class III	Cooper Surgical, Inc.
Feb 26, 2013	LEEP REDIKIT Product No. 6060 In a Loop Electrosurgical Excision Proc...	LEEP RediKit Products (for use in Loop Electrosurgical Excision Procedures) have Xylocaine (Lidoc...	Class II	Cooper Surgical, Inc.
Feb 26, 2013	Cooper Surgical Incontinence Dish w/ Support Pessary #0, 55mm. Milex Part Nu...	Pessary mislabeled outer package may not reflect the size of the product contained in the package	Class III	Cooper Surgical, Inc.
Feb 26, 2013	Cooper Surgical Gellhorn Flexible Pessary 3", 76mm. Milex Part Number: MXPGE...	Pessary mislabeled outer package may not reflect the size of the product contained in the package	Class III	Cooper Surgical, Inc.
Feb 11, 2013	Covidien Endo GIA AutoSuture Universal Loading Unit, 30mm-2.0mm ...	Single Use Loading Unit contained two staples loaded in each cartridge pocket and may result in d...	Class II	Covidien LP
Nov 16, 2012	Praxair Vantage Grab n Go - Gas Cylinder pressure regulator Catalog Number: ...	Isolated incidents of ignition inside Grab n' Go cylinders that had been knocked over or otherwis...	Class I	Praxair Inc.
Oct 31, 2012	Cooper Surgical Advincula Arch , Reusable Uterine Manipulator Handle Ref: U...	Excessive pressure exerted on the uterine tip when attached to the Arch may, under certain circu...	Class II	Cooper Surgical, Inc.
Oct 31, 2012	Cooper Surgical RUMI Arch, Reusable Uterine Manipulator Handle Ref: UMH700 ...	Excessive pressure exerted on the uterine tip when attached to the Arch may, under certain circu...	Class II	Cooper Surgical, Inc.
Oct 24, 2012	Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the quant...	Spectrolyse PAI-1 activity assay, producing lower than expected absorbance values 0 IU/ml standa...	Class II	Sekisui Diagnostics Llc
Aug 28, 2012	Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination...	SPECTROLYSE PAI-1 activity assay producing lower than expected absorbance values with "0" standa...	Class II	Sekisui Diagnostics Llc
Aug 21, 2012	Covidien Duet TRS 45 4.8 mm Universal Straight Single Use Loading Unit. Prod...	Duet TRS may have the potential to injure adjacent anatomical structures which may result in life...	Class II	Covidien LP
Aug 21, 2012	Covidien Duet TRS 60 4.8 mm Universal Straight Single Use Loading Unit. Prod...	Duet TRS may have the potential to injure adjacent anatomical structures which may result in life...	Class II	Covidien LP
Aug 21, 2012	Covidien Duet TRS 60 3.5 mm Universal Straight Single Use Loading Unit Produ...	Duet TRS may have the potential to injure adjacent anatomical structures which may result in life...	Class II	Covidien LP
Aug 21, 2012	Covidien Duet TRS 45 4.8 mm Universal Articulating Single Use Loading Unit. ...	Duet TRS may have the potential to injure adjacent anatomical structures which may result in life...	Class II	Covidien LP
Aug 21, 2012	Covidien Duet TRS 45 3.5 mm Universal Articulating Single Use Loading Unit. ...	Duet TRS may have the potential to injure adjacent anatomical structures which may result in life...	Class II	Covidien LP
Aug 21, 2012	Covidien Duet TRS 45 3.5 mm Universal Straight Single Use Loading Unit. Prod...	Duet TRS may have the potential to injure adjacent anatomical structures which may result in life...	Class II	Covidien LP
Aug 21, 2012	Covidien Duet TRS 60 3.5 mm Universal Articulating Single Use Loading Unit. ...	Duet TRS may have the potential to injure adjacent anatomical structures which may result in life...	Class II	Covidien LP
Aug 21, 2012	Covidien Duet TRS 60 4.8 mm Universal Articulating Single Use Loading Unit. ...	Duet TRS may have the potential to injure adjacent anatomical structures which may result in lif...	Class II	Covidien LP
Jul 9, 2012	Beekley O-Spots Floral Skin Markers -Order Number: 752 Product Usage: Mam...	Digital Skin Mammography Marker separating from the backing of the spot material	Class II	Beekley Corporation
Jul 9, 2012	Beekley A-Spots Floral Skin Markers -Order Number: 751 Product Usage: Mam...	Digital Skin Mammography Marker separating from the backing of the spot material	Class II	Beekley Corporation

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.