Browse Device Recalls

264 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 264 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 264 FDA device recalls.

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Date	Product	Reason	Class	Firm
Jul 30, 2019	Hudson RCI Sheridan EZ-ENDO: a) 5.0 mm, REF 5-22510 b) 5.5 mm, REF 5-22511 ...	Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connec...	Class I	Teleflex Medical
Jul 1, 2019	Rusch EasyCath Kit	Potential for product not to be sterile.	Class II	Teleflex Medical
May 24, 2019	Hudson RCI Sheridan: 1) Uncuffed 6.0 mm, Product Code 5-10412 2) Uncuffed 6...	This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product...	Class I	Teleflex Medical
May 24, 2019	Hudson RCI Sheridan: 1) Preformed 6.0 mm, Product Codes: a) 5-22212, b)...	This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product...	Class I	Teleflex Medical
May 24, 2019	Sheridan/HVT: 1) Novaplus 7.0 mm, Product Code V5-10314 2) Novaplus 7.5 mm,...	This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product...	Class I	Teleflex Medical
May 24, 2019	Hudson RCI Sheridan LTS, Product Code 5-11112 Product Usage: Tracheal tub...	This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product...	Class I	Teleflex Medical
May 24, 2019	Sheridan/CF Novaplus 7.0 mm, Product Code V5-10114 Product Usage: Trachea...	This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product...	Class I	Teleflex Medical
May 24, 2019	Hudson RCI Sheridan: 1) HVT 6.0 mm, Product Code 5-10312 2) HVT 6.5 mm, Pro...	This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product...	Class I	Teleflex Medical
May 24, 2019	Hudson RCI Sheridan: 1) CF 6.0 mm, Product Codes: 5-10112, 5-10212 2) CF 6...	This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product...	Class I	Teleflex Medical
May 24, 2019	Hudson RCI Sheridan: 1) EZ-ENDO 6.0 mm, Product Code 5-22512 2) EZ-ENDO 6.5...	This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product...	Class I	Teleflex Medical
May 10, 2019	Teleflex HUDSON RDI NEONATAL ConchaSmart Breathing Circuit with Dual Heated L...	Reported complaints of cracks being observed, prior to use, on swivel wye adaptors of the Neonata...	Class I	Teleflex Medical
Apr 1, 2019	RUSCH LASERTUBE (Rubber), Order No. : 102004-000070, REF 102004, SIZE I.D. mm...	The firm received reports indicating that the laser guard foil partially separated and/or slightl...	Class II	Teleflex Medical
Apr 1, 2019	RUSCH LASERTUBE (Rubber), Order No. : 102004-000080, REF 102004, SIZE I.D. mm...	The firm received reports indicating that the laser guard foil partially separated and/or slightl...	Class II	Teleflex Medical
Apr 1, 2019	RUSCH LASERTUBE (Rubber), Order No. : 102004-000060, REF 102004, SIZE I.D. mm...	The firm received reports indicating that the laser guard foil partially separated and/or slightl...	Class II	Teleflex Medical
Apr 1, 2019	RUSCH LASERTUBE (Rubber), Order No. : 102004-000040, REF 102004, SIZE I.D. mm...	The firm received reports indicating that the laser guard foil partially separated and/or slightl...	Class II	Teleflex Medical
Apr 1, 2019	RUSCH LASERTUBE (Rubber), Order No. : 102004-000050, REF 102004, SIZE I.D. m...	The firm received reports indicating that the laser guard foil partially separated and/or slightl...	Class II	Teleflex Medical
Feb 27, 2019	Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape, REF ...	The device label incorrectly states that the device is sterile. This product is an externally app...	Class III	Teleflex Medical
Feb 27, 2019	Teleflex MEDICAL RuSCH One piece Male External Regular Catheter W/O Tape, REF...	The device label incorrectly states that the device is sterile. This product is an externally app...	Class III	Teleflex Medical
Jan 14, 2019	RUSCH CARE Premium Drain bag, 2000mlm REF 390000 urine collection device	The device labels are not UDI compliant. The missing UDI compliance information on the labelling ...	Class III	Teleflex Medical
Jan 14, 2019	RUSCH Urinary Drainage bag, 2000mlm REF 390060 urine collection device	The device labels are not UDI compliant. The missing UDI compliance information on the labelling ...	Class III	Teleflex Medical
Jan 7, 2019	Pilling COOLEY SUMP-SUCTION TUBE, REF 351547	The internal tip is missing from the device, causing the device to not function as intended.	Class II	Teleflex Medical
Jun 12, 2018	Teleflex MEDICAL Pilling(R) UNIVERSAL SHEARS 7 1/2", REF 142542 Product Us...	The incorrect plastic was used to manufacture the handles of these shears, which causes the handl...	Class II	Teleflex Medical Europe Ltd
Mar 27, 2018	Teleflex MEDICAL HUDSON RCI One Way Valve w. Capped Monitoring Port, REF 1644...	These one-way valves may disconnect at the joint between the two components that make up the devi...	Class II	Teleflex Medical Europe Ltd
Mar 19, 2018	Teleflex MEDICAL LMA(TM) MADgic(TM) LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVI...	Teleflex Medical is recalling the affected product because there may be missing or incomplete inf...	Class II	Teleflex Medical Europe Ltd
Mar 15, 2018	Baker Jejunostomy Tubes: Product Code Equivalent Code (a) 655300160 655...	These products contain latex, but the following statement is not included on any level of product...	Class II	Teleflex Medical Europe Ltd
Mar 15, 2018	Latex Rebreathing Bags: Product Code Equivalent Code (a) 151174050 151174 ...	These products contain latex, but the following statement is not included on any level of product...	Class II	Teleflex Medical Europe Ltd
Mar 15, 2018	Rectal Catheters; Product Code Equivalent Code 580114 580114 ...	These products contain latex, but the following statement is not included on any level of product...	Class II	Teleflex Medical Europe Ltd
Mar 15, 2018	Simplastic Suprapubic Puncture Instruments: Product Code Equivalent...	These products contain latex, but the following statement is not included on any level of product...	Class II	Teleflex Medical Europe Ltd
Feb 15, 2018	Teleflex MEDICAL WECK Visistat 35. Used for the external skin closure of lac...	Some boxes are labeled as Visistat Wide devices, when in fact the contain Visistat Regular device...	Class II	Teleflex Medical
Jan 3, 2018	Percuvance(R) Percutaneous Shaft 29cm, PCVSH3 The Percutaneous Surgical Sy...	There is potential for a piece of the distal tip on the Percuvance shaft to become deformed and p...	Class II	Teleflex Medical
Jan 3, 2018	Percuvance(R) Percutaneous Shaft 36cm, PCVSHL3 The Percutaneous Surgical S...	There is potential for a piece of the distal tip on the Percuvance shaft to become deformed and p...	Class II	Teleflex Medical
Oct 18, 2017	Teleflex(R) Percuvance(TM) Percutaneous Surgical System, Components: (a) 5 m...	Teleflex is recalling these products because the jaws of the tool tip may break, causing a fragm...	Class II	Teleflex Medical
Oct 5, 2017	WECK(R) from TELEFLEX Auto Endo5(R), Automatic Hem-o-lok(R) Clip Applier, REF...	The product has a non-conformity that may cause clips to mislead, jam or fall out of the applier.	Class II	Teleflex Medical
Jul 19, 2017	Percuvance Clip Applier Tool Tip The Percutaneous Surgical System with 5mm ...	For some of the recalled products, the security of the connection between the shaft and the tool ...	Class II	Teleflex Medical
Jul 19, 2017	Percuvance Scissors Tool Tip The Percutaneous Surgical System with 5mm atta...	For some of the recalled products, the security of the connection between the shaft and the tool ...	Class II	Teleflex Medical
Jul 19, 2017	Percuvance Johans Grasper Tool Tip The Percutaneous Surgical System with 5m...	For some of the recalled products, the security of the connection between the shaft and the tool ...	Class II	Teleflex Medical
Jul 19, 2017	Percuvance 29cm Shaft The Percutaneous Surgical System with 5mm attachments...	For some of the recalled products, the security of the connection between the shaft and the tool ...	Class II	Teleflex Medical
Jul 19, 2017	Percuvance Gripper Grasper Tool Tip The Percutaneous Surgical System with 5...	For some of the recalled products, the security of the connection between the shaft and the tool ...	Class II	Teleflex Medical
Jul 19, 2017	Percuvance Maryland Dissector Tool Tip The Percutaneous Surgical System wit...	For some of the recalled products, the security of the connection between the shaft and the tool ...	Class II	Teleflex Medical
Jul 5, 2017	LMA(TM) MADgic(TM) Laryngo-Tracheal Mucosal Atomization Devices: (a) MAD600 M...	Teleflex Medical is recalling the affected product because there may be missing or incomplete inf...	Class II	Teleflex Medical
May 11, 2017	Sheridan SHER-I-SLIP and SOFT-TIP Intubating Stylets are intubating stylets m...	Product size listed on the labeling is incorrect.	Class II	Teleflex Medical
May 9, 2017	Hudson RCI, Pediatric Nasal Cannula, Non-Flared Prongs, Rx only,	Incorrect labeling; the box label indicates Pediatric, the product insert indicates an Adult ...	Class II	Teleflex Medical
Apr 21, 2017	INFANT 20/BX, Sterile, Single use Product Usage: Catheter Connector/Acces...		Class II	Teleflex Medical
Apr 21, 2017	PE CONNECTOR 5 IN 1 20/BX, Sterile, Single use, Product Usage: Catheter C...	Labeling: The expiration date is not stated on the labeling, there is a potential for expired pro...	Class II	Teleflex Medical
Apr 21, 2017	PE CONNECTOR 3/8 STRAIGHT 20/BX, Sterile, Single use, Product Usage: Cat...	Labeling: The expiration date is not stated on the labeling, there is a potential for expired pro...	Class II	Teleflex Medical
Apr 21, 2017	PE CONNECTOR 3/8 Y 20/BX, Sterile, Single use, Product Usage: Catheter C...	Labeling: The expiration date is not stated on the labeling, there is a potential for expired pro...	Class II	Teleflex Medical
Mar 29, 2017	Arrow EZ-IO Needle Set 45 mm 15 ga, Ref 9079.	Some of the individual unit packaging (pouches) may be missing the lot number an expiration date.	Class III	Teleflex Medical
Mar 24, 2017	WECK Visistat 35R Disposable Skin Stapler, Ref 528135, Rx Only, Sterile EO, ...	Some boxes are labeled as containing Visistat Wide devices, when they in fact they contained Visi...	Class II	Teleflex Medical
Jan 13, 2017	Teleflex Green Non-Latex Robertazzi Nasopharyngeal Airway, Catalog No. 123130...	Labeling error	Class II	Teleflex Medical
Jan 10, 2017	Rusch Greenlite MAC 1, Catalog Number 004551001. Used during tracheal intuba...	The pouch may contain the incorrect Rusch Green Lite product size. Pouches that are labeled as c...	Class II	Teleflex Medical

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.