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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 17, 2014 | Hudson RCI Adult Universal Ventilator Circuit, Duel Heated Limb and Hudson RC... | Product is being recalled due to complaints that the inspiratory and expiratory tubes are transpo... | Class II | Teleflex Medical |
| Mar 11, 2014 | Sutures, Non-absorbable, Synthetic, Polyethylene, Sterile, Rx only, Produ... | The products are being recalled because they did not meet minimum needle attachment strength requ... | Class II | Teleflex Medical |
| Mar 11, 2014 | 5/10/12 mm Weck¿ Vista" Universal Cannula, Product Usage: An endoscope ... | Complaints were received of leakage of insufflation gas through the device, which can cause diffi... | Class II | Teleflex Medical |
| Mar 11, 2014 | Monodek Violet Synthetic Absorbable Surgical Sutures, MF 0 TC43/HR26 48 | Product does not meet minimum knot tensile strength requirements. | Class II | Teleflex Medical |
| Mar 11, 2014 | 5/10 Weck¿ Vista" Universal Balloon Open Access Port - Standard Length (70mm)... | Complaints were received of leakage of insufflation gas through the device, which can cause diffi... | Class II | Teleflex Medical |
| Mar 11, 2014 | 5/10 Weck Vista Universal Balloon Open Access Port - Standard Length (70mm), ... | Complaints of leakage of insufflation gas through the device. | Class II | Teleflex Medical |
| Mar 11, 2014 | Sutures, Non-absorbable, Silk, Sterile, Rx only, Product Usage: Natural ... | The products are being recalled because they did not meet minimum needle attachment strength requ... | Class II | Teleflex Medical |
| Mar 11, 2014 | 5/10 mm Weck¿, Vista" Universal Cannula, Teleflex Medical, Product Usage:... | Complaints were received of leakage of insufflation gas through the device, which can cause diffi... | Class II | Teleflex Medical |
| Mar 11, 2014 | 5/10/12 Weck¿ Vista" Universal Balloon Open Access Port Standard Length (70... | Complaints were received of leakage of insufflation gas through the device, which can cause diffi... | Class II | Teleflex Medical |
| Mar 11, 2014 | Bard Fixt Suture Braided Polyester, Rx Only, Teleflex Medical, Research Trian... | Product does not meet minimum needle attachment strength requirements; thus, the needle can becom... | Class II | Teleflex Medical |
| Mar 11, 2014 | 5/10 mm Weck Vista Universal Cannula, Catalog No. 405910RC; 5/10/12 mm Weck V... | Complaints of leakage of insufflation gas through the device. | Class II | Teleflex Medical |
| Mar 11, 2014 | Weck¿ Vista" Universal Laparoscopic Port, Size 5/10/12mmx125mm, Product U... | Complaints were received of leakage of insufflation gas through the device, which can cause diffi... | Class II | Teleflex Medical |
| Mar 11, 2014 | Weck¿ Vista" Universal Laparoscopic Port, Size 5/10/12mmx100mm, Product U... | Complaints were received of leakage of insufflation gas through the device, which can cause diffi... | Class II | Teleflex Medical |
| Mar 11, 2014 | Suture, Non-absorbable, Synthetic, Polyamide, Sterile, Rx only, Product U... | The products are being recalled because they did not meet minimum needle attachment strength requ... | Class II | Teleflex Medical |
| Mar 11, 2014 | Weck Vista Universal Laparoscopic Port, Size 5/10mm x 100mm, Catalog No. 4059... | Complaints of leakage of insufflation gas through the device. | Class II | Teleflex Medical |
| Mar 11, 2014 | Monofilament and Multifilament Non-absorbable Steel Suture; Product Codes: 05... | The products are being recalled because they did not meet minimum diameter requirements. | Class II | Teleflex Medical |
| Mar 11, 2014 | Sutures, Non-absorbable, Steel, Monofilament and Multifilament, Sterile, Rx o... | The products are being recalled because they did not meet minimum needle attachment strength requ... | Class II | Teleflex Medical |
| Mar 11, 2014 | 5/10/12 mm x 100mm Weck Vista Universal Cone Open Access, Catalog No. 405933.... | Complaints of leakage of insufflation gas through the device. | Class II | Teleflex Medical |
| Mar 11, 2014 | Fixt Suture Bonded Plus Violet Braided Polyglycolic Acid Coated Suture, Synth... | Product does not meet minimum needle attachment strength requirements; thus, the needle can becom... | Class II | Teleflex Medical |
| Mar 11, 2014 | 5/10/12MM X 100MM Weck¿ Vista" UNIVERSAL CONE OPEN ACCESS, Product Usage:... | Complaints were received of leakage of insufflation gas through the device, which can cause diffi... | Class II | Teleflex Medical |
| Mar 11, 2014 | Nonabsorbable Surgical Suture, U.S.P., Sterile - Do Not Resterilize, Deknate... | Product does not meet minimum needle attachment strength requirements; thus, the needle can becom... | Class II | Teleflex Medical |
| Mar 11, 2014 | 12mm Weck¿ Vista" Cannula-only, Teleflex Medical, Product Usage: An en... | Complaints were received of leakage of insufflation gas through the device, which can cause diffi... | Class II | Teleflex Medical |
| Mar 11, 2014 | Teleflex Medical, Research Triangle Park, NC, Braided Polyester Rx Only, Ste... | Product does not meet minimum needle attachment strength requirements; thus, the needle can becom... | Class II | Teleflex Medical |
| Mar 11, 2014 | 10mm Weck Vista Cannula-only, Catalog No. 405910C, 12mm Weck Vista Cannula-on... | Complaints of leakage of insufflation gas through the device. | Class II | Teleflex Medical |
| Mar 11, 2014 | 5/10/12 Weck¿ Vista" Universal Balloon Open Access Port Long Length (100mm)... | Complaints were received of leakage of insufflation gas through the device, which can cause diffi... | Class II | Teleflex Medical |
| Mar 11, 2014 | 5/10 Weck¿ Vista" Universal Balloon Open Access Port Short Length (53mm), ... | Complaints were received of leakage of insufflation gas through the device, which can cause diffi... | Class II | Teleflex Medical |
| Mar 11, 2014 | 10mm Weck¿ Vista" Cannula-only, Teleflex Medical, Product Usage: An en... | Complaints were received of leakage of insufflation gas through the device, which can cause diffi... | Class II | Teleflex Medical |
| Mar 11, 2014 | Teleflex Medical, Research Triangle Park, NC, Polypropylene, Rx Only, Steril... | Product does not meet minimum needle attachment strength requirements; thus, the needle can becom... | Class II | Teleflex Medical |
| Mar 11, 2014 | 5/10 Weck¿ Vista" Universal Balloon Open Access Port - Long Length (100mm), ... | Complaints were received of leakage of insufflation gas through the device, which can cause diffi... | Class II | Teleflex Medical |
| Mar 11, 2014 | 5/10 mm Weck Vista Optical Bladeless Laparoscopic Access Port, Catalog No. 40... | Complaints of leakage of insufflation gas through the device. | Class II | Teleflex Medical |
| Mar 11, 2014 | Deknatel Teleflex Medical Silk Black Braided Silk Suture Nonabsorbable Surgic... | Product does not meet minimum needle attachment strength requirements; thus, the needle can becom... | Class II | Teleflex Medical |
| Mar 11, 2014 | Weck¿ Vista", Universal Laparoscopic Port, Size 5/10mmx100mm, Product Usa... | Complaints were received of leakage of insufflation gas through the device, which can cause diffi... | Class II | Teleflex Medical |
| Mar 11, 2014 | Dekna-lok, 1 x 17.78 cm, Violet Braided Polyglycolic Acid Coated Suture, Synt... | The product did not meet minimum and/or average minimum Teleflex resorption strength requirements. | Class II | Teleflex Medical |
| Mar 11, 2014 | Sutures, Non-absorbable, Synthetic, Polypropylene, Sterile, Rx only, Prod... | The products are being recalled because they did not meet minimum needle attachment strength requ... | Class II | Teleflex Medical |
| Mar 11, 2014 | 5/10 mm Weck¿, Vista" Optical Bladeless Laparoscopic Access Port, Product... | Complaints were received of leakage of insufflation gas through the device, which can cause diffi... | Class II | Teleflex Medical |
| Mar 11, 2014 | CAPIO, Monodeck, Violet Monofilament Polydioxanone Suture, 1 x 48 inches (122... | The product did not meet minimum and/or average minimum Teleflex resorption strength requirements. | Class II | Teleflex Medical |
| Mar 11, 2014 | 5/10/12 mm Weck¿ Vista" Optical Bladeless Laparoscopic Access Port, Produ... | Complaints were received of leakage of insufflation gas through the device, which can cause diffi... | Class II | Teleflex Medical |
| Mar 11, 2014 | Deknatel Teleflex Medical Stainless Steel 2 (metric 5) Monofilament Stainless... | Product does not meet minimum needle attachment strength requirements; thus, the needle can becom... | Class II | Teleflex Medical |
| Mar 11, 2014 | Sutures, Absorbable, Synthetic, Polyglycolic Acid, Sterile, Rx only, Prod... | The products are being recalled because they did not meet minimum needle attachment strength requ... | Class II | Teleflex Medical |
| Mar 4, 2014 | Sengstaken Tube and Sengstaken-Blakemore Tube. Teleflex product codes 204800... | Sterility of the product cannot be guaranteed. | Class II | Teleflex Medical |
| Feb 28, 2014 | Rusch Brochopart and Rusch Brochopart White The Rush Endobronchial Tube se... | The product may fail to achieve seal of right lung due to the cuff inflating to one side | Class II | Teleflex Medical |
| Jan 6, 2014 | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Prel... | The tracheal tube can kink during patient use. | Class I | Teleflex Medical |
| Jan 6, 2014 | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.0, Rx... | The tracheal tube can kink during patient use. | Class I | Teleflex Medical |
| Jan 6, 2014 | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Prel... | The tracheal tube can kink during patient use. | Class I | Teleflex Medical |
| Jan 6, 2014 | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.0, Rx... | The tracheal tube can kink during patient use. | Class I | Teleflex Medical |
| Jan 6, 2014 | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Prel... | The tracheal tube can kink during patient use. | Class I | Teleflex Medical |
| Jan 6, 2014 | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 9.0, Rx... | The tracheal tube can kink during patient use. | Class I | Teleflex Medical |
| Jan 6, 2014 | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Prel... | The tracheal tube can kink during patient use. | Class I | Teleflex Medical |
| Jan 6, 2014 | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Prel... | The tracheal tube can kink during patient use. | Class I | Teleflex Medical |
| Jan 6, 2014 | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Prel... | The tracheal tube can kink during patient use. | Class I | 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.