Browse Device Recalls
726 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 726 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 726 FDA device recalls in NC.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 5, 2014 | Aquapak 340 SW, 340, mL w/040 Adaptor, International, Teleflex Medical, respi... | The seals of the respiratory gas humidifier adaptor packaging may be creased which may potentiall... | Class II | Teleflex Medical |
| Jun 5, 2014 | Aqua 540 SW, 540 w/040 Adaptor, Teleflex Medical, respiratory gas humidifier ... | The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | Class II | Teleflex Medical |
| Jun 5, 2014 | Humidifier Adaptor 040, Teleflex Medical, respiratory gas humidifier adaptor. | The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | Class II | Teleflex Medical |
| Jun 5, 2014 | Adaptor, 040 Hum, International, Teleflex Medical, respiratory gas humidifier... | The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | Class II | Teleflex Medical |
| Jun 5, 2014 | Aquapak 640 SW, 650 mL w/040 Adaptor, Japan, Teleflex Medical, respiratory ga... | The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | Class II | Teleflex Medical |
| Jun 5, 2014 | Aquapak 101 SW, 190, mL w/040 Adaptor, Japan, Teleflex Medical, respiratory g... | The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | Class II | Teleflex Medical |
| Jun 5, 2014 | Aquapak 640 SW, 650 mL w/040 Adaptor, Teleflex Medical, respiratory gas humid... | The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | Class II | Teleflex Medical |
| Jun 5, 2014 | Aquapak 340 SW, 340, mL w/040 Adaptor, Teleflex Medical, respiratory gas humi... | The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | Class II | Teleflex Medical |
| Jun 5, 2014 | Humidifier Adaptor, 040 Shelf Pak, French, Teleflex Medical, respiratory gas ... | The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | Class II | Teleflex Medical |
| Jun 5, 2014 | Aquapak 640 SW, 650, mL w/040 Adaptor, International, Teleflex Medical, respi... | The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | Class II | Teleflex Medical |
| May 23, 2014 | RUSCH, LaserTube (Rubber), Laser Resistant Tracheal Tube, cuffed, Teleflex Me... | Although the Natural Rubber Latex caution symbol is clearly displayed on the product label, the ... | Class II | Teleflex Medical |
| May 21, 2014 | RUSCH Easy Cath Coude Kit, 10 FR, Rx Only, Sterile, Distributed by: Teleflex ... | Product was packaged with a straight catheter rather than the correct coude (curved) catheter. | Class II | Teleflex Medical |
| May 16, 2014 | Taut Operative Cholangiogram Catheter, 4.5FR (1.5mm) x 76cm To facilitate ... | Several complaints were received for the metal support tube missing from the cholangiogram catheter. | Class II | Teleflex Medical |
| 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 |
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.