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 |
|---|---|---|---|---|
| Jan 14, 2015 | Hudson RCI¿ Humidifier Adaptor, 040 contained in the following units: HUMIDIF... | The packages may contain foreign material (black particles). | Class II | Teleflex Medical |
| Jan 14, 2015 | AQUAPAK 340 SW, 340 ML W/040B ADAPTOR, BRI Product Usage: The Humidifier ... | The packages may contain foreign material (black particles). | Class II | Teleflex Medical |
| Jan 14, 2015 | AQUAPAK 640 SW, 650ML W/040 ADAPTOR, FREN. Product Usage: The Humidifier ... | The packages may contain foreign material (black particles). | Class II | Teleflex Medical |
| Jan 14, 2015 | AQUAPAK SW/EAU STERILE, 650 ML W/ADAPTOR. Product Usage: The Humidifier A... | The packages may contain foreign material (black particles). | Class II | Teleflex Medical |
| Jan 14, 2015 | ADAPTOR, 040 HUM, INTL. Product Usage: The Humidifier Adaptor is an acces... | The packages may contain foreign material (black particles). | Class II | Teleflex Medical |
| Jan 14, 2015 | AQUAPAK 101 SW, 190ML W/040 ADAPTOR, JAPA Product Usage: The Humidifier A... | The packages may contain foreign material (black particles). | Class II | Teleflex Medical |
| Jan 14, 2015 | AQUA 540 SW, 540 W/040 ADAPTOR. Product Usage: The Humidifier Adaptor is ... | The packages may contain foreign material (black particles). | Class II | Teleflex Medical |
| Jan 14, 2015 | AQUAPAK 340 SW, 340, ML W/040, ADAPTOR, JAPA. Product Usage: The Humidifi... | The packages may contain foreign material (black particles). | Class II | Teleflex Medical |
| Jan 14, 2015 | AQUAPAK 340 SW, 340ML W/040 ADAPTOR, INTL. Product Usage: The Humidifier ... | The packages may contain foreign material (black particles). | Class II | Teleflex Medical |
| Jan 14, 2015 | AQUAPAK 640 SW, 650ML W/040 ADAPTOR, INTL. Product Usage: The Humidifier ... | The packages may contain foreign material (black particles). | Class II | Teleflex Medical |
| Jan 13, 2015 | LMA (Laryngeal Mask Airway) Supreme (New Cuff) Size 5, Sterile, Single use, ... | The labelling of units from the affected lot indicates that it contains a size 5 LMA Supreme (New... | Class II | Teleflex Medical |
| Jan 12, 2015 | MAQUET, SERVO Humidifier 163, Rx Only, Inmed Mfg. Sdn Bhd. Catalog No: XKC01... | Defects: Cracks that may occur in the center of the corrugated flex tube of the 15 mm and 22 mm I... | Class I | Teleflex Medical |
| Jan 9, 2015 | Hudson RCI, Sheridan, Preformed Tracheal Tubes, Cuffed and Uncuffed, Rx Only,... | Labeling; The affected product packaging is incorrectly labeled as being a cuffed oral ET tube; T... | Class II | Teleflex Medical |
| Jan 8, 2015 | Pilling Modular Verres Body/Obturator, Product Code 140880 | Packaging error in which customers who ordered product code 140880 (Verres cannula for use with a... | Class II | Teleflex Medical |
| Dec 12, 2014 | R¿SCH Curved Reinforced Endotracheal Tube: Rusch Reinforced Endotracheal Tube... | Teleflex Medical has issued an advisory notification for the RUSCH Curved Reinforced Endotracheal... | Class II | Teleflex, Inc. |
| Dec 3, 2014 | WECK Hemoclip¿ Traditional Medium Tantalum Ligating Clips. Weck Ligating C... | The manufacturing dates and expiration dates were transposed on the Tyvek label. | Class II | Teleflex Medical |
| Nov 12, 2014 | Sheridan/CF Cuffed Tracheal Tube, Sterile, Rx only, Teleflex Medical, Researc... | Product Labeling; Units from the affected lot indicates that it contains a size 8mm tracheal tube... | Class II | Teleflex Medical |
| Sep 26, 2014 | Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) RE... | The knife handles slot depth is out of specification, so blades may not fit on the handles properly. | Class II | Teleflex Medical |
| Sep 8, 2014 | Hudson braces are bone cutting and drilling instruments that are used without... | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... | Class II | Instrumed International, Inc. |
| Sep 8, 2014 | CVB distraction screws are bone cutting and drilling instruments that are use... | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... | Class II | Instrumed International, Inc. |
| Sep 8, 2014 | A circumcision clamp is an instrument used to compress the foreskin of the pe... | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... | Class II | Instrumed International, Inc. |
| Sep 8, 2014 | Hudson RCI¿ Pediatric Anesthesia Breathing Circuits, Single Patient Use, Rx ... | The pediatric breathing circuits can crack prior to and during use. | Class I | Teleflex Medical |
| Sep 8, 2014 | A uterine tenaculum is a hook-like instrument used to seize and hold the cerv... | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... | Class II | Instrumed International, Inc. |
| Sep 8, 2014 | D'errico perforator drills are bone cutting and drilling instruments that are... | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... | Class II | Instrumed International, Inc. |
| Sep 4, 2014 | Rusch, Soft Rubber (Nelaton and Nelaton Robinson), Bladder Catheter, Sterile.... | Misbranding: Although the product labeling identifies the catheters as "soft rubber," t... | Class II | Teleflex Medical |
| Sep 3, 2014 | Aquapak Adaptor, 028 NEB, INTL, Product No. 403128; Aquapak Adaptor, 033 NEB... | Possibility that the nebulizer adaptor packaging may have open or weak seals which may affect the... | Class II | Teleflex Medical |
| Sep 3, 2014 | Aqauapak 728 SW, 760 ML W/028 Adaptor, Intl, Product No. 403728; Aqauapak 102... | Possibility that the nebulizer adaptor packaging may have open or weak seals which may affect the... | Class II | Teleflex Medical |
| Jul 10, 2014 | RUSCH Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, S... | Labeling error: The manufacturing date is the same as the expiration date. The manufacturing date... | Class III | Teleflex Medical |
| Jul 9, 2014 | Emerald Fiberoptic Blade, Macintosh 4, Teleflex Medical. A rigid laryngoscop... | Packaging Error: Customers have reported receiving incorrect product. The box labeling indicates ... | Class II | Teleflex Medical |
| Jul 9, 2014 | Hudson RCI, Breathing Circuit, Adult Single Limb (W/Connector, Adaptor, Y Pie... | The temperature probe does not properly connect to the temperature port. | Class II | Teleflex Medical |
| Jul 9, 2014 | Hudson RCI, Breathing Circuit, Adult, Single Limb w/Heated Wire, [Respiratory... | The temperature probe does not properly connect to the temperature port. | Class II | Teleflex Medical |
| Jun 30, 2014 | RUSCH, TruLite, One-Piece Disposable Laryngoscope Handle Blade Combination, N... | There is a possibility the handle of the laryngoscope may heat up and melt the end cap. | Class II | Teleflex Medical |
| Jun 5, 2014 | Aquapak 340 SW, 340, mL w/040 Adaptor, French, Teleflex Medical, respiratory ... | The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | Class II | Teleflex Medical |
| Jun 5, 2014 | Aquapak SW/EAU, Sterile, 340 mL, w/Adaptor, 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, French, 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 SW/EAU Sterile, 650 mL w/Adaptor, Teleflex Medical, respiratory gas h... | 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, 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 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 |
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.