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 |
|---|---|---|---|---|
| Jan 14, 2015 | AQUAPAK 340 SW, 340 ML W/404 ADAPTOR. Product Usage: The Humidifier Adapt... | The packages may contain foreign material (black particles). | Class II | Teleflex Medical |
| Jan 14, 2015 | AQUAPAK 640 SW, 650ML W/040 ADAPTOR. Product Usage: The Humidifier Adapto... | The packages may contain foreign material (black particles). | Class II | Teleflex Medical |
| Jan 14, 2015 | AQUAPAK SW/EAU STERILE, 340 ML W/ADAPTOR Product Usage: The Humidifier Ad... | The packages may contain foreign material (black particles). | Class II | Teleflex Medical |
| Jan 14, 2015 | AQUAPAK 340 SW, 340 ML W/040 ADAPTOR, FREN. 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 | 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 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 20, 2014 | UniStrip1, Blood Glucose Test Strips, 50 count box. The test strips are in... | Failure to submit a 510(k) for device labeling changes. | Class II | Unistrip Technologies LLC |
| 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 |
| Nov 10, 2014 | Infinite 200 The Tecan Infinite 200 is a multifunctional microplate reader w... | Incorrect lumi firmware version installed (E.027 instead of V2.00) | Class III | Tecan US, Inc. |
| Nov 10, 2014 | Infinite 200PRO The Tecan Infinite 200 is a multifunctional microplate reade... | Incorrect lumi firmware version installed (E.027 instead of V2.00) | Class III | Tecan US, Inc. |
| Oct 23, 2014 | ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for:... | Some of vials were found to be partially filled. | Class II | TEM Systems Inc |
| Sep 26, 2014 | Freedom EVO-2 100 Base Unit, with Air LiHa Arms The Freedom EVO is an open... | Distortion (noise interference) of the liquid level capacitance can result in air aspiration inst... | Class II | Tecan US, Inc. |
| 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 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 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 15, 2014 | Paragon Laboratory Management | For Paragon Laboratory Management 12.1 and 12.1.1 releases, if used with Microsoft SQL Server 201... | Class II | McKesson Technologies, Inc. |
| Jun 12, 2014 | McKesson Medi-Pak, Laceration Trays with Cotton O.R. Towels, Sterile, Single ... | Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. | Class II | Medical Action Industries Inc |
| Jun 12, 2014 | Port-A-Cath Tray, Stage One: Sterile Single Use, Stage Two: Clean Ready to Us... | Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. | Class II | Medical Action Industries Inc |
| Jun 12, 2014 | Laceration Kit: W/Needles, Sterile Single Use, Latex Free, 20/case, Medical A... | Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. | Class II | Medical Action Industries Inc |
| Jun 12, 2014 | Laceration Trays, Sterile Single Use, Latex Free, 20/case, Medical Action Ind... | Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. | Class II | Medical Action Industries Inc |
| Jun 12, 2014 | Laceration/Suture Removal, Sterile Single Use, Latex Free, 20/case, Medical A... | Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. | Class II | Medical Action Industries Inc |
| Jun 12, 2014 | Max Barrier Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Indu... | Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. | Class II | Medical Action Industries Inc |
| Jun 12, 2014 | Safety Laceration Kit, Sterile Single Use, Latex Free, 20/case, Medical Actio... | Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. | Class II | Medical Action Industries Inc |
| Jun 12, 2014 | Suture Set, Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20... | Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. | Class II | Medical Action Industries Inc |
| 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 |
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.