Browse Device Recalls
712 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 712 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 712 FDA device recalls in NC.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 3, 2016 | PICC/CVC Secure Dressing Change kit, Ref: 73775, Lot 213403, Sterile Single U... | Misbranding; Due to the presence of CHG in the Tegaderm PICC/CVC dressing change convenience kit,... | Class II | Medical Action Industries Inc |
| Feb 2, 2016 | Auto Endo5 Hem-o-lok Automatic Clip Applier, Medium Large Polymer Clips, Rx O... | The clip in the applier may be missing a boss. A boss is the part of the clip that is used to ho... | Class II | Teleflex Medical |
| Dec 24, 2015 | BacT/ALERT¿ FA, bioM¿rieux, Inc., Product Usage: BacT/ALERT¿ Culture Bott... | Bottles may have been exposed to non-normal shipping conditions which may lead to media degradati... | Class II | bioMerieux, Inc. |
| Dec 24, 2015 | BacT/ALERT¿ SN, bioM¿rieux, Inc. Product Usage: BacT/ALERT¿ Culture Bottl... | Bottles may have been exposed to non-normal shipping conditions which may lead to media degradati... | Class II | bioMerieux, Inc. |
| Dec 10, 2015 | Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Co... | Due to a malfunction of software, the secondary module will not automatically take over messaging... | Class II | Ascom US, INC. |
| Dec 3, 2015 | MAQUET Servo Humidifier 163, Inmed Mfg. Sdn. Bhd. Lot PT 2577, Jalan Perusaha... | Cracking may occur at the 15mm and 22mm ISO female connector. | Class II | Teleflex Medical |
| Dec 3, 2015 | Servo Humidifier 163, Model 01-06-8125-8, REF 6419365 Product Usage: A he... | Cracks may occur at the 15mm and 22mm ISO female connector. | Class II | Teleflex Medical |
| Nov 11, 2015 | Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended... | The Nebulizer mask malfunctions in that there is reduced or no aerosol output. The malfunction o... | Class II | ConvaTec, Inc |
| Nov 6, 2015 | Unolok Blunt Fill Needle 18G x 1.5" Red, Sterile, Single use, Non-injectable ... | Particulates: Complaints of rubber coring from the closure of injection vials. | Class II | Myco Medical Supplies Inc |
| Nov 3, 2015 | MYLA MASTER DVD V4.0 CLI Product Usage: MYLA is a computer application (... | MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the p... | Class II | bioMerieux, Inc. |
| Nov 3, 2015 | MYLA MASTER DVD V4.1 CLI Product Usage: MYLA is a computer application (... | MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the p... | Class II | bioMerieux, Inc. |
| Nov 3, 2015 | MYLA CLINIC PATCH 3.3.0 CD Product Usage: MYLA is a computer application ... | MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the p... | Class II | bioMerieux, Inc. |
| Nov 3, 2015 | MYLA CLI V3.X TO V4.1 DL380 SERVER Product Usage: MYLA is a computer appl... | MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the p... | Class II | bioMerieux, Inc. |
| Nov 3, 2015 | MYLA CLI V3.X TO V4.1 ML350 SERVER Product Usage: MYLA is a computer appl... | MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the p... | Class II | bioMerieux, Inc. |
| Nov 3, 2015 | MYLA MASTER DVD 3.2 CLI DL380 Product Usage: MYLA is a computer applicati... | MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the p... | Class II | bioMerieux, Inc. |
| Nov 3, 2015 | MYLA CLINIC PATCH 3.2.0 CD Product Usage: MYLA is a computer application ... | MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the p... | Class II | bioMerieux, Inc. |
| Oct 26, 2015 | PROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5. A restorable impl... | The expiration date encoded in the UDI barcode on the label on the product carton and the peelabl... | Class II | Merz North America, Inc. |
| Oct 26, 2015 | Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated fo... | The expiration date encoded in the UDI barcode on the label on the product carton and the peelabl... | Class II | Merz North America, Inc. |
| Oct 26, 2015 | PROLARYN PLUS Injectable Implant 1.0 cc Plus Calcium Hydroxlyapatite (CaHA) I... | The expiration date encoded in the UDI barcode on the label on the product carton and the peelabl... | Class II | Merz North America, Inc. |
| Oct 14, 2015 | Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93. To provide an access p... | The defective component can cause gas leakage through the device. This can result in loss of pne... | Class II | Teleflex Medical |
| Aug 24, 2015 | R¿sch Flexi-Slip Endotracheal Tube Stylet with Soft Distal Tip, Sterile, Rx o... | Due to reports of the plastic coating of the stylet splitting and/or breaking off of the stylet. | Class II | Teleflex Medical |
| Aug 24, 2015 | Rusch Flexi-slip tracheal tube Stylet, Size Ch 6, Sterile, Teleflex Medical. | Due to reports of the plastic coating of the stylet splitting and/or breaking off of the stylet. | Class II | Teleflex Medical |
| Jun 1, 2015 | HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Left sided), Sizes: 2... | The double swivel connector may crack or separate on the endobronchial tube. | Class I | Teleflex Medical |
| Jun 1, 2015 | HUDSON RCI, Sheridan, SHER-I-SWIV and SHER-I-SWIV/FO Double Swivel, Rx Only, ... | The double swivel connector may crack or separate on the endobronchial tube. | Class I | Teleflex Medical |
| Jun 1, 2015 | HUDSON RCI, Sheridan SHER-I BRONCH Accessory Pack, Rx Only, Sterile. Used... | The double swivel connector may crack or separate on the endobronchial tube. | Class I | Teleflex Medical |
| Jun 1, 2015 | HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Right sided), Sizes: ... | The double swivel connector may crack or separate on the endobronchial tube. | Class I | Teleflex Medical |
| May 29, 2015 | Infinite 200 in vitro diagnostic. Product Usage: The Tecan Infinite 20... | A firmware bug causes incorrect values to be displayed for specific measured luminescence values. | Class II | Tecan US, Inc. |
| May 29, 2015 | Infinite 200 PRO in vitro diagnostic. Product Usage: The Tecan Infinite... | A firmware bug causes incorrect values to be displayed for specific measured luminescence values. | Class II | Tecan US, Inc. |
| May 29, 2015 | Infinite M1000 in vitro diagnostic. Product Usage: The Tecan Infinite M... | A firmware bug causes incorrect values to be displayed for specific measured luminescence values. | Class II | Tecan US, Inc. |
| May 29, 2015 | Infinite M1000 PRO in vitro diagnostic. Product Usage: The Tecan Infini... | A firmware bug causes incorrect values to be displayed for specific measured luminescence values. | Class II | Tecan US, Inc. |
| May 29, 2015 | Infinite F500, in vitro diagnostic. Product Usage: The Tecan Infinite F... | A firmware bug causes incorrect values to be displayed for specific measured luminescence values. | Class II | Tecan US, Inc. |
| May 14, 2015 | Lifesaver Single Patient Use Manual Resuscitator Product Usage: The Huds... | The intake port may be blocked which can cause the bag to fail to fill. | Class I | Teleflex Medical |
| Apr 14, 2015 | MYLA server HP Proliant: DL380-G8 and ML350-G6 version 3.xx computer applicat... | The MYLA¿ server could slow down due to the volume (weight) of the data to manage and it could... | Class II | bioMerieux, Inc. |
| Apr 1, 2015 | Teleflex Medical Hudson RCI ConchaTherm Neptune Heated Humidifier, Rx Only. | Customer complaints were received of power to the unit ceasing and the display going blank. | Class II | Teleflex Medical |
| Mar 27, 2015 | AmTryke Model 1424 Community Cruiser Hand Cycle. Therapeutic tricycle. | Product is being recalled due to complaints of cracked frames. | Class II | Amtryke LLC |
| Mar 13, 2015 | Pluer-evac Sahara Chest Drainage System, S-1100-08LF, Dry Suction/Dry Seal Co... | Package contains incorrect sized unit: The adult sized S-1100-08LF product contains an infant siz... | Class II | Teleflex Medical |
| 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 |
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.