Browse Device Recalls
709 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 709 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 709 FDA device recalls in CT.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 29, 2021 | Mechanical Filter with Connector Small, Tethered Cap, Item Code 351/5979 - Pr... | The company was notified by their supplier of sterilization services for airway products in Italy... | Class II | Covidien, LP |
| Apr 29, 2021 | Adult-Pediatric Electrostatic Filter HME, Item Code 352/5877Z - Product Usage... | The company was notified by their supplier of sterilization services for airway products in Italy... | Class II | Covidien, LP |
| Apr 26, 2021 | NES Reprocessed Visions PV .035 IVUS Catheter, Sterile. For use in the eva... | 510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles. | Class II | Northeast Scientific Inc. |
| Apr 23, 2021 | The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornice... | The affected Koh Cup were incorrectly packaged with a 3.5cm Ultem Koh cup, P/N 34131-04, instead ... | Class II | CooperSurgical, Inc. |
| Mar 4, 2021 | Covidien Signia Grey Small Diameter Curved Tip Intelligent Reload 30 mm Vascu... | Potential for the device safety interlock to fail. The safety interlock prevents an empty single-... | Class II | Covidien, LP |
| Mar 4, 2021 | Covidien Signia Small Diameter Curved Tip Intelligent Reload 30 mm Vascular/... | Potential for the device safety interlock to fail. The safety interlock prevents an empty single-... | Class II | Covidien, LP |
| Mar 4, 2021 | Covidien Signia Small Diameter Curved Tip Intelligent Reload 45 mm Vascular/T... | Potential for the device safety interlock to fail. The safety interlock prevents an empty single-... | Class II | Covidien, LP |
| Jan 21, 2021 | Milex Gellhorn Flexible under the following labels: 1) Gellhorn Flexible w/S... | The affected Milex Gellhorn pessaries were incorrectly manufactured with a long stem (2.170 ), in... | Class II | CooperSurgical, Inc. |
| Sep 8, 2020 | MediCult Vitrification Cooling Media, Model Number 12284001F | There is a discrepancy between the printing on the Product Tyvek label of the individual componen... | Class II | CooperSurgical, Inc. |
| Aug 12, 2020 | Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 3.5 mm, Item... | The device staples may not properly form upon application preventing adequate hemostasis. Use of... | Class II | Covidien, LP |
| Aug 12, 2020 | Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 2.5 mm, Item... | The device staples may not properly form upon application preventing adequate hemostasis. Use of... | Class II | Covidien, LP |
| Aug 12, 2020 | Endo GIA Auto Suture Universal Articulating Loading Unit 60 mm - 3.5 mm, Item... | The device staples may not properly form upon application preventing adequate hemostasis. Use of... | Class II | Covidien, LP |
| Aug 12, 2020 | Endo GIA Auto Suture Universal Loading Unit, Item Code 030457 - Product Usage... | The device staples may not properly form upon application preventing adequate hemostasis. Use of... | Class II | Covidien, LP |
| Aug 12, 2020 | Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item... | The device staples may not properly form upon application preventing adequate hemostasis. Use of... | Class II | Covidien, LP |
| Aug 12, 2020 | Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm,... | The device staples may not properly form upon application preventing adequate hemostasis. Use of... | Class II | Covidien, LP |
| Aug 12, 2020 | Endo GIA Auto Suture Universal Loading Unit 45 mm - 2.5mm, Item Code 030454 -... | The device staples may not properly form upon application preventing adequate hemostasis. Use of... | Class II | Covidien, LP |
| Aug 12, 2020 | Covidien Best Practices Procedure Kits containing Auto Suture Endo GIA Univer... | The device staples may not properly form upon application preventing adequate hemostasis. Use of... | Class II | Covidien, LP |
| Aug 12, 2020 | Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 3.5 mm, Item... | The device staples may not properly form upon application preventing adequate hemostasis. Use of... | Class II | Covidien, LP |
| Jun 3, 2020 | COOPERSURGICAL Os FinderTM Cervical Dilator, Taper: 2.0 mm to 4.0 mm OD Len... | Mislabeled: Printing on the top web or Tyvek lid of the individual product blister tray indicati... | Class II | CooperSurgical, Inc. |
| Apr 27, 2020 | DDU-2400EN Lifeline PRO, UDI 00815098020270 - Product Usage: Automated Extern... | A component issue may cause the AED to abort a shock delivery or reset unexpectedly, which may ca... | Class II | Defibtech, LLC |
| Apr 27, 2020 | DDU-2300 Lifeline/ReviveR View, Model Numbers DDU-C2300EN, DDU-C2300CA, DDU-A... | A component issue may cause the AED to abort a shock delivery or reset unexpectedly, which may ca... | Class II | Defibtech, LLC |
| Apr 27, 2020 | DDU-2450 Lifeline ECG Model Numbers DDU-A2450EN DDU-E2450DE DDU-E2450EN ... | A component issue may cause the AED to abort a shock delivery or reset unexpectedly, which may ca... | Class II | Defibtech, LLC |
| Apr 9, 2020 | CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P... | The seal of the sterile pouch may be compromised on one lot of the Milex Cervical Dilators. | Class II | CooperSurgical, Inc. |
| Feb 28, 2020 | Wallace Artificial Insemination Catheter, 180 mm, Sterile, Quantity: 1 Box (1... | Expiration date discrepancy. Marked as 5 years. Expiration date should be 3 years. | Class III | CooperSurgical, Inc. |
| Feb 24, 2020 | Butterfly iQ Ultrasound System containing the Auto EF(Ejection Fraction) Tool... | Distributed without an approved 510(k) | Class II | Butterfly Network, Inc. |
| Feb 24, 2020 | Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder Volu... | Distributed without an approved 510(k) | Class II | Butterfly Network, Inc. |
| Jan 28, 2020 | McGRATH X3 Disposable Laryngoscope Blades-used with the McGRATH MAC Video Lar... | Blades do not fit the McGRATH MAC video laryngoscope handle or were tight fitting on the handles ... | Class II | Medtronic, PLC |
| Jan 21, 2020 | Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimens... | The recalling firm has received reports from the field of the C-arm on the Selenia Dimensions sys... | Class II | Hologic, Inc. |
| Dec 18, 2019 | Polysorb Braided Absorbable Suture 1 36 VIOLET GS-21, Item Code CL925 - Produ... | There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... | Class II | Covidien LLC |
| Dec 18, 2019 | Polysorb Braided Absorbable Suture 1 36 VIOLET GS-24, Item Code CL915 - Produ... | There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... | Class II | Covidien LLC |
| Dec 18, 2019 | Polysorb Braided Absorbable Suture UD 4/0 18 P-13, Item Code SL5690 - Product... | There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... | Class II | Covidien LLC |
| Dec 18, 2019 | Polysorb Braided Absorbable Suture UD 3/0 30 P-14, Item Code SL5679 - Product... | There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... | Class II | Covidien LLC |
| Dec 18, 2019 | Polysorb Braided Absorbable Suture 0 VIOLET 30" V-20, Item Code GL124 - Produ... | There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... | Class II | Covidien LLC |
| Dec 18, 2019 | Polysorb Braided Absorbable Suture 2-0 UNDYED 36" GS-21, Item Code CL953 - Pr... | There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... | Class II | Covidien LLC |
| Dec 18, 2019 | Polysorb Braided Absorbable Suture 2-0 VIOLET 36" GS-21, Item Code CL923 - Pr... | There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... | Class II | Covidien LLC |
| Dec 18, 2019 | Polysorb Braided Absorbable Suture 2-0 VIOLET 30" V-20, Item Code GL123 - Pro... | There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... | Class II | Covidien LLC |
| Dec 18, 2019 | Polysorb Braided Absorbable Suture 2/0 UNDYED 30" V-30 (75CM), Item Code GL22... | There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... | Class II | Covidien LLC |
| Dec 18, 2019 | Polysorb Braided Absorbable Suture 13-0 VIOLET 30" GS-23, Item Code CL892 - P... | There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... | Class II | Covidien LLC |
| Dec 18, 2019 | Polysorb Braided Absorbable Suture 2/0 30"VIOLET GU-46, Item Code UL878 - Pro... | There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... | Class II | Covidien LLC |
| Dec 18, 2019 | Polysorb Braided Absorbable Suture 0 30" VIOLET GU-46, Item Code UL877 - Prod... | There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... | Class II | Covidien LLC |
| Dec 18, 2019 | Polysorb Braided Absorbable Suture 0 36 VIOLET GS-24, Item Code CL914 - Produ... | There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... | Class II | Covidien LLC |
| Dec 18, 2019 | Polysorb Braided Absorbable Suture 3/0 VIOLET 30" CV-24 (75CM), Item Code CL4... | There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... | Class II | Covidien LLC |
| Dec 18, 2019 | Polysorb Braided Absorbable Suture 4/0 30 VIOLET CVF23, Item Code UL203 - Pro... | There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... | Class II | Covidien LLC |
| Dec 18, 2019 | Polysorb Braided Absorbable Suture 6/0 12"" VL SS-24 D/A, Item Code L1742K - ... | There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... | Class II | Covidien LLC |
| Dec 18, 2019 | Polysorb Braided Absorbable Suture 1 30 VIOLET GS-22, Item Code CL885 - Produ... | There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... | Class II | Covidien LLC |
| Dec 18, 2019 | Polysorb Braided Absorbable Suture 2-0 UNDYED 30" V-20, Item Code GL323 - Pro... | There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... | Class II | Covidien LLC |
| Dec 18, 2019 | Polysorb Braided Absorbable Suture 3/0 30 VIOLET GS-11, Item Code CL815 - Pro... | There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... | Class II | Covidien LLC |
| Dec 18, 2019 | Polysorb Braided Absorbable Suture 2/0 30 VIOLET GS-21, Item Code CL811 - Pro... | There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... | Class II | Covidien LLC |
| Dec 18, 2019 | Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201 | There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... | Class II | Covidien LLC |
| Dec 18, 2019 | Polysorb Braided Absorbable Suture 3/0 30" UNDYED V-20, Item Code GLS322 - Pr... | There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... | Class II | Covidien LLC |
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.