Browse Device Recalls
84 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 84 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 84 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 11, 2025 | HSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is for us... | The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, h... | Class II | CooperSurgical, Inc. |
| Jun 11, 2025 | Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Con... | The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, h... | Class II | CooperSurgical, Inc. |
| Jun 11, 2025 | Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. End... | The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, h... | Class II | CooperSurgical, Inc. |
| Nov 15, 2024 | Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K2401... | The warming surfaces or incubator well temperatures of the listed products may exceed the desired... | Class II | CooperSurgical, Inc. |
| Nov 15, 2024 | Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number:... | The warming surfaces or incubator well temperatures of the listed products may exceed the desired... | Class II | CooperSurgical, Inc. |
| Nov 15, 2024 | Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Nu... | The warming surfaces or incubator well temperatures of the listed products may exceed the desired... | Class II | CooperSurgical, Inc. |
| Nov 15, 2024 | Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: ... | The warming surfaces or incubator well temperatures of the listed products may exceed the desired... | Class II | CooperSurgical, Inc. |
| Nov 15, 2024 | Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number:... | The warming surfaces or incubator well temperatures of the listed products may exceed the desired... | Class II | CooperSurgical, Inc. |
| Nov 15, 2024 | Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number... | The warming surfaces or incubator well temperatures of the listed products may exceed the desired... | Class II | CooperSurgical, Inc. |
| Jul 31, 2024 | Silver-Plated Copper Sims Uterine Sound, Part Number 64-600 | During the manufacturing process the devices were laser-marked with the incorrect part number. | Class II | CooperSurgical, Inc. |
| Jul 31, 2024 | Stainless Steel Sims Uterine Sound, Part Number 64-601 | During the manufacturing process the devices were laser-marked with the incorrect part number. | Class II | CooperSurgical, Inc. |
| Feb 16, 2024 | Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of ... | Low concentration of sodium pyruvate in the wash could compromise gamete development | Class II | CooperSurgical, Inc. |
| Feb 16, 2024 | Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of s... | Low concentration of sodium pyruvate in the wash could compromise gamete development | Class II | CooperSurgical, Inc. |
| Feb 16, 2024 | Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of ... | Low concentration of sodium pyruvate in the wash could compromise gamete development | Class II | CooperSurgical, Inc. |
| Dec 20, 2023 | global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), ... | The firm has become aware of a sudden increase in complaints for three associated lots. Performan... | Class II | CooperSurgical, Inc. |
| Aug 29, 2023 | Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quan... | Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual ki... | Class II | CooperSurgical, Inc. |
| Feb 13, 2023 | Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5... | It has come to CooperSurgical's attention that the affected Product may contain a medium other th... | Class II | CooperSurgical, Inc. |
| Dec 15, 2022 | BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy o... | The affected product may contain a medium other than the Biopsy Medium. There is a risk that use... | Class II | CooperSurgical, Inc. |
| Oct 20, 2022 | NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540 | Firm has received 11 complaints involving a loose or detached metal clips, including 3 cases wher... | Class II | CooperSurgical, Inc. |
| Aug 12, 2022 | Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark... | There is a potential breach to the sterile barrier containing the Humidifier Bottles due to the p... | Class II | CooperSurgical, Inc. |
| Aug 12, 2022 | Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark... | There is a potential breach to the sterile barrier containing the Humidifier Bottles due to the p... | Class II | CooperSurgical, Inc. |
| Jun 13, 2022 | LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055 | There was translation error in the Spanish version of the IFU where the Spanish version instructs... | Class II | CooperSurgical, Inc. |
| Apr 1, 2022 | VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a... | Products in this lot may have compromised barrier seals, introducing a risk to sterility. | Class II | CooperSurgical, Inc. |
| Mar 31, 2022 | CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model: 61-4005S ... | Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment o... | Class II | CooperSurgical, Inc. |
| Mar 31, 2022 | Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-For administering contrast me... | Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment o... | Class II | CooperSurgical, Inc. |
| Mar 31, 2022 | Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media... | Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment o... | Class II | CooperSurgical, Inc. |
| Sep 29, 2021 | LEEP PRECISION Generator 120V Cooper Surgical Part Number: LP-20-120 | Coagulate function may not operate with the use of the Hand Switch, failure of the device to coag... | Class II | CooperSurgical, Inc. |
| Sep 29, 2021 | Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05 | Coagulate function may not operate with the use of the Hand Switch, failure of the device to coag... | Class II | CooperSurgical, Inc. |
| Sep 29, 2021 | LEEP PRECISION Integrated System, 120V CooperSurgical part number: LP-10-120 | Coagulate function may not operate with the use of the Hand Switch, failure of the device to coag... | Class II | CooperSurgical, Inc. |
| Sep 29, 2021 | LEEP PRECISION Generator 220V Cooper Surgical Part Number: LP-20-220 | Coagulate function may not operate with the use of the Hand Switch, failure of the device to coag... | Class II | CooperSurgical, Inc. |
| Sep 29, 2021 | Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05W | XXX | Class II | CooperSurgical, Inc. |
| Sep 29, 2021 | LEEP PRECISION Integrated System, 220V CooperSurgical part numbers: LP-10-220 | Coagulate function may not operate with the use of the Hand Switch, failure of the device to coag... | Class II | CooperSurgical, Inc. |
| Sep 29, 2021 | Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075 | Coagulate function may not operate with the use of the Hand Switch, failure of the device to coag... | Class II | CooperSurgical, Inc. |
| Jun 30, 2021 | Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Wo... | Units are displaying output readings that differ from the measurements taken using a Gas Analyzer... | Class II | CooperSurgical, Inc. |
| Apr 30, 2021 | CooperSurgical Wallach Loop Electrode 10mm x 10mm Square P/N: 909131. Dispo... | The affected Wallach LOOP Electrodes were incorrectly packaged with a Round Electrode inside a pa... | Class II | CooperSurgical, 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. |
| 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. |
| 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 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. |
| Dec 13, 2019 | ADVANCED ENDOSEE System CANNULA, Cooper Surgical Product Code/Model Number: E... | Potential for unsealed pouches in two (2) lots of the Endosee Advance Cannula (P/N: ESPX5). | Class II | CooperSurgical, Inc. |
| Oct 16, 2019 | Quantam 2000 Electrosurgical Generator, Part number 909075-05. | Potential for the Quantum 2000 Electrosurgery Generator, part numbers 909075, 909075-05 and 90907... | Class II | CooperSurgical, Inc. |
| Oct 16, 2019 | Quantam 2000 Electrosurgical Generator, Part number 909075. | Potential for the Quantum 2000 Electrosurgery Generator, part numbers 909075, 909075-05 and 90907... | Class II | CooperSurgical, Inc. |
| Oct 16, 2019 | Quantam 2000 Electrosurgical Generator, Part number 909075-05W. | Potential for the Quantum 2000 Electrosurgery Generator, part numbers 909075, 909075-05 and 90907... | Class II | CooperSurgical, Inc. |
| Sep 5, 2019 | Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-8... | The touchpad may not work properly after cleaning. | Class III | CooperSurgical, Inc. |
| Aug 19, 2019 | LEEP Return Patient Pads (10/ box) Model # 6050Pl used in electrosurgical ... | Discrepancy between the correct expiration dates on the individual pouches inside the boxes and i... | Class III | CooperSurgical, Inc. |
| Jul 8, 2019 | TransWarmer Warming Infant Transport Mattress, Model no. 20421 Product Us... | The firm updated the IFU in April 2019 to clarify that use of the TRANSWARMER Mattress with other... | Class II | CooperSurgical, Inc. |
| Jun 18, 2019 | LEEP Precision Integrated System 120V & LEEP Precision Generator, Model Nos. ... | The products' cut, coagulate, or blend function may not operate with the use of the Foot Pedal. | Class II | CooperSurgical, Inc. |
| Jun 14, 2019 | Advincula Delineator with Ultem Plastic Soft Cup size 2.5 cm; Part No. AD750S... | The soft, flexible cup of the Advincula Delineator may be unvalidated and could potentiall crack ... | Class II | CooperSurgical, Inc. |
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.