Browse Device Recalls
163 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 163 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 163 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 29, 2025 | IV Administration Set utilized in gravity IV administration sets and pump adm... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | Outlook set utilized in gravity IV administration sets and pump administratio... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | IV Administration Set utilized in gravity IV administration sets and pump adm... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | Extension Set utilized in gravity IV administration sets and pump administrat... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | IV Administration Set utilized in gravity IV administration sets and pump adm... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | Extension Set utilized in gravity IV administration sets and pump administrat... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | IV Administration Set utilized in gravity IV administration sets and pump adm... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | IV Administration Set utilized in gravity IV administration sets and pump adm... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | IV Administration Set utilized in gravity IV administration sets and pump adm... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | IV Administration Set utilized in gravity IV administration sets and pump adm... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | IV Administration Set utilized in gravity IV administration sets and pump adm... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | Extension Set utilized in gravity IV administration sets and pump administrat... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | Infusomat utilized in gravity IV administration sets and pump administration ... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | Anesthesia IV Set utilized in gravity IV administration sets and pump adminis... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | IV Administration Set utilized in gravity IV administration sets and pump adm... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | SafeDAY set utilized in gravity IV administration sets and pump administratio... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | Blood Administration Set utilized in gravity IV administration sets and pump ... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | IV Administration Set utilized in gravity IV administration sets and pump adm... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Oct 29, 2025 | Blood Administration Set utilized in gravity IV administration sets and pump ... | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... | Class II | B Braun Medical Inc |
| Sep 30, 2025 | Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET F... | The potential for micro-air bubbles observed in the bloodline and air-in-line alarms due to damag... | Class I | B BRAUN MEDICAL INC |
| Sep 18, 2025 | PERIFIX FX Continuous Epidural Anesthesia Set, PERIFIX Tuohy Epidural Needle ... | Potential for the lid of the catheter connector to be in the incorrect position. | Class II | B BRAUN MEDICAL INC |
| Sep 18, 2025 | PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in... | Potential for the lid of the catheter connector to be in the incorrect position. | Class II | B BRAUN MEDICAL INC |
| Sep 18, 2025 | PERIFIX FX Continuous Epidural Anesthesia Tray, 17 Ga. x 3-1/2 in. (8.9 cm) T... | Potential for the lid of the catheter connector to be in the incorrect position. | Class II | B BRAUN MEDICAL INC |
| Sep 18, 2025 | PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8... | Potential for the lid of the catheter connector to be in the incorrect position. | Class II | B BRAUN MEDICAL INC |
| Sep 18, 2025 | Design Options, Pain Management Tray. Product Code: SESK. Product Description... | Potential for the lid of the catheter connector to be in the incorrect position. | Class II | B BRAUN MEDICAL INC |
| Sep 18, 2025 | PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8... | Potential for the lid of the catheter connector to be in the incorrect position. | Class II | B BRAUN MEDICAL INC |
| Sep 18, 2025 | Design Options, PERIFIX FX Epidural Anesthesia Tray. Product Code: CESK. Prod... | Potential for the lid of the catheter connector to be in the incorrect position. | Class II | B BRAUN MEDICAL INC |
| Sep 18, 2025 | PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in... | Potential for the lid of the catheter connector to be in the incorrect position. | Class II | B BRAUN MEDICAL INC |
| Sep 18, 2025 | ESPOCAN Combined Spinal and Epidural Anesthesia Tray, ESPOCAN 17 Ga. x 3-1/2 ... | Potential for the lid of the catheter connector to be in the incorrect position. | Class II | B BRAUN MEDICAL INC |
| Sep 18, 2025 | PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in... | Potential for the lid of the catheter connector to be in the incorrect position. | Class II | B BRAUN MEDICAL INC |
| Sep 18, 2025 | Combined Spinal and Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9... | Potential for the lid of the catheter connector to be in the incorrect position. | Class II | B BRAUN MEDICAL INC |
| Sep 18, 2025 | Combined Spinal and Epidural Anesthesia Tray 2, PERIFIX 17 Ga. x 3-1/2 in. (8... | Potential for the lid of the catheter connector to be in the incorrect position. | Class II | B BRAUN MEDICAL INC |
| Sep 18, 2025 | PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in... | Potential for the lid of the catheter connector to be in the incorrect position. | Class II | B BRAUN MEDICAL INC |
| Jul 9, 2025 | Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for us... | Label is incorrect. The product label indicates that the device contains an air eliminating filte... | Class I | B BRAUN MEDICAL INC |
| Feb 17, 2025 | Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive saf... | Increased risk for valve housing detachment causing leakage. | Class II | B Braun Medical Inc |
| Aug 15, 2024 | STREAMLINE BLOODLINE SET FOR DIALOG DR-Tubing to be used to transfer blood be... | Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloo... | Class II | B Braun Medical Inc |
| Aug 15, 2024 | STREAMLINE BLOODLINE LONG VERSION, FMC-Tubing to be used to transfer blood be... | Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloo... | Class II | B Braun Medical Inc |
| Aug 15, 2024 | STREAMLINE LONG-Tubing to be used to transfer blood between a patient and a h... | Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloo... | Class II | B Braun Medical Inc |
| Aug 15, 2024 | STREAMLINE BLOODLINE SET FOR DIALOG-Tubing to be used to transfer blood betwe... | Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloo... | Class II | B Braun Medical Inc |
| Aug 15, 2024 | STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a... | Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloo... | Class II | B Braun Medical Inc |
| Aug 15, 2024 | STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a... | Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloo... | Class II | B Braun Medical Inc |
| Aug 15, 2024 | SL BLOODLINE FOR FMC 2008 SERIES-Tubing to be used to transfer blood between ... | Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Blood... | Class II | B Braun Medical Inc |
| Aug 7, 2024 | Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U | Extension of previous recall RES 92978. Pumps have the potential for upstream occlusion sensor to... | Class I | B Braun Medical Inc |
| Jun 14, 2024 | Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Non-Wi... | Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an ... | Class II | B Braun Medical Inc |
| Jun 14, 2024 | Brand Name: Perfusor Space Product Name: Perfusor Space Infusion Pump System... | Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an ... | Class II | B Braun Medical Inc |
| Jun 14, 2024 | Brand Name: Perfusor Space Product Name: PERFUSOR SPACE ACM-KIT Model/Catal... | Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an ... | Class II | B Braun Medical Inc |
| Jun 14, 2024 | Brand Name: Perfusor Space Product Name: Perfusor PCA Syringe Pump Model/Ca... | Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an ... | Class II | B Braun Medical Inc |
| Jun 14, 2024 | Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Wirele... | Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an ... | Class II | B Braun Medical Inc |
| May 17, 2024 | Stimuplex A, 30 DEG, 20GX6", 0.90x150mm, Catalogue Number: 4894278 | The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used cont... | Class II | B Braun Medical Inc |
| May 17, 2024 | Stimuplex A, 30 DEG, 22GX2", 0.70x50mm, Catalogue Number: 4894502 | The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used cont... | Class II | B Braun Medical 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.