Browse Device Recalls

2,888 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,888 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 2,888 FDA device recalls in PA.

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DateProductReasonClassFirm
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
Oct 24, 2025 MAMMOMAT Revelation; There were instances where the operator table was sold together with a bus-installation kit. The ... Class II Siemens Medical Solutions USA, Inc
Oct 24, 2025 MAMMOMAT Fusion; There were instances where the operator table was sold together with a bus-installation kit. The ... Class II Siemens Medical Solutions USA, Inc
Oct 24, 2025 MAMMOMAT Inspiration; There were instances where the operator table was sold together with a bus-installation kit. The ... Class II Siemens Medical Solutions USA, Inc
Oct 22, 2025 Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Firm is initiating a removal due to continued reports of adverse events. Class II Olympus Corporation of the Americas
Oct 22, 2025 Olympus Thunderbeat, 5 mm, 45 cm Inline Grip Firm is initiating a removal due to continued reports of adverse events. Class II Olympus Corporation of the Americas
Oct 22, 2025 Olympus Thunderbeat, 5 mm, 35 cm, Inline Grip Firm is initiating a removal due to continued reports of adverse events. Class II Olympus Corporation of the Americas
Oct 22, 2025 Olympus Thunderbeat, 5 mm, 45 cm Front-Actuated Grip Firm is initiating a removal due to continued reports of adverse events. Class II Olympus Corporation of the Americas
Oct 22, 2025 Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S Firm is initiating a removal due to continued reports of adverse events. Class II Olympus Corporation of the Americas
Oct 22, 2025 Olympus Thunderbeat 5 mm, 10 cm, Inline Grip Firm is initiating a removal due to continued reports of adverse events. Class II Olympus Corporation of the Americas
Oct 22, 2025 Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip Firm is initiating a removal due to continued reports of adverse events. Class II Olympus Corporation of the Americas
Oct 22, 2025 Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip Firm is initiating a removal due to continued reports of adverse events. Class II Olympus Corporation of the Americas
Oct 22, 2025 Olympus Thunderbeat, 5 mm, 20 cm, Inline Grip Firm is initiating a removal due to continued reports of adverse events. Class II Olympus Corporation of the Americas
Oct 22, 2025 Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S Firm is initiating a removal due to continued reports of adverse events. Class II Olympus Corporation of the Americas
Oct 22, 2025 Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip Firm is initiating a removal due to continued reports of adverse events. Class II Olympus Corporation of the Americas
Oct 22, 2025 Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S Firm is initiating a removal due to continued reports of adverse events. Class II Olympus Corporation of the Americas
Oct 17, 2025 Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit P... Device kits contained an incorrectly sized 4mm x 4cm urinary tract balloon catheter (BURS0404) in... Class II Olympus Corporation of the Americas
Oct 14, 2025 Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V... Continued reports of positive cultures and infections have identified updates to the reprocessing... Class II Olympus Corporation of the Americas
Oct 8, 2025 Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Tr... The device may either fail to start up, or the transducer may start briefly and then stop, accomp... Class II Olympus Corporation of the Americas
Oct 7, 2025 SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected ... Certain serial numbers of the SimplyGo Mini standard battery kit contain a defective chip which c... Class II Philips Respironics, Inc.
Oct 6, 2025 Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Si... Sterility compromised from small holes that may occur during packaging of the device pouches into... Class II Olympus Corporation of the Americas
Oct 6, 2025 Brand Name: Olympus Single Use Single Use Electrosurgical Snare SD-400 Produ... Sterility compromised from small holes that may occur during packaging of the device pouches into... Class II Olympus Corporation of the Americas
Oct 1, 2025 MAGNETOM Cima.X Upgrade. Model Number: 11689304. There is a potential for an ice blockage to form or currently exist within the primary and/or the... Class I Siemens Medical Solutions USA, 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 26, 2025 LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 0... Although the etched length on the screw is correct, the length marked on the external packaging i... Class II Synthes (USA) Products LLC
Sep 26, 2025 LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 0... Although the etched length on the screw is correct, the length marked on the external packaging i... Class II Synthes (USA) Products LLC
Sep 24, 2025 Brand Name: AESCULAP Product Name: SEALING UNIT FOR 10/12MM TROCARS Model/C... It was determined there is the potential of silicone fragments detaching from the yellow sealing ... Class II Aesculap Inc
Sep 24, 2025 Brand Name: Aesculap Product Name: SEALING CAP FOR 10/12MM TROCARS Model/Ca... It was determined there is the potential of silicone fragments detaching from the yellow sealing ... Class II Aesculap Inc
Sep 24, 2025 Brand Name: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM Model/... It was determined there is the potential of silicone fragments detaching from the yellow sealing ... Class II Aesculap Inc
Sep 24, 2025 Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER ... It was determined there is the potential of silicone fragments detaching from the yellow sealing ... Class II Aesculap 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

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.