Browse Device Recalls
35,653 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,653 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 35,653 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 17, 2025 | Brand Name: Molift Product Name: Molift Mover 205 Model/Catalog Number: (1)... | A customer experienced that during assembly and load testing of the device, the bolt for mounting... | Class II | ETAC A/S |
| Nov 17, 2025 | Brand Name: Molift Product Name: Molift 4-point sling bars (Accessory to mob... | A customer experienced that during assembly and load testing of the device, the bolt for mounting... | Class II | ETAC A/S |
| Nov 17, 2025 | The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pres... | Customer complaints of Pressio monitor rebooting. | Class II | Sophysa |
| Nov 14, 2025 | Halyard, MIDTOWN GENERAL ARTERIOGRAM. Catalog Number: EUHM009-01. | Potential for incomplete seal on header bag. | Class II | AVID Medical, Inc. |
| Nov 14, 2025 | Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lit... | Ongoing investigations identified additional instances of the device Generator remaining in a bli... | Class II | Olympus Corporation of the Americas |
| Nov 14, 2025 | Halyard, MAJOR PACK. Catalog Number: JEMJ10-01. | Potential for incomplete seal on header bag. | Class II | AVID Medical, Inc. |
| Nov 14, 2025 | Halyard, HEAD AND NECK TRAY. Catalog Number: EURO016-09. | Potential for incomplete seal on header bag. | Class II | AVID Medical, Inc. |
| Nov 14, 2025 | Halyard, EP LAB PK. Catalog Number: ESJH009-03. | Potential for incomplete seal on header bag. | Class II | AVID Medical, Inc. |
| Nov 14, 2025 | Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-... | Ongoing investigations identified additional instances of the device Generator remaining in a bli... | Class II | Olympus Corporation of the Americas |
| Nov 14, 2025 | Halyard, GENERAL LAPAROSCOPY PACK. Catalog Number: VAST018-10. | Potential for incomplete seal on header bag. | Class II | AVID Medical, Inc. |
| Nov 14, 2025 | Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse... | Ongoing investigations identified additional instances of the device Generator remaining in a bli... | Class II | Olympus Corporation of the Americas |
| Nov 13, 2025 | Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20 | Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immun... | Class II | Abbott Laboratories |
| Nov 13, 2025 | InPen App, Model/CFN Number: MMT-8061 (Android Users) | When app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification St... | Class II | Medtronic MiniMed, Inc. |
| Nov 13, 2025 | SCISSORS, OR, SHARP/BLUNT, 5.5", STERILE, Item Number DYND04000 | The items may have weak packaging seals that may result in a breach of sterility if the seal fail... | Class II | Medline Industries, LP |
| Nov 13, 2025 | FORCEP, STD STR, STERILE KELLY, 5.5 IN, Item Number DYNJ04048 | The items may have weak packaging seals that may result in a breach of sterility if the seal fail... | Class II | Medline Industries, LP |
| Nov 13, 2025 | KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus der... | Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10. | Class II | Microbiologics Inc |
| Nov 12, 2025 | ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Co... | Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-l... | Class II | Cardinal Health 200, LLC |
| Nov 12, 2025 | The Stryker CranialMask Tracker is a single-use device consisting of a flexib... | When the device is activated during surgery, the device software issues an error message "Instrum... | Class II | Howmedica Osteonics Corp. |
| Nov 12, 2025 | 1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10... | Products may contain contamination, which may result in a darker or brown media color. | Class II | Remel, Inc |
| Nov 11, 2025 | Olympus Resection Sheath, 26 Fr.; Model No. A22042A. Resection sheath for uro... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Inner Sheath, Long; Model No. WA22017T. Inner sheath for urological ... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Inner Sheath. Model No. A2642. for endoscopic diagnosis and treatmen... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagn... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | DEXLOCK Achilles Repair Implant Kits, MAKT4520 | There have been multiple complaints of drill bit fusing to the bushing/sleeve within the drill gu... | Class II | Medline Industries, LP |
| Nov 11, 2025 | Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic appl... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gyne... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. ... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for uro... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for ur... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological ... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treat... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and t... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Resection Sheath. Model No. A2666T. for endoscopic diagnosis and tre... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatmen... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. R... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 10, 2025 | Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right,... | The device has been delivered with a preassembled locking screw that had been inserted from the w... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Nov 10, 2025 | COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For us... | Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts... | Class II | Beckman Coulter, Inc. |
| Nov 7, 2025 | Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter Procedure Tr... | IFU and device kit labeling contains misleading statements leading to improper securing of the de... | Class II | Rocket Medical Plc |
| Nov 7, 2025 | Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter with Safety ... | IFU and device kit labeling contains misleading statements leading to improper securing of the de... | Class II | Rocket Medical Plc |
| Nov 7, 2025 | Access 2 Reaction Vessels, individual, disposable, plastic tubes used to proc... | It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing d... | Class II | Beckman Coulter, Inc. |
| Nov 7, 2025 | Brand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter Procedure Tr... | IFU and device kit labeling contains misleading statements leading to improper securing of the de... | Class II | Rocket Medical Plc |
| Nov 7, 2025 | Brand Name: Rocket Product Name: Rocket 20Fg Seldinger Catheter Procedure Tr... | IFU and device kit labeling contains misleading statements leading to improper securing of the de... | Class II | Rocket Medical Plc |
| Nov 7, 2025 | Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vin... | Due to a software implementation error that allowed instruments arms failing an important diagnos... | Class II | Intuitive Surgical, Inc. |
| Nov 7, 2025 | Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter with Safety ... | IFU and device kit labeling contains misleading statements leading to improper securing of the de... | Class II | Rocket Medical Plc |
| Nov 7, 2025 | Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter Procedure Tr... | IFU and device kit labeling contains misleading statements leading to improper securing of the de... | Class II | Rocket Medical Plc |
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.