Browse Device Recalls
39,885 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,885 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 39,885 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 21, 2026 | A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgi... | Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the d... | Class I | Windstone Medical Packaging, Inc. |
| May 21, 2026 | 1174108 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154935 ... | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufactu... | Class II | Bard Access Systems, Inc. |
| May 21, 2026 | CRE Wireguided 10-12mm 240cm | Potential sterile breach of the pouches in which devices are packaged. | Class II | Boston Scientific Corporation |
| May 21, 2026 | Solar GI System (Water Perfusion); Product Name (Catalog Number): Solar GI ... | Under extended clinical use conditions (e.g., long duration studies), moisture generated within t... | Class II | Laborie Medical Technologies Corp |
| May 21, 2026 | Medline Convenience Kits: 1) MERCY MEDICAL CIRCUMCISION TRAY, Model Number: ... | The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(... | Class II | Medline Industries, LP |
| May 21, 2026 | Medline Convenience Kits: 1) ARTERIAL LINE KIT, Model Number: ART890B; 2) ... | The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(... | Class II | Medline Industries, LP |
| May 21, 2026 | 4380 ECONOMY SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108563 4382A ... | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufactu... | Class II | Bard Access Systems, Inc. |
| May 21, 2026 | CRE Pro Wireguided 8-10mm 240cm | Potential sterile breach of the pouches in which devices are packaged. | Class II | Boston Scientific Corporation |
| May 21, 2026 | Medline Convenience Kits: 1) OPHTHALMIC PACK W/LIDO, Model Number: DYNJ57922A | The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(... | Class II | Medline Industries, LP |
| May 21, 2026 | CRE Wireguided 18-20mm 240cm | Potential sterile breach of the pouches in which devices are packaged. | Class II | Boston Scientific Corporation |
| May 21, 2026 | CK000980A PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236150 ... | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufactu... | Class II | Bard Access Systems, Inc. |
| May 21, 2026 | CRE Wireguided 6-8mm 240cm | Potential sterile breach of the pouches in which devices are packaged. | Class II | Boston Scientific Corporation |
| May 21, 2026 | 7617408 Groshong NXT ClearVue Catheter 4 Fr Single-Lumen UDI-DI Code: 008017... | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufactu... | Class II | Bard Access Systems, Inc. |
| May 21, 2026 | Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/... | There have been reports of air and medication leakage from the nebulizer cup during therapy of Vo... | Class I | Baxter Healthcare Corporation |
| May 21, 2026 | A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, ... | Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the d... | Class I | Windstone Medical Packaging, Inc. |
| May 21, 2026 | OTP5000 THORA/PARA TRAY, 5FR, NON-VALVED UDI-DI Code: 0110885403284748 PI... | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufactu... | Class II | Bard Access Systems, Inc. |
| May 21, 2026 | A M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Number AMS7200D, surgi... | Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the d... | Class I | Windstone Medical Packaging, Inc. |
| May 21, 2026 | Medline Convenience Kits: 1) BLOCK TRAY, Model Number: DYNJRA1590 | The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(... | Class II | Medline Industries, LP |
| May 21, 2026 | CRE Wireguided 15-18mm 240cm | Potential sterile breach of the pouches in which devices are packaged. | Class II | Boston Scientific Corporation |
| May 21, 2026 | CRE Wireguided 12-15mm 240cm | Potential sterile breach of the pouches in which devices are packaged. | Class II | Boston Scientific Corporation |
| May 21, 2026 | Medline Convenience Kits: 1) LUMBAR PUNCTURE CHOICE, Model Number: DYNDH1215 | The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(... | Class II | Medline Industries, LP |
| May 21, 2026 | CK000662 PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741... | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufactu... | Class II | Bard Access Systems, Inc. |
| May 21, 2026 | CRE Wireguided 8-10mm 240cm | Potential sterile breach of the pouches in which devices are packaged. | Class II | Boston Scientific Corporation |
| May 21, 2026 | Medline Convenience Kits: 1) ARTERIAL ACCESS TRAY W/LIDOCAINE, Model Number:... | The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(... | Class II | Medline Industries, LP |
| May 21, 2026 | CRE Pro Wireguided 6-8mm 240cm | Potential sterile breach of the pouches in which devices are packaged. | Class II | Boston Scientific Corporation |
| May 21, 2026 | CRE Pro Wireguided 15-18mm 240cm | Potential sterile breach of the pouches in which devices are packaged. | Class II | Boston Scientific Corporation |
| May 21, 2026 | 1274108D PowerPICC SV Catheter 4 Fr Dual-Lumen REKW2449 00801741087110 31731... | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufactu... | Class II | Bard Access Systems, Inc. |
| May 21, 2026 | CRE Pro Wireguided 10-12mm 240cm | Potential sterile breach of the pouches in which devices are packaged. | Class II | Boston Scientific Corporation |
| May 21, 2026 | Medline Convenience Kits: 1) PAIN MGMT/ PREF W. MED NDL, Model Number: PAIN00... | The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(... | Class II | Medline Industries, LP |
| May 21, 2026 | Medline Convenience Kits: 1) DYNJ0621189X, Model Number: SM RADIOLOGY-ANGIO ... | The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(... | Class II | Medline Industries, LP |
| May 21, 2026 | Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Ca... | There have been reports of air and medication leakage from the nebulizer cup during therapy of Vo... | Class I | Baxter Healthcare Corporation |
| May 21, 2026 | CK000525B PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801... | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufactu... | Class II | Bard Access Systems, Inc. |
| May 21, 2026 | 5625240 DuoGlide Short-Term Straight Dialysis Catheter 13 Fr Dual-Lumen UDI-... | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufactu... | Class II | Bard Access Systems, Inc. |
| May 21, 2026 | CK000880 Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 0080174118877... | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufactu... | Class II | Bard Access Systems, Inc. |
| May 21, 2026 | Medline Convenience Kits: 1) SUTURING SET, Model Number: SUT13710 | The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(... | Class II | Medline Industries, LP |
| May 21, 2026 | Medline Convenience Kits: 1) PI CVC KIT 3L 7 FR 16 CM, Model Number: ECVC8520... | The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(... | Class II | Medline Industries, LP |
| May 21, 2026 | CK000727 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741138478... | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufactu... | Class II | Bard Access Systems, Inc. |
| May 21, 2026 | Medline Convenience Kits: 1) IMAGING BIOPSY TRAY, Model Number: DYNDH1068; ... | The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(... | Class II | Medline Industries, LP |
| May 21, 2026 | Medline Convenience Kits: 1) STD, INTRO-FLEX INTRODUCER 6F, C, Model Number:... | The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(... | Class II | Medline Industries, LP |
| May 21, 2026 | 5855240 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr... | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufactu... | Class II | Bard Access Systems, Inc. |
| May 21, 2026 | Medline Convenience Kits: 1) SUTURE TRAY, Model Number: SUT12260; 2) CHEST... | The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(... | Class II | Medline Industries, LP |
| May 21, 2026 | CRE Pro Wireguided 12-15mm 240cm | Potential sterile breach of the pouches in which devices are packaged. | Class II | Boston Scientific Corporation |
| May 21, 2026 | CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 0080174112160... | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufactu... | Class II | Bard Access Systems, Inc. |
| May 21, 2026 | BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD C... | Due to stopcock issues when using the plastic luer-lok syringe, the connection at the Port C may ... | Class II | BD SWITZERLAND SARL |
| May 21, 2026 | MOSAIQ Oncology Information System | Software may fail to load adapted baseline shift plan during treatment delivery when a communicat... | Class II | Elekta, Inc. |
| May 20, 2026 | Brand Name: U2 Total Knee System Product Name: Femoral valgus offset adaptor... | Due to an incomplete process of the component screw by a subcontractor which prevents the properl... | Class II | United Orthopedic Corp. |
| May 20, 2026 | Brand Name: USTAR II Knee System Product Name: Hinge Box Trial, L, #1-6 and ... | Due to an incomplete process of the component screw by a subcontractor which prevents the properl... | Class II | United Orthopedic Corp. |
| May 20, 2026 | Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PS... | Due to an incomplete process of the component screw by a subcontractor which prevents the properl... | Class II | United Orthopedic Corp. |
| May 20, 2026 | Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left ... | Due to an incomplete process of the component screw by a subcontractor which prevents the properl... | Class II | United Orthopedic Corp. |
| May 20, 2026 | ARTIS icono ceiling. Model Number: 11328100. | Potential for loss of movement capability after adjusting the detector lift height to its maximum... | Class II | Siemens Medical Solutions USA, 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.