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 |
|---|---|---|---|---|
| May 21, 2026 | GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 000... | The active ingredient concentration in the lysing bag solution of specific GEM Premier 7000 with ... | Class II | Instrumentation Laboratory |
| May 21, 2026 | Brand Name: Medical Action Industries Product Name: Dialysis Change Tray Cl... | Convenience kits contain needle free access device that has an improper seal which may result in... | Class II | Medical Action Industries, Inc. 306 |
| May 21, 2026 | GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 000554075... | The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 lots ... | Class II | Instrumentation Laboratory |
| May 21, 2026 | Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain exp... | Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures... | Class II | Karl Storz Endoscopy |
| May 21, 2026 | Papablic Replacement Brush Heads. Model Number: Papablic18B | Potential for brush heads to break. | Class II | Papablic Inc |
| May 21, 2026 | Papablic Replacement Brush Heads. Model Number: PAPA317AA. | Potential for brush heads to break. | Class II | Papablic Inc |
| May 21, 2026 | Medline Convenience Kits: 1) L&D CONTINUOUS EPIDURAL TRAY, Model Number: PAI... | 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) MULTIMED, 7FR, 20CM, 3L, CVC BUNDLE, Model Numb... | The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(... | Class II | Medline Industries, LP |
| May 21, 2026 | 5605150 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lu... | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufactu... | Class II | Bard Access Systems, Inc. |
| May 21, 2026 | CRE Pro Wireguided 18-20mm 240cm | Potential sterile breach of the pouches in which devices are packaged. | Class II | Boston Scientific Corporation |
| 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 | 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 | 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 | 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. |
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.