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  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 61–80 of 1,000 recalls

Class IIOngoing

Medline Convenience Kits: 1) BLOCK TRAY, Model Number: DYNJRA1590

Medline Industries, LP

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.

May 21, 2026 · DeviceView details →
Class IIOngoing

OTP5000 THORA/PARA TRAY, 5FR, NON-VALVED UDI-DI Code: 0110885403284748 PIG1260T SAFE-T-CENTESIS TRAY 6FR X 16CM UDI-DI Code: 0110885403108365 TPT1000 THORACENTESIS/PARACENTESIS TRAY UDI-DI Code: 0110885403108488 The Acute Drainage devices are indicated for use in removing fluid from either the pleural or peritoneal spaces during an acute drainage / aspiration procedure.

Bard Access Systems, Inc.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

May 21, 2026 · Device
View details →
Class IIOngoing

BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD Connecta" Stopcocks are used to administer fluids or medication through one or two different ports via an IV cannula or extension tube. The ports can be used to sample blood or for hemodynamic monitoring. When used with IV lipid nutritional products, the stopcock device can be used for up to 24 hours.

BD SWITZERLAND SARL

Due to stopcock issues when using the plastic luer-lok syringe, the connection at the Port C may over thread or continue to spin rather than tightening securely. This behavior has led some clinical users to perceive the connection as unstable.

May 21, 2026 · DeviceView details →
Class IIOngoing

7617408 Groshong NXT ClearVue Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741035258 The Groshong¿ NXT PICC provides short (less than 30 days) or long (greater than 30 days) term peripheral access to the central venous system for intravenous therapy or blood sampling.

Bard Access Systems, Inc.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

May 21, 2026 · DeviceView details →
Class IIOngoing

CRE Wireguided 6-8mm 240cm

Boston Scientific Corporation

Potential sterile breach of the pouches in which devices are packaged.

May 21, 2026 · DeviceView details →
Class IIOngoing

CK000980A PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236150 P4254108 PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741129278 P4254108D PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741129353 The PowerMidline" Catheter is intended for short term peripheral access for selected intravenous therapies, blood sampling, and power injection of contrast media.

Bard Access Systems, Inc.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

May 21, 2026 · DeviceView details →
Class IIOngoing

CRE Wireguided 18-20mm 240cm

Boston Scientific Corporation

Potential sterile breach of the pouches in which devices are packaged.

May 21, 2026 · DeviceView details →
Class IIOngoing

Medline Convenience Kits: 1) OPHTHALMIC PACK W/LIDO, Model Number: DYNJ57922A

Medline Industries, LP

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.

May 21, 2026 · DeviceView details →
Class IIOngoing

CRE Pro Wireguided 8-10mm 240cm

Boston Scientific Corporation

Potential sterile breach of the pouches in which devices are packaged.

May 21, 2026 · DeviceView details →
Class IIOngoing

4380 ECONOMY SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108563 4382A SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108501 The Soft Tissue Biopsy devices are indicated for use in the collection of aspirate tissue (e.g. liver, kidney, etc.).

Bard Access Systems, Inc.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

May 21, 2026 · DeviceView details →
Class IIOngoing

Medline Convenience Kits: 1) ARTERIAL LINE KIT, Model Number: ART890B; 2) ULTRASOUND GUIDED IV SECUREMENT SET, Model Number: IVS3350

Medline Industries, LP

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.

May 21, 2026 · DeviceView details →
Class IIOngoing

Medline Convenience Kits: 1) MERCY MEDICAL CIRCUMCISION TRAY, Model Number: CIT6780; 2) CIRCUMCISION TRAY W/1.1CM CIRCLAMP, Model Number: CIT3225A; 3) CIRCUMCISION TRAY, Model Number: CIT6325

Medline Industries, LP

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.

May 21, 2026 · DeviceView details →
Class IIOngoing

Solar GI System (Water Perfusion); Product Name (Catalog Number): Solar GI LGI H2O, 12p, Trolley system (G3-6), Solar GI HRM H2O, 24p, Compact Pole system (G3-7), Solar GI HRM H2O, 24p, Trolley system (G3-8), Solar GI HRM H2O, 36p, Trolley system (G3-12), Solar GI HRAM H2O, 24p, Trolley system (G3-14);

Laborie Medical Technologies Corp

Under extended clinical use conditions (e.g., long duration studies), moisture generated within the pneumatic circuit may accumulate inside the system's internal tubing or at the hydrophobic filter and waterproof pressure sensors. Accumulated moisture may affect airflow or pressure measurement performance if not properly removed.

May 21, 2026 · DeviceView details →
Class IIOngoing

CRE Wireguided 10-12mm 240cm

Boston Scientific Corporation

Potential sterile breach of the pouches in which devices are packaged.

May 21, 2026 · DeviceView details →
Class IIOngoing

1174108 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154935 1295108 PowerPICC SOLO Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741034602 1174108D3 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154935 1174108D4 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741155048 1174108D5 PowerPICC Catheter 4 Fr Singel-Lumen UDI-DI Code: 00801741155147 1194108D PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741034510 1194108D1 PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154782 1194108D4 PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741155093 1194108D5 PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741155192 1275108D PowerPICC Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741034558 1295108FD PowerPICC SOLO FT Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741034626 3194108D PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741027727 3275108D PowerPICC Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741027871 3295108D PowerPICC SOLO FT Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741028052 9194108D PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741035609 CK000267A PowerPICC SOLO2 Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741185021 CK000289C PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741161148 CK000293 PowerPICC HF Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741038020 CK000586B PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741212789 CK000613 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121395 CK000631B PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741143748 CK000632B PowerPICC Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741143755 CK000746A PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741227066 CK000886 PowerPICC Provena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741188831 CK000966A PowerPICC Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741215858 CK000988 PowerPICCProvena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741216022 CK001006 PowerPICC Provena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741219849 CK001030 PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741223976 S1275108FD2 PowerPICC Provena FT Catheter 5 Fr Dual-Lumen UDI-Di Code: 00801741154850 S1275108FD3 PowerPICC Provena FT Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741154959 S1295108FD1 PowerPICC Provena Catheter SOLO 5 Fr Dual-Lumen UDI-DI Code: 00801741154805 S1295108FD3 PowerPICC Provena SOLO FT Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741155017 S1295108FD5 PowerPICC Provena SOLO FT Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741155215 S1385108D PowerPICC Provena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741112720 S1385108D2 PowerPICC Provena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741154867 S1385108D3 PowerPICC Provena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741154966 S1385108D4 PowerPICC Provena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741155079 S1395108D PowerPICC Provena SOLO Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741112751 S1395108D1 PowerPICC Provena SOLO Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741154812 S1395108D2 PowerPICC Provena SOLO Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741154911 S1395108D3 PowerPICC Provena SOLO Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741155024 S1395108D4 PowerPICC Provena SOLO Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741155123 S1395108D5 PowerPICC Provena SOLO Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741155222

Bard Access Systems, Inc.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

May 21, 2026 · DeviceView details →
Class IIOngoing

CRE Pro Wireguided 18-20mm 240cm

Boston Scientific Corporation

Potential sterile breach of the pouches in which devices are packaged.

May 21, 2026 · DeviceView details →
Class IIOngoing

5605150 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086953 5605240 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086977 5605300 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086984 5615120 Power-Trialysis Short-Term Curved Extension Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741075087 5615200 Power-Trialysis Short-Term Curved Extension Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741075100 5615200 Power-Trialysis Short-Term Curved Extension Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741075100 5615200 Power-Trialysis Short-Term Curved Extension Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741075100 5655120 Power-Trialysis Short-Term Alphacurve Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741066054 The Power-Trialysis" Short-Term Dialysis Catheter, with a third internal lumen for intravenous therapy, power injection of contrast media, and central venous pressure monitoring, is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, and apheresis treatments. The catheter is intended to be inserted in the jugular, femoral, or subclavian vein as required. The maximum recommended infusion rate is 5 mL/sec for power injection of contrast media.

Bard Access Systems, Inc.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

May 21, 2026 · DeviceView details →
Class IIOngoing

Medline Convenience Kits: 1) MULTIMED, 7FR, 20CM, 3L, CVC BUNDLE, Model Number: ECVC5995; 2) TRIPLE LUMEN CENTRAL LINE BUNDLE, Model Number: ECVC2625; 3) INTROFLEX 6F, 1L, TB, US, Model Number: STCVC26US; 4) AVA HIGH FLOW, Model Number: ECVC3720; 5) CDP, MM, 3L, 7F, 16CM, H, Model Number: 3K16H1838; 6) CVC Insertion Bundle 3L 7FR 20CM, Model Number: ECVC5610; 7) TRIPLE LUMEN CVC INSERTION BUNDLE, Model Number: ECVC3810; 8) 16CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number: ECVC2555; 9) CENTRAL LINE BUNDLE W/7F, 20CM, 3L, Model Number: ECVC2750; 10) TRIPLE LUMEN COMPLETE CATH KIT, Model Number: ECVC5200; 11) TRIPLE LUMEN CVC 20CM BUNDLE W/O SUTURE, Model Number: ECVC7290; 12) AVA HIGH FLOW, Model Number: ECVC3720; 13) 7FR 3L 16CM CVC INSERTION BUNDLE, Model Number: ECVC8215; 14) CENTRAL LINE INSERTION BUNDLE, Model Number: ECVC2080; 15) 3L 7FR 16 CM CVC INSERTION TRAY, Model Number: ECVC8165; 16) VANTEX 7FR 3L 20CM CVC BUNDLE, Model Number: ECVC6505; 17) VANTEX 7FR, 16CM, 3L CVC BUNDLE, Model Number: STCVC02; 18) O.R. CVC TRIPLE LUMEN BUNDLE, Model Number: ECVC1377; 19) INTROFLEX 8.5FR. 1L CVC BUNDLE, Model Number: CMPI851LBA; 20) INTROFLEX 5F, 1L, TB, US, BAS, Model Number: STCVC49US; 21) CVC BUNDLE, Model Number: ECVC8090; 22) TRIPLE LUMEN INSERTION KIT W/CATHETER, Model Number: ECVC2885; 23) O.R. CVC TRIPLE LUMEN BUNDLE, Model Number: ECVC1377; 24) MULTIMED, 7FR, 20CM, 3L, CVC BUNDLE, Model Number: ECVC5995; 25) 3L 7FR 20CM CVC INSERTION BUNDLE, Model Number: ECVC6845; 26) CVC BUNDLE TRIPLE LUMEN 16CM, Model Number: ECVC5540A; 27) CDP, MM, 3L, 7F, 16CM, H, Model Number: 3K16H1838; 28) CVC INSERTION BUNDLE, Model Number: ECVC1120; 29) TRIPLE LUMEN CENTRAL LINE BUNDLE, Model Number: ECVC2625; 30) TRIPLE LUMEN COMPLETE CATH KIT, Model Number: ECVC5200; 31) VANTEX 7FR 3L 16CM CVC BUNDLE W/US, Model Number: ECVC8075; 32) CENTRAL LINE BUNDLE W/7F, 16CM, 3L, Model Number: ECVC2745; 33) VANTEX 7FR 3L 16CM CVC BUNDLE W/US, Model Number: ECVC7945; 34) CENTRAL LINE BUNDLE W/7F, 20CM, 3L, Model Number: ECVC2750

Medline Industries, LP

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.

May 21, 2026 · DeviceView details →
Class IIOngoing

Medline Convenience Kits: 1) L&D CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1699A

Medline Industries, LP

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.

May 21, 2026 · DeviceView details →
Class IIOngoing

RayCare 2024A SP1. Oncology Information Systems.

RAYSEARCH LABORATORIES AB

Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change.

May 20, 2026 · DeviceView details →
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