June 11, 2025Medical DevicesFDA
Silex Medical, LLC recalls Signature Laparoscopic Instruments, Debakey Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connect
Hazard: Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
June 11, 2025Medical DevicesFDA
Silex Medical, LLC recalls Signature Laparoscopic Instruments, Allis Clamp Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Con
Hazard: Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
June 11, 2025Medical DevicesFDA
Silex Medical, LLC recalls Signature Laparoscopic Instruments, Dolphin Nose Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Co
Hazard: Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
June 11, 2025Medical DevicesFDA
Civco Medical Instruments Co. Inc. recalls BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagno
Hazard: During the attachment of the needle guide to the covered probe, the tight tolerance and fit of the needle guide can cause a pinhole breach in the transducer cover when latching the guide in place.
June 11, 2025Medical DevicesFDA
Foundation Medicine, Inc. recalls FoundationOne Companion Diagnostic (F1CDx)
Hazard: An incorrect negative claim was identified on the claims page; the device variant information was displayed correctly in the tumor profiling section of the FDA-approved test report.
June 11, 2025Medical DevicesFDA
Foundation Medicine, Inc. recalls FoundationOne Companion Diagnostic (F1CDx)
Hazard: Two (2) reports were sent to customers with an incorrect negative claim on the claims page; the device variant information was displayed correctly in the tumor profiling section of both FDA-approved test reports.
June 11, 2025Medical DevicesFDA
Mozarc Medical US LLC recalls MAHURKAR Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Hazard: Potential breach of sterile barrier packaging.
June 11, 2025Medical DevicesFDA
Mozarc Medical US LLC recalls Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Hazard: Potential breach of sterile barrier packaging.
June 11, 2025Medical DevicesFDA
Mozarc Medical US LLC recalls Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Hazard: Potential breach of sterile barrier packaging.
June 11, 2025Medical DevicesFDA
Mozarc Medical US LLC recalls Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Hazard: Potential breach of sterile barrier packaging.
June 11, 2025Medical DevicesFDA
Mozarc Medical US LLC recalls Palindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Hazard: Potential breach of sterile barrier packaging.
June 11, 2025Medical DevicesFDA
Flux Technology Inc. recalls Lazervida 10W diode laser cutter and engraver with Lazervida shield.
Hazard: Lazervida 10W Diode Laser Engraver does not fully meet current Federal performance standards in certain areas. Specifically, the product does not incorporate the additional beam attenuator, remote interlock connector, key switch, specific labels and manual instructions required under current regulations.
June 11, 2025Medical DevicesFDA
SunMed Holdings, LLC recalls Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F
Hazard: Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead of the exhalation port). If not noticed prior to patient use, there would be interruption or delay in patient resuscitation, which may lead to life threatening consequences, including hypoxia, hypercapnia, organ failure, and death.
June 11, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ACCESSORY PACK SKU DYNJ59270 2. CRANI PA
Hazard: Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.
June 11, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY, SKU DYNJ35349C
Hazard: Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.
June 11, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ADD A PACK, SKU DYNJ30926O 2. CRANIOTOMY, SKU C
Hazard: Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.
June 4, 2025Medical DevicesFDA
Onkos Surgical, Inc. recalls Male-Female Midsection with the following sizes and model numbers. a. Male-Female Midsection, 40mm, 1 EACH; Model Num
Hazard: Potential for breach of Tyvek seals.
June 4, 2025Medical DevicesFDA
Onkos Surgical, Inc. recalls Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03
Hazard: Potential for breach of Tyvek seals.
June 4, 2025Medical DevicesFDA
Onkos Surgical, Inc. recalls Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M, FB-12152-03M, FB-13152-03M, FB-14152-03
Hazard: Potential for breach of Tyvek seals.
June 4, 2025Medical DevicesFDA
Onkos Surgical, Inc. recalls Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-1412
Hazard: Potential for breach of Tyvek seals.
June 4, 2025Medical DevicesFDA
Onkos Surgical, Inc. recalls Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, CB-13152-03M, CB-15152-03M, CB-17152-03M.
Hazard: Potential for breach of Tyvek seals.
June 4, 2025Medical DevicesFDA
Onkos Surgical, Inc. recalls a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. b. Segmental Stem, C
Hazard: Potential for breach of Tyvek seals.
June 4, 2025Medical DevicesFDA
BioFire Diagnostics, LLC recalls BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
Hazard: Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results.
June 4, 2025Medical DevicesFDA
Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 9
Hazard: Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and cartridge (cart) label.
June 4, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumen
Hazard: Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
June 4, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen
Hazard: Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
June 4, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen
Hazard: Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
June 4, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen
Hazard: Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
June 4, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen
Hazard: Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
June 4, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs
Hazard: Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.