Medical Device Recalls | FDA Device Safety Alerts And Recall Notices

Medical Device Recall Alerts List

Showing 1,101 - 1,125 of 1,678 matching product recalls.

Product Recall	Source	Type	Risk	Date	Action
Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-026, 2088026-115, 2088026-043, K2042VJED, 2088026-132, 2088026-003, 2088026-110, 2089629-003, 2066908-136, 2066908-150 There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data.	FDA Z-1571-2026	Medical Device	High	Mar 25, 2026 Recall: Jan 30, 2026	Details
Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No Due to product exhibiting potential to generate either invalid or false negative results.	FDA Z-1586-2026	Medical Device	High	Mar 25, 2026 Recall: Feb 18, 2026	Details
Cub Pediatric Crib, Model FL19H Cribs sold in the USA are missing two access door warning labels.	FDA Z-1580-2026	Medical Device	High	Mar 25, 2026 Recall: Feb 18, 2026	Details
Artegraft Vascular Graft; REF#: AG740; Labeling mix-up resulting in the incorrect lot outer packaging of product.	FDA Z-1574-2026	Medical Device	High	Mar 25, 2026 Recall: Feb 10, 2026	Details
Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm Drainable large pouch may leak due to manufacturing issue.	FDA Z-1583-2026	Medical Device	High	Mar 25, 2026 Recall: Feb 16, 2026	Details
Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm Drainable large pouch may leak due to manufacturing issue.	FDA Z-1582-2026	Medical Device	High	Mar 25, 2026 Recall: Feb 16, 2026	Details
Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: The STA¿ - Liatest ¿ D-Di kit is an immuno-turbidimetric assay for the quantitative determination of D-dimer in venous plasma (in 3.2 % sodium citrate) for use on STA-R¿, STA Compact¿ and STA Satellite¿ analyzers by professional laboratory personnel. The STA¿ - Liatest¿ D-Di is intended for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude pulmonary embolism (PE) and deep venous thrombosis (DVT) in outpatients suspected of PE or DVT. Component: After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.	FDA Z-1585-2026	Medical Device	High	Mar 25, 2026 Recall: Feb 5, 2026	Details
Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-406, 2100169-001, 2088026-985, 2088026-971, 2088026-614, 2088026-713, 2088026-994, 2100491-006, 2088026-723, 2088026-308, 2104867-044, 2100491-012, 2088026-962, 2088026-969, 2102676-001, 2088026-936, 2088026-960, K1220JWED, 2088026-806, 2088026-506, 2088026-026, 2088026-970, 2088026-943, 2088026-990, 2088026-940, 2088026-959, 2088026-967, 2088026-989, 2104867-045, 2088026-993, 2088026-306, 2102675-010, There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data.	FDA Z-1570-2026	Medical Device	High	Mar 25, 2026 Recall: Jan 30, 2026	Details
Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" Leksell Gamma Knife¿ Elekta Esprit Leksell Gamma Knife¿ (available models Elekta Esprit, Icon", and Perfexion") is a radiosurgery system for use in the stereotactic irradiation of head structures. Surgery is achieved by delivering a prescribed dose as one or more shots of ionizing radiation to the exact site of the target. Due to adapter not being properly aligned or locked in place.	FDA Z-1581-2026	Medical Device	High	Mar 25, 2026 Recall: Feb 18, 2026	Details
MICS3 Angled Sagittal Saw Attachment; Part Number: 210490 A potential issue was identified with the torque strength on the external screws of the MICS3 Angled Sagittal Saw Attachment. These screws, which secure the cover to the Angled Saw Housing, may loosen during use and detach from the attachment.	FDA Z-1572-2026	Medical Device	High	Mar 25, 2026 Recall: Feb 2, 2026	Details
Battery Charging Station; Model: 0998-00-0802; The Battery Charging Station is an optional dual-bay charger used to charge the Cardiosave IABP Lithium- Ion batteries when they are not being used to operate the IABP. Getinge has identified that a protruding screw in the left battery bay limits full insertion of certain batteries and prevents proper charging. The right bay of the Battery Charging Station is not affected by this issue.	FDA Z-1587-2026	Medical Device	High	Mar 25, 2026 Recall: Feb 6, 2026	Details
Endo-Model Replacement Plateau; Item Number: 15-0027/16; The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.	FDA Z-1523-2026	Medical Device	High	Mar 18, 2026 Recall: Jan 12, 2026	Details
Endo-Model Replacement Plateau; Item Number: 15-0027/12; The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.	FDA Z-1522-2026	Medical Device	High	Mar 18, 2026 Recall: Jan 12, 2026	Details
Endo-Model Replacement Plateau; Item Number: 15-8521/11; The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.	FDA Z-1519-2026	Medical Device	High	Mar 18, 2026 Recall: Jan 12, 2026	Details
GEM Premier 5000 PAK; Part No. 00055407504. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.	FDA Z-1528-2026	Medical Device	High	Mar 18, 2026 Recall: Jan 20, 2026	Details
EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000; Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile swabstick packaging, which could result in loss of sterility or drying of the antiseptic solution. This component is placed outside of the sterile barrier of the tray manufactured by Boston Scientific, which contains the majority of the kit components. As such, inclusion of the affected ChloraPrep Triple Swabsticks does not degrade the integrity of the other components within the PEG kit.	FDA Z-1551-2026	Medical Device	High	Mar 18, 2026 Recall: Feb 10, 2026	Details
Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection. Product not cleared by the FDA.	FDA Z-1559-2026	Medical Device	High	Mar 18, 2026 Recall: Dec 19, 2025	Details
Endo-Model Replacement Plateau; Item Number: 15-8521/09; The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.	FDA Z-1518-2026	Medical Device	High	Mar 18, 2026 Recall: Jan 12, 2026	Details
Penner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2 The device does not bear a unique device identifier.	FDA Z-1505-2026	Medical Device	High	Mar 18, 2026 Recall: Aug 13, 2025	Details
Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs. Product not cleared by the FDA.	FDA Z-1561-2026	Medical Device	High	Mar 18, 2026 Recall: Dec 19, 2025	Details
Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5850.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot. Component: Not applicable. Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.	FDA Z-1550-2026	Medical Device	High	Mar 18, 2026 Recall: Jan 9, 2026	Details
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02; The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.	FDA Z-1513-2026	Medical Device	High	Mar 18, 2026 Recall: Jan 12, 2026	Details
GEM Premier 5000; Part No. 00055445010 & 00055445011. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.	FDA Z-1543-2026	Medical Device	High	Mar 18, 2026 Recall: Jan 20, 2026	Details
GEM Premier 5000 PAK; Part No. 00055415004. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.	FDA Z-1532-2026	Medical Device	High	Mar 18, 2026 Recall: Jan 20, 2026	Details
GEM Premier 5000 PAK; Part No. 00055360010. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.	FDA Z-1526-2026	Medical Device	High	Mar 18, 2026 Recall: Jan 20, 2026	Details

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Medical Device Recalls Today

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