Latest Product Recalls Today

Recent Product Recall Alerts List

Showing 2,101 - 2,125 of 3,085 matching product recalls.

Product Recall	Source	Type	Risk	Date	Action
Endo-Model Replacement Plateau; Item Number: 15-0027/15; 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-1512-2026	Medical Device	High	Mar 18, 2026 Recall: Jan 12, 2026	Details
Penner Pacific Bathing Spa, Model Numbers 361910-1A, 361910-1A, 361910-XA, 361910-2I, 361910-1A, 361910-1, 361910-XI, 361910-1I, 361910-2A, 36191-1A, 361910-X The device does not bear a unique device identifier.	FDA Z-1504-2026	Medical Device	High	Mar 18, 2026 Recall: Aug 13, 2025	Details
Penner Pacific Bathing Spa, Model Numbers 360010-2WT, 360010-1, 370000-1W, 360010-1WT, 362010-1, 370000-1WL, 360010-1L, 360010-1W, 360010-XWTL, 370000-XWL, 360010-1WTL, 360010-XWT, 360010-2, 370000-2W, 360010-2L, 370000-2WL, 360010-X, 370000-XW, 360010-2W, 362010-2, 360010, 37000-XWL, 362010-X, 362010-XL, 362010-1L, 360010-XL, 37000-1W, 360010-XW, 3700000-1W, 362010-2L, 36010-XWT, 370000-1L, 360010-2WT, 360000-1, 360010-XWSB, 360010-XLSB The device does not bear a unique device identifier.	FDA Z-1500-2026	Medical Device	High	Mar 18, 2026 Recall: Aug 13, 2025	Details
HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI codes: Vital Sync 3.3.1 / 10884521844933 Vital Sync 3.4.0 / 10884521844940 Vital Sync 3.4.1 / 10884521847569 (OUS Only) Vital Sync 3.4.2 / 10884521856127 Product Number: VSLBASE04P / VITALSYNCSW04 Model / UDI-DI codes: Vital Sync 4.0.0 / 10884521849358 Vital Sync 4.0.2 / 10884521856134 The Vital Sync" Informatics Manager is software that is intended to route and store medical device data and device diagnostic information from supported devices to the Virtual Pat Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system.	FDA Z-1557-2026	Medical Device	High	Mar 18, 2026 Recall: Jan 30, 2026	Details
Penner Pacific Bathing Spa, Model Numbers 760010-1, 770010-1 The device does not bear a unique device identifier.	FDA Z-1507-2026	Medical Device	High	Mar 18, 2026 Recall: Aug 13, 2025	Details
GEM Premier 5000; Part No. 00055430004. 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-1537-2026	Medical Device	High	Mar 18, 2026 Recall: Jan 20, 2026	Details
Artelon FlexBand Plus Ref: 41054 & 41057 Augmentation devices failed bacterial endotoxin testing.	FDA Z-1555-2026	Medical Device	High	Mar 18, 2026 Recall: Feb 6, 2026	Details
MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010 Due to labeling error. Incomplete ingredients listed. Labeling did not include castor oil or calamine.	FDA Z-1495-2026	Medical Device	High	Mar 18, 2026 Recall: Jan 15, 2026	Details
Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1) Augmentation devices failed bacterial endotoxin testing.	FDA Z-1556-2026	Medical Device	High	Mar 18, 2026 Recall: Feb 6, 2026	Details
GEM Premier 5000; Part No. 00055415010. 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-1535-2026	Medical Device	High	Mar 18, 2026 Recall: Jan 20, 2026	Details
GEM Premier 5000; Part No. 00055445004. 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-1541-2026	Medical Device	High	Mar 18, 2026 Recall: Jan 20, 2026	Details
Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX GO Kit/RF4001-01BK, CVS TRUE METRIX GO Kit/RF4007-01, Meijer TRUE METRIX GO Kit/RF4019-01, Fred's Phamarcy TRUE METRIX GO Kit/RF4023-01, HEB TRUE METRIX GO Kit/RF4031-01, Hyvee TRUE METRIX GO Kit/RF4048-01, Rite Aid TRUE METRIX GO Kit/RF4066-01, TopCo TRUE METRIX GO Kit/RF4209-01, TRUE METRIX GO Kit/RF4H01-01BK, TRUE METRIX GO NFRS Meter Only/RF4H01-40, TRUE METRIX GO Kit (Jamaica - mmol/L)/RF4i29-11BK, TRUE METRIX GO Kit (Australia - mmol/L)/RF4i8 The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.	FDA Z-1548-2026	Medical Device	High	Mar 18, 2026 Recall: Feb 6, 2026	Details
GEM Premier 5000 PAK; Part No. 00055360008. 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-1525-2026	Medical Device	High	Mar 18, 2026 Recall: Jan 20, 2026	Details
GEM Premier 5000 PAK; Part No. 00055407510. 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-1530-2026	Medical Device	High	Mar 18, 2026 Recall: Jan 20, 2026	Details
GEM Premier 5000; Part No. 00055445008. 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-1542-2026	Medical Device	High	Mar 18, 2026 Recall: Jan 20, 2026	Details
GEM Premier 5000 PAK; Part No. 00055407508. 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-1529-2026	Medical Device	High	Mar 18, 2026 Recall: Jan 20, 2026	Details
Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5750.16/1 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-1549-2026	Medical Device	High	Mar 18, 2026 Recall: Jan 9, 2026	Details
PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 UDI-DI code: 00721902629013 Catalog Number: 11101-000017 UDI-DI code: 00721902682483 Infant/Child Reduced Energy Defibrillation Electrodes are pre gelled, self-adhesive, therapy electrodes that allow hands free defibrillation. These electrodes reduce the energy delivered to the patient by a factor of 4:1. The Infant/child reduced energy defibrillation electrodes are therapy electrodes designed to allow personnel who are trained on AED device operation and in basic life support, or other physician Due to pediatric defibrillator electrode delamination	FDA Z-1544-2026	Medical Device	High	Mar 18, 2026 Recall: Jan 21, 2026	Details
DxC 700 AU, REF: B86444, B86446 A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL Server 2022 Express is open beyond15 minutes may lead to: Reagent Blank and calibration databases not opening errors: CAL History DB Open Error.., RB History DB Open Error..; system will stop analyzing, firm service must visit to apply software solution; may lead to delay in diagnosis and/or patient treatment.	FDA Z-1552-2026	Medical Device	High	Mar 18, 2026 Recall: Jan 30, 2026	Details
GEM Premier 5000 PAK; Part No. 00055360011. 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-1527-2026	Medical Device	High	Mar 18, 2026 Recall: Jan 20, 2026	Details
Penner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC, 360030-1CT, 360030-1C, 360030-XC, 360030-XCT, 360030-1CTS, 360030-XCTS, 3600301-CTS, 360030-XCE, 360030-1CT, 360030-1CE, 36030-XCT The device does not bear a unique device identifier.	FDA Z-1503-2026	Medical Device	High	Mar 18, 2026 Recall: Aug 13, 2025	Details
Penner Pacific Bathing Spa, Model Numbers 360020-1EP The device does not bear a unique device identifier.	FDA Z-1501-2026	Medical Device	High	Mar 18, 2026 Recall: Aug 13, 2025	Details
Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05 Impactor handle may be missing cross-pin	FDA Z-1509-2026	Medical Device	High	Mar 18, 2026 Recall: Feb 3, 2026	Details
Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART, Model Number: DYNJ902487A; 2) CARDIAC PROCEDURE, Model Number: DYNJ908126; 3) CARDIO CONGENITO, Model Number: DYNJ910851 The instructions for use (IFUs) on specified Cardinal Health Chest Drainage Units (CDUs) and accessories have been updated to clarify the intended target patient population as adults, 18 years and older.	FDA Z-1562-2026	Medical Device	High	Mar 18, 2026 Recall: Jan 30, 2026	Details
GEM Premier 5000 PAK; Part No. 00055407511. 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-1531-2026	Medical Device	High	Mar 18, 2026 Recall: Jan 20, 2026	Details

Showing 2,101 - 2,125 of 3,085 product recalls

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