Safety Recall Directory
Browse and filter the latest official safety alerts globally.
FDA DevicesArtelon FlexBand Plus Ref: 41054 & 41057
Artelon FlexBand Plus Ref: 41054 & 41057
Augmentation devices failed bacterial endotoxin testing.
FDA DevicesGEM Premier 5000; Part No. 00055430004.
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 DevicesPenner Pacific Bathing Spa, Model Numbers 760010-1, 770010-1
Penner Pacific Bathing Spa, Model Numbers 760010-1, 770010-1
The device does not bear a unique device identifier.
FDA DevicesPenner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X
Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X
The device does not bear a unique device identifier.
FDA FoodMade Fresh Salads brand Lox Cream Cheese; 5 lb white plastic tub
Made Fresh Salads brand Lox Cream Cheese; 5 lb white plastic tub
Products may be contaminated with Listeria monocytogenes.
FDA DevicesEndo-Model Replacement Plateau; Item Number: 15-0027/11;
Endo-Model Replacement Plateau; Item Number: 15-0027/11;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
FDA FoodMade Fresh Salads brand Scallion Cream Cheese; 5 lb white plastic tub
Made Fresh Salads brand Scallion Cream Cheese; 5 lb white plastic tub
Products may be contaminated with Listeria monocytogenes.
FDA FoodMade Fresh Salads brand Strawberry Cream Cheese; 5 lb white plastic tub
Made Fresh Salads brand Strawberry Cream Cheese; 5 lb white plastic tub
Products may be contaminated with Listeria monocytogenes.
FDA FoodMade Fresh Salads brand Jalapeno Cream Cheese; 5 lb white plastic tub
Made Fresh Salads brand Jalapeno Cream Cheese; 5 lb white plastic tub
Products may be contaminated with Listeria monocytogenes.
FDA FoodMade Fresh Salads brand Walnut Raisin Cream Cheese; 5 lb white plastic tub
Made Fresh Salads brand Walnut Raisin Cream Cheese; 5 lb white plastic tub
Products may be contaminated with Listeria monocytogenes.
FDA FoodMade Fresh Salads brand Garlic & Herb Cream Cheese; 5 lb white plastic tub
Made Fresh Salads brand Garlic & Herb Cream Cheese; 5 lb white plastic tub
Products may be contaminated with Listeria monocytogenes.
FDA DevicesPenner Pacific Bathing Spa, Model Numbers 360020-1P
Penner Pacific Bathing Spa, Model Numbers 360020-1P
The device does not bear a unique device identifier.
FDA FoodMade Fresh Salads brand Whipped Cream Cheese; 5 lb white plastic tub
Made Fresh Salads brand Whipped Cream Cheese; 5 lb white plastic tub
Products may be contaminated with Listeria monocytogenes.
FDA DevicesWondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection.
Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection.
Product not cleared by the FDA.
FDA DevicesMedline Medcrest Surgical Gowns: MDTGXC4J5XL DBQ-GOWN,SURG,XALT,L4, CRTCL CVR, GRN, 5 MDTGXC4JL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,L MDTGXC4JXL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,XL MDTGXC4JXXL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,XX MDTGXP4JL DBD-GOWN,SURG,XALT,L4,PANEL CVR,GREEN,L MDTGXP4JXL DBD-GOWN,SURG,XALT,L4,PANEL CVR,GREEN,XL MDTGXP4JXXL DBD-GOWN,SURG,XALT,L4,PANEL CVR,GREEN,XX MDTL1002862EF DBD-GOWN,SURG,XALT,L4,PANEL CVR,GREEN,XL MDTZ1000893AJ DBD-GOWN,SRG,PNL CVR, GREEN,SNPS,XL
Medline Medcrest Surgical Gowns: MDTGXC4J5XL DBQ-GOWN,SURG,XALT,L4, CRTCL CVR, GRN, 5 MDTGXC4JL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,L MDTGXC4JXL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,XL MDTGXC4JXXL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,XX MDTGXP4JL DBD-GOWN,SURG,XALT,L4,PANEL CVR,GREEN,L MDTGXP4JXL DBD-GOWN,SURG,XALT,L4,PANEL CVR,GREEN,XL MDTGXP4JXXL DBD-GOWN,SURG,XALT,L4,PANEL CVR,GREEN,XX MDTL1002862EF DBD-GOWN,SURG,XALT,L4,PANEL CVR,GREEN,XL MDTZ1000893AJ DBD-GOWN,SRG,PNL CVR, GREEN,SNPS,XL
Fabric may experience premature delamination when using included laundering instructions. Identifying delaminated gown or drape in a surgical setting may result in brief delay in patient care. If delaminated product is used and surgical strikethrough occurs, there may be risk of infection.
FDA Devices10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk non-sterile units per case.
10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk non-sterile units per case.
During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes.
FDA DevicesEndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000;
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 FoodMade Fresh Salads brand Apple Cinnamon Cream Cheese; 5 lb white plastic tub
Made Fresh Salads brand Apple Cinnamon Cream Cheese; 5 lb white plastic tub
Products may be contaminated with Listeria monocytogenes.
NHTSAJaguar Land Rover North America, LLC - Insufficiently Welded Seat Belt Anchorage Bracket
Jaguar Land Rover North America, LLC - Insufficiently Welded Seat Belt Anchorage Bracket
A seat belt assembly with an insufficient weld may not properly restrain an occupant during a crash, increasing the risk of injury.
FDA DevicesGEM Premier 5000; Part No. 00055445010 & 00055445011.
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 DevicesPenner 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
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 DevicesPenner Pacific Bathing Spa, Model Numbers 560010-2L, 560010-XL, 560010-1L, 560010-XL
Penner Pacific Bathing Spa, Model Numbers 560010-2L, 560010-XL, 560010-1L, 560010-XL
The device does not bear a unique device identifier.
FDA DevicesGEM Premier 5000 PAK; Part No. 00055360010.
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 DevicesHealthCast "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 Patient Monitoring Platform, 3rd Party Annunciation Systems, Electronic Medical Record (EMR) and Clinical Information System (CIS).
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 Patient Monitoring Platform, 3rd Party Annunciation Systems, Electronic Medical Record (EMR) and Clinical Information System (CIS).
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.