Vereinigte Staaten Recalls
Verbraucherrückrufe von FDA, CPSC, NHTSA und USDA FSIS.
FDA DevicesOwner's Booklets and Instructions for Use that are used with the following blood glucose measurement devices. Description/Item: TRUE METRIX PRO Meter Only/RE4H01P-40, TRUE METRIX PRO Starter Kit/RE4H01P-43, PROCURE TRUE METRIX PRO Meter Only/RE4212P-00, Henry Schein TRUE METRIX PRO Meter Only/RE4099P-40, Henry Schein TRUE METRIX PRO Kit/RE4099P-43, McKESSON TRUE METRIX PRO Meter Only/RE4051P-00, Moore Medical TRUE METRIX PRO Meter Only/RE4068P-01.
Owner's Booklets and Instructions for Use that are used with the following blood glucose measurement devices. Description/Item: TRUE METRIX PRO Meter Only/RE4H01P-40, TRUE METRIX PRO Starter Kit/RE4H01P-43, PROCURE TRUE METRIX PRO Meter Only/RE4212P-00, Henry Schein TRUE METRIX PRO Meter Only/RE4099P-40, Henry Schein TRUE METRIX PRO Kit/RE4099P-43, McKESSON TRUE METRIX PRO Meter Only/RE4051P-00, Moore Medical TRUE METRIX PRO Meter Only/RE4068P-01.
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 DevicesBrand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X
Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X
Impactor handle may be missing cross-pin
FDA DevicesOwner'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)/RF4i81-11BK, TRUE METRIX GO Kit (United Kingdom - mmol/L)/RF4i82-11BK, TRUE METRIX GO Starter Kit (United Kingdom - mmol/L)/RF4i82-12BK
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)/RF4i81-11BK, TRUE METRIX GO Kit (United Kingdom - mmol/L)/RF4i82-11BK, TRUE METRIX GO Starter Kit (United Kingdom - mmol/L)/RF4i82-12BK
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 DevicesGEM Premier 5000 PAK; Part No. 00055407504.
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 FoodCoco's Italian Market Cannoli Making Kit with 6 Cannoli Shells & Cream, Net Wt. 8 oz. (227g), Keep Frozen, packaged in a plastic container, UPC 0680334992716
Coco's Italian Market Cannoli Making Kit with 6 Cannoli Shells & Cream, Net Wt. 8 oz. (227g), Keep Frozen, packaged in a plastic container, UPC 0680334992716
Label lists flour as a sub-ingredient of the shells, and ricotta cheese as a sub-ingredient of the cream but does not declare wheat or milk.
FDA DevicesMedline Surgical Drapes: MDTBTCS6070GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X MDTBTCS6090GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X MDTDXUNDBGN DBD-DRAPE,UNDERBUTTOCK,28 X 50.5,XALT GR MDTMAYOXGN DBD-DRAPE,COVER,MAYO STAND,RESISTAT/XALT MDTZ1003656GN DBD-POCKET SHEET,RESISTAT/XALT
Medline Surgical Drapes: MDTBTCS6070GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X MDTBTCS6090GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X MDTDXUNDBGN DBD-DRAPE,UNDERBUTTOCK,28 X 50.5,XALT GR MDTMAYOXGN DBD-DRAPE,COVER,MAYO STAND,RESISTAT/XALT MDTZ1003656GN DBD-POCKET SHEET,RESISTAT/XALT
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 FoodMade Fresh Salads brand Vegetable Cream Cheese; 5 lb white plastic tub
Made Fresh Salads brand Vegetable Cream Cheese; 5 lb white plastic tub
Products may be contaminated with Listeria monocytogenes.
FDA DevicesEndo-Model Replacement Plateau; Item Number: 15-0027/12;
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 FoodMade Fresh Salads brand Tofu Whipped; 5 lb white plastic tub
Made Fresh Salads brand Tofu Whipped; 5 lb white plastic tub
Products may be contaminated with Listeria monocytogenes.
FDA FoodC2O Coconut Water with Pulp (17.5 oz) 15 Pack UPC: 8-50274-00792-8
C2O Coconut Water with Pulp (17.5 oz) 15 Pack UPC: 8-50274-00792-8
The outer cardboard box for the canned coconut water has the incorrect Nutrition Facts Panel and Ingredient List, which does not include added sugar (5g per 17.5oz can), while the primary packaging (the can) has the correct Nutrition Facts Panel and Ingredient List.
FDA DevicesEndo-Model Replacement Plateau; Item Number: 15-8521/09;
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.
NHTSAToyota Motor Engineering & Manufacturing - Rearview Camera Image May Not Display/FMVSS 111
Toyota Motor Engineering & Manufacturing - Rearview Camera Image May Not Display/FMVSS 111
A rearview image that does not display reduces the driver's view behind the vehicle, increasing the risk of a crash.
FDA DevicesMEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010
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 DevicesEndo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;
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 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 DevicesGEM Premier 5000; Part No. 00055430011.
GEM Premier 5000; Part No. 00055430011.
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 DevicesBrand 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.
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 FoodVEGETARIAN CHICKEN FLAVOR RAMEN Express Net wt 3oz (85g) Ingredients: Enriched unbleached flour (wheat flour***) Vegetable oil***" Contains: Wheat, Soy. UPC 8 10037 81061 5 Produced by PALMETTO GOURMET FOODS, INC SALUDA, SC 29138
VEGETARIAN CHICKEN FLAVOR RAMEN Express Net wt 3oz (85g) Ingredients: Enriched unbleached flour (wheat flour***) Vegetable oil***" Contains: Wheat, Soy. UPC 8 10037 81061 5 Produced by PALMETTO GOURMET FOODS, INC SALUDA, SC 29138
Product contains undeclared Yellow #5
FDA DevicesGEM Premier 5000 PAK; Part No. 00055360008.
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 DevicesEndo-Model Replacement Plateau; Item Number: 15-2836/11;
Endo-Model Replacement Plateau; Item Number: 15-2836/11;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
FDA DevicesPenner Pacific Bathing Spa, Model Numbers 860010-1L
Penner Pacific Bathing Spa, Model Numbers 860010-1L
The device does not bear a unique device identifier.
FDA DevicesPenner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2
Penner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2
The device does not bear a unique device identifier.