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ResinAngel brand epoxy resin products recalled due to improper labelling
ResinAngel brand epoxy resin products recalled due to improper labelling
Labelling and packaging
Medline Disposible Manifolds
Medline Disposible Manifolds
Performance
PMS-BUSULFAN 6mg/mL: impurity could be out of specification
PMS-BUSULFAN 6mg/mL: impurity could be out of specification
Product quality
Transport Canada Recall - 2026198 - GOODYEAR
Transport Canada Recall - 2026198 - GOODYEAR
Tires
Transport Canada Recall - 2026200 - WINNEBAGO INDUSTRIES
Transport Canada Recall - 2026200 - WINNEBAGO INDUSTRIES
Accessories
LSL Healthcare, Foley Urine Collection Kit, Model/Catalog Number: 1555
LSL Healthcare, Foley Urine Collection Kit, Model/Catalog Number: 1555
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.
FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.
Lack of Assurance of Sterility
LSL Healthcare, Infant Central Line Dressing Change Kit, Model/Catalog Number: 2925H
LSL Healthcare, Infant Central Line Dressing Change Kit, Model/Catalog Number: 2925H
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs NDC 0555-1054-60; b) 30-count carton, NDC 0555-1054-86, with 3X10 blister pack NDC 0555-1054-60; Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs NDC 0555-1054-60; b) 30-count carton, NDC 0555-1054-86, with 3X10 blister pack NDC 0555-1054-60; Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7388-60.
0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7388-60.
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF 1205-20
Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF 1205-20
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided with the following materials: " Sensors (8 containers of 24 each; 192 tests) " Treatment Reagent Tubes (8 containers of 24 each; 192 tests) " Calibration Button (1 @) " Lead Control Level 1 (1 @ 2 mL) " Lead Control Level 2 (1 @ 2 mL)
LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided with the following materials: " Sensors (8 containers of 24 each; 192 tests) " Treatment Reagent Tubes (8 containers of 24 each; 192 tests) " Calibration Button (1 @) " Lead Control Level 1 (1 @ 2 mL) " Lead Control Level 2 (1 @ 2 mL)
Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BARIATRIC DYNJ905153M, DYNJ905153N GENERAL LAPAROSCOPY PACK DYNJ81602 LAPAROSCOPY DYNJ905157K, DYNJ905157L LAPAROTOMY PACK DYNJ46675G MAJOR LITHOTOMY PACK DYNJ81607 MAJOR PLUS PACK DYNJ905160O MINOR GENERAL PACK DYNJ81599
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BARIATRIC DYNJ905153M, DYNJ905153N GENERAL LAPAROSCOPY PACK DYNJ81602 LAPAROSCOPY DYNJ905157K, DYNJ905157L LAPAROTOMY PACK DYNJ46675G MAJOR LITHOTOMY PACK DYNJ81607 MAJOR PLUS PACK DYNJ905160O MINOR GENERAL PACK DYNJ81599
Unapproved design changes to the products outside of the 510(k) clearance.
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).
CHIPS AHOY! Baked Bites Brookie .22.4 oz Carton ( 2.8 oz pouch ) and 7.7 oz Carton ( 1.4 oz pouch)
CHIPS AHOY! Baked Bites Brookie .22.4 oz Carton ( 2.8 oz pouch ) and 7.7 oz Carton ( 1.4 oz pouch)
Hard corn starch lumps were found in the product
Medline Kits: 1) D AND C PACK, Model Number: DYNJ41254B
Medline Kits: 1) D AND C PACK, Model Number: DYNJ41254B
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 65CM 038 NB 0SH; Catalog No.: 10714011; Product/UPN No.: H787107140115 (Box), H787107140110 (Pouch); Box Quantity: 5 pouches;
Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 65CM 038 NB 0SH; Catalog No.: 10714011; Product/UPN No.: H787107140115 (Box), H787107140110 (Pouch); Box Quantity: 5 pouches;
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Medline Kits: 1) ANGIO CATH PACK-MARY IMMACULAT, Model Number: DYNJ24517D
Medline Kits: 1) ANGIO CATH PACK-MARY IMMACULAT, Model Number: DYNJ24517D
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Medline Kits: 1) PICC TRAY, Model Number: DYNJ41648A
Medline Kits: 1) PICC TRAY, Model Number: DYNJ41648A
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc., Bethlehem, PA 18018-3524, NDC: 0264-7385-60.
Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc., Bethlehem, PA 18018-3524, NDC: 0264-7385-60.
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Medline Namic Guidewires: 1) GUIDEWIRE 3MMJ 0.035X260CM LT, Model Number: DYNJGWIRE20L; 2) GWIRE HYDRO 0.035 180CM ANG S, Model Number: DYNJHWIRE105; 3) GWIRE HYDRO 0.035 260CM ANG S, Model Number: DYNJHWIRE107; 4) GWIRE HYDRO 0.035 260CM STR S, Model Number: DYNJHWIRE115; 5) GWIRE HYDRO 0.035 150CM STR, Model Number: DYNJHWIRE108; 6) GWIRE HYDRO 0.035 150CM ANG S, Model Number: DYNJHWIRE104; 7) GWIRE HYDRO 0.035 180CM STR S, Model Number: DYNJHWIRE113; 8) GWIRE HYDRO 0.035 260CM ANGLE, Model Number: DYNJHWIRE103; 9) GDWIRE .035INX150CM 3MMJ LT, Model Number: DYNJGWIRE01L; 10) GDWIRE .035INX180CM 3MMJ LT, Model Number: DYNJGWIRE03L; 11) GWIRE HYDRO 0.035 150CM STR S, Model Number: DYNJHWIRE112; 12) GWIRE HYDRO 0.035 180CM STR, Model Number: DYNJHWIRE109; 13) GWIRE HYDRO 0.035 210CM ANGLE, Model Number: DYNJHWIRE102; 14) GWIRE HYDRO 0.035 210CM ANG S, Model Number: DYNJHWIRE106; 15) GWIRE HYDRO 0.035 210CM STR, Model Number: DYNJHWIRE110; 16) GWIRE,HYDRO,0.038,180CM,ANG S, Model Number: DYNJHWIRE121; 17) GWIRE HYDRO 0.038 210CM ANG S, Model Number: DYNJHWIRE122; 18) GWIRE HYDRO 0.038 210CM ANGLE, Model Number: DYNJHWIRE118; 19) GWIRE HYDRO 0.038 260CM STR, Model Number: DYNJHWIRE127; 20) GWIRE,HYDRO,0.038,210CM,STR S, Model Number: DYNJHWIRE130; 21) GWIRE,HYDRO,0.038,260CM,ANG S, Model Number: DYNJHWIRE123; 22) GWIRE,HYDRO,0.038",150CM,STR, Model Number: DYNJHWIRE124; 23) GWIRE HYDRO 0.038 150CM ANGLE, Model Number: DYNJHWIRE116; 24) GWIRE,HYDRO,0.038",210CM,STR, Model Number: DYNJHWIRE126; 25) GWIRE HYDRO 0.035 260CM STR, Model Number: DYNJHWIRE111; 26) GWIRE HYDRO 0.035 150CM ANGLE, Model Number: DYNJHWIRE100; 27) GWIRE HYDRO 0.035 180CM ANGLE, Model Number: DYNJHWIRE101; 28) GWIRE,HYDRO,0.038",180CM, STR, Model Number: DYNJHWIRE125; 29) GWIRE HYDRO 0.038 260CM ANGLE, Model Number: DYNJHWIRE119; 30) GWIRE HYDRO 0.038 150CM ANG S, Model Number: DYNJHWIRE120
Medline Namic Guidewires: 1) GUIDEWIRE 3MMJ 0.035X260CM LT, Model Number: DYNJGWIRE20L; 2) GWIRE HYDRO 0.035 180CM ANG S, Model Number: DYNJHWIRE105; 3) GWIRE HYDRO 0.035 260CM ANG S, Model Number: DYNJHWIRE107; 4) GWIRE HYDRO 0.035 260CM STR S, Model Number: DYNJHWIRE115; 5) GWIRE HYDRO 0.035 150CM STR, Model Number: DYNJHWIRE108; 6) GWIRE HYDRO 0.035 150CM ANG S, Model Number: DYNJHWIRE104; 7) GWIRE HYDRO 0.035 180CM STR S, Model Number: DYNJHWIRE113; 8) GWIRE HYDRO 0.035 260CM ANGLE, Model Number: DYNJHWIRE103; 9) GDWIRE .035INX150CM 3MMJ LT, Model Number: DYNJGWIRE01L; 10) GDWIRE .035INX180CM 3MMJ LT, Model Number: DYNJGWIRE03L; 11) GWIRE HYDRO 0.035 150CM STR S, Model Number: DYNJHWIRE112; 12) GWIRE HYDRO 0.035 180CM STR, Model Number: DYNJHWIRE109; 13) GWIRE HYDRO 0.035 210CM ANGLE, Model Number: DYNJHWIRE102; 14) GWIRE HYDRO 0.035 210CM ANG S, Model Number: DYNJHWIRE106; 15) GWIRE HYDRO 0.035 210CM STR, Model Number: DYNJHWIRE110; 16) GWIRE,HYDRO,0.038,180CM,ANG S, Model Number: DYNJHWIRE121; 17) GWIRE HYDRO 0.038 210CM ANG S, Model Number: DYNJHWIRE122; 18) GWIRE HYDRO 0.038 210CM ANGLE, Model Number: DYNJHWIRE118; 19) GWIRE HYDRO 0.038 260CM STR, Model Number: DYNJHWIRE127; 20) GWIRE,HYDRO,0.038,210CM,STR S, Model Number: DYNJHWIRE130; 21) GWIRE,HYDRO,0.038,260CM,ANG S, Model Number: DYNJHWIRE123; 22) GWIRE,HYDRO,0.038",150CM,STR, Model Number: DYNJHWIRE124; 23) GWIRE HYDRO 0.038 150CM ANGLE, Model Number: DYNJHWIRE116; 24) GWIRE,HYDRO,0.038",210CM,STR, Model Number: DYNJHWIRE126; 25) GWIRE HYDRO 0.035 260CM STR, Model Number: DYNJHWIRE111; 26) GWIRE HYDRO 0.035 150CM ANGLE, Model Number: DYNJHWIRE100; 27) GWIRE HYDRO 0.035 180CM ANGLE, Model Number: DYNJHWIRE101; 28) GWIRE,HYDRO,0.038",180CM, STR, Model Number: DYNJHWIRE125; 29) GWIRE HYDRO 0.038 260CM ANGLE, Model Number: DYNJHWIRE119; 30) GWIRE HYDRO 0.038 150CM ANG S, Model Number: DYNJHWIRE120
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 100CM 038 NB 0SH; Catalog No.: 10714016; Product/UPN No.: H787107140165 (Box), H787107140160 (Pouch); Box Quantity: 5 pouches;
Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 100CM 038 NB 0SH; Catalog No.: 10714016; Product/UPN No.: H787107140165 (Box), H787107140160 (Pouch); Box Quantity: 5 pouches;
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117.
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Medline Kits: 1) NEWBORN ADMISSION, Model Number: DYKB1038; 2) DRAINAGE TRAY, Model Number: DYNDA3188; 3) VA ORLANDO SHOULDER PACK, Model Number: DYNJG001027B; 4) TUMESCENT SYRINGE KIT, Model Number: DYNJTUMSYR; 5) OMC PTCA PACK, Model Number: DYNJT3719; 6) PORT PACK, Model Number: DYNJT5667; 7) WASTE MANAGEMENT KIT - 2, Model Number: DYNJWASTEKIT2; 8) CARDIAC CATH, Model Number: DYNJ20175J; 9) D&C PACK-POB, Model Number: DYNJ33521D; 10) BASIC PACK, Model Number: DYNJ38533F; 11) CATH PACK IMPLANT, Model Number: DYNJ39230D; 12) CERVICAL SPINE PACK, Model Number: DYNJ40886B; 13) MV-IR ANGIO DRAPE PACK-LF, Model Number: DYNJ41553F; 14) TV ENDOVASCULAR-LF, Model Number: DYNJ41558D; 15) MAJOR PACK-LF, Model Number: DYNJ44816J; 16) ANGIOGRAPHY PACK, Model Number: DYNJ48683A; 17) EXTREMITY PACK, Model Number: DYNJ55922C; 18) NEURO PACK, Model Number: DYNJ57785C; 19) PACEMAKER PACK, Model Number: DYNJ61377B; 20) VASCULAR PACK, Model Number: DYNJ62683D; 21) LINQ INSERTION PK W/OUT LIDO, Model Number: DYNJ63668B; 22) BASIC PACK, Model Number: DYNJ83324; 23) OMF MINOR PACK, Model Number: DYNJ83991B; 24) ARTERIOGRAM SUMMIT PACK, Model Number: DYNJ84040B; 25) HMWB NEURO NAMIC PACK, Model Number: DYNJ86600; 26) VCH CARDIAC CATH PACK, Model Number: DYNJ89064; 27) RADIOLOGY PACK, Model Number: DYNJ89080; 28) LITHOTOMY PACK, Model Number: DYNJ89959; 29) AHT SPINE PACK, Model Number: DYNJ903566D; 30) LAP, Model Number: DYNJ904576B; 31) EP MERCY JANESVILLE, Model Number: DYNJ907013; 32) LHK, US, RUBY MEMORIAL HOSP, Model Number: NAM0032; 33) CHERIAN CATH KIT, Model Number: VASC1086; 34) RIGHT HEART KIT - LAKE NONA, Model Number: VASC1120; 35) KIT ANGIO CSTM-SHAWNEE, Model Number: VASC1151; 36) LEFT HEART KIT - OAKBEND, Model Number: VASC1155; 37) IR 2 PORT-ARROWHEAD REGIONAL, Model Number: VASC1404; 38) LHK - ARROWHEAD REGIONAL MED, Model Number: VASC1405; 39) LHK - UMC DOUBLE TRANSDUCER, Model Number: VASC1415A; 40) SDMC, EP TWO PORT CUSTOM KIT, Model Number: VASC1533; 41) ARTERIOGRAM TRAY, Model Number: 00-402001V
Medline Kits: 1) NEWBORN ADMISSION, Model Number: DYKB1038; 2) DRAINAGE TRAY, Model Number: DYNDA3188; 3) VA ORLANDO SHOULDER PACK, Model Number: DYNJG001027B; 4) TUMESCENT SYRINGE KIT, Model Number: DYNJTUMSYR; 5) OMC PTCA PACK, Model Number: DYNJT3719; 6) PORT PACK, Model Number: DYNJT5667; 7) WASTE MANAGEMENT KIT - 2, Model Number: DYNJWASTEKIT2; 8) CARDIAC CATH, Model Number: DYNJ20175J; 9) D&C PACK-POB, Model Number: DYNJ33521D; 10) BASIC PACK, Model Number: DYNJ38533F; 11) CATH PACK IMPLANT, Model Number: DYNJ39230D; 12) CERVICAL SPINE PACK, Model Number: DYNJ40886B; 13) MV-IR ANGIO DRAPE PACK-LF, Model Number: DYNJ41553F; 14) TV ENDOVASCULAR-LF, Model Number: DYNJ41558D; 15) MAJOR PACK-LF, Model Number: DYNJ44816J; 16) ANGIOGRAPHY PACK, Model Number: DYNJ48683A; 17) EXTREMITY PACK, Model Number: DYNJ55922C; 18) NEURO PACK, Model Number: DYNJ57785C; 19) PACEMAKER PACK, Model Number: DYNJ61377B; 20) VASCULAR PACK, Model Number: DYNJ62683D; 21) LINQ INSERTION PK W/OUT LIDO, Model Number: DYNJ63668B; 22) BASIC PACK, Model Number: DYNJ83324; 23) OMF MINOR PACK, Model Number: DYNJ83991B; 24) ARTERIOGRAM SUMMIT PACK, Model Number: DYNJ84040B; 25) HMWB NEURO NAMIC PACK, Model Number: DYNJ86600; 26) VCH CARDIAC CATH PACK, Model Number: DYNJ89064; 27) RADIOLOGY PACK, Model Number: DYNJ89080; 28) LITHOTOMY PACK, Model Number: DYNJ89959; 29) AHT SPINE PACK, Model Number: DYNJ903566D; 30) LAP, Model Number: DYNJ904576B; 31) EP MERCY JANESVILLE, Model Number: DYNJ907013; 32) LHK, US, RUBY MEMORIAL HOSP, Model Number: NAM0032; 33) CHERIAN CATH KIT, Model Number: VASC1086; 34) RIGHT HEART KIT - LAKE NONA, Model Number: VASC1120; 35) KIT ANGIO CSTM-SHAWNEE, Model Number: VASC1151; 36) LEFT HEART KIT - OAKBEND, Model Number: VASC1155; 37) IR 2 PORT-ARROWHEAD REGIONAL, Model Number: VASC1404; 38) LHK - ARROWHEAD REGIONAL MED, Model Number: VASC1405; 39) LHK - UMC DOUBLE TRANSDUCER, Model Number: VASC1415A; 40) SDMC, EP TWO PORT CUSTOM KIT, Model Number: VASC1533; 41) ARTERIOGRAM TRAY, Model Number: 00-402001V
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.