Safety Recalls
RSS ↗15,364 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 9,551–9,600 of 15,364
- Class II
Medical Device Recall · October 23, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use in Peritoneal DialysisThere has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- Class II
Drug Recall · October 23, 2024
Ramipril Capsules USP 10 mg, a) 90 count (NDC 68180-591-09), b) 100 count NDC 68180-591-01), and c) 500 count (NDC 68180-591-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., BaltimoCGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
- Class II
Drug Recall · October 23, 2024
Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Cipla USA, NDC 69097-0936-98Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
- Class II
Medical Device Recall · October 23, 2024
MEDLINE INDUSTRIES, LP - Northfield
Clean Catch Kit, SKU DYKM1833A; Component No. 503581Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
- Class II
Medical Device Recall · October 23, 2024
Baxter MiniCap Extended Life PD Transfer Set (short) with Titanium Spike, Part Number T5C4326K; use in Peritoneal DialysisThere has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- Class II
Medical Device Recall · October 23, 2024
MEDLINE INDUSTRIES, LP - Northfield
URINE COLLECTION KIT, SKU DYKM1848A DYKM2005 DYKM2151 DYLAB1004 DYLAB1004A DYLAB1006 DYLAB1012 ; Component No. 503581Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
- Class I
Food Recall · October 22, 2024
FreshPoint Denver, Incorporated
Item Number PACK/SZ BRAND DESCRIPTION Lot Codes 082076 4/5 LBS IMPERIALFRESH PROC ONION YELLOW JULIENNE 3/8 All lot codes; 170992 4/5 LB IMPERIALFRESH PROC ONION YELLOW DICED 3/8 All lot codes; 258147Potentially contaminated with E. coli O157:H7.
- Class II
Medical Device Recall · October 22, 2024
Ivalon Anatomical Nasal Packing with Airway Tube and String, 8.0 cm x 1.5cmx 3.0 cm- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q770410Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.
- Class I
Food Recall · October 22, 2024
raw, yellow onions (whole unpeeled), intended for food service, in 50-lb corrugated boxesPotential contamination of E. coli O157:H7
- Class I
Food Recall · October 22, 2024
raw, yellow onions (sliced, diced, slivered, ringed), intended for food service, packaged in plastic bagsPotential contamination of E. coli O157:H7
- Class I
Medical Device Recall · October 22, 2024
Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems: Plum 360" Infusion System, Pump List Number 30010; Plum A+ & Plum A+3" Infusion Systems, Pump ListICU Medical has received reports of allegedly counterfeit CSB batteries being used with Plum Infusion Systems. While these non-OEM batteries are visually similar to the Plum batteries supplied by ICU Medical, they are in fact not the same batteries and have not been tested or validated for use with Plum Infusion Systems. Preliminary reports suggest that these non-OEM batteries fail to hold their charge and the pump may display messages to replace batteries earlier than expected. OSI Batteries and their customers are distributing these non-OEM CSB batteries without authorization from ICU Medical.
- Class I
Food Recall · October 22, 2024
raw, yellow onions (whole peeled), intended for food service, packaged into plastic bags (5-lbs)Potential contamination of E. coli O157:H7
- Class II
Medical Device Recall · October 22, 2024
Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q604237Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.
- Class II
Drug Recall · October 22, 2024
Dr. Reddy's Laboratories, Inc.
Morphine Sulfate Extended-Release Tablets 30 mg, 100-count bottles, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-186-01.Failed Impurities/Degradation Specification
- Class I
Food Recall · October 22, 2024
KIRKLAND Signature Smoked Salmon NET WT 340 g (12 oz) MUST KEEP REFRIGERATED. INGREDIENTS: Atlantic Salmon (Salmo Salar), Salt, and Natural Hardwood Smoke. Color Added. Distributed by: Costco WholesalThe firm was notified after laboratory analysis that the product test positive for Listeria monocytogenes.
- Class I
Food Recall · October 22, 2024
FreshPoint Denver, Incorporated
154784 1 / 5LB IMPERIALFRESH PROC FAJITA GRN PEPRED PEP W All lot codesPotentially contaminated with E. coli O157:H7.
- Class II
Drug Recall · October 22, 2024
Dr. Reddy's Laboratories, Inc.
Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-185-01.Failed Impurities/Degradation Specification
- Class I
Food Recall · October 22, 2024
raw, yellow onions (whole unpeeled), intended for food service, repacked into in 5-lb plastic bagsPotential contamination of E. coli O157:H7
- Class II
Medical Device Recall · October 22, 2024
Ivalon Eye Wick 20cm- Intended to be used for the removal and collection of fluids from the Opthalmic surgical site. Model Number: Q604206Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.
- Class II
Medical Device Recall · October 22, 2024
MICRO-X Rover Mobile X-ray System, # MXU-RV35Mobile x-ray system receiving/storage(operation) requirements to be followed: Temp:14 to 131(50 to 86) degrees F, RH:10% to 86%(30% to 60%) allow condensation dry time, Atmospheric Pressure:50kPa to 106 kPa(70kPa to 106kPa), Altitude:-102ft to 12,000 ft, (Maximum Gradient:9 degrees Fahrenheit), which mitigate risk of capacitor malfunction, unpredictable behavior, overheating, unintended start-up.
- Class I
Medical Device Recall · October 21, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use in Peritoneal DialysisBaxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
- Class I
Medical Device Recall · October 21, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use in Peritoneal DialysisBaxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
- Class II
Medical Device Recall · October 21, 2024
Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PCDue to improper labeling of products. An intended use on the label has not been reviewed and approved by FDA for distribution in the U.S.
- Class II
Medical Device Recall · October 21, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline Iris Scissors, Single-Use, Curved, Standard 4.5 , Model Nos. DYNJ04049 (cases), DYNJ04049H (eaches)Tip protector may fall off within the packaging, resulting in compromised sterile barrier system and loss of sterility.
- Class II
Drug Recall · October 21, 2024
Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Athlete's Needs, Novi, MI 48377, NDC 53185-277-24Superpotent Drug: Stability failure for assay at 6 months test time-point.
- Class II
Medical Device Recall · October 21, 2024
Siemens Healthcare Diagnostics, Inc.
Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate the sample reaction volumes and present them to each processing step. Siemens Material Number(SMN): 11099326A manufacturing defect causes Atellica CH Reaction Ring Cuvette Segments with lot numbers N15 on the packaging or 15 on the underside of the cuvette segment have a potential for imprecision and erroneously depressed or elevated QC and patient results for seven (7) analytes: Ammonia, Acetaminophen, Alanine Aminotransferase (ALT), Hemoglobin A1c, Creatinine Kinase (CK), Cystatin C, and Salicylate.
- Class II
Medical Device Recall · October 21, 2024
JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357Firm received complaints reporting that guides were warped when pulled out of packaging. This issue may result in extension of surgery to find another product, or may lead to adverse local tissue reaction leading to surgical intervention.
- Class I
Medical Device Recall · October 21, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4484; use in Peritoneal DialysisBaxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
- Class II
Medical Device Recall · October 21, 2024
Siemens Healthcare Diagnostics, Inc.
Atellica¿ CH ¿2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative determination of ¿2-microglobulin in human serum and plasma. Siemens Material Number (SMN): 11097635Potential for falsely depressed auto-diluted results for samples above the measuring interval of 18.00 mg/L, up to 30.00 mg/L, when using the Atellica CH ¿2-Microglobulin (B2M) reagent.
- Class I
Medical Device Recall · October 21, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use in Peritoneal DialysisBaxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
- Class I
Food Recall · October 21, 2024
Atwater's Spider Web Tarts, 26 tarts packaged individually, 5.73 in x 5.95 in x 3 in clear plastic clamshell container, Julienne date 292Undeclared tree nuts (almonds)
- Class I
Medical Device Recall · October 21, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T5C4482; use in Peritoneal DialysisBaxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
- Class I
Medical Device Recall · October 21, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal DialysisBaxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
- Class I
Medical Device Recall · October 21, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in Peritoneal DialysisBaxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
- Class I
Medical Device Recall · October 21, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in Peritoneal DialysisBaxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
- Class I
Medical Device Recall · October 21, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use in Peritoneal DialysisBaxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
- Class I
Medical Device Recall · October 21, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp EX Short, Part Number T5C4484; use in Peritoneal DialysisBaxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
- Class II
Drug Recall · October 18, 2024
Sunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-902-28Labeling: Label Mix-Up
- Class I
Food Recall · October 18, 2024
Fresh Express Gourmet Cafe Santa Fe Greek 5.2 oz, Labeled Salad Bowls, Refrigerate, UPC Code: 71279 40713 5 and Case Code :71279-56704Potential Listeria Monocytogenes Contamination. The pre-packaged condiment trays contains chicken linked to the Bruce Pac recall.
- Class II
Drug Recall · October 18, 2024
Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-901-28Labeling: Label Mix-Up
- Class II
Medical Device Recall · October 18, 2024
human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.The cannula tubes do not comply with the specification. The water jet emerging from the nozzle of the nonconforming cannulas may emerge as a spot jet rather than a fan-shaped spray jet.
- Class II
Medical Device Recall · October 18, 2024
Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with SoftwareHeart-Lung Machine GUI touchscreen may go dark for 10-15 seconds, safety/performance functions remain operational before reset, control maintained through backup control panel, but second reset may occur, may lead to gas blender standby, then gas blender must be reactivated using user interface on blender, sensors deactivated until new case started; GUI reset can lead to Hypoxia and Hypoperfusion.
- Class I
Food Recall · October 18, 2024
Fresh Express Gourmet Cafe Chicken Caesar 5.75oz, Labeled Salad Bowls, Refrigerate, UPC Code: 71279407074 and Case Code:071279565620Potential Listeria Monocytogenes Contamination. The pre-packaged condiment trays contains chicken linked to the Bruce Pac recall.
- Class II
Medical Device Recall · October 18, 2024
Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood, and blood productsPotential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains.
- Class II
Medical Device Recall · October 17, 2024
Roche Diagnostics Operations, Inc.
cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteineAbnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias)
- Class II
Food Recall · October 17, 2024
H-E-B 12/14.1oz GRDL PNCK MINI HSTYLE ORG-HEBUT UPC 041220982714 TRADER JOE'S 16/11.3oz GRDL PNCK MINI HSTYLE ORG-TRDJO UPC 686151803778potential to be contaminated with Listeria monocytogenes
- Class II
Food Recall · October 17, 2024
KODIAK CAKES 8/10.72oz GRDL WFL CHOC CHIP-KDKCS UPC 705599013201potential to be contaminated with Listeria monocytogenes
- Class II
Food Recall · October 17, 2024
SELECTION 12/320g GRDL WFL WW-SLCTN UPC 059749977678potential to be contaminated with Listeria monocytogenes
- Class II
Food Recall · October 17, 2024
WESTERN FAMILY 12/280g GRDL WFL BTRMLK - WSTCN UPC 062639310141 GREAT VALUE 12/280g GRDL WFL BTRMLK - GRVLC UPC 605388923455 NO NAME 12/280g GRDL WFL BTRMLK - NNAME UPC 060383987688 COMPLIMENTS 12/280potential to be contaminated with Listeria monocytogenes
- Class II
Food Recall · October 17, 2024
PRESIDENT'S CHOICE 12/320g GRDL WFL BLBRY GF-PCHOI UPC 060383038663 WILD HARVEST 12/11.3oz GRDL WFL BLBRY GF-WLDHR UPC 711535515173 WEGMANS 12/11.3oz GRDL WFL BLBRY GF-WEGMN UPC 077890519653 FULL CIRCpotential to be contaminated with Listeria monocytogenes