The Recall Desk

Archive

February 2023 recalls

503 recalls were announced in February 2023.

What the numbers show

Critical
6
Severe
69
High
395
Moderate
32
Low
1

Of the 503 recalls this month scored against our rubric, 1% are Critical, 14% are Severe.

201–300 of 503

  • HighFDA (Drugs)·D-0268-2023·2023-02-15

    Posaconazole Antifungal Tablets Recalled for Degradation Impurities

    Biocon Pharma Inc. is recalling Posaconazole Delayed-Release Tablets due to failed degradation specifications and out-of-specification impurities that may compromise medication safety and efficacy.

    Product
    POSACONAZOLE — POSACONAZOLE (POSACONAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1106-2023·2023-02-15

    Roche Influenza A/B and RSV Test Kit Recalled for False Negative Results

    Roche Molecular Systems recalled 727 diagnostic test kits used to detect influenza and RSV due to reports of false negative influenza A results that could delay proper diagnosis and treatment.

    Product
    cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for use on the cobas 6800/8800 Systems; Material number 09233962190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1105-2023·2023-02-15

    Roche cobas Influenza Test Recall Due to False Negative Results

    Roche Molecular Systems is recalling its cobas Influenza A/B & SARS-CoV-2 test because it has reported false negative results for Influenza A, which may delay diagnosis and treatment.

    Product
    cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems; Material Number 09446125190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0340-2023·2023-02-15

    Fiber Powder Dietary Supplement Recalled for Cronobacter sakazakii Contamination

    Ortho Molecular Products is recalling fiber powder dietary supplements due to Cronobacter sakazakii detected in raw material. About 4,929 bottles distributed nationwide and to Canada are affected.

    Product
    Fiber Powder, Dietary Supplement, Apple Cinnamon Flavored, packaged under the following brands and sizes. 1. Ortho Molecular Products Fiber Plus, Product #608445, Net Wt. 15.9 oz (450 Grams) UPC 6 15033-00608 2. Ortho Molecular Products, Inc., 3017 Business Park Drive, Stevens
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0347-2023·2023-02-15

    Kirkland Signature 18 Sandwich Rolls Recalled for Potential Plastic Fragments

    Kirkland Signature 18 Sandwich Rolls may contain Lexan plastic fragments. The affected product was distributed in Montana and Washington.

    Product
    Kirkland Signature 18 Sandwich Rolls Ideal for Hot Dogs, net wt. 54 oz. UPC 0 96619 49013 4. Product is ambient does not require special storage.
    Category
    Food
    Distribution
    2 states
  • HighUSDA FSIS·PHA-02152023-01·2023-02-15

    USDA Issues Public Health Alert for Frozen Signature Select Breakfast Bowls

    USDA FSIS issued a public health alert for frozen Signature Select Breakfast Bowls due to possible temperature abuse at a distribution center. Consumers are urged not to consume the products.

    Product
    FSIS Issues Public Health Alert for Frozen, Not-Ready-To-Eat Signature Select Breakfast Bowl Products Due to Possible Temperature Abuse at Distribution Center
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0344-2023·2023-02-15

    Chocolate Almonds Recalled for Undeclared Peanut Allergen

    Skinny Dipped Dark Chocolate Cocoa Almonds are recalled due to undeclared peanut. Consumers with peanut allergies should not consume this product.

    Product
    Skinny Dipped Dark Chocolate Cocoa Almonds, 3.5 oz, packaged in flexible plastic pouches inside cardboard cases. Ingredients: Almonds, Dark Chocolate (Unsweetened Chocolate Processed with Alkali, Cane Sugar, Cocoa Butter, Milk Fat, Sunflower Lecithin, Vanilla), Maple Sugar, Sea S
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-1068-2023·2023-02-15

    Sterile Procedural Trays Recalled Due to Blade Package Puncture Risk

    Medline sterile procedural trays are recalled because sterile blades within the kits can puncture the outer foil packaging, potentially compromising sterility. 622 cases (1,619 units) have been distributed worldwide.

    Product
    Sterile Procedural Trays, labeled as the following: a. PORT/TRACH INSERTION CDS-3 b. RESIDENT DERM SURG PACK c. THROMBECTOMY PACK-LF d. AV FISTULA PACK e. AV SHUNT PACK-LF f. RR-VP SHUNT PACK-LF g. VEIN HARVESTING PACK-LF h. AV FISTULA PACK-LF i. PK, GEN-BARIATRIC j.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0264-2023·2023-02-15

    Ohm Sanitizer Spray Recalled Due to Chemical Contamination

    Urban Electric Power is recalling Ohm Sanitizer Spray nationwide because FDA analysis found the product contains acetaldehyde and acetal above specification limits.

    Product
    Ohm Sanitizer Spray (alcohol (ethyl alcohol) 80% v/v, 8 FL OZ (237 ML) bottles.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0263-2023·2023-02-15

    Ohm Hand Sanitizer Recalled for Acetaldehyde and Acetal Contamination

    Urban Electric Power is recalling Ohm Hand Sanitizer products in multiple sizes due to FDA findings of acetaldehyde and acetal above specification limits resulting from manufacturing deviations.

    Product
    Ohm Hand Sanitizer (alcohol (ethanol) 70 % v/v), packaged in a) 2 FL OZ (60 ML), b) 3 FL OZ (88 ML) bottles, c) 10 FL OZ (295 ML) bottles, d)12 FL OZ (355 ML) bottles, e)16 FL OZ (473 ML) bottles, f) 64 FL OZ (1892 ML) bottles, g) 128 FL OZ (3785 ML) bottles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1100-2023·2023-02-15

    Precision Delivery Sets recalled due to potential tubing detachment

    Quest Medical recalls Precision Delivery Sets (models PD06F and PDT05CV2) due to tubing that may detach, potentially causing patient infection. Approximately 13,900 units were distributed nationwide.

    Product
    Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer, REF: PDT05CV2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1077-2023·2023-02-15

    Sterile Surgical Trays Recalled for Blade Puncture of Packaging

    Medline Industries is recalling sterile surgical trays used in plastic and reconstructive surgery because blades within the kits can puncture the outer foil packaging, potentially compromising sterility. Approximately 15,009 units were distributed nationwide and internationally.

    Product
    Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINOPLASTY CDS d. ACH PLASTICS BREAST-LF e. NE BREAST RECON CDS f. PLASTIC SURGERY CDS g. MINOR PLASTIC CDS h. GROTH BREAST CDS i. BREAST ABD j. MINOR/U-BAR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1060-2023·2023-02-15

    Medline Sterile Procedural Trays Recalled for Packaging Puncture Risk

    Medline Industries is recalling ANCILLARY PACK-LF sterile procedural trays because sterile blades in the kits may puncture the outer foil layer of sterile packaging, potentially compromising the sterility of the contents.

    Product
    ANCILLARY PACK-LF. Sterile Procedural Tray.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1078-2023·2023-02-15

    Medline Sterile Surgical Trays Recalled for Potential Blade Puncture of Packaging

    Medline Industries is recalling sterile procedural trays because blades in the kits may puncture the outer packaging, potentially compromising sterility.

    Product
    Sterile Procedural Trays, labeled as the following: a. ST. ANNE'S MAJOR BASIN SET UP b. SINGLE BASIN SET c. DOUBLE BASIN SET d. LAPAROTOMY BASIN e. ORTHOPEDIC CUSTOM BASIN SET f. OISC BASIN TRAY g. BASIN PACK h. BASIN SET i. SURGI START PACK j. PK, GEN-SET UP - MIDWE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1097-2023·2023-02-15

    Sterile arthroscopy trays recalled for potential blade puncture risk

    Medline Industries recalls multiple sterile arthroscopy surgical trays because blades in the kits may puncture the outer foil packaging, potentially compromising sterility. Affected products were distributed worldwide.

    Product
    Sterile Procedural Trays, labeled as the following: a. KNEE ARTHROSCOPY CDS-LF b. ARTHROSCOPY CDS c. ARTHROSCOPY LV - EDOC PACK-LF d. ARTHROSCOPY PACK-LF e. ARTHROSCOPY PACK f. ARTHRO PACK-LF g. ARTHROSCOPY PACK-LF h. ARTHROSCOPY PACK-LF i. ARTHROSCOPY KNEE TRAY-LF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1090-2023·2023-02-15

    Sterile Procedural Trays Recalled Due to Potential Packaging Compromise

    Medline Industries recalls sterile pelviscopy trays because blades inside may puncture the protective foil packaging, potentially compromising sterility. 316 units distributed worldwide are affected.

    Product
    Sterile Procedural Trays, labeled as the following: a. PELVISCOPY PACK b. D-PELVISCOPY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1096-2023·2023-02-15

    Medline Sterile Procedural Trays Recalled Due to Packaging Puncture Risk

    Medline recalls sterile procedural trays because blades may puncture the foil packaging, potentially compromising sterility. The recall affects over 227,000 units distributed worldwide.

    Product
    Sterile Procedural Trays, labeled as the following: a. SPINAL b. SPINE CDS c. TOTAL ORTHO CDS d. TOTAL KNEE CDS e. CDS HIP-LF f. KNEE TOTAL PACK-LF g. EXTREMITY CDS h. SHOULDER ARTHRO CDS i. GLENNON EXTREMITY CDS j. KNEE ARTHROSCOPY k. TOTAL KNEE l. TOTAL HIP REPLACEMENT m. TO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1069-2023·2023-02-15

    Medline Sterile Procedural Trays Risk Package Puncture and Sterility Compromise

    Medline Industries is recalling sterile procedural trays because sterile blades may puncture the outer foil packaging, potentially compromising sterility. The recall affects 858 units distributed worldwide.

    Product
    Sterile Procedural Trays, labeled as the following: a. BREAST BIOPSY PACK-LF b. BREAST BIOPSY PACK c. LAPAROTOMY PACK d. BREAST PACK e. SOFT TISSUE PACK f. HEMORRHOID PACK g. RECTAL h. BREAST i. BREAST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1088-2023·2023-02-15

    Medline Sterile Surgical Trays Recalled Due to Blade Puncture Risk

    Medline Industries recalls sterile surgical procedural trays because sterile blades within the kits may puncture the outer foil packaging, potentially compromising sterility. No injuries or illnesses have been reported.

    Product
    Sterile Procedural Trays, labeled as the following: a. AV SHUNT CDS b. ZALE V-P SHUNT CDS c. NEURO CDS-LF d. MAJOR NEURO e. NEURO PACK-LF f. CUSTOM NEURO PACK-LF g. NEURO PACK-LF h. NEURO PACK-LF i. NEURO PACK-LF j. NEURO PACK-LF k. NEURO/LAMINECTOMY BASIN PK-LF l
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1087-2023·2023-02-15

    Medline Procedural Trays Recalled for Blade Packaging Risk

    Medline Industries is recalling Ambulatory Mini Pack sterile procedural trays because blades within the kits may puncture the outer sterile packaging, potentially compromising sterility.

    Product
    Sterile Procedural Trays, labeled as the following: AMBULATORY MINI PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1072-2023·2023-02-15

    Medline Sterile Procedural Trays Recalled for Potential Packaging Puncture Risk

    Medline Industries is recalling approximately 27,563 units of sterile procedural trays used in surgery because sterile blades may puncture the outer foil packaging layer, potentially compromising sterility.

    Product
    Sterile Procedural Trays, labeled as the following: a. EAR CDS-LF b. SINUS CDS-1 c. ZALE FESS CDS d. ZALE OTOLOGY CDS e. ZALE HEAD & NECK CDS f. CUH PARA/THYROIDECTOMY CDS g. CAM ENDOSCOPIC SINUS/SEPTO CDS h. HEAD AND NECK CDS i. HEAD AND NECK CDS-LF j. NASAL k. ENT SET UP CDS l
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1067-2023·2023-02-15

    Sterile Procedural Trays Recalled Due to Blade Puncture Risk

    Medline Industries is recalling sterile procedural trays because sterile blades within the kits may puncture the protective foil packaging. Approximately 12,964 cases (23,379 units) distributed worldwide are affected.

    Product
    Sterile Procedural Trays, labeled as the following: a. EP LAB PACEMAKER PACK b. OPEN HEART CDS c. OPEN HEART CDS d. AAA CDS e. OPEN HEART CDS f. PACEMAKER CDS g. HEART CDS h. VALVE PACK i. OPEN HEART CDS-3 j. OPEN HEART PACK k. OPEN HEART PACK l. OPEN HEART ADULT m. OPEN HEART C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1099-2023·2023-02-15

    Spinal Cement System Recalled for Incorrect Expiration Date

    TEKNIMED SAS is recalling HIGH V+ Spinal Cement System (236 units) due to mislabeling showing expiration date of February 28, 2027 instead of the correct date February 28, 2025.

    Product
    HIGH V+ Spinal Cement System REF T040321K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1094-2023·2023-02-15

    Sterile Procedural Trays Recalled Due to Blade Puncture Risk

    MEDLINE INDUSTRIES is recalling sterile surgical trays used in robotic and laparoscopic procedures because blades within the kits can puncture the outer foil packaging. The recall affects 1,212 cases (2,101 units) distributed worldwide.

    Product
    Sterile Procedural Trays, labeled as the following: a. CELEBRATION ROBOTIC CDS b. DAVINCI CDS UCC-LF c. ROBOTICS PACK-LF d. ROBOTICS PACK-LF e. ROBOTIC PACK f. PELVISCOPY PACK-LF g. CUSTOM LITHOTOMY ROBOT PACK h. PERI GYN PACK i. ROBOTICS PACK j. LAP HYSTO PACK k.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1074-2023·2023-02-15

    Sterile Procedural Trays Recalled Due to Blade Packaging Puncture Hazard

    Medline Industries is recalling multiple sterile procedural trays because blades within the kits can puncture the outer foil packaging. The products were distributed worldwide.

    Product
    Sterile Procedural Trays, labeled as the following: a. LAPAROTOMY CDS-LF b. LAPAROSCOPY CDS-LF c. BASIC LAPAROSCOPY CDS d. LAPAROSCOPY CDS-LF e. GENERAL LAPAROSCOPY PROCEDURE f. LAP CHOLE CDS g. COLO-RECTAL CDS-LF h. MAJOR PROCEDURE-LF i. HYPOSPADIUS CDS j. LAPAROSCOPY-GENERAL k
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1062-2023·2023-02-15

    Medline sterile procedural trays recalled for blade packaging puncture

    Medline is recalling sterile procedural trays (Lot 22IBG550) because sterile blades can puncture the foil packaging, compromising sterility. Units were distributed worldwide.

    Product
    LOCAL PACK. Sterile Procedural Tray.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1071-2023·2023-02-15

    Medline Sterile Procedural Trays Recalled Due to Blade Puncture Risk

    Medline Industries is recalling sterile procedural trays (Rhinoplasty Pack, OSC Otology Pack-LF, and Rhyzotomy) distributed worldwide because sterile blades within the kits may puncture the outer foil layer of sterile packaging, potentially compromising sterility.

    Product
    Sterile Procedural Trays, labeled as the following: a. RHINOPLASTY PACK b. OSC OTOLOGY PACK-LF c. RHYZOTOMY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1102-2023·2023-02-15

    Smart Correction External Fixation Struts: Collar Release Pin May Back Out

    The collar release pin on affected Smart Correction Dual Joint Express Struts may back out, preventing proper length adjustment and potentially delaying surgical correction.

    Product
    WishBone Medical Smart Correction Dual Joint Express Struts, external skeleton fixation device Type Part Number XXS 10-702-080095-0 XS 10-702-095115-0 Short 10-702-115150-0 Medium 10-702-140200 Long 10-702-190300-0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1065-2023·2023-02-15

    Blade Puncture Risk in Femoral Artery Sterile Procedural Trays

    Medline's Femoral Artery Sterile Procedural Trays are being recalled because sterile blades within the kits can puncture the outer foil layer of the sterile packaging. This puncture creates a contamination risk.

    Product
    FEMORAL ARTERY PACK-LF. Sterile Procedural Tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1080-2023·2023-02-15

    Medline Sterile Procedural Trays Recalled Due to Blade Puncture Risk

    Medline recalls sterile surgical trays (Universal Plastic and Knee Arthroscopy Pack) because sterile blades can puncture the outer foil packaging, potentially compromising sterility.

    Product
    Sterile Procedural Trays, labeled as the following: a. UNIVERSAL PLASTIC b. KNEE ARTHROSCOPY PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1083-2023·2023-02-15

    Medline Sterile Procedural Trays Recalled for Potential Blade Puncture in Packaging

    Medline Industries is recalling sterile procedural trays because blades in the kits may puncture the outer foil sterile packaging, compromising sterility. No injuries have been reported.

    Product
    Sterile Procedural Trays, labeled as the following: a. MAJOR CDS-LF b. BURN PACK-LF c. BURN PACK d. SMALL BURN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1084-2023·2023-02-15

    Sterile Procedural Trays Recalled Due to Potential Packaging Puncture

    Medline Industries is recalling sterile procedural trays because sterile blades may puncture the outer packaging foil, potentially compromising sterility. No injuries have been reported.

    Product
    Sterile Procedural Trays, labeled as the following: MINOR BASIC PACK-LF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1070-2023·2023-02-15

    Sterile Procedural Trays recalled for potential blade puncture of packaging

    Medline Industries is recalling five types of sterile procedural trays because sterile blades inside can puncture the outer foil packaging, potentially compromising sterility and creating contamination risk.

    Product
    Sterile Procedural Trays, labeled as the following: a. ORAL SURGERY PACK-LF b. EXTRACTION PACK c. ORAL SURGERY PACK d. DENTAL MINOR PACK e. ORAL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1093-2023·2023-02-15

    Sterile Surgical Trays Recalled for Blade Puncture Risk

    Medline Industries recalls sterile surgical procedural trays because blades inside could puncture the outer sterile packaging, potentially compromising kit sterility.

    Product
    Sterile Procedural Trays, labeled as the following: a. GYN ABD CDS b. LAVH PROCEDURE c. TAH CDS d. CUH LITHOTOMY CDS e. LAVH CDS f. GROTH VAGINAL CDS g. MAJOR LITHOTOMY h. MAJOR VAGINAL HARPER PACK-LF i. VAG. HYST TRAY-LF j. VAGINAL HYSTERECTOMY PACK-LF k. HYSTEREC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1081-2023·2023-02-15

    Sterile Procedural Trays Recalled Due to Potential Blade Puncture of Packaging

    Medline Industries recalls sterile procedural trays (Wound Closure Tray and Wound Pack) distributed worldwide because sterile blades may puncture the outer foil packaging.

    Product
    Sterile Procedural Trays, labeled as the following: a. WOUND CLOSURE TRAY b. WOUND PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1075-2023·2023-02-15

    Sterile endoscopy trays recalled for potential blade packaging puncture

    Medline is recalling sterile procedural trays labeled GENERAL ENDOSCOPY because sterile blades within the kits may puncture the outer foil layer of sterile packaging, potentially compromising sterility.

    Product
    Sterile Procedural Trays, labeled as the following: GENERAL ENDOSCOPY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1066-2023·2023-02-15

    Medline Sterile Procedural Trays Recalled Over Blade Puncture Risk

    Medline recalls sterile procedural trays because sterile blades may puncture the outer foil packaging, compromising device sterility. The 314-case recall affects hospitals in the US, Canada, Japan, Mexico, Panama, Turks & Caicos, and UAE.

    Product
    Sterile Procedural Trays, labeled as the following: a. CARDIAC CATH PACK-LF; b. ANGIOGRAPHY-NS-LF; c. EP BASIC SET UP PACK; d. IMPLANT PACK-LF; e. PORT PACEMAKER INSERTION PACK; f. OPEN HEART PACK; g. LAP BASIN TRAY; h. ANGIO ACCESS; i. ANGIO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1079-2023·2023-02-15

    Sterile Procedural Trays Recalled for Potential Blade Puncture of Packaging

    Medline Industries is recalling multiple sterile procedural trays because blades within the kits can potentially puncture the outer foil packaging, compromising sterility. The recall affects approximately 215,456 units distributed worldwide.

    Product
    Sterile Procedural Trays, labeled as the following: a. BASIN SET-UP PACK b. LAP CHOLE CDS c. MAJOR CDS d. UROLOGY MINOR CDS e. UROLOGY MAJOR CDS f. SINGLE BASIC CDS g. ORGAN RECOVERY CDS h. GENERAL ABD CDS i. BURN CDS j. MINOR k. MAJOR VASCULAR l. BASIC CORE CDS m. ROBOTIC PROC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1085-2023·2023-02-15

    Sterile Procedural Trays Recalled Due to Blade Puncture Risk

    Medline Industries is recalling Sterile Procedural Trays (LS MS PACK) because the sterile blade inside can potentially puncture the outer packaging layer, compromising sterility.

    Product
    Sterile Procedural Trays, labeled as the following: LS MS PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1086-2023·2023-02-15

    Sterile Procedural Trays Recalled Due to Potential Blade Packaging Puncture

    Medline Industries is recalling sterile procedural trays because blades within the kits may puncture the outer foil packaging, potentially compromising sterility.

    Product
    Sterile Procedural Trays, labeled as the following: DR MOTT DRAPE PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1061-2023·2023-02-15

    Sterile Trach Pack procedure kits recalled due to blade puncture risk

    Medline Industries is recalling TRACH PACK sterile procedure kits because sterile blades within the kits can puncture the outer foil packaging, potentially compromising product sterility.

    Product
    TRACH PACK. Sterile Procedural Tray.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1091-2023·2023-02-15

    Sterile Surgical Trays Recalled for Potential Sterile Packaging Puncture

    Medline Industries recalls sterile surgical procedural trays because blades within the kits could puncture the sterile outer packaging, potentially compromising sterility during surgical use.

    Product
    Sterile Procedural Trays, labeled as the following: a. GYN-URO LAPSCP CDS-LF b. ROBOTIC CDS c. GYN LAPAROSCOPY CDS-LF d. GYN LAPAROSCOPY e. GYN LAPAROSCOPY CDS f. UNIVERSAL ROBOTIC ORLANDO g. GYN ROBOTIC CDS h. GYN LAPAROSCOPY CDS-1 i. CUH GYN LAPAROSCOPY CDS j. CUH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1052-2023·2023-02-15

    NuVasive Pulse III Multimodality System remote monitoring connection failure

    An incorrect security key prevents the NuVasive Pulse III system from connecting to remote monitoring during spinal, thoracic, and extremity surgeries. Affected facilities should contact NuVasive for corrective action.

    Product
    NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0265-2023·2023-02-15

    Akorn Atropine Sulfate Eye Solution Recalled for Failed Stability Testing

    Akorn is recalling 45,117 bottles of Atropine Sulfate Ophthalmic Solution because stability testing found viscosity measurements out of specification. The affected product should not be used.

    Product
    Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL bottle, Sterile, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. NDC: 17478-215-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1059-2023·2023-02-15

    Face Masks Packaged in Incorrect Dispenser Boxes with Mismatched Labeling

    73 cases of FLUIDSHIELD 3 procedure masks were placed in dispenser boxes labeled for masks with ties, when the actual masks have ear loops. Distributed to IL, NC, NY, OH, and PA.

    Product
    FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147
    Category
    Medical Device
    Distribution
    5 states
  • SevereNHTSA·23V079000·2023-02-14

    2022-2023 BMW IX and X1 driver airbag may fail to deploy in crash

    Certain 2022 and 2023 BMW IX and X1 vehicles have defective driver-side airbags that may not deploy during a crash. Dealers will replace the airbags at no charge.

    Product
    BMW — BMW IX, X1
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V080000·2023-02-14

    2019-2022 Subaru Crosstrek Hybrid battery charging system recall

    Subaru is recalling 2019-2022 Crosstrek Hybrid vehicles because the harness terminal supplying power to the 12-Volt battery may corrode and break, preventing charging. A non-functioning battery can cause loss of drive power and increase crash risk.

    Product
    SUBARU — SUBARU CROSSTREK HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-02142023-01·2023-02-14

    Tampa Bay Fisheries Stuffed Chicken Products Recalled for Undeclared Allergens

    USDA FSIS issued a public health alert for raw stuffed chicken products missing ingredient labels, posing a risk to consumers with soy or milk allergies.

    Product
    Tampa Bay Fisheries, Inc. — FSIS Issues Public Health Alert for Raw, Ready-To-Cook Stuffed Chicken Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    3 states
  • HighNHTSA·23E014000·2023-02-13

    Braun Recalls Child Seat Weldments Due to Improper Welds

    Braun Corporation is recalling child seat weldments for the BraunAbility Turny Seat because improper welds may cause anchors to detach in a crash.

    Product
    EQUIPMENT ADAPTIVE/MOBILITY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V076000·2023-02-13

    Subaru Recalls 2004-2005 Impreza and WRX for Air Bag Defect

    Subaru is recalling 2004-2005 Impreza and WRX vehicles because previously replaced passenger air bag inflators may have been installed incorrectly, increasing injury risk in a crash.

    Product
    SUBARU — SUBARU IMPREZA, WRX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V078000·2023-02-13

    Proterra Catalyst and ZX5 buses recalled for wiper motor failure

    Proterra is recalling certain 2020–2022 Catalyst and ZX5 buses due to windshield wiper motor failure. Inoperative wipers reduce visibility and increase crash risk.

    Product
    PROTERRA — PROTERRA CATALYST, ZX5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V074000·2023-02-10

    Mercedes-Benz Recalls 2022 EQS 580 for Windshield Camera Attachment Defect

    Mercedes-Benz is recalling 2022 EQS 580 vehicles because the windshield-mounted camera and rearview mirror may detach, potentially impairing air bag deployment and driver assistance systems.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ EQS 580
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V066000·2023-02-10

    Navistar Recalls 2022-2023 IC Bus CE and RE Models for Roof Defect

    Navistar is recalling 2022-2023 IC Bus CE and RE transit buses because roof panels may have insufficient joint strength, increasing injury risk in a crash.

    Product
    IC BUS — IC BUS CE, RE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V073000·2023-02-10

    Freightliner Cascadia and Western Star trucks recalled for brake defect

    Daimler Trucks North America is recalling certain 2017-2023 Freightliner Cascadia and Western Star trucks. Corroded brake modulator valves may cause vehicles to pull to one side during braking, increasing crash risk.

    Product
    WESTERN STAR — WESTERN STAR, FREIGHTLINER 49X, 47X, 114SD, CASCADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V067000·2023-02-10

    Nissan Recalls Armada, Quest, Pathfinder, Xterra for Air Bag Cover Defect

    Nissan is recalling certain 2008-2011 vehicles because the driver's air bag cover emblem may crack and detach during deployment, posing an injury risk.

    Product
    NISSAN — NISSAN ARMADA, QUEST, PATHFINDER, XTERRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V068000·2023-02-10

    2021-2023 Thor Motor Coach RIZE and SCOPE Retractable Awning Recall

    Thor Motor Coach is recalling certain 2021-2023 RIZE and SCOPE camper vans because the retractable awning may extend unintentionally during transit. This can become a distraction or road hazard, increasing the risk of a crash.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH RIZE, SCOPE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23C001000·2023-02-10

    Cybex Infant Car Seat Recall for Fraying Harness Adjustment Straps

    Columbus Trading-Partners USA is recalling specific Cybex infant car seats because the front harness adjustment strap webbing may fray, reducing strength and increasing injury risk in a crash.

    Product
    CHILD SEAT:HARNESS:STRAP/WEBBING recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V065000·2023-02-10

    2022-2024 IC Bus School Buses Roof Panel Joint Strength Defect Recall

    Navistar is recalling certain 2022-2024 IC Bus school buses because roof panels may have insufficient joint strength and could separate during a crash, increasing injury risk. Dealers will add fasteners to secure the joints at no cost.

    Product
    IC BUS — IC BUS RESB, CESB, EV, CE SBUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23E012000·2023-02-10

    Nissan Recalls Driver Air Bag Assemblies Due to Detaching Emblem Risk

    Nissan is recalling specific driver's air bag assemblies sold as replacement parts because the resin emblem may crack and detach during deployment, posing an injury risk.

    Product
    AIR BAGS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23E010000·2023-02-09

    Chrysler Recalls Mopar Intake Heater Grid Relays for Fire Risk

    Chrysler is recalling Mopar Generation 1 Intake Heater Grid Relays because an electrical short can cause an engine compartment fire. Owners should park vehicles outside until the free repair is completed.

    Product
    ELECTRICAL SYSTEM:WIRING:RELAYS/SOLENOIDS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23117·2023-02-09

    Skip Hop Silver Lining Cloud Activity Gyms Recalled for Choking Hazard

    Skip Hop is recalling Silver Lining Cloud Activity Gyms because raindrops attached to the included cloud toy can detach and pose a choking hazard to children. No injuries have been reported.

    Product
    Silver Lining Cloud Activity Gyms
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·23V059000·2023-02-09

    RAM 1500 and 2500 Rearview Display May Fail When in Reverse

    Certain 2021-2023 RAM 1500 and 2023 RAM 2500 vehicles have a software defect that may prevent the rearview image from displaying when in reverse, reducing driver visibility.

    Product
    RAM — RAM 1500, 2500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V062000·2023-02-09

    Spartan Motorhome Chassis Software Error Causes Loss of Drive Power and Visibility

    Shyft Group is recalling 2022–2024 Spartan motorhome chassis due to a software error that may cause loss of drive power or safety functions like headlights and wipers. Owners should contact Shyft Group at 1-800-237-7806 for a free software update.

    Product
    SPARTAN — SPARTAN K1, K2, K3, K4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V064000·2023-02-09

    2023 Subaru Solterra: hub bolts may loosen and cause wheels to detach

    Certain 2023 Subaru Solterra vehicles have improperly tightened hub bolts that may loosen and cause wheel detachment. Owners should not drive until dealers complete repairs.

    Product
    SUBARU — SUBARU SOLTERRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23116·2023-02-09

    Ovation Protégé Equestrian Helmets Recalled for Impact Injury Hazard

    English Riding Supply is recalling about 49,300 Ovation Protégé equestrian helmets because they fail to meet safety impact standards. Riders who fall face an injury risk.

    Product
    Equestrian helmets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23725·2023-02-09

    LiftMaster myQ Garage Door Control Panels Recalled for Entrapment Hazard

    Chamberlain Group is recalling about 96,400 LiftMaster myQ garage door control panels because the secondary entrapment protection system can fail, allowing the garage door to close even when an obstruction is present. No injuries have been reported in the U.S.

    Product
    LiftMaster myQ Garage Door Control Panels
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23118·2023-02-09

    IKEA ODGER Swivel Chairs Recalled Due to Leg Base Breakage and Fall Risk

    IKEA is recalling about 12,000 ODGER Swivel Chairs in anthracite because the leg base can break, creating a fall hazard. Four reports of leg base breaking have been received, including two reports of consumer injuries from falls.

    Product
    IKEA ODGER Swivel Chairs, Anthracite
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·23V063000·2023-02-09

    Freightliner Recalls Coronado Trucks Due to Loose Upper Bunk Bolts

    Daimler Trucks North America is recalling 2021-2023 Freightliner Coronado vehicles because upper bunk mounting bolts may loosen, posing an injury risk.

    Product
    FREIGHTLINER — FREIGHTLINER CORONADO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V058000·2023-02-09

    2022 Jeep Compass instrument panel display insufficient illumination during daytime

    The 2022 Jeep Compass instrument panel center cluster display may be insufficiently illuminated and may not be visible during daytime driving. This could prevent drivers from seeing safety-critical information like the fuel gauge and warning lights.

    Product
    JEEP — JEEP COMPASS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V061000·2023-02-09

    Motorhome Cooktops May Leak Gas and Create Fire Risk

    Forest River is recalling certain 2022-2023 Coachmen motorhomes with faulty cooktops. The burner tubes may fracture and leak gas, creating a fire hazard.

    Product
    COACHMEN — COACHMEN GALLERIA, BEYOND, NOVA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23723·2023-02-09

    Model Year 2023 Can-Am Side-by-Side Vehicles Recalled for Fire Hazard

    BRP is recalling about 3,310 Model Year 2023 Can-Am side-by-side vehicles because a defective fuel hose assembly could leak fuel and create a fire hazard. Consumers should stop using the vehicles and contact a Can-Am dealer for a free repair.

    Product
    Model Year 2023 Can-Am side-by-side vehicles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23726·2023-02-09

    E-Z-GO Personal Transportation Vehicles Recalled for Fire Hazard

    Textron Specialized Vehicles is recalling about 143,000 E-Z-GO personal transportation vehicles because the electronic board powering the USB port can overheat and ignite, creating a fire hazard. Consumers should stop using the vehicles immediately and contact Textron for a free repair.

    Product
    E-Z-GO Personal Transportation Vehicles (PTVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V060000·2023-02-09

    RAM pickup and cab chassis trucks recalled for engine compartment fire risk

    Chrysler is recalling 2021–2023 RAM 2500, 3500, 4500, and 5500 Cummins diesel trucks due to an electrical short in the heater grid relay that can cause engine compartment fires. Owners should park outside and away from structures until repairs are completed.

    Product
    RAM — RAM 3500, 2500, 4500, 5500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateCPSC·23724·2023-02-09

    WeeSprout Baby Sleep Sacks Recalled Due to Choking Hazard

    WeeSprout baby sleep sacks are being recalled because the zipper can detach, posing a choking hazard to infants. The company has received 17 reports of zipper detachment but no injuries have been reported.

    Product
    Baby Sleep Sacks
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0250-2023·2023-02-08

    Easy Care First Aid Kit Recalled for Bacterial Contamination

    GFA Production is recalling Easy Care First Aid Kits distributed nationwide and in Canada due to bacterial contamination of included After Burn Cream packets. The FDA confirmed the presence of Bacillus lichenformis and Bacillus sonorensis.

    Product
    Easy Care First Aid Class A ANSI 25 Person, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 9999-2150
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0246-2023·2023-02-08

    First Aid Kit with Burn Cream Recalled for Bacterial Contamination

    GFA Production is recalling Adventure First Aid 1.0 kits containing Easy Care After Burn Cream due to confirmed bacterial contamination found in FDA testing. The affected product was distributed nationwide and in Canada.

    Product
    Adventure First Aid 1.0, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 0120-0213
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0244-2023·2023-02-08

    Easy Care first aid burn cream recalled for microbial contamination

    Easy Care first aid burn cream distributed nationwide and in Canada is recalled due to FDA-detected contamination with Bacillus lichenformis and Bacillus sonorensis. The product should not be used.

    Product
    Easy Care first aid Burn Cream (benzalkonium chloride 0.13% and lidocaine hydrochloride 0.5%), 0.9 g (0.03 oz) packets packaged in boxes of 10, Treatment for Burns, Made in China for Adventure Ready Brands, 944 Industrial Park Rd., Littleton, NH 03561, NDC 90107-0210, Product # 9
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0929-2023·2023-02-08

    SARS-CoV-2 Antigen Rapid Test Kits Recalled for Lack of FDA Authorization

    Universal Meditech Inc. is recalling approximately 56,300 SARS-CoV-2 Antigen Rapid Test Kits distributed without FDA approval, clearance, or Emergency Use Authorization. Products were distributed nationwide in California and Texas.

    Product
    Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 20 TESTS/1 KIT Green and white box under the brand DiagnosUS, and, White box without brand name labeled as "SARS -COV-2 ANTIGEN DEVELOPMENT MADE IN USA ORAL SWAB TES
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0248-2023·2023-02-08

    FDA Recalls Easy Care First Aid Kits for Bacterial Contamination

    GFA Production's Easy Care First Aid 25 Person kits are being recalled nationwide due to contamination with Bacillus bacteria. The affected first aid cream packets could pose a risk if applied to open wounds.

    Product
    Easy Care First Aid 25 Person 2009 ANSI, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 9999-2129
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0253-2023·2023-02-08

    Easy Care First Aid Kit Recalled for Microbial Contamination

    The FDA is recalling Easy Care First Aid kits containing After Burn Cream due to microbial contamination. The affected product was distributed nationwide and in Canada with lot number W06H15 (expiration August 15, 2024).

    Product
    Easy Care First Aid 10 Person 2009 ANSI, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 9999-2131
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0966-2023·2023-02-08

    CADD Administration Sets recall for delivery failure and false alarms

    Smiths Medical is recalling CADD Administration Sets due to potential tubing occlusion causing medication underdelivery and false alarm errors. The FDA classified this as a Class I recall affecting nearly 48 million units worldwide.

    Product
    CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24, 3) REF 21-7302-24, 4) REF 21-7308-24, 5) REF 21-7309-24, 6) REF 21-7310-24, 7) REF 21-7322-24, 8) REF 21-7323-24, 9) REF 21-7324-24, 10) REF 21-7333-24, 11) REF 21-7343-24, 12) REF 21-7346-24
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0252-2023·2023-02-08

    CVS First Aid Home Burn Cream Packets Recalled for Bacterial Contamination

    CVS First Aid Home, First Aid Kit burn cream packets have been recalled due to bacterial contamination. The product contains Bacillus lichenformis and Bacillus sonorensis bacteria, creating a risk when applied to wounds or burns.

    Product
    CVS First Aid Home, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 2980-0700
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0249-2023·2023-02-08

    Easy Care First Aid Kits Recalled for Bacterial Contamination

    GFA Production is recalling Easy Care First Aid 10 Person First Aid Kits because the included After Burn Cream packets are contaminated with Bacillus bacteria. Contamination was identified through FDA laboratory testing.

    Product
    Easy Care First Aid 10 Person 2009 ANSI, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 9999-2128
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0319-2023·2023-02-08

    James Farm Frozen Red Raspberries Recalled for Hepatitis A Contamination

    James Farm brand frozen red raspberries from Chile may be contaminated with Hepatitis A Virus. The product was distributed to food service facilities in the Northeast.

    Product
    James Farm brand Frozen Red Raspberries; 2-5lb Bags; NET WT 10 LB (4.5 kg); KEEP FROZEN; IQF; Individually Quick Frozen; FOR FOOD SERVICE SALE ONLY; Distributed by: RD/JET, LLC; 15-24 132nd Street, College Point, NY 11356; Country of Origin: CHILE.
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Food)·F-0338-2023·2023-02-08

    Wegmans tiramisu products contain undeclared wheat

    Wegmans bakery tiramisu products contain undeclared wheat not listed on the label. The products are marked as made with no gluten-containing ingredients but do not declare wheat as an allergen.

    Product
    Wegmans bakery Tiramisu, Half Tiramisu, and Tiramisu Slices; Made with No Gluten-Containing Ingredients; ALLERGENS: Contains Egg, Milk, Soy, Other allergens may be present due to shared preparation area.
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0245-2023·2023-02-08

    First Aid Kit Product Recalled Due to Bacterial Contamination

    A first aid kit containing topical burn cream has been recalled due to bacterial contamination with Bacillus species. The product (Lot W06I20) was distributed nationwide and in Canada.

    Product
    Adventure Marine 150, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 1015-0150
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0324-2023·2023-02-08

    Fullei Fresh Alfalfa Sprouts Recalled for Possible E. coli Contamination

    Fullei Fresh brand alfalfa sprouts are recalled due to possible contamination with Shiga toxin-producing E. coli. The recall affects 333 cases distributed in Florida, lot number 336.

    Product
    Fullei Fresh brand Alfalfa Sprouts in a 4 oz. clear plastic clamshell container; UPC Code 17442 30012. Packaged in 5lb carboard box 12 packages of 4 oz
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0247-2023·2023-02-08

    FDA Recalls First Aid Cream Packets Over Bacterial Contamination

    The FDA is recalling Adventure First Aid 1.5 first aid kits due to bacterial contamination found in the included burn cream packets. The contamination was identified through FDA laboratory testing.

    Product
    Adventure First Aid 1.5, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 0120-0212
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0251-2023·2023-02-08

    FDA Recalls Easy Care First Aid Kit for Bacterial Contamination

    The FDA is recalling Easy Care First Aid Kits with contaminated After Burn Cream packets distributed nationwide and in Canada. Lab testing identified Bacillus lichenformis and Bacillus sonorensis contamination.

    Product
    Easy Care First Aid 25 Person 2009 ANSI, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 9999-2132
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0964-2023·2023-02-08

    CADD Infusion Administration Sets Recalled for Delivery Failure and Alarms

    FDA recalls 726,878 CADD Infusion Administration Sets due to potential tubing occlusion causing delivery failure and false alarm warnings.

    Product
    CADD Administration Set, List Numbers: a) REF 21-7308-24, b) REF 21-7309-24, c) REF 21-7310-24, d) REF 21-7308-24JP, e) REF 21-7309-24JP. Computerized Ambulatory Delivery Device
    Category
    Medical Device
    Distribution
    Distributed nationwide

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