The Recall Desk

Archive

July 2023 recalls

787 recalls were announced in July 2023.

What the numbers show

Critical
65
Severe
365
High
307
Moderate
50

Of the 787 recalls this month scored against our rubric, 8% are Critical, 46% are Severe.

501–600 of 787

  • HighFDA (Devices)·Z-2059-2023·2023-07-12

    Fenestrated Graspers Recalled Due to Potential Breakage and Fragment Risk

    Intuitive Surgical is recalling 46,033 da Vinci Xi/X Tip-Up Fenestrated Graspers worldwide due to a manufacturing issue that can cause grip breakage, potentially allowing stainless steel fragments to enter the patient.

    Product
    da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2052-2023·2023-07-12

    Treadmill Recalled for Drive PCB Malfunction Causing Unexpected Belt Movement

    Full Vision Inc is recalling approximately 565 TrackMaster TMX428 treadmills due to a drive circuit board malfunction that can cause the belt to unexpectedly stop, reverse, or accelerate, posing a risk of falls or injury.

    Product
    TRACKMASTER, TREADMILL TMX428 110V, MODEL NUMBER 317-07926
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2100-2023·2023-07-12

    Giraffe OmniBed neonatal devices recalled due to incorrect secondary latch

    GE HealthCare is recalling approximately 4,540 Giraffe OmniBed and Giraffe OmniBed Carestation neonatal warming devices worldwide due to potentially incorrect secondary latches on bedside panels.

    Product
    Giraffe OmniBed Carestation CS1, Model Numbers: a. 2082844-001-XXX, b. 2074920-001-XXXXXX, c. M1050205, d. M1135822, e. M1145475, f. M1145476, g. M1235957, h. M1149051, i. M1146098; Labeled as the following: GIRAFFE OMNIBED CARESTATION CS1, GIRAFFE OMNIBED CARESTATI
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2069-2023·2023-07-12

    SurgiMend soft tissue collagen matrix recalled for endotoxin testing verification issues

    TEI Biosciences recalls 14,535 units of SurgiMend collagen matrices distributed nationwide due to potential endotoxin testing verification problems. Affected devices cannot be confirmed to meet endotoxin specifications.

    Product
    SurgiMend; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 1.0 5x6 cm, 1.0 6x12 cm, 1.0 10x10 cm, 1.0 10x15 cm, 1.0 10x20 cm, 1.0 16x20 cm, 1.0 13x25 cm, 1.0 4x16 cm, 1.0 3x3 cm, 1.0 4x7 cm, 1.0 4x12 cm, 1.0 6x16 cm, 1.0 25x40 cm, 1.0 20 x 30 cm, 1.0 8x16 cm, 1.0 4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2080-2023·2023-07-12

    PriMatrix Ag Dermal Repair Scaffold Recalled for Endotoxin Testing Issues

    TEI Biosciences is recalling 1,689 units of PriMatrix Ag dermal repair scaffolds distributed nationwide due to potential endotoxin testing deficiencies. Testing procedures may not have been conducted reliably.

    Product
    PriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2079-2023·2023-07-12

    Dermal Repair Scaffold Recalled Due to Endotoxin Testing Issues

    TEI Biosciences is recalling PriMatrix Meshed dermal repair scaffolds due to endotoxin testing failures. The recall affects 33,277 units distributed nationwide.

    Product
    PriMatrix Meshed; Dermal Repair Scaffold; Rx Only; Sizes 20x25 cm (1:1), 3x3 cm (2:1), 4x4 cm (2:1), 5x5 cm (2:1), 6x6 cm (2:1), 8x12 cm (2:1), and 8x8 cm (2:1).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2073-2023·2023-07-12

    SurgiMend MP Collagen Matrix Recalled for Endotoxin Testing Issues

    TEI Biosciences recalled approximately 3,992 units of SurgiMend MP surgical implants nationwide due to issues with endotoxin testing procedures that may have resulted in unreliable test results.

    Product
    SurgiMend MP; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm, 20x20 cm, 13x25 cm, 16x20 cm, 20x25 cm, 20x30 cm, and 25x40 cm.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2058-2023·2023-07-12

    Treadmill recalled for drive PCB malfunction causing unexpected acceleration

    Full Vision Inc recalls 95 TRACKMASTER GE T2100-ST2 treadmills with a defective drive PCB that may misread signals, causing the equipment to unexpectedly stop, reverse, or accelerate forward.

    Product
    TRACKMASTER, TREADMILL GE T2100-ST2 220V CHINA, MODEL NUMBER 317-07927GE CHINA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1023-2023·2023-07-12

    Cricket Creek Farm Tobasi Cheese Recalled Due to Listeria

    Cricket Creek Farm brand Tobasi cheese may contain Listeria monocytogenes. The recall affects 250.81 lbs distributed in New York, Massachusetts, and Connecticut between March and May 2023.

    Product
    Cricket Creek Farm brand Tobasi cheese
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2082-2023·2023-07-12

    Dermal repair scaffold recalled due to endotoxin testing failures

    TEI Biosciences is recalling 10,159 units of PriMatrix Ag Meshed dermal repair scaffolds due to testing failures that cannot verify endotoxin levels. Procedures for testing bacterial toxin levels during manufacturing quality control were found to be flawed.

    Product
    PriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm (2:1), 10x25 cm (2:1), 20x25 cm (1:1), 4x4 cm (2:1), 6x6 cm (2:1), 8x12 cm (2:1), 8x8 cm (2:1).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2070-2023·2023-07-12

    Surgical collagen matrix recall due to endotoxin testing failures

    TEI Biosciences is recalling 22,163 units of SurgiMend PRS collagen matrices due to endotoxin testing deficiencies that may have resulted in contaminated products being distributed. No injuries have been reported.

    Product
    SurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm Semi-Oval, 7x17 cm Fenestrated, 10x20 cm Fenestrated, 8x16 cm Semi-Oval, 15x15 cm Semi-Oval, 8x20 cm Fenestrated, 10x15 cm Slant Fenestrated, 7x17 cm Semi-Oval, 8x16 cm Thin Semi-Oval, 10x20 cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2090-2023·2023-07-12

    Custom Medical Procedure Packs Recalled for Compromised Package Seals

    DeRoyal Industries is recalling 306 custom medical procedure packs because the outer package seals could be open or compromised, affecting the sterility of the contents. Affected packs were distributed nationwide.

    Product
    Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102; b) CHOLANGIOGRAPHY KIT, REF 89-7322; c) CATH LAB PACK, REF 89-9183
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2083-2023·2023-07-12

    Revize Collagen Matrix Recalled for Potential Endotoxin Testing Issues

    TEI Biosciences recalls 199 units of Revize Collagen Matrix due to possible out-of-specification endotoxin test results from faulty testing procedures. The product is distributed nationwide.

    Product
    Revize; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x10 cm, 4x12 cm, 4x16 cm.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2097-2023·2023-07-12

    Teleflex Pilling Surgical Retractor Recalled for Incomplete Cleaning Instructions

    Teleflex recalls the Pilling LOWSLEY PROSTATIC TRACTOR STR due to incomplete pre-cleaning instructions in the product manual. The issue affects 32 units distributed nationwide and internationally.

    Product
    Pilling LOWSLEY PROSTATIC TRACTOR STR, REF 243201; retractor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2067-2023·2023-07-12

    LinkSymphoKnee Knee Augment Recalled for Incorrect Screw Orientation

    Waldemar Link GmbH & Co. KG recalled LinkSymphoKnee Distal Femoral Augments due to incorrect screw orientation during manufacturing. The fixation screw may be inserted through the wrong side of the augment, affecting 20 units distributed across seven US states.

    Product
    LinkSymphoKnee Distal Femoral Augment - Tilastan - Size. 7-8, Lateral-Right/Medial-Left, 5mm-Intended for primary and revision total knee replacement in skeletally mature patients. Product Code: 880-307/21
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1019-2023·2023-07-12

    Everest Sambhar Masala Spice Recalled Due to Salmonella Contamination Risk

    Amin Trading Agency LLC is recalling Everest Sambhar Masala spice packets due to potential Salmonella contamination. The affected product was distributed to retail stores across multiple states.

    Product
    Everest Sambhar Masala, 100 grams, Packaged in paper cartons. 120 cartons per case
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-2091-2023·2023-07-12

    Aptio Storage and Retrieval Module firmware error may cause incorrect test results

    Siemens Aptio Automation Storage and Retrieval Module has a firmware error that may incorrectly associate test results to patient samples, potentially leading to incorrect patient results. Eighty-three units are affected worldwide.

    Product
    Aptio Automation Storage and Retrieval Module (SRM)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V477000·2023-07-12

    Jayco Seneca recreational vehicles recalled for windshield wiper linkage failure

    Jayco is recalling certain 2021-2022 Seneca recreational vehicles because the windshield wiper arms may fail, reducing driver visibility and increasing crash risk. Owners should contact Jayco customer service at 1-800-283-8267 for a free inspection and replacement.

    Product
    JAYCO — JAYCO, ENTEGRA SENECA PRESTIGE, SENECA, ACCOLADE XL, ACCOLADE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1020-2023·2023-07-12

    Everest Garam Masala recalled for potential Salmonella contamination

    Amin Trading Agency LLC is recalling Everest Garam Masala due to potential Salmonella contamination. The affected product was distributed to retail stores across 11 states.

    Product
    Everest Garam Masala, 100 grams, Packaged in paper cartons. 120 cartons per case
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-2088-2023·2023-07-12

    Medical Procedure Packs with Compromised Package Seals Recalled

    DeRoyal Industries is recalling 328 surgical procedure packs because outer package seals could be open or compromised, affecting product sterility. The affected packs are used in operating rooms nationwide.

    Product
    Custom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION WI, REF 89-10640 b) ANGIO PACK, REF 89-10901 c) BASIN, REF 89-1924 d) CYSTO PACK, REF 89-7133 e) TOTAL HIP PACK, REF 89-9134 f) EMERGENCY C-SECTION PACK, REF 89-9478
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2094-2023·2023-07-12

    BD Pyxis CII Safe Dispensing Cabinets Recalled for Electrical Current Leakage

    BD Pyxis CII Safe automated dispensing cabinets may leak excessive electrical current when connected to multi-socket power strips, risking electric shock and system downtime.

    Product
    BD Pyxis CII Safe, Software: V7, REF: 107-96, 107-97, 107-97-201; BD Pyxis CII Safe, Software: V7, REF: 107-223, 107-224, 111-191, 111-192, 111-193, 111-194, 111-195, 111-196, 111-197, 111-198; BD Pyxis CII Safe, Software: V8, 111-199-01, 111-200-01, 111-201-01, 111-202-01, 111-2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2105-2023·2023-07-12

    Stryker Infinity Alignment Frame Distal Sub-Assembly Recalled for Manufacturing Defect

    Wright Medical Technology is recalling the Stryker Infinity Alignment Frame Distal Sub-Assembly due to manufacturing defects that prevent proper assembly. The pin sleeve holes were manufactured too narrow, preventing insertion of pin sleeves and proper device configuration.

    Product
    Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2054-2023·2023-07-12

    TrackMaster Treadmill Recalled for Drive PCB Malfunction Risk

    Full Vision Inc. is recalling 39 TrackMaster treadmills with a drive PCB malfunction that can cause unexpected stopping, reversal, or acceleration.

    Product
    TRACKMASTER, TREADMILL TMX428CP 110V, MODEL NUMBER 317-07928
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2101-2023·2023-07-12

    Giraffe OmniBed neonatal incubator recall due to incorrect secondary latch installation

    GE HealthCare is recalling Giraffe OmniBed neonatal incubators with potentially incorrect secondary latches on bedside panels. An incorrect latch type may have been installed on northeast and/or northwest panels of affected units.

    Product
    Giraffe OmniBed, with the following Model Numbers: 6650-0004-901, 6650-0001-901, 6650-0003-901, 6650-0002-901, 6650-0094-901, 6650-0001-9901, 6650-0029-901, 6650-0080-901, 6650-0032-901, 6650-0077-901, 6650-001-901, 6650-0006-901, 6650-0129-901, 6650-0063-902, 6650-0130-901, 6650
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1224-2023·2023-07-12

    Havasu Beetroot Powder Recalled for Undeclared Milk Allergen

    Havasu Beetroot Powder (11.5 oz.) is being recalled because it contains undeclared milk. Consumers with milk allergies who consume this product may experience allergic reactions.

    Product
    Havasu Beetroot Powder, 11.5 oz.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1222-2023·2023-07-12

    Cargill Recalls Trisodium Citrate Dihydrate Due to Potential Metal Contamination

    Cargill is recalling Trisodium Citrate Dihydrate due to potential metal contamination. The food additive ingredient was distributed to manufacturers and operations in multiple states and Canada.

    Product
    Cargill Trisodium Citrate Dihydrate packaged in 50 lb. paper bags and 2,000 lb. supersacks. Product item ids: 1. SKU 100002299, TSC DIHYD FN 50LB BG 6132-04-3 KH FC 2. SKU 100105400, TSC DIHYD FN 2000LB RED HNDL SS KH 3. SKU 100106066, TSC DIHYD FN 2000LB RED HNDL SS KH FCC 4.
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-1017-2023·2023-07-12

    Martinelli's Apple Juice Recalled for Potential Glass Chips

    S. Martinelli is recalling Martinelli's Gold Medal Apple Juice (10 oz bottles) due to potential glass chips in the product. Affected product was distributed to customers in Rhode Island, New York, and California.

    Product
    Martinelli's Gold Medal 100% Apple Juice 10 oz. glass bottles, 24 units per case Apple shaped glass bottles Shelf stable UPC: 041244000098
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2064-2023·2023-07-12

    Surgical drill guides may bend and produce metal shavings during use

    T.A.G. MEDICAL PRODUCTS CORPORATION is recalling Betta Link LG Reusable ProngED Guides used in orthopedic surgery because the guides may bend when force is applied, creating metal shavings that could injure patients.

    Product
    Betta Link LG Reusable ProngED Guide - Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Part Number: 110045156
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1229-2023·2023-07-12

    Pearl Milling Company Corn Meal Mix Recalled for Undeclared Milk

    Pearl Milling Company Self-Rising Yellow Corn Meal Mix bags may contain undeclared milk, posing a risk to people with milk allergies. Approximately 91,760 bags were distributed across multiple US states.

    Product
    Pearl Milling Company Self-Rising Yellow Corn Meal Mix Net Wt 80 oz (5 lb) UPC 3000057380 packaged in paper bag with printed label
    Category
    Food
    Distribution
    27 states
  • HighFDA (Food)·F-1013-2023·2023-07-12

    Romaine Lettuce Recalled for Potential Contamination from Deer Feces

    G.O. Corporation is recalling romaine lettuce due to potential contamination with deer feces. The recall affects lettuce distributed in Iowa, Minnesota, North Dakota, and Wisconsin with lot number 130166.

    Product
    Romaine lettuce, packaged into the following configurations and sizes: 1. Medium, Produce Code 720832, 6-2lb per shipping case. 2. Medium, Produce Code 720840, 10-2lb per shipping case. 3. 1.5XRandom, Produce Code 720625, 4-2.5lb bags per shipping case. 4. 1.5XRandom,
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-1230-2023·2023-07-12

    Pearl Milling Company Corn Meal Mix Recalled for Undeclared Milk

    Pearl Milling Company Self-Rising White Corn Meal Mix may contain undeclared milk. The FDA is recalling approximately 412,760 bags distributed to multiple states.

    Product
    Pearl Milling Company Self-Rising White Corn Meal Mix Net Wt 80 oz (5 lb) UPC 3000057381 packaged in paper bag with printed label and Pearl Milling Company Self-Rising White Corn Meal Mix Net Wt 30 oz (2 lb) UPC 3000057387 packaged in paper bag with printed label
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-2076-2023·2023-07-12

    Collagen surgical matrix recalled for potential endotoxin testing issues

    TEI Biosciences is recalling 9,215 units of SurgiMend PRS Meshed, a surgical collagen matrix, due to possible out-of-specification endotoxin test results.

    Product
    SurgiMend PRS Meshed; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Size 10cm x 20cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2062-2023·2023-07-12

    Surgical drill guide may bend and produce metal shavings during use

    T.A.G. Medical is recalling BETTA LINK SR surgical drill guides due to risk of bending and metal shavings during surgery.

    Product
    BETTA LINK SR REUSABLE PRONGED GUIDE- Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Part Number: 110045150
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1024-2023·2023-07-12

    Cricket Creek Farm Berkshire Bloom Cheese Recalled for Improper Pasteurization

    Cricket Creek Farm Berkshire Bloom Cheese has been recalled because it was not properly pasteurized. Batch #076 (140 units) was distributed in New York, Massachusetts, and Connecticut.

    Product
    Cricket Creek Farm brand Berkshire Bloom Cheese
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1115-2023·2023-07-12

    Barbecue Hickory Seasoning Recalled Due to Salmonella Risk

    Newly Weds Foods, Inc. is recalling barbecue hickory seasoning (product code YE675419) due to potential Salmonella contamination. Approximately 6.4 million pounds were distributed across multiple U.S. states and Canada.

    Product
    G06779 BARBEQUE HICKORY SEASONING X1 50.00 BOX
    Category
    Food
    Distribution
    28 states
  • HighFDA (Food)·F-1018-2023·2023-07-12

    Maggi Masala ae Magic Spice Sachets Recalled for Potential Salmonella Contamination

    Amin Trading Agency LLC is recalling Maggi Masala ae Magic sachets distributed across multiple U.S. states due to potential Salmonella contamination. Consumers should not use the product.

    Product
    Maggi Masala ae Magic, 6 grams, Packaged in plastic sachets. 1920 sachets per case.
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-2066-2023·2023-07-12

    LinkSymphoKnee Distal Femoral Augment Recalled for Improper Screw Placement

    The LinkSymphoKnee Distal Femoral Augment is being recalled because fixation screws were inserted in the wrong direction during manufacturing. The improper placement could affect the implant's structural stability.

    Product
    LinkSymphoKnee Distal Femoral Augment - Tilastan - Size 7-8, Medial-Right/Lateral Left, 5mm- Intended for primary and revision total knee replacement in skeletally mature patients. Product Code: 880-307/11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2072-2023·2023-07-12

    SurgiMend 2.0 Collagen Matrix Recalled for Endotoxin Testing Issues

    TEI Biosciences is recalling SurgiMend 2.0 collagen matrices nationwide due to possible out-of-specification endotoxin test results from issues with in-process and finished goods testing procedures.

    Product
    SurgiMend 2.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25 cm, 25x40 cm, 20x30 cm, 20x20 cm, 20x25cm, 10x15cm Semi-Oval,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1021-2023·2023-07-12

    Beer Recall: Avery Gose con Sandia Cans May Explode

    Avery Brewing Company is recalling Gose con Sandia beer due to over pressurization of cans, which may fail or explode. Affected consumers in 13 states should check their purchases and contact the manufacturer for return instructions.

    Product
    Gose con Sandia, Sour Ale with watermelon, limes and sea salt, 12 oz. Can 6 pk. (72 oz. total) Can UPC 7 96363 00495 2, Carton UPC 7 96363 00495 2 (6 cans per carton, 4 cartons per case)
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-1014-2023·2023-07-12

    Lettuce Salad Blend Monterey Recalled Due to Potential Deer Feces Contamination

    G.O. Corporation is recalling Lettuce Salad Blend Monterey (Produce Code 404709) distributed in IA, MN, ND, and WI due to potential contamination with deer feces. Consumers should not consume this product.

    Product
    Lettuce Salad Blend Monterey, Produce Code 404709, 4-5lb bags per shipping case.
    Category
    Food
    Distribution
    4 states
  • HighNHTSA·23V478000·2023-07-12

    2021-2022 Toyota RAV4 Prime recalled for electrical fire risk

    Toyota is recalling 43,442 2021-2022 RAV4 Prime and 2022 Lexus NX450H+ plug-in hybrid vehicles. A defective DC-DC converter electrical module can overheat and cause vehicle fire. Dealers will replace the component free of charge.

    Product
    LEXUS — LEXUS, TOYOTA NX450H+, RAV4 PRIME
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2075-2023·2023-07-12

    SurgiMend 4.0 Collagen Implants Recalled for Endotoxin Testing Failures

    TEI Biosciences is recalling 5,664 units of SurgiMend 4.0 soft tissue reconstruction implants nationwide due to issues with endotoxin testing that may have resulted in out-of-specification test results.

    Product
    SurgiMend 4.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 13x25 cm, 25x40 cm, 20x30 cm, 10x25 cm, 20x0.5 cm, and 10x25 cm Fenestrated.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2078-2023·2023-07-12

    PriMatrix Dermal Scaffold Recalled Due to Endotoxin Testing Issues

    TEI Biosciences is recalling 30,528 units of PriMatrix Fenestrated dermal repair scaffolds due to possible out-of-specification endotoxin test results. The FDA Class II recall affects wound healing products distributed nationwide.

    Product
    PriMatrix Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm, 8x8 cm, 14mm Disc, 18mm Disc, 2x2 cm, and 10x25 cm (Meshed 2:1).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2061-2023·2023-07-12

    BETTA LINK LG Implant Drill Guide Bending Risk

    T.A.G. MEDICAL PRODUCTS is recalling BETTA LINK LG KNOTLESS IMPLANT KIT because drill guides may bend during surgical use, potentially creating metal shavings that could injure patients.

    Product
    BETTA LINK LG KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Part Number: 110045160
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2068-2023·2023-07-12

    OmniTom CT imaging device recalled for wheel loosening and battery contamination

    NeuroLogica is recalling OmniTom CT imaging devices due to wheels that may loosen and battery boards that may be contaminated, both of which could prevent the device from operating properly and delay patient imaging.

    Product
    OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck Model Number: NL5000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2106-2023·2023-07-12

    Ventilator Instructions for Use Contain Translation Error in Korean Materials

    Korean-language instructions for Trilogy Evo ventilators contain a mistranslation where 'invasive' was incorrectly rendered as 'noninvasive.' This error could lead to improper device configuration by Korean-speaking users.

    Product
    Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853) Instructions for Use
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2087-2023·2023-07-12

    Custom Medical Procedure Packs Recalled for Compromised Package Seals

    DeRoyal Industries is recalling 40 units of STURDI STRAINER TRAY STANDARD procedure packs nationwide due to potentially compromised outer package seals that could affect sterility.

    Product
    Custom medical procedure packs labeled as: a) STURDI STRAINER TRAY STANDARD, REF '89-5014
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2053-2023·2023-07-12

    TrackMaster TMX428 Treadmill drive circuit board malfunction recall

    Drive board malfunction in TrackMaster TMX428 treadmills can cause unexpected belt reversal or acceleration, creating fall and impact injury risks. 376 units affected.

    Product
    TRACKMASTER, TREADMILL TMX428 220V, MODEL NUMBER 317-07927
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2099-2023·2023-07-12

    BD Synapsys Informatics Solution risks patient data mis-association

    The BD Synapsys Informatics Solution may incorrectly associate patient demographic data under specific conditions when the system operates near capacity during rapid manual result processing.

    Product
    BD Synapsys Informatics Solution, Catalog Number 444150
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-2057-2023·2023-07-12

    TrackMaster GE Treadmill Recall Due to Drive Circuit Board Malfunction

    Full Vision Inc is recalling 1,416 TrackMaster GE T2100-ST2 220V treadmills worldwide due to a drive circuit board defect that can cause the treadmill to stop suddenly, reverse unexpectedly, or accelerate forward, posing a risk of falls or injury.

    Product
    TRACKMASTER, TREADMILL GE T2100-ST2 220V, MODEL NUMBER 317-07927GE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2086-2023·2023-07-12

    Medical procedure packs recalled for compromised package seals

    DeRoyal Industries is recalling 4,225 custom medical procedure packs nationwide because outer package seals may be open or compromised, potentially affecting sterility of the surgical materials inside.

    Product
    Custom medical procedure packs labeled as: a) OPEN HEART TRACECART, REF '53-1941; b) CARDIAC CATH PACK, REF '89-10045; c) SHOULDER PACK, REF '89-10115; d) MINOR ORTHO PACK, REF '89-10213; e) TOTAL KNEE PACK PGYBK, REF '89-10505; f) ANTERIOR HIP PACK PGYBK, REF '89
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2074-2023·2023-07-12

    SurgiMend 3.0 Soft Tissue Graft Recalled for Endotoxin Testing Defect

    SurgiMend 3.0 collagen matrix is being recalled nationwide (13,390 units) due to possible endotoxin contamination from deficiencies in endotoxin testing procedures.

    Product
    SurgiMend 3.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25 cm, 25x40 cm, 20x30 cm, 20x20 cm, 20x25 cm, 1x5 cm, 10x25 cm 4x7cm Fenestrated, and 10x25 cm Fenestrated.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1223-2023·2023-07-12

    Cargill Tripotassium Citrate Monohydrate Recalled for Potential Metal Contamination

    Cargill is recalling Tripotassium Citrate Monohydrate in 50 lb. bags due to potential metal contamination. The product was distributed to manufacturers and distributors across multiple states and Canada.

    Product
    Cargill Tripotassium Citrate Monohydrate packaged in 50 lb. paper bag. Product item: SKU 100105392, TPC GNLR 50LB BG KH FCC
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-2085-2023·2023-07-12

    Soft tissue repair matrix recalled due to possible endotoxin contamination

    TEI Biosciences is recalling 4,832 units of TissueMend Advanced Soft Tissue Repair Matrix due to possible out-of-specification endotoxin test results. No illnesses or injuries have been reported.

    Product
    TissueMend; Advanced Soft Tissue Repair Matrix; Rx Only; Sizes 5x6 cm, 6x10 cm, and 3x3 cm.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V481000·2023-07-12

    2023 Nova Bus LFS Transit Buses Power Steering Hose Defect Recall

    Nova Bus is recalling 2023 and 2022 LFS transit buses due to power steering hose assembly defects that could result in loss of steering assist and increased crash risk.

    Product
    NOVA BUS — NOVA BUS LFS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2065-2023·2023-07-12

    Betta Link LG Surgical Guide May Deform and Produce Metal Shavings

    Betta Link LG surgical guides used in soft tissue and bone repair may bend under pressure during surgery, potentially releasing metal shavings that could injure patients. The manufacturer is recalling affected units in the U.S. and internationally.

    Product
    Betta Link LG Reusable Fishmouth Guide-Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Part Number: 110045157
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2056-2023·2023-07-12

    TrackMaster Treadmill Control Malfunction Can Cause Unexpected Acceleration

    Full Vision's TrackMaster treadmill can experience drive PCB malfunctions causing unexpected stopping, reversal, and acceleration. The malfunction affects 264 units distributed worldwide.

    Product
    TRACKMASTER, TREADMILL GE T2100-ST1 110VV, MODEL NUMBER 317-07926GE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1226-2023·2023-07-12

    Wegmans snack trays recalled for undeclared almonds and wheat

    Wegmans single serve snack trays are being recalled due to undeclared almonds and/or wheat. Consumers with allergies to these ingredients should not consume the product.

    Product
    Wegmans single serve snack tray (4.1oz) packaged in a clear square plastic packaging with apples, cheese, pretzels, and peanut butter 6 trays per case
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2077-2023·2023-07-12

    PriMatrix Dermal Repair Scaffold recalled due to endotoxin testing issues

    TEI Biosciences is recalling 4,159 units of PriMatrix Dermal Repair Scaffold nationwide due to possible out-of-specification endotoxin test results. Quality control issues during testing led to this recall.

    Product
    PriMatrix; Dermal Repair Scaffold; Rx Only; Sizes 0.2x26.5 cm (3 pack), 10x12cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, and 8x8 cm.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V482000·2023-07-12

    Nova Bus LFS Transit Buses Recalled for Driveshaft Separation

    Nova Bus is recalling certain 2019-2023 LFS and LFS Artic transit buses. The transmission yoke may separate, causing driveshaft separation and sudden loss of drive power, increasing the risk of crashes and passenger injury.

    Product
    NOVA BUS — NOVA BUS LFS, LFS ARTIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1228-2023·2023-07-12

    Gelato Boy Chocolate Chunk Gelato Recalled for Undeclared Milk

    Gelato Boy is recalling Chocolate Chunk Gelato frozen dessert because it contains undeclared milk, which poses a risk to consumers with milk allergies.

    Product
    Gelato Boy Chocolate Chunk Gelato, frozen dessert, 24 month shelf life, paper cup and lid. 14 FL OZ, UPC: 853457008002, distributed by Gelato Boy, 5401 Western Ave., Boulder, CO 80301
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-2102-2023·2023-07-12

    Giraffe OmniBed bedside panel kits recalled for incorrect secondary latch

    GE HealthCare is recalling Beside panel field replacement unit kits for Giraffe OmniBed devices due to potential incorrect secondary latch installation on northeast and northwest panels.

    Product
    Beside panel FRU (Field Replacement Units) Kits
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·23V476000·2023-07-12

    Polestar 2 Recalled for Potential Steering Loss Due to Defective Ball Joint

    Polestar is recalling certain 2023 Polestar 2 vehicles due to a defect in the front left lower ball joint that could cause loss of steering control. Owners should contact their dealer for a free inspection and replacement.

    Product
    POLESTAR — POLESTAR POLESTAR 2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1225-2023·2023-07-12

    Wegmans Single Serve Snack Tray Recalled Due to Undeclared Allergens

    Wegmans single serve snack trays (5.7oz) are being recalled due to undeclared almonds and/or wheat allergens. Consumers with allergies to these ingredients should not consume them and should return them to the retailer.

    Product
    Wegmans single serve snack tray (5.7oz) packaged in a clear square plastic packaging with fruit, almonds and cheese 6 trays per case
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1025-2023·2023-07-12

    Cricket Creek Farm Feta Cheese Recalled for Improper Pasteurization

    Cricket Creek Farm Feta Cheese (Batch #101097) is recalled for improper pasteurization, posing a Listeria contamination risk. Affected cheese was distributed in NY, MA, and CT.

    Product
    Cricket Creek Farm brand Feta Cheese
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0892-2023·2023-07-12

    Prescription Drug Tizanidine Tablets Recalled for Failed Dissolution Specifications

    Amerisource Health Services LLC recalls approximately 4,971 cartons of Tizanidine Tablets due to failed dissolution specifications. Tablets that do not dissolve properly may not provide intended therapeutic benefit.

    Product
    TIZANIDINE — TIZANIDINE (TIZANIDINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2096-2023·2023-07-12

    Teleflex Surgical Retractor Recalled for Incomplete Pre-Cleaning Instructions

    Teleflex LLC is recalling 170 units of the Pilling Lowsley Prostatic Retractor due to incomplete pre-cleaning instructions in the user manual. Incomplete instructions may prevent proper sterilization of the surgical instrument.

    Product
    Pilling LOWSLEY PROSTATIC TRACTOR CVD, REF 243200; retractor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0894-2023·2023-07-12

    Tizanidine tablets recalled nationwide for failed stability specifications

    Preferred Pharmaceuticals is recalling 541 bottles of Tizanidine 4mg tablets nationwide due to failed stability specifications. Consumers with affected lot numbers should contact their pharmacist or healthcare provider.

    Product
    TIZANIDINE — TIZANIDINE (TIZANIDINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2084-2023·2023-07-12

    Collagen matrix recalled for endotoxin testing methodology issues

    TEI Biosciences recalled 665 units of Revize-X collagen matrix nationwide due to possible out-of-specification endotoxin test results caused by issues with the company's testing procedures. No illnesses have been reported.

    Product
    Revize-X; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 12x6 cm and 10x9 cm.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2095-2023·2023-07-12

    Teleflex Pilling O'Reilly Esophageal Retractor Recalled for Incomplete Cleaning Instructions

    TELEFLEX LLC recalled the Pilling O'REILLY ESOPHAGEAL RETRACTOR (REF 381801A) due to incomplete pre-cleaning instructions in the product's Instructions for Use. The recall affects 365 units distributed nationwide and internationally.

    Product
    Pilling O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A; ENT retractor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2093-2023·2023-07-12

    COVID-19 Test Strips Recalled for Lot Number Label Discrepancy

    NeuMoDx SARS-CoV-2 test strips from lot 123909 have conflicting lot numbers between the package label and barcode label that the instrument reads.

    Product
    NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-CoV-2 RNA from nasal, nasopharyngeal and oropharyngeal swabs in transport medium and bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider (HCP). RE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2071-2023·2023-07-12

    SurgiMend collagen matrices recalled for endotoxin test result quality issues

    TEI Biosciences recalls SurgiMend 1.0 collagen matrices due to problems with endotoxin testing procedures that may have produced inaccurate test results. 52 units were distributed nationwide.

    Product
    SurgiMend 1.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 18x12 cm Thin and 10x15 cm Thin.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2098-2023·2023-07-12

    KLS Martin Battery Packs Recalled for Switched Expiration Date Labels

    Pro-Dex Inc recalls KLS Martin Battery Packs used in surgical screwdrivers due to manufacturing and expiration dates being reversed on sterile pouch labels, causing batteries to appear prematurely expired.

    Product
    KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2092-2023·2023-07-12

    NexGen Tibial Plate Recalled for Incorrect Outer Packaging Label

    Zimmer, Inc. is recalling NexGen Precoat Stemmed Tibial Plate Size 5 devices due to incorrect outer packaging labeling. Affected units were distributed internationally in India.

    Product
    NexGen Precoat Stemmed Tibial Plate Size 5
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·23V474000·2023-07-11

    Prevost H3-45 Turn Signal Light Failure Increases Crash Risk

    Prevost is recalling 2022-2024 H3-45 and H3-45 VIP vehicles because the right front turn signal light may fail when activated. Inoperative turn signals and hazard lights reduce visibility to other drivers and increase crash risk.

    Product
    PREVOST — PREVOST H3-45 VIP, H3-45
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V485000·2023-07-11

    2023 Toyota RAV4 Recalled for Improperly Installed Tire Valve Stems

    Gulf States Toyota is recalling 195 2023 Toyota RAV4 vehicles equipped with 17" black alloy wheels. The tire valve stems may be improperly installed or damaged, potentially causing air leakage, underinflation, and crash risk.

    Product
    TOYOTA — TOYOTA RAV4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V475000·2023-07-11

    Prevost Recalls X3-45 Commuter Buses Due to Seat Bolt Loosening

    Prevost is recalling 2021 and 2023 X3-45 Commuter buses because a seat bolt may loosen, leaving the seat back unsecured and increasing crash injury risk.

    Product
    PREVOST — PREVOST X3-45 COMMUTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V473000·2023-07-10

    Boreas Camper XT Travel Trailers Recalled for Gas Leak Risk

    Boreas Campers is recalling 2021-2022 XT travel trailers because a cooktop component may fracture and cause a gas leak, increasing fire risk.

    Product
    BOREAS CAMPER — BOREAS CAMPER XT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V471000·2023-07-10

    2023 BMW XM and 2024 X5-X7 vehicles recalled for knee air bag defect

    BMW of North America is recalling 2023 XM and certain 2024 X5, X6, and X7 vehicles because the knee air bag may not have been manufactured correctly and could fail to deploy during a crash. Dealers will replace the air bag free of charge.

    Product
    BMW — BMW X5, X6, XM, X7
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23E052000·2023-07-10

    Dana Spicer Driveshafts Recalled for Risk of Breaking Under Load

    Dana Incorporated is recalling specific Dana-Spicer driveshafts that can break under certain loading conditions, potentially causing a loss of drive power and increasing crash risk.

    Product
    POWER TRAIN:DRIVELINE:DRIVESHAFT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V468000·2023-07-07

    2023 Toyota Tundra Spare Tire Carrier May Detach Due to Insufficient Welds

    Toyota is recalling certain 2023 Tundra, Tundra Hybrid, and Sequoia Hybrid vehicles due to insufficiently welded spare tire carrier assemblies that may break and allow the spare tire to detach, increasing crash risk.

    Product
    TOYOTA — TOYOTA TUNDRA HYBRID, TUNDRA, SEQUOIA HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V469000·2023-07-07

    Newmar motorhomes recalled for defective seat belt mounting brackets

    Newmar is recalling certain 2019–2023 motorhomes because modified seat belt mounting brackets can fail to properly restrain occupants in a crash, violating federal safety standards.

    Product
    NEWMAR — NEWMAR BAY STAR, BAY STAR SPORT, SUPER STAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V467000·2023-07-06

    Freightliner Recalls eCascadia Trucks for E-Axle Welding Defect

    Daimler Trucks is recalling 2023-2024 Freightliner eCascadia vehicles because a defective e-axle weld may cause sudden loss of drive power, increasing crash risk.

    Product
    FREIGHTLINER — FREIGHTLINER E-CASCADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·23238·2023-07-06

    VRURC Portable Chargers Recalled Due to Fire Hazard

    VRURC portable chargers (model OD-B7) sold on Amazon.com from July 2021 through May 2023 can ignite and pose a fire hazard. One charger caught fire on a commercial flight, injuring four flight attendants.

    Product
    VRURC portable chargers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23772·2023-07-06

    Yamaha Model Year 2023 Golf Cars and PTVs Recalled for Crash and Death Hazards

    Yamaha is recalling about 11,000 Model Year 2023 Golf Cars, Personal Transportation Vehicles, and Umax models because the accelerator spring can become dislodged, preventing the accelerator pedal from returning to rest and posing crash, injury, and death hazards.

    Product
    Model Year 2023 Yamaha Golf Car, Personal Transportation Vehicles (PTV) and Umax
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23239·2023-07-06

    woom ORIGINAL Kids' Bicycles Recalled Due to Fall Hazard

    woom Bikes USA recalls about 84,000 woom ORIGINAL children's bicycles from model years 2018–2021. The stem and handlebar can detach, causing riders to lose control and fall.

    Product
    woom ORIGINAL Bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·23240·2023-07-06

    Husqvarna 300 Series Snow Blowers Recalled for Unexpected Drive Engagement

    Husqvarna is recalling about 2,700 Residential 300 Series Snow Blowers because the auger pulley bolt can loosen, causing the drive to unexpectedly engage and potentially collide with users. No injuries have been reported.

    Product
    Residential 300 Series Snow Blowers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1890-2023·2023-07-05

    Teleflex endotracheal tubes recalled for connector disconnection defect

    Teleflex LLC is recalling 170,179 endotracheal tubes nationwide due to reports of 15mm connector disconnection. The tubes are used for airway management in medical facilities.

    Product
    Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082080
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1828-2023·2023-07-05

    Teleflex Slick Set endotracheal tubes recalled for connector disconnection

    Teleflex Slick Set endotracheal tubes (REF 170055) are being recalled by the FDA following reports of disconnection of the 15mm connector. This Class I recall affects approximately 3,530 units distributed nationwide.

    Product
    Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170055
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1876-2023·2023-07-05

    Endotracheal Tube Connector Disconnection Recall — FDA Class I

    TELEFLEX endotracheal tubes (Murphy design) may have a disconnected 15mm connector. Approximately 12,382 affected units were distributed nationwide. Healthcare facilities should inspect tubes before use.

    Product
    Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382050
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1927-2023·2023-07-05

    Endotracheal Tubes Recalled for Connector Disconnection Risk

    Teleflex LLC is recalling 2,860 endotracheal tubes due to reports of 15mm connector disconnection. Affected tubes were distributed nationwide including Puerto Rico.

    Product
    Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380035
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1874-2023·2023-07-05

    Endotracheal Tube Recall Due to 15mm Connector Disconnection

    TELEFLEX is recalling endotracheal tubes due to reports of 15mm connector disconnection. Approximately 25,160 units were distributed nationwide.

    Product
    Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382030
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1841-2023·2023-07-05

    Slick Set Uncuffed Endotracheal Tube Connector Disconnection Recall

    Teleflex LLC is recalling approximately 10,650 units of Slick Set Uncuffed Endotracheal Tubes due to reports of 15mm connector disconnection from the tube.

    Product
    Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170140
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1947-2023·2023-07-05

    Preformed AGT Endotracheal Tubes Recalled Due to Connector Disconnection

    Teleflex is recalling 25,520 Preformed AGT endotracheal tubes due to reports of 15mm connector disconnection. This is an FDA Class I recall affecting units distributed nationwide.

    Product
    Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780070
    Category
    Medical Device
    Distribution
    Distributed nationwide

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