August 2021 recalls

482 recalls were announced in August 2021.

What the numbers show

Critical: 11
Severe: 122
High: 293
Moderate: 54
Low: 2

Of the 482 recalls this month scored against our rubric, 2% are Critical, 25% are Severe.

Which agencies issued them

201–300 of 482

HighFDA (Devices)·Z-2214-2021·2021-08-18
S3 MedSurg hospital beds recalled from residential sale due to misuse risk
Stryker's S3 MedSurg hospital beds designed for healthcare facilities were distributed to home customers. The device labeling is correct but home users may not understand professional-use instructions, posing a risk of improper operation.
Product
S3 MedSurg Bed - intended to support and transport patients within the Med/Surg and Critical Care hospital environments, Model Number 3002, Part 3002S3CUSTOM, 3002S3EX, 3002S3PATRIOT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2232-2021·2021-08-18
Medline Knee Arthroscopy Kit Recalled for Expired Irrigation Component
Medline Industries is recalling 286 knee arthroscopy kits containing an expired NaCl irrigation bag. The kits should not be used due to the expired component.
Product
Medline Knee Arthroscopy Kit, convenience kit, REF DYNJ902838C, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2263-2021·2021-08-18
Biomet Hip Implant Cone Bodies Recalled Due to Fretting Corrosion Risk
Biomet is recalling 22 units of Arcos hip implant cone bodies that may develop inner taper fretting corrosion, potentially causing device failure and requiring surgical intervention.
Product
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 60 MM Item Number: 11-301311
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2281-2021·2021-08-18
Edwards PediaSat Oximetry Catheters Recalled for Potential Internal Leaks
Edwards Lifesciences is recalling Edwards PediaSat Oximetry Catheter Sets due to a potential for internal leaks within the catheters. The recall affects 178 units distributed across multiple US states and international locations.
Product
Edwards PediaSat Oximetry Catheter Set, REF: XT358SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 9 cm, Number of Lumens: 3, Recommended Guidewire Size: GW: 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197525 *NOT DISTRIBUTED WITHIN THE US
Category
Medical Device
Distribution
12 states
HighFDA (Devices)·Z-2278-2021·2021-08-18
Edwards PediaSat Oximetry Catheter Kit Recalled for Potential Internal Leaks
Edwards Lifesciences is recalling the Edwards PediaSat Oximetry Catheter Kit (REF: XT3515KTP) due to potential for internal leaks. The recall affects 70 units distributed across the US and internationally.
Product
Edwards PediaSat Oximetry Catheter Kit, REF: XT3515KTP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of Lumens 3, Recommended Guidewire Size 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197563
Category
Medical Device
Distribution
12 states
HighFDA (Devices)·Z-2205-2021·2021-08-18
Transport Stretcher 747 distributed to home users without professional training
Stryker's Transport Stretcher 747, designed for healthcare facilities, was distributed to home users who may not understand its intended-use instructions. The recall addresses risks from improper use by untrained consumers.
Product
Transport Stretcher 747 - a non-powered, wheeled device designed to support patients in a horizontal position, Part Number 0747000000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2248-2021·2021-08-18
Bard Jamshidi Evolve Bone Marrow Needle Recall Due to Open Packaging
Bard recalls Jamshidi Evolve bone marrow needles due to incomplete packaging seals that could compromise sterility. The recall affects 560 devices distributed in the U.S. and internationally.
Product
EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen Cradle. 11G x 10cm
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2221-2021·2021-08-18
Stryker CUB Pediatric Crib distributed to home users instead of healthcare facilities
Stryker's CUB Pediatric Crib, designed for hospital use by healthcare professionals, was distributed to home users who may not understand the complex instructions and safety procedures required to operate pediatric medical equipment safely.
Product
CUB Pediatric Crib- intended to provide a pediatric patient support surface for medical purposes and to provide a method of transporting pediatric patients within a healthcare facility Model Number: FL19 Part #5050000000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2220-2021·2021-08-18
Stretcher Chair Model 5050 Incorrectly Distributed to Residential Customers
Stryker's Model 5050 stretcher chair was distributed to residential customers despite being designed for healthcare professionals. Home users may not understand instructions intended for trained medical staff, creating a risk of misuse.
Product
Stretcher Chair-for use in all acute care hospitals and medical outpatient services Model Number: 5050¿¿¿¿ Part # 5050000000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2262-2021·2021-08-18
Hip Replacement Component Recalled for Potential Device Failure Risk
Biomet is recalling 81 units of a hip replacement component due to potential device failure that could require additional surgery. The affected device is the Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A.
Product
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 50 MM Item Number: 11-301310
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2242-2021·2021-08-18
Smith & Nephew Orthopedic Nail May Detach During Surgery
Smith & Nephew is recalling an orthopedic surgical nail (BHR SQUARE HEADED, catalog #999908) that may detach during surgery. Forty-seven affected units have been distributed worldwide.
Product
smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during orthopedic surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2273-2021·2021-08-18
Biomet Hip Implant System Recalled Due to Potential Fretting Corrosion
Biomet is recalling the Arcos Modular Revision Hip System component due to potential inner taper fretting corrosion that could lead to device failure requiring surgery. No injuries have been reported.
Product
Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 80 MM Item Number: 11-301342
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2271-2021·2021-08-18
Biomet Hip Replacement Component Recalled Over Corrosion and Device Failure Risk
Biomet is recalling Arcos Modular Revision Hip System components that may develop fretting corrosion in the inner taper, risking device failure and the need for revision surgery. Affected patients should contact their healthcare provider.
Product
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size C, 70 MM Item Number: 11-301333
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2266-2021·2021-08-18
Hip Implant Component Failure Risk From Inner Taper Fretting Corrosion
Biomet's Arcos hip implant replacement components may develop inner taper fretting corrosion, leading to device failure requiring surgical intervention. Seven units nationwide are affected.
Product
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 60 MM Item Number: 11-301315
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2246-2021·2021-08-18
Mislabeled Cutting Electrode May Contain Wrong Electrode Type
Richard Wolf's Cutting Electrode Bipo 24.5FR may be mislabeled and contain a BIVAP electrode instead. Affected lot 21002858 was distributed to healthcare facilities in five states.
Product
CUTTING ELECTRODE BIPO 24.5FR, REF 4653.1323
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2228-2021·2021-08-18
Medtronic StimLoc Burr Hole Cover Recalled for Excess Nylon Flash on Clip
Medtronic is recalling StimLoc Burr Hole Cover neurosurgical devices and related components due to excess nylon flash on the clip. The defect could affect device function during implantation or use.
Product
Medtronic StimLoc Burr Hole Cover, Part Numbers: a) 3387S-40 b) 3389S-28 c) 3389S-40 d) 3391S-40 e) 3550S-01 f) 924256 g) DB-5000
Category
Medical Device
Distribution
47 states
HighFDA (Devices)·Z-2239-2021·2021-08-18
Cardiac Sheath Introducer Devices Recalled Due to Size Mislabeling
Merit Medical Systems recalls 760 units of Prelude SNAP Splittable Sheath Introducer (7F) due to packaging errors where devices are labeled as 10F instead of the correct 7F size.
Product
Prelude SNAP Splittable Sheath Introducer, REF: PLS-1007, size 7F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, UDI:(01) 00884450467985. For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.
Category
Medical Device
Distribution
29 states
HighFDA (Devices)·Z-2237-2021·2021-08-18
Advance Dx 100 Blood Collection Cards Recalled for Inaccurate Glucose Results
Advance Dx, Inc. is recalling Advance Dx 100 Blood Collection Cards due to inaccurate blood glucose test results. The recall affects 179,750 cards distributed in Maryland and North Carolina.
Product
Advance Dx 100 Blood Collection Card Quantity 25 REF CMT01 Advance Dx 100 Blood Collection Card and Foil Bags Quantity 500 Cards and Foil Bags REF CMT01/F02 IFU: Advance Dx 100 SSE(Serum Separating Extraction) Technology BLOOD COLLECTION INSTRUCTIONS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2245-2021·2021-08-18
FDA Recalls Blood Culture Identification Panel for False Negative Results
BioFire Diagnostics is recalling 29 FilmArray Blood Culture Identification Panel kits distributed nationwide due to false negative test results caused by a pouch manufacturing error.
Product
FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: FilmArray BCID Panel Part No: RFIT-ASY-0126 Part No: RFIT-ASY-0127
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2249-2021·2021-08-18
Bard Bone Marrow Aspiration Needles Recalled for Incomplete Packaging Seals
Bard Peripheral Vascular is recalling Illinois Bone Marrow Aspiration/Intraosseous Infusion Needles due to incomplete or open packaging seals that could compromise sterility. Approximately 1,200 devices are affected.
Product
TIN3018 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 18G x 79mm TIN3015 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 15G x 79mm
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2280-2021·2021-08-18
Edwards PediaSat Oximetry Catheter Kits Recalled for Potential Internal Leaks
Edwards Lifesciences is recalling PediaSat Oximetry Catheter Kits due to potential internal leaks within the devices. The recall involves 218 units distributed across multiple U.S. states and internationally.
Product
Edwards PediaSat Oximetry Catheter Kit, REF: XT358SJ, Usable Length 8 cm, Number of Lumens 3, Exterior Diameter 5.5F, Rx Only, Sterile EO, UDI: (01)00690103197495 *NOT DISTRIBUTED WITHIN THE US
Category
Medical Device
Distribution
12 states
HighFDA (Devices)·Z-2282-2021·2021-08-18
Edwards PediaSat Oximetry Catheter Set recalled for potential internal leaks
Edwards Lifesciences is recalling its PediaSat Oximetry Catheter Set due to potential for internal leaks within the device.
Product
Edwards PediaSat Oximetry Catheter Set, REF: XT358KTP, Exterior Diameter 5.5F, Usable Length 8 cm, Number of Lumens: 3, Recommended Guidewire Size: GW: 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197556
Category
Medical Device
Distribution
12 states
HighFDA (Devices)·Z-2268-2021·2021-08-18
Arcos Hip System Cones Recalled for Potential Inner Taper Corrosion
Biomet recalled 11 Arcos Modular Revision Hip System proximal cones due to potential inner taper fretting corrosion and device failure that could require surgical intervention. Affected units distributed nationwide.
Product
Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 70 MM Item Number: 11-301322
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2224-2021·2021-08-18
Codman Raney Scalp Clips recalled for compromised sterile barrier packaging
Integra LifeSciences is recalling Codman Raney Scalp Clips (lot numbers W2102045, W2102046, W2102048, W2102049) due to wrinkles in the packaging that may compromise the sterile barrier.
Product
CODMAN RANEY SCALP CLIPS-Disposable cylindrical clips designed to provide hemostasis to the scalp wound edge. Part Number: 201037
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2217-2021·2021-08-18
TruRize Clinical Chair distributed to home users who may misuse it
Stryker's TruRize Clinical Chair was distributed to residential customers despite being designed for healthcare facility use only. Home users may not understand safety instructions intended for trained professionals.
Product
TruRize Clinical Chair - support structure that places human occupants in upright, seated, recline, supine, and trend positions, Model Number: 3333, Part #¿3333000000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2277-2021·2021-08-18
Spectrum Medical Quantum Standard Heat Exchanger Sterilization Defect Recall
QURA S.R.L. is recalling 1088 units of Spectrum Medical Quantum Standard heat exchangers that may not be adequately sterilized. The devices also lack required 510(k) clearance for US distribution.
Product
Spectrum Medical Quantum Standard heat exchanger
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2267-2021·2021-08-18
Biomet Arcos Hip Implant Component Recalled for Potential Fretting Corrosion
Biomet is recalling 11 units of Arcos Modular Revision Hip System Standard Cone Prox Body components due to potential fretting corrosion at the inner taper joint that could cause device failure and require revision surgery.
Product
Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 70 MM Item Number: 11-301321
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2251-2021·2021-08-18
Exactech hip prosthesis femoral head labeling and marking discrepancy
Exactech BIOLOX delta Femoral Head prosthesis components were labeled as one size but marked as a different size. This labeling discrepancy could result in implantation of the incorrect component.
Product
Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF 170-36-03. Hip prosthesis component.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2252-2021·2021-08-18
Dutch Ophthalmic Vitrectomy Pack Contains Mismatched Infusion Line Gauge
Dutch Ophthalmic USA is recalling TDC Vitrectomy Pack VGPC 25g surgical kits. The packages are labeled as containing 25-gauge infusion lines but actually contain 23-gauge lines instead.
Product
The device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled TDC Vitrectomy Pack VGPC 25g, Product Number 8525.201.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2264-2021·2021-08-18
Hip Implant Component Recalled for Fretting Corrosion Risk
Biomet is recalling 33 units of the Arcos Modular Revision Hip System due to potential inner taper fretting corrosion that could lead to device failure and require surgical intervention.
Product
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size B, 60 MM Item Number: 11-301312
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2269-2021·2021-08-18
Hip implant component recalled due to potential corrosion and failure risk
Biomet is recalling 11 units of a hip replacement component that could experience inner taper corrosion and failure, potentially requiring surgical intervention. No injuries have been reported.
Product
Arcos Modular Revision Hip System Standard Cone Prox Body, Size E, 70 MM Item Number:11-301325
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2207-2021·2021-08-18
Stryker Prime Fifth Wheel Stretcher distributed to residential customers instead of healthcare facilities
A medical stretcher designed for healthcare professionals was distributed to residential customers. The device labeling is appropriate for healthcare settings, but home users may not understand or follow the professional-use instructions.
Product
Prime Fifth Wheel Stretcher-stretcher may be used for minor procedures and short-term stay (treatment and recovery, Model 1105, Part Numbers 1105000026 and 1105000000X
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2235-2021·2021-08-18
Cordis SABER PTA Balloon Catheter Recalled for Foreign Material Contamination
Cordis Corporation is recalling the SABER PTA Balloon Dilation Catheter due to potential contamination with foreign material from manufacturing. The contamination may transfer from the protective sheath to the balloon itself.
Product
Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0852-2021·2021-08-18
5000 Years Foods Whole Cabbage Kimchi Listeria Contamination Recall
5000 Years Foods is recalling NO MSG Whole Cabbage Kimchi in 5-gallon plastic tubs and glass jars due to potential Listeria monocytogenes contamination. The product was distributed in Illinois and potentially nationwide through retail stores.
Product
5000 Years Foods NO MSG WHOLE CABBAGE KIMCHI in 5GAL plastic tubs, and 128 oz and 64 oz glass jars
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2216-2021·2021-08-18
Hospital Bed Model 3005 Recalled for Distribution to Home Residents
Stryker's S3 MedSurg hospital bed was distributed to home residents instead of healthcare facilities. The devices are designed for professional operation, and untrained home users may not understand safety instructions.
Product
S3 MedSurg Bed - intended to support and transport patients within the Med/Surg and Critical Care hospital environments, Model Number: 3005, Part # 3005S3EX
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0853-2021·2021-08-18
5000 Years Foods Kimchi Recalled for Listeria Contamination Risk
5000 Years Foods is recalling NO MSG Sliced Cabbage Kimchi sold in multiple container sizes due to potential Listeria monocytogenes contamination. The product was distributed in Illinois and may have reached customers nationwide through retail stores.
Product
5000 Years Foods NO MSG SLICED CABBAGE KIMCHI in 5GAL plastic tubs, and 128 oz, 64 oz, 32 oz, & 16 oz glass jars
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-0849-2021·2021-08-18
5000 Years Foods Kimchi Recalled for Listeria Contamination Risk
5000 Years Foods is recalling whole cabbage kimchi sold in plastic tubs and glass jars due to potential contamination with Listeria monocytogenes. The recalled product was distributed in Illinois and potentially nationwide through retail stores.
Product
5000 Years Foods WHOLE CABBAGE KIMCHI in 5GAL plastic tubs, and 128 oz and 64 oz glass jars
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-0850-2021·2021-08-18
5000 Years Foods Julrado Whole Cabbage Kimchi Recall for Listeria
5000 Years Foods is recalling Julrado Whole Cabbage Kimchi in multiple sizes due to potential Listeria monocytogenes contamination. The product was distributed in Illinois and potentially nationwide through retail distributors.
Product
5000 Years Foods JULRADO WHOLE CABBAGE KIMCHI in 5GAL plastic tubs, and 128 oz and 64 oz glass jars
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-0856-2021·2021-08-18
5000 Years Foods White Whole Kimchi Recall Due to Listeria Risk
5000 Years Foods is recalling White Whole Kimchi in 32 oz, 64 oz, and 128 oz glass jars due to potential Listeria monocytogenes contamination. The affected product was distributed through Illinois to retail locations potentially nationwide.
Product
5000 Years Foods WHITE WHOLE KIMCHI in 128 oz, 64 oz, and 32 oz glass jars
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-0857-2021·2021-08-18
5000 Years Foods Baby Napa Kimchi Recall for Listeria Contamination
5000 Years Foods is recalling Baby Napa Kimchi in 128 oz, 64 oz, and 32 oz glass jars due to potential contamination with Listeria monocytogenes. The product was distributed in Illinois and potentially nationwide through retail distributors.
Product
5000 Years Foods BABY NAPA KIMCHI in 128 oz, 64 oz, and 32 oz glass jars
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2276-2021·2021-08-18
Automated diagnostic analyzer from Abbott recalled for waste pressure buildup
Abbott is recalling 260 Alinity s System analyzers due to a design defect allowing waste pressure to build up and spray operators. No injuries reported.
Product
Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening, plasma and plasmapheresis screening, and organ donor centers, hospitals, and reference laboratories.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2225-2021·2021-08-18
MYLA Laboratory Software: Potential Test Result Alteration from Software Anomaly
BioMerieux is recalling MYLA microbiology software due to a software anomaly that could cause unwanted alterations to test results when using the BCI Connect scripting feature. 248 systems nationwide are affected.
Product
MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission of results by transferring, storing, and displaying medical device data.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2260-2021·2021-08-18
Biomet Arcos Hip Prosthesis Recalled Due to Device Failure Risk
Biomet is recalling certain Arcos Modular Revision Hip System components due to risk of device failure and fretting corrosion. Affected patients may require revision surgery.
Product
Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 60 MM Item Number: 11-301301
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2229-2021·2021-08-18
Shent USA Grasper/Retriever Endoscopic Instruments Recalled for Mislabeling
Shent USA is recalling Grasper/Retriever endoscopic instruments (lot 020377208) due to mislabeling. Products bearing one catalog number may contain different devices with different jaw specifications, potentially resulting in wrong instrument selection.
Product
Grasper/Retriever, Alligator Jaw 2.4 mm x 5 mm x 230 cm Catalog Number: 7208 Intended use: single use accessory devices used through the working channel of a GI endoscope
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2274-2021·2021-08-18
FDA Recalls Biomet Hip Implant for Potential Fretting Corrosion
Biomet is recalling its Arcos Modular Revision Hip System Standard Cone Prox Body due to risk of fretting corrosion and device failure in the inner taper. Affected patients should consult their surgeon.
Product
Arcos Modular Revision Hip System Standard Cone Prox Body, Size C, 80 MM Item Number: 11-301343
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2258-2021·2021-08-18
ACCESS SARS-CoV-2 Antigen Extraction Solution recalled for potential false positive results
Beckman Coulter is recalling ACCESS SARS-CoV-2 Antigen Extraction Solution nationwide because the assay test may generate false positive results, leading to incorrect diagnosis.
Product
ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION, CONTENTS: 6 x 6.0 mL EXTRACTION SOLN, IVD, Rx Only, UDI: (01)15099590743017
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2218-2021·2021-08-18
Symmetry Plus Treatment Recliner distributed to home users instead of healthcare facilities
A medical treatment recliner designed for healthcare facilities was distributed to home consumers. Home users may not understand the specialized instructions intended for healthcare professionals, creating a potential safety risk.
Product
Symmetry Plus Treatment Recliner - general hospital use as a convenient seating surface for patients or guests to sit, Model Number 3500, Part # 3500000710
Category
Medical Device
Distribution
Distributed nationwide
HighCPSC·21184·2021-08-18
TJX Recalls Swivel Counter Stools Due to Fall and Injury Hazards
TJX Companies is recalling about 4,300 swivel counter stools sold at HomeGoods and Homesense stores because they can break or collapse, causing falls. The company has received 20 reports of stools breaking, including 17 reports of minor injuries.
Product
Swivel Counter Stools
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Food)·F-0846-2021·2021-08-18
Solumeve Hydrolyzed Collagen Peptides Recalled for Undeclared Milk
IHERB LLC is recalling Solumeve Hydrolyzed Collagen Peptides dietary supplements because the MCT ingredient contains undeclared milk, which poses a risk to consumers with milk allergies.
Product
Solumeve Hydrolyzed Collagen Peptides, Turmeric + MCT and Ginger; Dietary Supplement, NET Wt. 14.1 oz. (400g) Suggested usage: Simply add 1 scoop (15.38 g) to a 6-8 fl oz. of room temperature water or juice once daily. UPC 8 98220 01828 4 Manufactured for Madre Labs, LLC 301 N
Category
Food
Distribution
31 states
HighFDA (Food)·F-0854-2021·2021-08-18
5000 Years Foods Kimchi Recalled for Listeria Contamination Risk
5000 Years Foods is recalling NO MSG JULRADO WHOLE CABBAGE KIMCHI in 128 oz and 64 oz glass jars due to potential Listeria monocytogenes contamination. The affected product was distributed through Illinois and reached customers nationwide.
Product
5000 Years Foods NO MSG JULRADO WHOLE CABBAGE KIMCHI in 128 oz and 64 oz glass jars
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-0855-2021·2021-08-18
5000 Years Foods Kimchi Recalled for Listeria Contamination Risk
5000 Years Foods is recalling NO MSG JULRADO SLICED CABBAGE KIMCHI in multiple sizes due to potential Listeria monocytogenes contamination. The product was distributed from Illinois to retailers potentially nationwide.
Product
5000 Years Foods NO MSG JULRADO SLICED CABBAGE KIMCHI in 128 oz, 64 oz, 32 oz, & 16 oz glass jars
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-0851-2021·2021-08-18
5000 Years Foods JULRADO Sliced Cabbage Kimchi Listeria Recall
5000 Years Foods is recalling JULRADO Sliced Cabbage Kimchi in multiple container sizes due to potential Listeria monocytogenes contamination. The product was distributed in Illinois and potentially nationwide through retail distributors.
Product
5000 Years Foods JULRADO SLICED CABBAGE KIMCHI in 5GAL plastic tubs, and 128 oz, 64 oz, 32 oz, & 16 oz glass jars
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-0847-2021·2021-08-18
BUBS Naturals MCT Oil Powder Recalled for Undeclared Milk Allergen
Slayer Forever, LLC (dba BUBS Naturals) is recalling BUBS Naturals MCT Oil Powder dietary supplement because the product contains undeclared milk allergens.
Product
BUBS Naturals MCT OIL Powder, Medium Chain Triglycerides from 100% virgin Coconut Oil. Dietary Supplement 10.6 oz. Gusset Bags
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-0858-2021·2021-08-18
Molly and Me Pecans Recalled for Undeclared Soy
Molly and Me Pecans praline pecans are being recalled because they contain undeclared soy, which poses a risk to consumers with soy allergies.
Product
MOLLY & ME PECANS all natural PRALINE PECANS, 4 oz., 7 oz., and 12 oz packages, INGREDIENTS: Pecans, Brown Sugar, Evaporated Milk, Margarine, Light Corn syrup, Artificial Vanilla Flavor. ALLERGEN INFORMATION CONTAINS MILK, PECANS & MAY CONTAIN OTHER TREE NUTS. PRODUCED & DISTRIBU
Category
Food
Distribution
28 states
HighFDA (Devices)·Z-2230-2021·2021-08-18
Endoscope Grasper/Retriever Devices Mislabeled with Incorrect Catalog Numbers
Shent USA recalls grasper/retriever endoscopy devices that are mislabeled with incorrect catalog numbers. Units labeled as catalog #7208 may actually be #7226 and vice versa, potentially causing use of the wrong jaw size.
Product
Grasper/Retriever, Alligator Jaw, Rat Tooth 2.4 mm x 8 mm x 230 cm Catalog Number: 7226 Intended use: single use accessory devices used through the working channel of a GI endoscope
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2211-2021·2021-08-18
Stryker Proform pressure ulcer support surface distributed to home users
Stryker Proform pressure ulcer support surfaces designed for healthcare facility use were distributed to residential customers. The device labeling is correct but home users may not understand professional-level instructions.
Product
Proform- support surface is used to assist in the prevention and treatment of all categories/stages of pressure ulcers, Model Number: 2710, Part #¿2710000027¿¿¿¿
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2259-2021·2021-08-18
Arcos Modular Hip Implant Cone Bodies Recalled for Fretting Corrosion
Biomet is recalling specific lots of Arcos Modular Revision Hip System cone bodies due to potential fretting corrosion and device failure that could require surgical intervention.
Product
Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 50 MM Item Number: 11-301300
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2234-2021·2021-08-18
Medline Arthroscopy Kit Recalled for Expired Irrigation Component
Medline Industries is recalling 286 Arthroscopy Kits (REF DYNJ904304B) containing an expired NaCl irrigation bag component. The affected kits were distributed to Minnesota, Nebraska, and Pennsylvania.
Product
Medline Arthroscopy Kit, convenience kit, REF DYNJ904304B, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2247-2021·2021-08-18
Jamshidi Bone Marrow Biopsy Needles Recalled for Packaging Seal Defects
Bard Peripheral Vascular Inc. is recalling multiple models of Jamshidi bone marrow biopsy needles due to incomplete or open packaging seals that may compromise sterility. No illnesses or injuries have been reported.
Product
TJM6008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 15 cm; TJC3513 Jamshidi" Bone Marrow Biopsy/Aspiration Needle. 13G x 8.9 cm; TJM4011 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 11G x 10cm
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2253-2021·2021-08-18
Medical imaging software displays anatomical orientation tags incorrectly
Simpleware ScanIP medical imaging software contains a bug where anatomical orientation tags display incorrectly. This could lead to operator misunderstanding and errors during image resampling and realignment.
Product
Simpleware ScanIP software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2254-2021·2021-08-18
Simpleware ScanIP Medical Software Recall: Incorrect Anatomical Orientation Display
Simpleware ScanIP medical software may display anatomical orientation tags incorrectly, potentially causing surgical planning errors. This FDA Class II recall affects versions from 2018–2021 distributed in the US and internationally.
Product
Simpleware ScanIP medical software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2265-2021·2021-08-18
Arcos Hip Implant Component Recalled for Potential Device Failure
Biomet recalled 10 units of Arcos hip implant components (lot 934870) nationwide due to potential inner taper corrosion and device failure that may require surgical intervention.
Product
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 60 MM Item Number: 11-301314
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2212-2021·2021-08-18
Medical device designed for healthcare professionals distributed to untrained home users
Stryker's ComfortGel pressure injury treatment device was distributed to residential customers for home use, though it was designed for trained healthcare professionals. Home users may not understand the complex instructions intended for professional use.
Product
ComfortGel - assists in the prevention and treatment of all pressure injury stages, Model Number 2850, Part # 2850000999, 2850000001, 2850000009
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2236-2021·2021-08-18
Orthopedic drill bit recalled for corrosion particle contamination risk
NEOSTEO cannulated drill bits are being recalled due to corrosion traces on the laser marking that could release particles into the surgical field. The recall affects Lot 243-20 distributed in New Jersey.
Product
Cannulated graduated drill bit 1.9 mm diameter, with AO QC system, REF: INS-114 for use in orthopedic surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2226-2021·2021-08-18
In Vitro Diagnostic Test Produces Incorrect Antibiotic Susceptibility Results
Biomerieux's ETEST IMIPENEM RELEBACTAM diagnostic test produces major errors when testing Pseudomonas aeruginosa, incorrectly identifying resistant strains as susceptible. Approximately 1,431 units distributed worldwide.
Product
ETEST IMIPENEM RELEBACTAM. in vitro diagnostic
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2243-2021·2021-08-18
Merit Medical Prelude Introducer Sheath Recalled for Incorrect Dilator
Merit Medical is recalling 373 Prelude Short Sheath Introducer units from lot H2069291 due to potential incorrect dilators in some packages. The defect could affect device functionality in clinical procedures.
Product
MERITMEDICAL Prelude Short Sheath Introducer, REF: PSS-6F-4-018MT, 21G 6F(2.0 mm) 4 cm, Max Guide Wire 0.018" (0.46 mm), STERILE EO, Single Use, Rx Only, CE2797, UDI: (01)00884450015391
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2275-2021·2021-08-18
Hip Prosthetic Component Recalled Due to Potential Fretting Corrosion and Device Failure
Biomet is recalling Arcos hip prosthetic components that may develop corrosion and fail, potentially requiring revision surgery.
Product
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 80 MM Item Number: 11-301354
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2279-2021·2021-08-18
Edwards PediaSat Oximetry Catheter Kit Recalled for Internal Leak Risk
Edwards Lifesciences recalls PediaSat Oximetry Catheter Kits (REF: XT3515SP) due to potential for internal leaks that could affect oxygen saturation monitoring.
Product
Edwards PediaSat Oximetry Catheter Kit, REF: XT3515SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of Lumens 3, Recommended Guidewire Size 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197532
Category
Medical Device
Distribution
12 states
HighFDA (Devices)·Z-2223-2021·2021-08-18
Stryker GoBed II Medical Bed Recalled for Improper Home Distribution
Stryker's GoBed II MedSurg Bed was distributed to residential customers but is intended for healthcare facility use. Home users may not understand professional-level safety instructions, creating a risk of misuse.
Product
GoBed II MedSurg Bed, Model Number FL28, Part #FL28EX
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2213-2021·2021-08-18
Stryker IsoGel Air Medical Device Distributed to Home Users Instead of Healthcare Facilities
Stryker has recalled 3 IsoGel Air pressure ulcer support surfaces that were distributed to home users when designed for use only in healthcare facilities. Home users may not understand the professional healthcare instructions required for proper use.
Product
IsoGel Air - support surface assists in the prevention and treatment of all pressure ulcers stages, Model Number 2860, Part 2860000999
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2231-2021·2021-08-18
Medline Shoulder CDS Kits Recalled Due to Expired Irrigation Component
Medline Industries is recalling 286 Shoulder CDS convenience kits that may contain an expired NaCl irrigation component. Users should stop using the kits and contact the manufacturer for return instructions.
Product
Medline Shoulder CDS convenience kits, REF DYNJ902837D and REF DYNJ902837F, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2261-2021·2021-08-18
Arcos Modular Revision Hip System Cone Bodies Recalled for Device Failure Risk
Biomet, Inc. is recalling 21 units of Arcos Modular Revision Hip System Standard Cone Prox Bodies due to risk of fretting corrosion and device failure that may require surgical intervention.
Product
Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 60 MM Item Number: 11-301302
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2206-2021·2021-08-18
Stryker Surgistool Model 830 distributed to home users instead of healthcare professionals
Stryker Medical recalls a surgical support tool that was distributed to home consumers but is intended only for healthcare professionals. The device labeling is correct, but home users may lack training to use it safely.
Product
Surgistool-intended to support a healthcare professional during surgical procedures Model 830, Part Number 0830000000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2256-2021·2021-08-18
SARS-CoV-2 Antigen Calibrators May Produce False Positive Test Results
Beckman Coulter is recalling Access SARS-CoV-2 Antigen Calibrators because the assay test may generate false positive results, potentially leading to incorrect diagnosis. Approximately 451 units were distributed nationwide and internationally.
Product
Access SARS-CoV-2 Antigen Calibrators, Catalog, REF: C68669, Contents: 1x2.5 mL C0, 1x2.5mL C1, 1x CAL CARD, UDI: (01)15099590742720;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2209-2021·2021-08-18
Prime TC Transport Chair Recalled for Improper Residential Distribution
The Prime TC-transport chair, designed for healthcare facility use, was distributed to residential customers who may not understand the professional-level operating instructions. The recall addresses potential risk of improper use by home users.
Product
Prime TC-transport chair intended for medical purposes to assist a person in performing an activity that the person would find difficult to do or be unable to do Model Number: 1460, Part #1460000000¿¿¿¿¿¿¿
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2233-2021·2021-08-18
Medline Total Knee Surgical Kit Recalled for Expired Irrigation Component
Medline Industries is recalling Total Knee convenience kits that may contain an expired saline irrigation solution component. The expired component may not maintain proper sterility for surgical use.
Product
Medline Total Knee, convenience kit, REF DYNJ907129B, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).
Category
Medical Device
Distribution
Distributed nationwide
ModerateCPSC·21185·2021-08-18
Primark Recalls 8-Pack Scent Stamper Pens for Elevated Benzyl Alcohol
Primark is recalling about 9,500 8-pack Scent Stamper Pens due to elevated levels of benzyl alcohol in the purple pen, which poses a risk of skin irritation. No injuries have been reported.
Product
8-Pack Scent Stamper Pens
Category
Consumer Product
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2210-2021·2021-08-18
InTouch 2131 Medical Device Recalled for Distribution to Residential Users
Stryker's InTouch 2131 medical device, intended for healthcare facilities, was distributed to residential customers. Home users may not understand healthcare-specific instructions, creating a risk of improper use.
Product
InTouch 2131-intended to support a human patient in an acute care setting, Model Number: 2131000000, Part #1460000000¿¿¿¿¿¿¿
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2241-2021·2021-08-18
Kaluza C Flow Cytometry Software Recalled for Potential Erroneous Results
The FDA is recalling Kaluza C Flow Cytometry Software versions 1.0, 1.1.1, and 1.1.2 due to software anomalies that may generate erroneous results affecting diagnostic interpretation.
Product
Kaluza C Flow Cytometry Software Versions: 1.0*, 1.1.1 and 1.1.2 Kits: C10574 - Kaluza C Single Perpetual License C10575 - Kaluza C Single User 1-year License C10576 - Kaluza C 10 User Network License C10577 - Kaluza C 5 User Network License C10578 - Kaluza C Single Perpet
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0723-2021·2021-08-18
Ethosuximide Oral Solution Recalled Due to Lack of CGMP Compliance
PAI Holdings is recalling Ethosuximide Oral Solution 250 mg/5 mL (Lot C9BC, expiration 31 October 2022) distributed nationwide due to potential carry-over contamination from Senna Syrup related to lack of current good manufacturing practices.
Product
ETHOSUXIMIDE — ETHOSUXIMIDE (ETHOSUXIMIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0719-2021·2021-08-18
Sulfamethoxazole and Trimethoprim Tablets Recalled for Metal Contamination
Aurobindo Pharma USA Inc. is recalling Sulfamethoxazole and Trimethoprim Tablets (800mg/160mg) due to potential metal contamination in the product. The recall affects approximately 3,800 bottles distributed nationwide.
Product
SULFAMETHOXAZOLE AND TRIMETHOPRIM — SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM)
Category
Drug
Distribution
Distributed nationwide
ModerateNHTSA·21V646000·2021-08-18
2022 BMW X4 Tire Information Label May Contain Incorrect Size and Pressure
BMW is recalling certain 2022 X4 vehicles because the tire information label may contain incorrect tire size and pressure information. Installing wrong-sized or improperly inflated tires increases the risk of a crash.
Product
BMW — BMW X4
Category
Vehicle
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0720-2021·2021-08-18
Zyprexa Intramuscular Injection Recalled for Manufacturing Defects
Eli Lilly is recalling 36,540 vials of Zyprexa (olanzapine) 10 mg intramuscular injection due to manufacturing deviations affecting the drug product's appearance, size, and color.
Product
Zyprexa Intramuscular, Olanzapine for Injection, 10 MG per Single Use Vial, Rx only, Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, NDC# 0002-7597-01
Category
Drug
Distribution
3 states
ModerateFDA (Food)·F-0860-2021·2021-08-18
Monfefo Turmeric Shot Recalled Due to Manufacturing Non-Compliance
Monfefo LLC is recalling Monfefo brand Turmeric Shot in 2oz glass bottles because the product was not manufactured according to specifications. Affected lots were distributed across multiple states.
Product
Monfefo brand Turmeric Shot; 2oz; Cold Pressed Juice Blend; packaged in glass bottle
Category
Food
Distribution
19 states
ModerateFDA (Drugs)·D-0722-2021·2021-08-18
Cimetidine Hydrochloride Oral Solution Recalled for CGMP Violation
Pharmaceutical Associates Inc. is recalling Cimetidine Hydrochloride Oral Solution 300 mg/5 mL due to a lack of Current Good Manufacturing Practice (CGMP) and potential carryover of Senna Syrup.
Product
Cimetidine Hydrochloride Oral Solution 300 mg/5 mL, 8 fl oz (237 mL) Rx ONLY, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0649-08
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0703-2021·2021-08-18
Venlafaxine 50 mg Tablets Recalled for Wrong Strength
SUN PHARMACEUTICAL INDUSTRIES INC is recalling Venlafaxine Tablets labeled as 50 mg because bottles contain Venlafaxine 37.5 mg tablets, creating a dosing error risk.
Product
Venlafaxine Tablets, USP 50 mg*, 100 Tablets Manufactured for Northstar Rx LLC Memphis, TN 38141 Manufactured by: ALKALOIDA Chemical Company Zrt. 4440 Tiszavasvari, Kabay Janos u.29.Hungary. Product of India NDC 16714-657-01
Category
Drug
Distribution
1 state
ModerateFDA (Devices)·Z-2227-2021·2021-08-18
CIRRUS HD-OCT Model 6000 imaging devices recalled for missing FDA pre-market clearance
Carl Zeiss Meditec is recalling 914 CIRRUS HD-OCT Model 6000 imaging devices. The manufacturer failed to obtain FDA pre-market clearance before selling the devices.
Product
Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000"
Category
Medical Device
Distribution
53 states
ModerateFDA (Drugs)·D-0721-2021·2021-08-18
Nystatin Oral Suspension Recalled Due to CGMP Violation
PAI Holdings is recalling Nystatin Oral Suspension nationwide due to a lack of Current Good Manufacturing Practice (CGMP) controls that could allow carryover of Senna Syrup into the product.
Product
NYSTATIN — NYSTATIN (NYSTATIN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2215-2021·2021-08-18
Support Surface Device Distributed to Home Patients Without Healthcare Professional Instructions
An Isolibrium Support Surface intended for healthcare facilities was distributed to home customers. While the labeling is correct, home users may not understand instructions intended for healthcare professionals.
Product
Isolibrium Support Surface - support surface assists in the prevention and treatment of all pressure injury stages (including stages 1, 2, 3, 4, Unstageable and Deep Tissue Pressure Injury, Model Number: 2972, Part # 2972000000
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Food)·F-0859-2021·2021-08-18
Wickles Relish 16oz Glass Jars Recalled for Wrong Label
Magnolia Vegetable Processors is recalling Wickles Relish 16oz glass jars (Lot No. 2001210406) due to an incorrect label applied to the product. The affected cases were distributed to eight states.
Product
Wickles Relish 16oz glass jars - 6 jars per case
Category
Food
Distribution
8 states
CriticalCPSC·21179·2021-08-17
Zen Magnets and Neoballs Magnets Recalled Due to Ingestion Hazard
Zen Magnets and Neoballs high-powered spherical magnets are being recalled because swallowing multiple magnets can cause intestinal perforation, blockage, and death. About 10 million magnets sold individually and in sets since January 2009 are affected.
Product
Zen Magnets and Neoballs Magnets
Category
Consumer Product
Distribution
Distributed nationwide
HighNHTSA·21V645000·2021-08-17
Kibbi Recalls 2019-2021 Renegade Vienna and Villagio RVs for Fire Risk
Kibbi, LLC is recalling 2019-2021 Renegade Vienna and Villagio recreational vehicles because exhaust heat may cause the storage box to melt or catch fire.
Product
RENEGADE — RENEGADE VILLAGIO, VIENNA
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·21V642000·2021-08-17
Newmar motorhomes recalled for fuel hose leak fire risk
Newmar is recalling 2021-2022 motorhomes with Cummins L9 diesel engines due to a potential fuel leak from a fuel hose that could cause fire.
Product
NEWMAR — NEWMAR VENTANA, NEW AIRE, DUTCH STAR
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·21V643000·2021-08-17
Swab Wagon Recalls Medic Vehicles with Excessively Bright LED Lights
Swab Wagon is recalling 2017-2019 Chevrolet and Ford medic vehicles because their LED lights are too bright, potentially blinding other drivers and increasing crash risk.
Product
SWAB WAGON — SWAB WAGON CHEVROLET 3500, FORD F-350, CHEVROLET 2500 HD
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·21V644000·2021-08-17
Renegade Recreational Vehicles Recalled for Window Adhesive Failure
Kibbi, LLC is recalling 2018-2020 Renegade RVs because window vent adhesive may fail, posing a crash or injury risk.
Product
RENEGADE — RENEGADE CLASSIC, GARAGE, VIENNA, TOTERS
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·21E075000·2021-08-17
Cummins Recalls Generator Sets Due to Improperly Crimped Lifting Cables
Cummins is recalling specific generator sets because lifting cables may be improperly crimped. This defect could cause the equipment to fall during lifting, increasing the risk of injury.
Product
EQUIPMENT recall
Category
Consumer Product
Distribution
Distributed nationwide
HighNHTSA·21V641000·2021-08-16
Alexis Fire Equipment Recalls 2015-2020 Fire Apparatus Due to Bright Lights
Alexis Fire Equipment is recalling 2015-2020 emergency vehicles because LED lights may be too bright, potentially affecting driver vision and increasing crash risk.
Product
ALEXIS FIRE EQUIPMENT — ALEXIS FIRE EQUIPMENT FIRE APPARATUS
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·21V640000·2021-08-15
Ferrara Recalls One 2020 Igniter Emergency Vehicle for Display Defect
Ferrara Fire Apparatus is recalling one 2020 Igniter emergency vehicle because the instrument cluster display may lock up or become nonfunctional due to low voltage spikes.
Product
FERRARA — FERRARA IGNITER
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·21V637000·2021-08-13
PL Custom Recalls 2016 Freightliner M2 Vehicles Due to Excessively Bright Lights
PL Custom is recalling 2016 Freightliner M2 emergency vehicles because their LED lights are too bright, potentially blinding other drivers and increasing crash risk.
Product
PL CUSTOM — PL CUSTOM FREIGHTLINER M2
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·21V636000·2021-08-13
2021 Grand Design Imagine trailers recalled for incorrect axle bearings
Grand Design is recalling certain 2021 Imagine recreational trailers with Dexter D30 axles due to incorrect inner bearings. The bearings can cause wheels to lock or reduce stopping ability, increasing crash risk.
Product
GRAND DESIGN — GRAND DESIGN IMAGINE
Category
Vehicle
Distribution
Distributed nationwide

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