Archive
519 recalls were announced in September 2021.
Of the 519 recalls this month scored against our rubric, 1% are Critical, 19% are Severe.
Which agencies issued them
Volvo is recalling 2001-2009 S60 and 2001-2006 S80 vehicles because the driver's air bag inflator may explode during deployment, posing a risk of serious injury or death.
Highland Ridge RV is recalling 2021 Open Range recreational trailers because the cooktop cabinet may not be sealed from the furnace, creating a fire risk.
Jayco is recalling 2021-2022 Flight SLX travel trailers because the cooktop may not be sealed from the furnace, creating a fire risk.
Ford is recalling 2020-2021 Ranger Super Cab vehicles because fixed head restraints may interfere with child seat installation and anchor attachment.
Starcraft is recalling 2021-2022 Autumn Ridge Outfitter recreational trailers because the cooktop may invert during furnace operation, increasing fire risk. Dealers will install sealant and plywood panels free of charge.
Seabear Company is recalling Banquet Cut European Style Cold Smoked Salmon due to potential for growth of Clostridium botulinum. The affected product was distributed in Arizona, California, and Georgia.
Glenmark Pharmaceuticals is recalling Fulvestrant Injection 250 mg/5 mL due to lack of assurance of sterility. The affected product was distributed nationwide in 28,658 cartons across multiple lots.
Phe Inc is recalling X Rated Honey For Men packets nationwide because the product contains Tadalafil and was marketed without FDA approval. Consumers should stop use immediately.
Golden Natural Product Inc. brand Dried Apricot Subkhon products (with bone and jumbo varieties) are being recalled because they contain high levels of undeclared sulfites. The affected products have lot number GC005 and expiration date 2023.
DuPont Nutrition USA is recalling Avicel RC-591 NF bulk powder (lot #2173766940) due to out-of-specification microbial contamination. The product was distributed as a component in finished drug formulations nationwide.
Joy Coriander Chutney (8 oz, best by 07/30/22) is being recalled because it contains high levels of undeclared sulfites. Consumers with sulfite sensitivity should not consume this product.
Eco-Med Pharmaceutical, Inc. is recalling ultrasound gels and lotions that may contain bacterial contamination. Products were distributed nationally and internationally.
Glenmark Pharmaceuticals is recalling Arformoterol Tartrate Inhalation Solution 15 mcg/2 mL nationwide because the manufacturer lacks assurance of sterility for affected lots.
The Kroger Co. is recalling Kroger Kale Bags (16 oz) due to potential contamination with Listeria Monocytogenes. The affected product was distributed to retail locations in seven states.
Ultrasound gels sold under multiple brand names have been recalled due to potential bacterial contamination. Approximately 100,114 units distributed nationwide between August 2018 and August 2021 are affected.
Roche Molecular Systems is recalling cobas SARS-CoV-2 & Influenza A/B test kits following reports of increased false positive SARS-CoV-2 results.
Siemens SOMATOM CT systems with certain software versions may experience sporadic errors causing workflow interruptions and diagnostic delays. Affected systems should be updated to prevent scan aborts and patient rescans.
Joy Mint Chutney (8 oz) is being recalled because it contains undeclared coconut. Consumers with coconut allergies should not consume this product.
Morton Grove Pharmaceuticals is recalling Promethazine With Codeine Oral Solution (Lot #UV1198) nationwide due to potential microbial contamination in liquid sugar batches used during manufacturing.
Olympus is recalling the EVIS EXERA BF-XT160 bronchofibervideoscope due to a missing gluing step in manufacturing. The affected devices may develop leaks in the insertion tube, posing an infection control risk.
Medtronic recalls DLP Left Heart Vent Catheters due to risk of wire protrusion through the catheter tip. The defect could cause internal injury during cardiac procedures.
Joy Gourmet Foods LLC is recalling Joy Tamarind Chutney (8 oz, best by 09/30/22) because it contains high levels of undeclared sulfites, which can pose a serious health risk to sensitive individuals.
C.R. Bard is recalling SureStep Foley Tray units due to potential packaging defects that may compromise the sterile barrier. The recalled product was distributed nationwide in the United States.
General Motors is recalling 2021-2022 Chevrolet Silverado and GMC Sierra pickup trucks due to brake modulator bolts that may fail to seal properly. Water intrusion can cause electrical short circuits, creating a fire risk.
General Motors is recalling 2016-2017 Cadillac CT6 vehicles because the park/position lights may be excessively bright, potentially affecting other drivers' vision and increasing crash risk.
C.R. Bard is recalling 420 units of Foley catheter care trays nationwide due to potential packaging defects that may impact the sterile barrier.
C.R. Bard is recalling 11,600 units of its Foley catheter tray assembly nationwide due to potential packaging defects that may compromise the sterile barrier.
Baker's Corner Bakery is recalling Lemon Blueberry Scones because milk is not declared in the "Contains" statement, even though butter and buttermilk are listed in the ingredients. Consumers with milk allergies may be at risk.
Aesculap Implant Systems recalls Univation X System knee implants nationwide due to risk of loosening that could require revision surgery. All lots are affected.
Aesculap Implant Systems is recalling Univation X System knee implant devices because they may loosen, potentially requiring revision surgery. All lots distributed in the US are affected.
Honda is recalling certain 2022 Odyssey vehicles equipped with Bridgestone tires that may contain a pinhole in the sidewall, causing slow air leaks and affecting tire performance. Dealers will inspect and replace affected tires at no cost.
C.R. Bard is recalling 2,660 units of SureStep Foley Catheter Trays nationwide due to potential packaging defects that may impact the sterile barrier.
C.R. Bard is recalling 11,780 Foley Tray units nationwide due to potential packaging defects that may compromise the sterile barrier.
C.R. Bard is recalling a Foley catheter tray system due to packaging defects that may compromise the sterile barrier. The recall affects 8,170 units distributed nationwide.
C.R. Bard Inc is recalling a Foley catheter tray due to potential packaging defects that may compromise the sterile barrier. Approximately 1,710 units were distributed nationwide.
Beckman Coulter is recalling Access SARS-CoV-2 IgG test kits nationwide due to insufficient evidence in the FDA authorization submission. The test validation may be inadequate for accurate COVID-19 antibody detection.
C.R. Bard Inc is recalling approximately 4830 SureStep Foley catheter trays due to potential packaging defects that could compromise the sterile barrier.
In2bones USA is recalling CoLink Bone Graft Harvesters after reports of the instruments breaking at the outer tube weld site. The recall affects 835 units distributed nationwide across 29 states.
Aesculap Implant Systems is recalling Univation X System knee implant devices (all lots, nationwide) because the implants may loosen, potentially requiring revision surgery. No injuries have been reported.
Philips Ultrasound is recalling Affiniti diagnostic ultrasound systems due to a software defect that intermittently causes device lock-ups when exiting Review Mode during patient exams. No illnesses or injuries have been reported.
C.R. Bard Inc is recalling SureStep Foley Trays (Catalog A902616) due to packaging defects that may compromise the sterile barrier. Affected units were distributed nationwide.
M.D.L. S.r.l. is recalling approximately 21,518 bone marrow biopsy needles distributed nationwide because sterility assurance may be compromised.
Baker's Corner Bakery is recalling Lemon Thyme Cookies because soybean oil, a sub-ingredient in the shortening, is not declared on the label. This poses a risk to consumers with soy allergies.
Greiner Bio-One is recalling 956,400 VACUETTE coagulation blood collection tubes that may clot due to anticoagulant variation or low vacuum.
The Baking Institute Baking Co. is recalling carrot cakes sold in the Chicago area because they contain undeclared milk, coconut, and walnuts. The products pose a serious risk to consumers with allergies to these ingredients.
Kohl's is recalling about 31,000 SONOMA Goods For Life-branded Ultimate Oversized Antigravity Chairs because the aluminum frame can break or collapse under weight, creating a fall hazard. The company has received 18 reports of breakage or collapse, including two reports of minor injuries.
Argon Medical Devices is recalling the Scorpion Portal Vein Access Set due to design changes that have caused the sheaths to crack or break at the tips. The affected product was distributed in the United States.
Jayco is recalling certain 2019-2021 Entegra and Jayco Class A motorhomes because the instrument cluster may go blank while driving, potentially hiding speed and warning lights.
Aesculap Implant Systems is recalling Univation X System knee implants because they may loosen, potentially requiring additional surgery. The recall affects devices distributed nationwide.
C.R. Bard is recalling 3,980 units of Foley catheter supply kits due to potential packaging defects that may compromise the sterile barrier. No illnesses have been reported.
GE Healthcare's Centricity PACS-IW system experiences image acquisition and synchronization failures that could impair the display of medical images. The software malfunction affects 392 devices globally.
The Sight OLO-E1/U1 diagnostic device software contains a labeling discrepancy: the operator's manual and software present different adult CBC reference ranges, potentially affecting the interpretation of diagnostic results.
Ad-Tech Lightweight CABRIO Cables with incorrect labels are being recalled. Mislabeling could cause product misidentification affecting proper use in clinical monitoring applications.
C.R. Bard is recalling Foley catheter kits due to packaging defects that may compromise the sterile barrier. No illnesses have been reported.
C.R. Bard Inc is recalling SureStep Foley Catheter Trays due to potential packaging defects that may compromise the sterile barrier. The recall affects 33,380 units distributed nationwide.
C.R. Bard Inc is recalling Foley Tray kits nationwide due to potential packaging defects that may compromise the sterile barrier. The product was distributed throughout the United States.
JAG Specialty Foods is recalling Daniele Plain Bulk breadsticks because the product may contain undeclared sesame seeds, which poses a risk to consumers with sesame allergies.
Paragon 28 is recalling Phantom Nail System surgical drills due to a thin wall condition between the cannulation and flutes. This defect could potentially cause the drill to fracture during use.
C.R. Bard is recalling 960 units of Foley Tray catheter kits (lot NGFR0101) due to potential packaging defects that may compromise the sterile barrier.
SSPI Mid-Atlantic, Inc. is recalling Dickies Seafood Cooked & Spiced Shrimp products because they contain undeclared sulfites, an allergen that may not be listed on the label.
Aesculap Implant Systems is recalling Univation X System knee implants nationwide due to potential loosening that may require revision surgery.
M.D.L. S.r.l. is recalling 320 units of Mammary Nodules Localization devices distributed nationwide due to potential compromise of sterility assurance.
Aesculap Implant Systems is recalling Univation X System knee implant devices nationwide due to potential loosening. The malfunction could require revision surgery.
C.R. Bard is recalling 18,060 units of SureStep Foley Catheter Trays due to potential packaging defects that may compromise the sterile barrier. No illnesses or injuries have been reported.
Baker's Corner Bakery is recalling Oatmeal Cranberry Cookies because soybean oil is not declared on the label, despite being present in the shortening ingredient. Consumers with soy allergies may be at risk.
C.R. Bard Inc is recalling Foley catheter care kits (catalog A303416A) because potential packaging defects could compromise the sterile barrier. Approximately 6,440 units were distributed nationwide.
Joy Gourmet Foods LLC is recalling 8 oz jars of Joy Green Chilli Chutney because the product contains sulfites, FD&C Yellow #5, and coconut that are not declared on the label. These are known allergens that may pose a risk to sensitive consumers.
C.R. Bard Inc is recalling a Foley catheter tray system due to potential packaging defects that may compromise the sterile barrier, affecting 1,760 units distributed nationwide.
Medtronic is recalling 51,494 DLP Left Heart Vent Catheters due to potential wire protrusion through the catheter tip. This defect could compromise proper device function during use.
Baker's Corner Bakery is recalling Oatmeal Butterscotch Cookies (12 oz bags) because soybean oil in the shortening and milk in the butterscotch chips are not declared on the label, posing a risk to consumers with allergies.
GE Healthcare is recalling Centricity Universal Viewer and Viewer 6.0 software due to image acquisition and synchronization failures with the Centricity Enterprise Archive that could impact diagnostic data integrity.
Aurobindo Pharma USA Inc. is recalling Metoprolol Tartrate 100 mg tablets due to the presence of metal wire found in at least one tablet. The FDA classified this as a Class II recall affecting 2,820 bottles distributed nationwide.
Baker's Corner Bakery is recalling 12-ounce bags of Snickerdoodle Cookies because soybean oil, a sub-ingredient in the shortening, is not declared on the label. Consumers with soy allergies are at risk.
Philips Ultrasound Inc is recalling EPIQ Diagnostic Ultrasound Systems due to a software defect that can cause the device to lock-up while exiting Review Mode during patient exams. Approximately 10,583 systems worldwide are affected.
Venom Motorsports is recalling about 500 youth all-terrain vehicles (ATVs) because they do not meet mandatory safety requirements, including speed restrictions, and were distributed without CPSC approval. The recalled ATVs pose a risk of serious injury or death.
C.R. Bard Inc is recalling approximately 29,890 units of Foley catheter trays due to potential packaging defects that may compromise the sterile barrier. No illnesses or injuries have been reported.
M.D.L. S.r.l. has recalled approximately 20,129 soft tissue biopsy needles nationwide because sterility assurance may be compromised.
Aesculap is recalling Univation X System Tray knee implants due to a loosening defect that may require revision surgery. All lots nationwide are affected.
C.R. Bard is recalling 5,950 SureStep Foley Tray kits nationwide due to potential packaging defects that may impact the sterile barrier.
ConvaTec is recalling DuoDERM CGF and Extra Thin dressings due to potential open seals that could compromise sterility. Approximately 2.7 million units were distributed internationally.
Luyuan Inc. is recalling about 6,800 youth all-terrain vehicles sold from August 2018 through August 2020 because they fail to comply with federal ATV safety standards, including maximum speed limitations required for children under 10.
Aesculap is recalling Univation X System knee implants nationwide because they may loosen, potentially requiring revision surgery.
C.R. Bard Inc is recalling the SureStep Foley Tray (Lot NGEVX108) due to potential packaging defects that may affect the sterile barrier. The product was distributed nationwide.
Macy's is recalling Martha Stewart Collection Oil & Vinegar Cruets because the glass portion can break during use, causing cuts. Six incidents have been reported, including three lacerations with two requiring stitches.
M.D.L. S.r.l. is recalling 2,750 Aspirated Cyto-Histological Biopsy needles nationwide due to compromised sterility assurance. Affected healthcare providers and patients should consult their healthcare provider for guidance.
Baker's Corner Bakery is recalling Chocolate Chip Cookies because soy-containing ingredients—soybean oil in the shortening and soy lecithin in the chocolate chips—are not declared on the label.
C.R. Bard Inc is recalling SureStep Foley Catheter Trays due to potential packaging defects that may compromise the sterile barrier. The affected lot includes 1140 units distributed nationwide.
M.D.L. S.r.l. is recalling approximately 4,120 units of general manual surgical instruments nationwide due to compromised sterility assurance. Healthcare facilities should verify lot numbers and quarantine affected instruments immediately.
Sysco Atlanta is recalling Imperial Fresh Potato Sweet Dice shipped to GA, NC, and TN due to improper temperature storage that may have rendered the product unsafe to consume.
Glenmark Pharmaceuticals is recalling specific lots of Naproxen Sodium 550 mg tablets nationwide due to manufacturing deviations. The firm initiated the voluntary recall on August 27, 2021.
Avrio Health L.P. is recalling Betadine Solution Swabstick in single and three-count packages nationwide because the product is subpotent—meaning it contains less active ingredient than specified. Consumers should stop using affected lots and consult their healthcare provider if needed.
Morton Grove Pharmaceuticals is recalling Valproic Acid Oral Solution (250 mg/5 mL) due to potential microbial contamination in liquid sugar batches used during manufacturing.
Glenmark Pharmaceuticals is recalling Chlorzoxazone 750 mg tablets nationwide due to current good manufacturing practice (CGMP) deviations. The voluntary recall affects 4,752 bottles with five affected lot numbers.
Pfizer is recalling certain lots of Chantix (varenicline tartrate) 0.5mg tablets nationwide due to the presence of N-nitroso-varenicline impurity above FDA's acceptable interim intake limit.
Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Zonisamide Capsules USP 100 mg nationwide due to CGMP (Current Good Manufacturing Practice) deviations. The recall affects multiple lot numbers distributed from August 2021.
Pfizer is recalling Chantix (varenicline) 1 mg tablets distributed nationwide due to the presence of N-nitroso-varenicline impurity above the FDA's acceptable interim intake limit. Affected lots have expiration dates from September 2021 to December 2023.
American Health Packaging is recalling Sirolimus 1 mg tablets (Lot #1000789, expiring 10/31/2022) distributed nationwide because they failed impurities and degradation specifications.
Monarch PCM, LLC is recalling Hydroquinone 4% Skin Bleaching Cream due to subpotency affecting the active ingredient assay and preservative assay in one product each.
The Harvard Drug Group is recalling Carbamazepine 200mg tablets (Lot R01562, expiring 10/2022) distributed in North Carolina because they failed to meet required dissolution specifications, which may affect the drug's effectiveness.
Sysco Atlanta is recalling Fleischmann's Yeast Compressed Fresh in 24/1 lb packages because the product was not stored at appropriate temperatures, creating potential food safety risk.
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