Safety Recalls

RSS ↗

15,379 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.

All

MedicalFood Drug Device

ConsumerProduct Vehicle

Showing 13,351–13,400 of 15,379

Medical Device Recall · March 6, 2024
Exactech, Inc.
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Ex
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).
Class II
Medical Device Recall · March 6, 2024
Exactech, Inc.
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).
Class II
Medical Device Recall · March 6, 2024
Exactech, Inc.
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).
Class II
Medical Device Recall · March 6, 2024
Exactech, Inc.
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).
Class II
Medical Device Recall · March 6, 2024
Wright Medical Technology, Inc.
stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty
Stryker has identified an issue that impacts specific lots of Infinity" Resection Guide Adjustment Blocks. The parts within these three lots were found to have been missing an internal screw in the finished instrument assembly. The missing screw is used to lockout the Medial/Lateral adjustment on the INFINITY Resection Adjustment Guide.
Class II
Medical Device Recall · March 6, 2024
Exactech, Inc.
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).
Class II
Medical Device Recall · March 5, 2024
Quidel Corporation
QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests
There are two windows on the test device, the control line window and the test results window. The line for the test results window were misaligned. In instances of positive test results, the positivite test line may not be visible/ hidden under the cassette of the test device thus potentially leading to a false negative result.
Class II
Vehicle Recall · March 5, 2024
Airstream, Inc.
2023 AIRSTREAM ATLAS
Flooring material exposed to heat increases the risk of fire and injury.
Unclassified
Medical Device Recall · March 5, 2024
MEDLINE INDUSTRIES, LP - Northfield
Bed Assist Bars, labeled as follows: a) Medline, Model Number BA6800, b) Medline Martha Stewart, Model Number MDS6800BAMMS
Medline is recalling certain lots of our Adult Portable Bed Rails that were manufactured after the mandatory compliance requirement (ASTM F3186-17, Standard Specification for Adult Portable Bed Rails and Related Products and 16 CFR Part 1270, Safety Standard for Adult Portable Bed Rails) and failed to meet all mandatory requirements outlined in these standards.
Class II
Medical Device Recall · March 5, 2024
Baxter Healthcare Corporation
Hill-Rom PRO+ 36" MRS Surface, REF P7924A03, The pro+ mattress is intended for patient support and for the prevention and/or treatment of pressure injuries.
Inconsistencies were identified with service records associated with corrections performed for a previous Medical Device Correction issued by Baxter (ref number: FA-2022-026). Your devices have been identified as potentially impacted by these service inconsistencies and therefore, Baxter will need to reassess the impacted mattresses to confirm they have been corrected as identified by the service order, and to confirm the correct serial numbers have been identified.
Class II
Medical Device Recall · March 5, 2024
Boston Scientific Corporation
OptiCross Coronary Imaging Catheter, REF H749518080120
Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect voltage setting, which may have resulted in decreased image brightness.
Class II
Medical Device Recall · March 5, 2024
MEDLINE INDUSTRIES, LP - Northfield
Bed Assist Bars, labeled as follows: a) Medline SwivAssist Bar, Model Number MDS6800SWIV (case of 3), b) Medline SwivAssist Bar, Model Number MDS6800SWIVRH (individual)
Medline is recalling certain lots of our Adult Portable Bed Rails that were manufactured after the mandatory compliance requirement (ASTM F3186-17, Standard Specification for Adult Portable Bed Rails and Related Products and 16 CFR Part 1270, Safety Standard for Adult Portable Bed Rails) and failed to meet all mandatory requirements outlined in these standards.
Class II
Drug Recall · March 5, 2024
Thea Pharma, Inc.
Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15
Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.
Class II
Medical Device Recall · March 5, 2024
Unomedical A/S
Neria Soft Infusion Set, Product Code 507302, intravascular administration set
Specific lots of Neria Soft Infusion Sets, which have been shipped into the US Market, have been shipped with the incorrect Instruction for Use (IFU) within the final pack. The IFU included is the IFU registered for the Rest of World (ROW) countries. The difference between the US IFU and the ROW IFU is the addition of an intended use section in the ROW IFU.
Class II
Medical Device Recall · March 5, 2024
Tandem Diabetes Care, Inc.
t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the iOS operating system. This cycle intermittently repeats, which leads to excessive Bluetooth communication that may result in pump battery drain and may lead to the pump shutting down sooner than typically expected. Pump shutdown will cause insulin delivery to suspend, which could lead to an under-delivery of insulin and may result in hyperglycemia, including severe hyperglycemia.
Class I
Medical Device Recall · March 5, 2024
Randox Laboratories Ltd.
Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests.
Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 & CAL10388, is running with a negative bias on RX Series instruments compared to other methods.
Class II
Medical Device Recall · March 5, 2024
Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human bo
Beckman Coulter manufacturing discovered cracks around a threaded insert on the bottom of the Internal Wash Buffer Tank that is used within the Wash Buffer Supply Drawer on the DxI 9000.This can result in leaking, leading to delays in reporting patient test results, exposure to physical and chemical hazards, and damage to equipment or the environment.
Class II
Medical Device Recall · March 5, 2024
Quidel Corporation
QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests
There are two windows on the test device, the control line window and the test results window. The line for the test results window were misaligned. In instances of positive test results, the positivite test line may not be visible/ hidden under the cassette of the test device thus potentially leading to a false negative result.
Class II
Food Recall · March 4, 2024
Albertsons Companies LLC
Signature Select, Athens, and Cal Pia brand Bread Butter White Bread 22 oz. loaf
Foreign object; metal and plastic shavings.
Class II
Food Recall · March 4, 2024
Bob Evans Farms (BEF)
Bob Evan's Original Mash Potato 2lbs (32 oz) packaged in black plastic tray with clear film and corrugate sleeve overwrap. 6 units per case
Potential for foreign material - Red Plastic
Class II
Drug Recall · March 4, 2024
SUN PHARMACEUTICAL INDUSTRIES INC
Febuxostat Tablets 80mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, D
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II
Vehicle Recall · March 4, 2024
Volkswagen Group of America, Inc.
2023 AUDI S5, 2023 AUDI A4 ALLROAD, 2023 AUDI Q5, 2024 AUDI Q3, 2024 AUDI Q5, 2024 AUDI Q7, 2024 AUDI Q8
A deactivated front passenger air bag will not deploy during a crash, increasing the risk of injury.
Unclassified
Food Recall · March 4, 2024
la fiesta food products
La Fiesta, Canela Molida, Cinnamon Ground, 0.87oz (24.8g), UPC #032327000449, packed in cello bags
Elevated levels of lead found in product
Class II
Vehicle Recall · March 4, 2024
Aston Martin The Americas
2024 ASTON MARTIN DBX
A sudden loss of oil and oil pressure can result in the engine stalling or seizing, increasing the risk of a crash or fire.
Unclassified
Medical Device Recall · March 4, 2024
Ion Beam Applications S.A.
IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.
There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance.
Class II
Medical Device Recall · March 4, 2024
Qiagen Sciences LLC
EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications. Model Number: 9003230
Insufficient welding leads to the heater cable becoming brittle and present with an error: ERROR 3481 HEATER UNABLE TO REACH TEMPERATURE; the instrument may stop, and the sample being processed will be lost
Class II
Medical Device Recall · March 4, 2024
X-NAV Technologies, LLC
X-Guide Handpiece Adaptor Sleeve 1, Model P010701
The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect geometry in turn causes the Handpiece Adaptor to not fit onto the doctor's dental handpiece.
Class II
Medical Device Recall · March 4, 2024
Abbott GmbH
Alinity i Anti-HCV Reagent Kit, List Number 08P0521
Customer complaints were received regarding falsely elevated results for some patient samples. Internal studies with customer return samples confirmed potential interactions that may lead to falsely elevated results when processed as below on the same instrument: " ARCHITECT Syphilis TP (LN 8D06) and/or ARCHITECT AdviseDx SARS-CoV-2-IgG II (LN 6S60) precedes ARCHITECT Anti-HCV testing (LN 1L79). " Alinity i Syphilis TP (LN 07P60) precedes Alinity i Anti-HCV testing (LN 08P05).
Class II
Drug Recall · March 4, 2024
Par Sterile Products LLC
Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenous Infusion Only, 20 mL Multiple-Dose Vial, Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977. NDC: 420
Presence of Particulate Matter.
Class I
Food Recall · March 4, 2024
EL Chilar-HF, LLC
El Chilar, Canela Molida, Ground Cinnamon NET WT. 1.25 Oz (35g) , BOPP Bag, 12 units per cases
Due to elevated levels of lead.
Class II
Medical Device Recall · March 4, 2024
Abbott GmbH
ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35
Customer complaints were received regarding falsely elevated results for some patient samples. Internal studies with customer return samples confirmed potential interactions that may lead to falsely elevated results when processed as below on the same instrument: " ARCHITECT Syphilis TP (LN 8D06) and/or ARCHITECT AdviseDx SARS-CoV-2-IgG II (LN 6S60) precedes ARCHITECT Anti-HCV testing (LN 1L79). " Alinity i Syphilis TP (LN 07P60) precedes Alinity i Anti-HCV testing (LN 08P05).
Class II
Medical Device Recall · March 4, 2024
Avanos Medical, Inc.
NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Blue NonSterile, Product Code BB-S05EO; b. 12mL Oral Syringe Blue NonSterile, Product Co
The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.
Class III
Food Recall · March 4, 2024
Natural Waters of Viti Limited
Fiji Natural Artesian Water 500 mL (24 pack) Case UPC Code: 6 32565 00004 3 Bottle UPC Code: 6 32565 00001 2
Firm testing revealed Manganese in addition to three bacterial genera.
Class III
Drug Recall · March 4, 2024
SUN PHARMACEUTICAL INDUSTRIES INC
Febuxostat Tablets 40mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38141 , Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15,
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II
Drug Recall · March 4, 2024
Novitium Pharma LLC
Digoxin Tablets, USP 125mcg, (0.125 mg), 1000-count bottle, Rx Only, Manufactured by: Novitium Pharma LLC., 70 Lake Drive, East Windsor, New Jersey 08520, NDC 70954-201-20
Cross Contamination with Other Products:(mycophenolate mofetil).
Class III
Medical Device Recall · March 4, 2024
Avanos Medical, Inc.
NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a.0.5mL Oral Syringe Orange NonSterile, Product Code BC-S05EO; b. 12mL Oral Syringe Orange NonSterile, Product
The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.
Class III
Medical Device Recall · March 4, 2024
Avanos Medical, Inc.
NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Amber NonSterile, Product Code BA-S05EO; b. 12mL Oral Syringe Amber NonSterile, Product
The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.
Class III
Medical Device Recall · March 4, 2024
X-NAV Technologies, LLC
X-Guide Handpiece Adaptor Sleeve 3, Model P010727
The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect geometry in turn causes the Handpiece Adaptor to not fit onto the doctor's dental handpiece.
Class II
Medical Device Recall · March 1, 2024
Alere San Diego, Inc.
Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170
There is a potential that the Cholestech LDX battery (an external battery pack available as an optional accessory to the Cholestech LDX Analyzer) may swell which could cause minor burns, cuts or abrasions, or low current electrical shock to the user.
Class II
Medical Device Recall · March 1, 2024
Cook Incorporated
Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary an
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Class II
Medical Device Recall · March 1, 2024
SleepNet Corporation
Phantom 2 Nasal Vented Mask
Update to contraindications and warning language due to CPAP masks containing magnets.
Class I
Medical Device Recall · March 1, 2024
SleepNet Corporation
iQ 2 Nasal Vented Mask
Update to contraindications and warning language due to CPAP masks containing magnets.
Class I
Medical Device Recall · March 1, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline medical procedure kits, labeled as follows: a) PARACERVICAL PUD TRAY, REF DYNDH1832; b) AHS PARACERVICAL/PUDENDAL KIT, REF DYNJRA2210; c) PARACERVICAL/PUDENDAL BLK KIT, REF DYNJRA9046;
Trumpet Needle Guide ring can detach when excessive pressure is applied.
Class II
Medical Device Recall · March 1, 2024
SleepNet Corporation
Mojo Full Face with Headgear, All Sizes
Update to contraindications and warning language due to CPAP masks containing magnets.
Class I
Food Recall · March 1, 2024
KALO Foods, LLC
KALO Chocolate Cake All Natural Gluten Free Serving size one slice (6 oz/177g) CONTAINS MILK, EGG UPC 8 53407 00418 4 Distributed by: Kalo Foods, LLC Stokesdale, NC 27357
The product is labeled as Chocolate Cake. However, the packaging contains slices of carrot cake. The Carrot Cake contains soy which is not listed in the ingredient or allergen contain statement.
Class II
Medical Device Recall · March 1, 2024
Randox Laboratories Ltd.
Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution.
The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC.
Class II
Drug Recall · March 1, 2024
Specialty Process Labs LLC
S.P Labs, Thyroid, USP, Rx only, For Manufacturing, Processing or Repackaging Use only, Specialty Process Labs, Phoenix, AZ, NDC #'s a) 81305-100-01, b)81305-100-02, c)81305-100-03
Failed Stability Specifications
Class II
Medical Device Recall · March 1, 2024
PACIFIC LASERTECH, LLC
N-LHP-928, HeNe Laser System, 35 mW
These laser products fail to comply with 21 CFR 1040.10(f)(4) Key control which requires, Each laser system classified as a Class IIIb or IV laser product shall incorporate a key-actuated master control. The key shall be removable and the laser shall not be operable when the key is removed. , because while the laser is switched on, the key can be removed from the key switch. The correction is replacement with a key switch that captures the key when in the on position.
Class II
Medical Device Recall · March 1, 2024
Cook Incorporated
Dilator With AQ Hydrophilic Coating - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Class II
Medical Device Recall · March 1, 2024
Cook Incorporated
Chiba Biopsy Needle - Used for aspiration biopsy. REFERENCE PART NUMBER (RPN) ORDER NUMBER (GPN): 1) DCHN-18-10.0 G01559 2) DCHN-18-10.0-U G05040 3) DCHN-18-15.0 G00850 4) DCHN-22-10.0 G00852
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Class II