May 2023 recalls

754 recalls were announced in May 2023.

What the numbers show

Critical: 15
Severe: 132
High: 528
Moderate: 72
Low: 7

Of the 754 recalls this month scored against our rubric, 2% are Critical, 18% are Severe.

Which agencies issued them

701–754 of 754

HighFDA (Devices)·Z-1421-2023·2023-05-03
Carefusion Vaginal Specula Recalled for Incorrect Labeling and Packaging
Carefusion recalled 726 units of two vaginal specula models with labels and laser etchings switched during packaging. This mislabeling could result in use of an unintended product.
Product
(1) Carefusion V. Mueller Graves Vaginal Speculum, Catalog #GL11, Medium Blade, 4 x 1 3/8" (10.2 X 3.5cm); and (2) Carefusion V. Mueller Pederson Vaginal Specula, Catalog #GL31, Medium, 4 x 7/8" (10.2 x 2.2cm).
Category
Medical Device
Distribution
36 states
HighFDA (Devices)·Z-1461-2023·2023-05-03
GEM NEUROTUBE Nerve Repair Mesh Recalled for Brittleness and Potential Crumbling
Baxter Healthcare's GEM NEUROTUBE absorbable mesh tube, used for peripheral nerve repair, is recalled because the product is brittle and may crumble when handled or removed from packaging. The recall affects 169 units distributed worldwide.
Product
GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a) 5311-01240-010, b) 5311-01240-012; for peripheral nerve repair
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1437-2023·2023-05-03
Surgical Convenience Kits Recalled Due to Separating Light Handle Covers
ROi CPS LLC is recalling sterile surgical convenience kits because light handle covers may separate and fall off during use. The affected kits were distributed in Florida and Missouri.
Product
Sterile surgical convenience kits: 1. regard Item Number: 800756005, NU00961E - OH Laminectomy Cust Pack; 2. regard Item Number: 880411008, NU01018H - Lumbar Universal ; 3. regard Item Number: 880396007, NU01001G - Craniotomy ; 4. regard Item: 880387005, NU00991E - An
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0842-2023·2023-05-03
Dole Chopped Kit Teriyaki Pineapple recalled for undeclared milk allergen
Dole Fresh Vegetables Inc is recalling Dole Chopped Kit Teriyaki Pineapple salads due to undeclared milk allergen. The product was distributed in Florida, Pennsylvania, Virginia, Tennessee, and Louisiana.
Product
Dole Chopped Kit Teriyaki Pineapple iceberg lettuce green leaf lettuce red cabbage sliced almonds teriyaki pineapple dressing crunchy noodles dried pineapples carrots Salad & Topping Net Wt.: 7.5 oz (212 g) Dressing Net: 1.9 fl oz (57 mL) Total Net Wt: 98.8 oz (276 g) Thoroughly
Category
Food
Distribution
5 states
HighFDA (Drugs)·D-0554-2023·2023-05-03
Tadalafil Tablets Recalled Due to Manufacturing Practice Violations
Northwind Pharmaceuticals is recalling 23 bottles of Tadalafil 5 mg tablets nationwide due to manufacturing process deviations. The FDA classified this as a Class II recall.
Product
TADALAFIL — TADALAFIL (TADALAFIL)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1433-2023·2023-05-03
Sterile surgical kit recalled due to light handle cover separation risk
ROi CPS LLC is recalling sterile surgical convenience kits because light handle covers may separate and fall off during use. Approximately 70 kits were distributed in Florida and Missouri.
Product
Sterile surgical convenience kit: regard Item Number: 800718003, GY00923C - WPH Major Vaginal Pack.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1438-2023·2023-05-03
Surgical Kit Light Handle Covers May Separate During Use
ROi CPS LLC is recalling 1,369 sterile surgical convenience kits because light handle covers may separate and fall off during use. The affected kits were distributed nationwide in Florida and Missouri.
Product
Sterile surgical convenience kits: 1. regard Item Number: 880473001, OR01105A - Total Shoulder/Hip; 2. regard Item Number: 880426004, OR01033D - Total Hip; 3. regard Item Number: 880427003, OR01034C - Total Knee; 4. regard Item Number: 880474001, OR01106A - Knee Arthro
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1472-2023·2023-05-03
Draeger Infinity M300 Patient Monitor Software Displays Inaccurate ECG Readings
Draeger Infinity M300/M300+ patient monitoring systems may display or print ECG waveforms with inaccurate QRS amplitudes due to software peaks being dropped on narrow waveforms.
Product
Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and pulse oximetry on ambulatory and non-ambulatory adult and pediatric patients using wireless communication over the Infinity patient monitoring network,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0752-2023·2023-05-03
Enriched Hot Dog Buns Recalled for Undeclared Sesame Allergen
Our Family White Hot Dog Enriched Buns are being recalled due to undeclared sesame. The recall affects approximately 28,700 units distributed in Michigan, Ohio, Indiana, and Illinois, and poses a risk to consumers with sesame allergies.
Product
Our Family White Hot Dog Enriched Buns, 8 count 12oz. retail unit UPC 0-70253-75107-3
Category
Food
Distribution
4 states
HighFDA (Devices)·Z-1436-2023·2023-05-03
Sterile surgical C-section kit light handle covers recalled for separation risk
ROi CPS LLC recalls sterile surgical C-section kits due to light handle covers that may separate and fall during use. The recall affects 1,312 kits distributed in Florida and Missouri.
Product
Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0569-2023·2023-05-03
Fyremadel Ganirelix Acetate Injection Recalled for Glass Contamination
Sun Pharmaceutical is recalling 24,194 prefilled syringes of Fyremadel (ganirelix acetate) injection due to glass contamination found in a unit from lot HAD1190A. The recall affects units distributed nationwide with expiration 02/2024.
Product
FYREMADEL — FYREMADEL (GANIRELIX ACETATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1467-2023·2023-05-03
Stryker ORTHOLOC 3Di Fusion Plate Recalled for Incorrect Marked Descriptions
Wright Medical Technology is recalling Stryker ORTHOLOC 3Di Fusion Plate MTP Right surgical implants due to incorrect dorsiflexion descriptions laser marked on 50 units distributed nationwide.
Product
stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization and fixation
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1463-2023·2023-05-03
VersaOne Reusable Positioning Cannula Recalled for Internal Metal Burr
Covidien LP is recalling 145 units of the VersaOne Reusable Positioning Cannula due to a manufacturing defect that may create a metal burr inside the device at the weld joint.
Product
VersaOne Reusable Positioning Cannula 8 mm Standard, Model Number RC8STS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0762-2023·2023-05-03
Rajbhog Sweets Orange Jalebi Recalled Due to Undeclared Milk Allergen
Rajbhog Sweets Orange Jalebi is recalled because the product label does not clearly disclose milk as an allergen, despite containing butter. Consumers with milk allergies who purchase this product face a health risk.
Product
Rajbhog Sweets Orange Jalebi Net Weight: 10 oz. UPC 3542647018 packaged in a plastic container and in bulk sold by weight
Category
Food
Distribution
1 state
HighFDA (Drugs)·D-0543-2023·2023-05-03
Peritoneal dialysis solution recalled due to sterility assurance concerns
Baxter Healthcare Corporation is recalling 9,788 bags of Dianeal Low Calcium with Dextrose peritoneal dialysis solution due to potential leaks in the Luer component. The recall affects Lot Y405201 distributed nationwide in the United States.
Product
DIANEAL LOW CALCIUM WITH DEXTROSE — DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1464-2023·2023-05-03
VersaOne Positioning Cannula Recalled for Metal Burr Manufacturing Defect
Covidien LP recalls VersaOne Reusable Positioning Cannula due to manufacturing defect that may leave a metal burr inside the device. No injuries reported.
Product
VersaOne Reusable Positioning Cannula 11mm Standard, Model Number RC11STS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0768-2023·2023-05-03
Cookies con Amore Italian Cookies Recalled for Undeclared Almond Allergen
Con Amore, Inc. is recalling Cookies con Amore Spring Assortment handmade Italian cookies because the product contains undeclared tree nuts (almonds), posing a serious risk to consumers with nut allergies.
Product
Cookies con Amore handmade italian cookies Spring Assortment 32 oz (907g) Contains Allergens: Wheat, Dairy, Egg This product is produced in a facility that uses wheat, sesame seeds, and a variety of tree nuts. www.cookiesconamore.com Con Amore, Inc. San Marcos, CA UPC 8 92886 000
Category
Food
Distribution
3 states
HighFDA (Devices)·Z-1469-2023·2023-05-03
Angiography system display malfunction affects diagnostic imaging capability
Siemens recalls the ARTIS one angiography system due to a hybrid cable display issue that may prevent image function on examination room monitors. Four US units are affected.
Product
ARTIS one with a hybrid cable- An angiography system developed for diagnostic imaging and interventional procedures. Material Number: 10848600
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1431-2023·2023-05-03
Surgical Convenience Kits Recalled for Separating Light Handle Covers
ROi CPS LLC is recalling sterile surgical convenience kits because light handle covers may separate and fall off during use. The recall affects 278 kits distributed in Florida and Missouri.
Product
Sterile surgical convenience kits: 1. regard Item Number: 880405003, GS01011C - General Laparoscopy; 2. regard Item Number: 880424004, GS01031D - Thoracic.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1426-2023·2023-05-03
Lateral lumbar spine implant plate may disassemble during surgery
SPINEART's JULIET Ti LL lateral lumbar implant plates may disassemble during preparation or implant removal, causing surgical delays. The FDA is recalling 544 affected units distributed across eight US states.
Product
JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE SMALL, REF: JLT-PL 02 08-S, JLT-PL 02 10-S, JLT-PL 02 12-S, JLT-PL 02 14-S, JLT-PL 02 16-S; JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE LARGE, REF: JLT-PL 04 08-S, JLT-PL 04 10-S, JLT-PL 04 12-S, JLT-PL 04 14-S, JLT-PL 04 16-S, JLT-PL
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1465-2023·2023-05-03
VersaOne Reusable Positioning Cannula Recalled Due to Internal Metal Burrs
Covidien LP is recalling VersaOne Reusable Positioning Cannulas (Model RC12STS) due to manufacturing defects that may produce metal burrs on the inside of the device, potentially causing internal tissue damage during use.
Product
VersaOne Reusable Positioning Cannula 12mm Standard, Model Number RC12STS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1424-2023·2023-05-03
Endoscopic Forceps May Fail to Open When Shaft Bent
Surgical grasping forceps may fail to open when the endoscope shaft is bent, potentially affecting their use during endoscopic procedures.
Product
FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 8735.685
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1471-2023·2023-05-03
Draeger Infinity CentralStation ECG waveform display inaccuracy due to software defect
Draeger Infinity CentralStation patient monitors may display ECG waveform amplitudes lower than actual values due to a software bug affecting versions VG2.1.3 and lower.
Product
Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment, Software versions VG2.1.3 and lower
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0761-2023·2023-05-03
Rajbhog Sweets Yellow Jalebi Recalled for Missing Milk Allergen Labeling
Rajbhog Sweets Yellow Jalebi is recalled because the product label lists butter but does not include the common allergen name 'milk.' Milk-allergic consumers face risk if they consume this product.
Product
Rajbhog Sweets Yellow Jalebi Net Weight: 10 oz. UPC 3542647018 packaged in a plastic container and in bulk sold by weight
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-1425-2023·2023-05-03
Surgical forceps may fail to open during endoscopic procedures
Richard Wolf surgical forceps may fail to open when the endoscope shaft is bent. Affected units distributed worldwide; users should check lot numbers and discontinue use if affected.
Product
FLEX. GRASP. FORCEPS 6.6FR WL 550MM, Product Number 8736.685
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1466-2023·2023-05-03
Stryker ORTHOLOC 3Di Fusion Plate Contains Incorrect Laser Markings
Wright Medical Technology recalls Stryker ORTHOLOC 3Di Fusion Plate MTP Right devices due to incorrect dorsiflexion descriptions laser marked on the parts. 41 units distributed nationwide.
Product
stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixation
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1432-2023·2023-05-03
Sterile Surgical Kits Recalled Due to Light Handle Cover Separation Risk
ROi CPS LLC is recalling 662 sterile surgical convenience kits because light handle covers may separate from the light handle and fall off during use. The kits were distributed in Florida and Missouri.
Product
Sterile surgical convenience kits: 1. regard Item Number: 880353009, GS00797I - Laparotomy Pk; 2. regard Item Number: 880429002, GS01036B - Universal Custom ; 3. regard Item Number: 800725004, GS00930D - OH Base Robot Pack ; 4. regard Item Number: 800725005, GS00930E - O
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1434-2023·2023-05-03
Sterile surgical cardiac catheterization kit recalled for light handle cover separation
A sterile surgical convenience kit for cardiac catheterization is being recalled because light handle covers may separate and fall off during use. The affected lot includes 322 kits distributed to Florida and Missouri.
Product
Sterile surgical convenience kit: regard Item Number: 880393003, HT00997C - Cardiac Cath.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1468-2023·2023-05-03
Mani Trocar Kits Recalled for Packaging Defect Compromising Sterility
Mani Trocar Kits (Models MTK23S and MTK25S) are being recalled due to a packaging defect that may compromise the sterile barrier. The recall affects 45 kits distributed to one consignee in Missouri.
Product
Mani Trocar Kit, Model MTK23S and Model MTK25S There are 3 kits contained in one box, and sterile 1 kit consists of 3 pcs. trocar with the valved cannula and 1 pc. infusion cannula.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1435-2023·2023-05-03
Sterile Surgical Kit Light Handle Covers May Separate During Use
ROi CPS LLC is recalling 386 sterile surgical convenience kits (WPH GYN Laparoscopy Pack) because light handle covers may separate and fall off during use.
Product
Sterile surgical convenience kit: regard Item Number: 800753005, GY00958E - WPH GYN Laparoscopy Pack.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0767-2023·2023-05-03
Baklava from Paximadi Co recalled for undeclared soybean oil
Paximadi Co LLC is recalling Baklava manufactured on 3/29/2023 for undeclared soybean oil. Consumers with soybean allergies should not consume the product.
Product
Baklava, 2 oz. Each cardboard box contains 25 units (net wt. 50 oz). No UPC. The Ingredients statement declares: Fillo (Enriched, Non-Bromine Bleached Wheat Flour, Thiamin, Mononitrate, Riboflavin, Niacin, Iron, Folic Acid, Water, Corn Starch, Vegetable Oil (Corn or Canola)***Wal
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-1429-2023·2023-05-03
Hamilton HAMILTON-C6 Ventilator Software Error Disables Patient Input Monitoring
The HAMILTON-C6 ventilator (103 units) has a software error that disables patient input monitoring when switching to adaptive ventilation modes with a connected controller or humidifier. The device will alarm but cannot respond to patient inputs.
Product
HAMILTON-C6, REF: 160021
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0542-2023·2023-05-03
Dianeal Low Calcium Dialysis Solution Recalled for Potential Sterility Loss
Baxter Healthcare is recalling Dianeal Low Calcium peritoneal dialysis solution nationwide due to potential leaks from the container that could compromise sterility. Affected patients should contact their healthcare provider.
Product
DIANEAL LOW CALCIUM WITH DEXTROSE — DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0550-2023·2023-05-03
Prescription drug recall for manufacturing quality control deviations
Northwind Pharmaceuticals is recalling 33 bottles of Doxazosin 4mg tablets due to manufacturing quality control deviations. No illnesses or injuries have been reported.
Product
DOXAZOSIN — DOXAZOSIN (DOXAZOSIN)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0750-2023·2023-05-03
Shirakiku Sanuki Udon Noodles Recalled for Undeclared Fish Allergen
Wismettac Asian Foods recalls Shirakiku Brand Japanese Style Noodle Sanuki Udon due to undeclared fish allergen. The product was distributed in California, Colorado, Georgia, and Arizona.
Product
Shirakiku Brand Japanese Style Noodle "Ajihel" Sanuki Udon 3-servings NET WT. 19.04 oz 1.19 LBS. (540g) Item #45545 Ingredients: Water, Wheat Flour, Salt, Acidity regulator (Lactic Acid, Trehalose, Roasted Rice Bran Extract, Corn). Allergy Information: Contains Wheat.
Category
Food
Distribution
4 states
HighFDA (Devices)·Z-1422-2023·2023-05-03
Surgical forceps may fail to open when endoscope shaft is bent
Richard Wolf surgical forceps may fail to open when used during endoscopic procedures if the endoscope shaft becomes bent. Approximately 838 units are affected worldwide.
Product
FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 828.051
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0546-2023·2023-05-03
DuPont Avicel PH-200 NF pharmaceutical ingredient recalled for conductivity specification failure
DuPont is recalling Avicel PH-200 NF microcrystalline cellulose, a pharmaceutical ingredient, for failing conductivity specifications. The bulk ingredient was distributed to drug manufacturers in the USA and internationally.
Product
Avicel PH-200 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA; Manufactured in USA; Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1,
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0548-2023·2023-05-03
Atorvastatin Calcium Tablets Recalled for Manufacturing Quality Violations
Northwind Pharmaceuticals is recalling 99 bottles of Atorvastatin Calcium 10 mg tablets nationally due to manufacturing process deviations identified in March 2023.
Product
ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0540-2023·2023-05-03
Pantoprazole Sodium Injection 40 mg Recalled Due to Manufacturing Procedure Deviation
Methapharm Inc is recalling Pantoprazole Sodium 40 mg injection vials due to a manufacturing procedure deviation. Affected products were inadvertently placed into distribution without proper compliance with approved procedures.
Product
Pantoprazole sodium for Injection 40 mg*/vial, Single-dose Vial, Rx only, For Intravenous Infusion Only, Mfd. for Methapharm, Inc. Coral Springs, FL, 33065, NDC 67850-150-10 (carton), NDC 67850-150-00 (vial).
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1462-2023·2023-05-03
Cardiosave Hybrid Intra-Aortic Balloon Pump Power Cord Incompatible with Brazilian Outlet
Datascope Corp. is recalling 54 units of the Cardiosave Hybrid Intra-Aortic Balloon Pump distributed to Brazil. The Type J power cord plug is incompatible with Brazilian Type N electrical receptacles.
Product
MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32
Category
Medical Device
Distribution
0 states
ModerateFDA (Drugs)·D-0549-2023·2023-05-03
Drug Recall: Buspirone Tablets Over Manufacturing Process Deviations
Northwind Pharmaceuticals is recalling Buspirone Hydrochloride 7.5 mg tablets due to manufacturing process deviations. The FDA Class II recall affects bottles distributed nationwide.
Product
BUSPIRONE HYDROCHLORIDE — BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0552-2023·2023-05-03
Prescription Drug Glimepiride Tablets Recalled Due to Manufacturing Deviations
Northwind Pharmaceuticals recalls specific lots of Glimepiride 4mg tablets due to manufacturing practice deviations. Affected tablets were distributed nationwide.
Product
GLIMEPIRIDE — GLIMEPIRIDE (GLIMEPIRIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0555-2023·2023-05-03
FDA recalls Oxytocin product for low potency nationwide
SCA Pharmaceuticals is recalling Oxytocin 30 units in 0.9% Sodium Chloride solution (73,312 containers) nationwide due to subpotency—product contains insufficient active ingredient.
Product
Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor, CT 06095, NDC# 70004-085-44
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0553-2023·2023-05-03
Tadalafil Tablets 20 mg recalled due to manufacturing deviations
Northwind Pharmaceuticals voluntarily recalls Tadalafil 20 mg tablets nationwide due to manufacturing practice deviations. No illnesses have been reported.
Product
TADALAFIL — TADALAFIL (TADALAFIL)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1430-2023·2023-05-03
Caspar Cervical Retractor Basket Lids Recalled for Incorrect GTIN Labeling
Aesculap Implant Systems recalls Caspar Cervical Retractor (CCR) Basket lids with incorrect GTIN labeling. The product bears GTIN #04046955299592 instead of the correct #04046955299607.
Product
Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cervical Retractor (CCR) Basket Full System - Lid Only. A lid to a container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments. Note: The CCR basket
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0541-2023·2023-05-03
CBD Metered Dose Inhaler Recalled for Marketing Without FDA Approval
Wellness BioSciences is recalling its CBD Metered Dose Inhaler nationwide because it was marketed without an approved NDA/ANDA.
Product
CBD Metered Dose Inhaler (CBD) 5 mg Dose, 1 Metered Dose Inhaler, 100 Metered Sprays, Wellness BioSciences Rx
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0547-2023·2023-05-03
DuPont Avicel DG pharmaceutical ingredient recalled for failed quality specification
DuPont Nutrition USA is recalling Avicel DG, a pharmaceutical ingredient, due to failed quality specifications. The product did not meet conductivity standards during manufacturing testing.
Product
Avicel DG, MCC/Dibasic Calcium Phosphate, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA; Manufactured in USA; Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copenh
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0551-2023·2023-05-03
FDA Recalls Glimepiride Tablets for Manufacturing Deviations
Northwind Pharmaceuticals is voluntarily recalling Glimepiride 2mg tablets distributed nationwide due to Good Manufacturing Practice (CGMP) deviations identified during manufacturing.
Product
GLIMEPIRIDE — GLIMEPIRIDE (GLIMEPIRIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0544-2023·2023-05-03
DuPont Recalls Avicel PH-101 Microcrystalline Cellulose for Out-of-Specification Conductivity
DuPont Nutrition USA is recalling specific batches of Avicel PH-101 NF microcrystalline cellulose due to failed conductivity specifications. The pharmaceutical excipient was distributed in bulk to manufacturers in the USA and multiple international locations.
Product
Avicel PH-101 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 50.0 KG / 54.5 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA; Manufactured in USA; Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1,
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0545-2023·2023-05-03
FDA recalls Avicel PH-102 microcrystalline cellulose bulk ingredient for specification failure
DuPont Nutrition is recalling Avicel PH-102 microcrystalline cellulose due to conductivity specification failures in 14 batches distributed across the USA and internationally.
Product
Avicel PH-102 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA; Manufactured in USA; Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1,
Category
Drug
Distribution
Distributed nationwide
HighNHTSA·23V310000·2023-05-02
Mack Recalls 2024 LR Electric Garbage Trucks Due to Inoperative Horns
Mack Trucks is recalling 2024 LR electric garbage trucks because a missing circuit renders the horn inoperative, increasing crash risk.
Product
MACK — MACK LR
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·23V309000·2023-05-02
Mercedes-Benz Recalls 2022-2023 EQS and EQE Models for Battery Software Defect
Mercedes-Benz is recalling 3,828 vehicles because high-voltage battery monitoring software may fail to alert drivers of malfunctions, increasing injury risk.
Product
MERCEDES-BENZ — MERCEDES-BENZ AMG EQS 53, EQS 580, EQS 450+, EQS580
Category
Vehicle
Distribution
Distributed nationwide
HighUSDA FSIS·PHA-050220230-01·2023-05-02
Frozen Meatloaf Entrees Recalled for Undeclared Milk Allergen
USDA FSIS issued a public health alert for A.J. Sons frozen meatloaf entrees containing undeclared milk. Consumers with allergies to milk, egg, soy, or wheat should not consume these products.
Product
A.J. Sons, Inc. — FSIS Issues Public Health Alert for Frozen Meatloaf Entree Products Due to Misbranding and Undeclared Allergens
Category
Food
Distribution
1 state
HighNHTSA·23V308000·2023-05-01
Tiffin Allegro Breeze motorhomes recalled for condensation water and fire hazard
Tiffin is recalling 2020-2023 Allegro Breeze motorhomes because condensation can leak into electrical connections and increase fire risk. Repairs are free at dealers.
Product
TIFFIN — TIFFIN ALLEGRO BREEZE
Category
Vehicle
Distribution
Distributed nationwide

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