Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

21251–21275 of 21633

ModerateFDA (Devices)·Z-2416-2012·2012-09-26
Kimberly-Clark MIC PEG Kit Recall Due to Placement Guidewire Size Issue
Kimberly-Clark is recalling MIC PEG Kits - Pull Type because the placement guidewire is too large to pass through the introducer needle.
Product
Kimberly-Clark MIC PEG Kit - Pull Type The Kimberly-Clark MIC PEG Kits - Pull type are Percutaneous Endoscopic gastrostomy (PEG) tubes intended for a non-surgical "pull" endoscopic placement technique. The PEG tube is held in place during use with an external retention disk.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2379-2012·2012-09-26
FDA Recalls HALO Flex Energy Generators Due to Standby Mode Failure
The FDA is recalling HALO Flex Energy Generators because they may fail to enter standby mode upon startup, rendering them unusable for patient care.
Product
HALO Flex Energy Generators Manufactured by B¿RRX Medical (now Covidien) 540 Oakmead Parkway Sunnyvale, CA 95085. The HALO Flex Energy Generator is indicated for use for the coagulation of soft tissue. The HALO Flex System is indicated for use in the coagulation of…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2398-2012·2012-09-26
Bio-Rad MONOLISA Anti-HBs EIA Recalled Due to Light Exposure Issues
Bio-Rad Laboratories is recalling MONOLISA Anti-HBs EIA kits because light exposure to the Conjugate Diluent may cause false positive or grey zone results.
Product
The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog number 25220. It is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2396-2012·2012-09-26
US Endoscopy Recalls Infinity Cytology Brushes Due to Deployment Issues
US Endoscopy is recalling 393 Infinity sampling devices because the cytology brush may be difficult to deploy through the catheter.
Product
Infinity¿ sampling device, Cytology Brush, United States Endoscopy Group, Inc., 5976 Heisley Road, Mentor, OH 44060 The Infinity sampling device is a disposable cytology brush used to retrieve cytological cell samples in the gastrointestinal tract.
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-2417-2012·2012-09-26
Steris Recalls Verify Bowie-Dick Test Cards Due to Performance Issues
Steris Corporation is recalling Verify Bowie-Dick Test Cards because they may produce false fail results, potentially indicating sterilizer issues when performance is actually acceptable.
Product
Verify¿ Bowie-Dick Test Card, Model #S3098, Steris Biological Operations, 9325 Pinecone Drive, Mentor, OH 44060 The Verify Bowie-Dick Test Card consists of a card printed on one side with bars of chemical indicator ink. On the opposite side of the card, space is provided for…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-2353-2012·2012-09-26
Friendly's Sundae Nut Football Ice Cream Recalled for Foreign Material
Friendly Ice Cream Corp. is recalling 59,052 cartons of Sundae Nut Football Limited Edition ice cream due to the presence of foreign material.
Product
Friendly's Sundae Nut Football Limited Edition, 48 oz. carton UPC :0-29839-00530-7
Category
Food
Distribution
13 states
ModerateFDA (Devices)·Z-2411-2012·2012-09-26
Haag-Streit Recalls Octopus 101 Perimeters Due to Luminance Deviation
Haag-Streit USA Inc recalled 64 Octopus 101 Perimeters because of a possible deviation in stimulus luminance. The devices are used to determine the extent of a patient's peripheral visual field.
Product
Octopus 101 Perimeter; PeriTrend Software Analysis A perimeter is a device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2381-2012·2012-09-26
Integra Recalls 2.7mm Drilling Guides Due to Breakage During Use
Integra Life Sciences is recalling 2,389 units of 2.7mm Drilling Guides because they may break during surgical use, potentially increasing procedure time.
Product
The 2.7mm Drilling Guide is a reusable instrument used in conjunction with a drill to prepare oriented holes in bone for insertion of a Standard Surfix¿ Locking Screw with plates for the Tiblaxis, Uni-CP, Advansys MLP and Advansys DLP compression plate systems. The Drilling…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2414-2012·2012-09-26
DePuy S-ROM Total Hip System Poly Liner Recalled for Labeling Error
DePuy Orthopaedics is voluntarily recalling four lots of S-ROM Total Hip System Poly Liners because the carton labels contain an incorrect color code series designation.
Product
S-Rom¿ Total Hip System Poly Liner Packaging: The insert is placed into an inner foil pouch and vacuum sealed; a ring is placed into a Tyvek/PET pouch and sealed; the foil pouch and Tyvek/PET pouch are placed into a nylon outer pouch and sealed. This is then placed into a…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2413-2012·2012-09-26
FDA Recalls Mislabeled Bard Ventralight ST Mesh Surgical Products
Davol, Inc. is recalling 49 units of Bard Ventralight ST Mesh due to packaging mislabeling where product sizes do not match package labels.
Product
Bard Ventralight ST Mesh. - Ellipse 7" x 9" (17.8 cm x 22.9 cm) Product Code 5954790. The Bard Ventralight ST Mesh is a dual-component (absorbable and nonabsorbable) sterile prosthesis. The device classification name is "Mesh, Surgical, Polymeric." It is in tented for use…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2415-2012·2012-09-26
Kimberly-Clark MIC Safety PEG Kit Recall Due to Guidewire Size Issue
Kimberly-Clark is recalling 277 units of MIC Safety PEG Kits because the placement guidewire is too large to pass through the introducer needle.
Product
Kimberly-Clark MIC Safety PEG Kit - Pull Type The Kimberly-Clark MIC PEG Kits - Pull type are Percutaneous Endoscopic gastrostomy (PEG) tubes intended for a non-surgical "pull" endoscopic placement technique. The PEG tube is held in place during use with an external retention…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-2348-2012·2012-09-26
R&S Tomato Basil Tortillas Recalled for Undeclared Yellow Dye
R&S Mexican Food Products is recalling Tomato/Basil Pressed Tortillas because they contain undeclared FD&C Yellow #6. The product was distributed to four accounts in Arizona.
Product
R&S Mexican Food Products, Inc. Tomato/Basil Pressed Tortillas, 1 Dozen. Packaged in sealed flexible plastic bag.
Category
Food
Distribution
1 state
ModerateFDA (Food)·F-2358-2012·2012-09-26
Tunnel Farms Recalls Watermelons Due to Unapproved Pesticide Residue
Tunnel Farms is recalling seedless watermelons labeled 'IT'S WATERMELON TIME!' because unapproved pesticide residue was detected.
Product
Watermelon, labeled IT'S WATERMELON TIME!, Produce of USA, Seedless, #4032.
Category
Food
Distribution
1 state
ModerateFDA (Food)·F-2354-2012·2012-09-26
Friendly's Fudge Nut Brownie Sundae Extreme Recalled for Foreign Material
Friendly Ice Cream Corp. is recalling 19,860 cartons of Fudge Nut Brownie Sundae Extreme due to the presence of foreign material.
Product
Friendly's Fudge Nut Brownie Sundae Extreme, 48 oz. carton UPC: 0-29839-00657-1
Category
Food
Distribution
13 states
ModerateFDA (Food)·F-2355-2012·2012-09-26
Friendly's Nutty Caramel Crunch Sundae Recalled for Foreign Material
Friendly Ice Cream Corp. is recalling 86,136 cups of Nutty Caramel Crunch Sundae due to the presence of foreign material.
Product
Friendly's Brand Nutty Caramel Crunch Sundae, 6 0z. UPC: 0-29839-00050 Weis Crunchy Caramel Nut Sundae, 6 0z cup UPC 0-41497-01573-3
Category
Food
Distribution
13 states
ModerateFDA (Devices)·Z-2409-2012·2012-09-26
Siemens ADVIA Centaur Prolactin Assay Recalled for Analytical Sensitivity Failure
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Prolactin Assay and Calibrator B kits because they fail to meet the analytical sensitivity stated in the instructions for use.
Product
ADVIA Centaur Prolactin Assay: ADVIA Centaur Calibrator B Catalog Number. Prolactin:110757 and 110758: US:Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) OUS: 2 pack REF: 00650577 and Ref: 00654130 (6 pack) Product Usage: ADVIA Centaur CP Prolactin assay: For in…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2431-2012·2012-09-26
Sekisui Spectrolyse PAI-1 Assay Recalled for Lower Absorbance Values
Sekisui Diagnostics is recalling Spectrolyse PAI-1 kits because they produce lower than expected absorbance values, which may require more frequent sample dilutions.
Product
Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of Plasminogen Activator Inhibitor Type- 1 (PAI-1) activity in human plasma. Catalog Number: 101201 For the determination of Plasminogen Activator Inhibitor Type 1 (PAI-1) activity in human…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2412-2012·2012-09-26
FDA Recalls Mislabeled Bard Ventralight ST Mesh Surgical Products
Davol, Inc. is recalling 49 units of Bard Ventralight ST Mesh due to size mislabeling on the packaging.
Product
Bard Ventralight ST Mesh. - Ellipse 8" x 10" (20.3 cm x 25.4 cm) Product Code 5954810. The Bard Ventralight ST Mesh is a dual-component (absorbable and nonabsorbable) sterile prosthesis. The device classification name is "Mesh, Surgical, Polymeric." It is in tented for use…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2401-2012·2012-09-26
Zoll X Series Defibrillators Recalled for Incorrect Software
ZOLL Medical Corporation is recalling 11 Zoll X Series Defibrillator/Pacemaker/Monitor units because they were shipped with incorrect software.
Product
Zoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The product is used by qualified medical personnel for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. In…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F2225-2012·2012-09-19
Thai Farmer Brand Preserved Star Gooseberry Recalled for Undeclared Dye
T.F. Foods Incorporated is recalling Thai Farmer Brand Preserved Star Gooseberry because it contains undeclared FD&C Yellow #6.
Product
Thai Farmer Brand Preserved Star Gooseberry, NET WT 7.0 OZ. Packaged 30 per case. Product labeling reads in part:"***THAI FARMER BRAND PRESERVED STAR GOOSEBERRY*** DISTRIBUTED BY: T.F. FOODS, INC. PARAMOUNT, CA 90723***NET WT. 7.0 OZ***PRODUCT OF THAILAND***".
Category
Food
Distribution
2 states
ModerateFDA (Devices)·Z-2376-2012·2012-09-19
GE Healthcare Recalls Innova 2121IQ and 3131IQ X-ray Systems
GE Healthcare is recalling Innova 2121IQ and 3131IQ systems due to a potential loss of imaging mode requiring a restart.
Product
GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging systems. K060259: The Innova 3131IQ (3131-IQ) and 2121 IQ (2121-IQ) biplane systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and…
Category
Medical Device
Distribution
33 states
ModerateFDA (Devices)·Z-2345-2012·2012-09-19
Volcano Intravascular Ultrasound Software Recall Due to Display Changes
Volcano Corporation is recalling specific Intravascular Ultrasound software versions because the system display may change unexpectedly. The issue requires a unique sequence of events to occur.
Product
Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version 3.2.1 or 3.2.2, Models/Part Numbers: 435-0607.01, 435-0607.04, 435-0602.01, 435-0602.02; Product is manufactured and distributed by Volcano Corporation, Rancho Cordova, CA. Medical device for use…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2368-2012·2012-09-19
Lucero Medical Recalls Enduramesh Spacers Due to Sterilization Validation Failure
Lucero Medical LLC is voluntarily recalling 169 Enduramesh Corpectomy Spacer Systems because the sterilization recommendations on the product insert did not pass sterilization validation.
Product
Enduramesh Corpectomy Spacer System Product Usage: The Enduramesh is a vertebral body replacement system intended for use in the thoracic and lumbar spine (T1-S1) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma/fracture. The device is…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2332-2012·2012-09-19
Sunquest Laboratory Software Recalled for Patient Data Merge Errors
Sunquest Information Systems is recalling specific versions of its Laboratory software because a merge function may cause receiving systems to incorrectly merge patient data.
Product
Sunquest Laboratory Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. Sunquest Laboratory is intended for use only by professionals who have received extensive training in the use of the software. Sunquest Laboratory is controlled via…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2340-2012·2012-09-19
Elekta Agility Multileaf Collimator Recall for Missing Compatibility Information
Elekta is recalling two Agility Multileaf Collimators because the original product information did not specify compatibility with the Dynamic Multileaf Collimator Apex add-on.
Product
Multileaf Collimator To be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated.
Category
Medical Device
Distribution
Distributed nationwide