Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

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.

44451–44475 of 50511

HighFDA (Devices)·Z-0346-2013·2012-11-28
Beckman Coulter Recalls UniCel Dxl 600 Access Immunoassay Systems
Beckman Coulter is recalling 432 UniCel Dxl 600 Access Immunoassay Systems due to confirmed field modifications to probe assemblies.
Product
UniCel Dxl 600 Access Immunoassay System, Part Numbers: A30260, A71460, and A71461. The UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0697-2013·2012-11-28
Rudi's Organic Bakery Recalls Cinnamon Raisin Bread Due to Metal Objects
Charter Baking Company is voluntarily recalling Rudi's Organic Bakery Cinnamon Raisin bread loaves due to the possible presence of small metal objects.
Product
Rudi's Organic Bakery, Cinnamon Raisin, 24 oz, UPC 031493-92183-1, packed in flexible plastic bags. Labeling is tan, yellow, white, blue, maroon, and orange with white, black, green, maroon, and orange print writing.
Category
Food
Distribution
1 state
HighFDA (Food)·F-0720-2013·2012-11-28
Sartori Salsa Recalled for Possible Listeria Contamination
Sartori Inspirations is recalling Famous Thick Salsa due to possible Listeria monocytogenes contamination from recalled onion mixes.
Product
Famous Thick Salsa packaged in 7 oz clear plastic containers, manufactured by Sartori Inspirations, LLC, Lafayette, CO 80026.
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0405-2013·2012-11-28
Carl Zeiss Meditec Recalls INTRABEAM Balloon Applicator Sets Due to Manufacturing Defect
Carl Zeiss Meditec is recalling 36 INTRABEAM Balloon Applicator Sets because a manufacturing defect could cause a small tube to become dislodged.
Product
INTRABEAM Balloon Applicator Set; 3.5 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0431-2013·2012-11-28
Stryker Orthobiologics Recalls Vita Plasma Separator Components
Stryker Orthobiologics is recalling 3,268 units of the Vita Plasma Separator due to a risk of blood displacement during use.
Product
Styker Orthobiologics Vita Plasma Separator, a component of Vitagel Surgical Hemostat. Sterile, single use device designed to prepare plasma from the patient's blood using a tabletop centrifuge.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0413-2013·2012-11-28
Captiva Spine Recalls CapLOX II Final Torque Driver Due to Premature Breakage
Captiva Spine is recalling 10 units of the CapLOX II Final Torque Driver because the device may break prematurely during use.
Product
CapLOX II Final Torque Driver, Indicator is a Pedicle screw spinal system. The CapLOX II Spinal System is a posterior, non-cervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to…
Category
Medical Device
Distribution
Distributed nationwide
HighCPSC·13052·2012-11-28
Sportspower Recalls Children's Waterslides Due to Injury Hazard
Sportspower is recalling Liquid Motion waterslides sold at Menards because inadequate warning labels pose a risk of serious neck injuries.
Product
Liquid Motion waterslides
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Food)·F-0709-2013·2012-11-28
Titan Gelatin Dessert Recalled for Undeclared Yellow #5 Allergen
Postres de Aqui, Inc. is recalling Titan Gelatin Dessert in Orange and Strawberry flavors due to undeclared Yellow #5.
Product
"Titan Gelatinas***Postres de gelatina (Gelatin Dessert)***Sabor a China (Orange flavored)***Sabor a Fresa (Strawberry flavored)"
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-0388-2013·2012-11-28
Stryker Recalls 6.5mm Cancellous Bone Screws Due to Packaging Mix-Up
Stryker is recalling 6.5mm Cancellous Bone Screws because packaging may contain the wrong screw length, potentially leading to incorrect surgical fixation.
Product
Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6535-1 The 6.5mm Cancellous Bone Screws are used in THA when the surgeon elects to use a cluster/multi-hole shell in the acetabulum. The screws are intended to provide initial cup fixation and help prevent…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0347-2013·2012-11-28
Beckman Coulter Recalls UniCel DxC Immunoassay Systems Due to Field Modifications
Beckman Coulter is recalling UniCel DxC and Dxl Immunoassay Systems because field modifications were made to the aspirate and dispense probe assemblies.
Product
UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems, Part Numbers: A64871, A64903, A64935, A59102. The UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0721-2013·2012-11-28
Sartori Salsa Cream Cheese Recalled for Listeria Risk
Sartori Inspirations is recalling Salsa Cream Cheese due to possible Listeria monocytogenes contamination from recalled onion mixes.
Product
Salsa Cream Cheese packaged in 7 oz clear plastic containers, manufactured by Sartori Inspirations, LLC, Lafayette, CO 80026.
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0430-2013·2012-11-28
Biomerieux Recalls 0.9% Sodium Chloride Injections for VITEK 2 System Use
Biomerieux Inc is recalling 0.9% Sodium Chloride Injections that were distributed as 0.45% Sodium Chloride Saline bags for use with the VITEK 2 system.
Product
0.9% Sodium Chloride Injections, USP, 1000ml, VWR/Baxter Product Usage: The concentrated sodium chloride is used to prepare inoculum that is analyzed by the VITEK 2 instrument. The VITEK 2 user manual instructs all users to prepare inoculum with 0.45%-0.50% sodium chloride…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0417-2013·2012-11-28
SpineFrontier Recalls S-Lift Implant Guides Due to Over-insertion Risk
SpineFrontier, Inc. is recalling 19 units of S-Lift Implant Guides because using them without stops may allow over-insertion, potentially causing patient injury.
Product
S-Lift Implant Guides (also known as S-LIF) Compressor Part Number: 11-50223 Product Usage: Surgical Guides allow a surgeon to place implants into tight spaces, such as a vertebral disc space, without having the implant contact the surrounding bone or tissue. In the case…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0344-2013·2012-11-28
Extremity Medical Recalls IO Fix IntraOsseous Fixation System Due to Screw Failure
Extremity Medical LLC is recalling 120 units of the IO Fix IntraOsseous Fixation System because product event reports indicate lag screws may pass through washers during surgery.
Product
IO Fix IntraOsseous Fixation System; Extremity Medical. www.extremitymedical.com; Customer Service: 888.499.0079. The Extremity Medical Screw and Washer System is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extrarticular fractures and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0372-2013·2012-11-28
NuVasive Recalls 5.5mm Noncannulated Screw Shanks Due to Disengagement Risk
NuVasive Inc is recalling 240 units of 5.5mm x 50mm Noncannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.
Product
5.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0406-2013·2012-11-28
INTRABEAM Balloon Applicator Set Recalled for Manufacturing Defect
Carl Zeiss Meditec is recalling INTRABEAM Balloon Applicator Sets due to a manufacturing defect that could cause a small tube to become dislodged.
Product
INTRABEAM Balloon Applicator Set; 4.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0410-2013·2012-11-28
Zimmer Recalls Multipolar Bipolar Cup Liners Due to Assembly Error
Zimmer, Inc. is removing 195 Multipolar Bipolar Cup Liners because the split poly ring was incorrectly assembled. The recall covers units distributed in the US and several international countries.
Product
Multipolar¿ Bipolar Cup Liner 22 mm LD.; Item 00-5001-040-22 Product Usage: The liner snaps into the Multipolar¿ Bipolar Cup and serves as the articulation surface for the femoral head. The split poly locking ring helps contain the head within the liner and also provides a…
Category
Medical Device
Distribution
Distributed nationwide
HighCPSC·13050·2012-11-28
G-U Hardware Recalls Window Fittings Due to Injury Hazard
G-U Hardware is recalling approximately 5,000 window fittings because they can break, causing windows to fall and posing an injury hazard.
Product
Window Fittings: Tilt-turn Stay Arms and Side-hung Sash Hinges
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0404-2013·2012-11-28
Carl Zeiss Meditec Recalls INTRABEAM Balloon Applicator Sets
Carl Zeiss Meditec is recalling 36 INTRABEAM Balloon Applicator Sets due to a manufacturing defect that could cause a small tube to become dislodged.
Product
INTRABEAM Balloon Applicator Set; 3.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0382-2013·2012-11-28
Stryker Spine Recalls Specialty Audible Torque Wrenches Due to Fracturing Tips
Stryker Spine is recalling 28 units of Specialty Audible Torque Wrenches because the hex tips have fractured during use.
Product
SPECIALTY AUDIBLE TORQUE WRENCH, XIA IS2217XLP MFG BY: STRYKER SPINE 2 PEARL COURT ALLENDALE NJ 07401-1677 The Xia 3/Mantis Redux/Specialty Audible Torque Wrenches are used to final tighten the blocker of the Xia 3/ Mantis Redux Polyaxial Screws, Hooks, Monoaxial…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0366-2013·2012-11-28
NuVasive Recalls 7.5mm Cannulated Screw Shanks Due to Disengagement Risk
NuVasive Inc is recalling 240 units of 7.5mm x 55mm Cannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.
Product
7.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-062-2013·2012-11-28
Sterling Gelatin Recalls Limed Bone Gelatin Due to C. Difficile Contamination
American Enterprises LLC is recalling 750 kgs of Limed Bone Gelatin due to possible C. difficile contamination in the raw material.
Product
Limed Bone Gelatin, packaged in six 125 kg fiber drums and labeled in part PO NO.: P8095 GELATIN 75 BLOOM ITEM NO. RM 164. MADE IN INDIA
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-0385-2013·2012-11-28
Mako Surgical Recalls RIO System Software Due to Tactile Feedback Loss
Mako Surgical Corporation is recalling 137 RIO System devices to replace software version 2.4 with 2.5, addressing a functional issue involving the loss of tactile feedback.
Product
The RIO (TGS 2.), Model # MAKO TGS 2.0 (Part No. 204000). The RIO is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The RIO is indicated for use…
Category
Medical Device
Distribution
33 states
HighFDA (Devices)·Z-0374-2013·2012-11-28
NuVasive Recalls 6.5mm Noncannulated Screw Shanks Due to Disengagement Risk
NuVasive Inc is recalling 240 units of 6.5mm x 45mm Noncannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.
Product
6.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0695-2013·2012-11-28
Rudi's Organic Bakery Bread Recalled for Possible Metal Contamination
Charter Baking Company is voluntarily recalling Rudi's Organic Bakery Colorado Cracked Wheat bread due to the possible presence of small metal objects.
Product
Rudi's Organic Bakery, Colorado Cracked Wheat, 22 oz, UPC 031493-54373-6, packed in flexible plastic bags. Labeling is tan, yellow, white, maroon, and orange with white, black, green, maroon, and orange print writing.
Category
Food
Distribution
1 state