November 2012 recalls

569 recalls were announced in November 2012.

What the numbers show

Critical: 111
Severe: 99
High: 164
Moderate: 162
Low: 33

Of the 569 recalls this month scored against our rubric, 20% are Critical, 17% are Severe.

Which agencies issued them

101–200 of 569

ModerateFDA (Devices)·Z-0338-2013·2012-11-28
Superstat Modified Collagen Hemostatic Sponge Recalled for Sterility Audit Documentation Issues
Superstat Corp is recalling 26,422 units of Modified Collagen Hemostatic Sponge because documentation verifying quarterly dose sterility audits is unavailable.
Product
Superstat Modified Collagen Hemostatic Sponge, 4x4 Pledget, 3.0%, Part# 9102-00. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capil
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0379-2013·2012-11-28
Microgenics Recalls Thermo Scientific Omni IMMUNE Immunoassay Controls Due to Stability Issues
Microgenics is recalling Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO controls because internal testing showed reduced stability for CK-MS and Insulin.
Product
Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO; Liquid Assayed Integrated Immunoassay Control. Intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. Assay values are provided for the specific systems listed.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-059-2013·2012-11-28
Dr. Reddy's Quetiapine Fumarate Tablets Recalled for Dissolution Failure
Dr. Reddy's is recalling Quetiapine Fumarate Tablets, 25mg, because they failed USP dissolution testing during stability studies.
Product
Dr. Reddy's Quetiapine Fumarate Tablets, 25mg, Rx Only, 500 tablets. Mfd By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325, India NDC 55111-249-05
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0393-2013·2012-11-28
Zimmer Recalls VerSys Provisional Femoral Heads for Surgical Technique Updates
Zimmer, Inc. is recalling VerSys Provisional Femoral Heads to update surgical instructions regarding the visual location of displaced heads.
Product
. 00789503601 VerSys Femoral Head Provisional 36mm -3.5 00789503602 VerSys Femoral Head Provisional 36mm +0 00789503603 VerSys Femoral Head Provisional 36mm +3.5 00789503604 VerSys Femoral Head Provisional 36mm +7 00789503605 VerSys Femoral Head Provisional 36mm +10.5 12/14
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0310-2013·2012-11-28
BioMerieux 3D B.40 Software Update Recalled for Mislabeling Patient Information
BioMerieux is recalling 556 units of 3D B.40 software updates because a software miscommunication may cause patient information to be mislabeled on culture specimen bottles.
Product
bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML02, Clinical instrument software, German, French, Swedish, catalog number 411925 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric pa
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-0327-2013·2012-11-28
BioMerieux B.40 Software Update Recalled for Patient Mislabeling
BioMerieux is recalling B.40 software updates because a defect may cause patient information to be mislabeled on culture specimen bottles.
Product
bioMerieux Kit, Instrument & Update, B.40, 3D I USB-ML02, Industry instrument software update, German, French, catalog number 413482 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients tha
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-0197-2013·2012-11-28
GE Healthcare Recalls Mobile Radiographic Systems Due to Firmware Issue
GE Healthcare is recalling specific mobile radiographic systems due to a firmware issue affecting technique accuracy.
Product
GE Healthcare Optima XR 200amx with digital upgrade Mobile general purpose radiographic imaging of the human head and body.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0299-2013·2012-11-28
bioMerieux BacT/ALERT Control Module Recalled for Patient Mislabeling
Biomerieux Inc is recalling 70 BacT/ALERT Control Modules due to a software issue that may mislabel patient information on culture specimen bottles.
Product
bioMerieux BacT/ALERT Control Module, catalog number 210147, Clinical instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection,
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-0313-2013·2012-11-28
BioMérieux BTA3D Control Software Recall for Patient Mislabeling
BioMérieux is recalling BTA3D Control software due to a defect that may mislabel patient information on culture specimen bottles.
Product
bioMerieux Kit, USB HDW, BTA3D CONTROL-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411958 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pedi
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-0392-2013·2012-11-28
Zimmer Recalls VerSys Provisional Femoral Heads for Surgical Technique Updates
Zimmer, Inc. is recalling VerSys Provisional Femoral Heads to update surgical instructions regarding locating displaced heads and reducing fit issues.
Product
00789503201 VerSys Femoral Head Provisional 32mm -3.5 00789503202 VerSys Femoral Head Provisional 32mm +0 00789503203 VerSys Femoral Head Provisional 32mm +3.5 00789503204 VerSys Femoral Head Provisional 32mm +7 00789503205 VerSys Femoral Head Provisional 32mm +10.5 12/14 Ne
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0334-2013·2012-11-28
Superstat Modified Collagen Hemostatic Sponge Recalled for Sterility Audit Documentation Gaps
Superstat Corp is recalling Modified Collagen Hemostatic Sponges because documentation is missing to verify that required quarterly dose sterility audits were performed.
Product
Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 3.0%, Part# 9200-30. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capilla
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0337-2013·2012-11-28
Superstat Modified Collagen Hemostatic Sponge Recalled Due to Missing Sterility Audit Documentation
Superstat Corp is recalling Modified Collagen Hemostatic Sponges because documentation verifying quarterly dose sterility audits is unavailable.
Product
Superstat Modified Collagen Hemostatic Sponge, 2x2 Pledget, 3.0%, Part# 9106-00. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capi
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0325-2013·2012-11-28
Biomerieux B.40 Software Update Recalled for Patient Mislabeling
Biomerieux Inc is recalling 22 B.40 software updates because a defect may cause patient information to be mislabeled on culture specimen bottles.
Product
bioMerieux Kit, Instrument & Update, B.40, 3D IND USB-ML02, Industry instrument software update, German, French, catalog number 412003 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients t
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-0324-2013·2012-11-28
BioMerieux B.40 Software Update Recalled for Patient Mislabeling
BioMerieux is recalling B.40 software updates because a defect may cause patient information to be mislabeled on culture specimen bottles.
Product
bioMerieux Kit, Instrument & Update, B.40, 3D IND USB-ML01, Industry instrument software update, English, Spanish, Italian, catalog number 412002 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-0320-2013·2012-11-28
Biomerieux BacT/ALERT Combo Module Recalled for Software Mislabeling
Biomerieux is recalling BacT/ALERT Combo Modules due to a software issue that may mislabel patient information on culture specimen bottles.
Product
bioMerieux BacT/ALERT Combo Module, catalog number 247014, Industrial instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection,
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-0390-2013·2012-11-28
Zimmer Recalls VerSys Provisional Femoral Heads for Surgical Technique Updates
Zimmer, Inc. is recalling VerSys provisional femoral heads to update surgical instructions regarding the visual location of displaced heads.
Product
00789502601 VerSys Femoral Head Provisional 26mm -3.5 00789502602 VerSys Femoral Head Provisional 26mm +0 00789502603 VerSys Femoral Head Provisional 26mm +3.5 00789502604 VerSys Femoral Head Provisional 26mm +7 00789502605 VerSys Femoral Head Provisional 26mm +10.5 12/14 Ne
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0318-2013·2012-11-28
BioMerieux BacT/ALERT Control Module Recalled for Software Mislabeling
BioMerieux is recalling BacT/ALERT Control Modules because a software issue may cause patient information to be mislabeled on culture specimen bottles.
Product
bioMerieux BacT/ALERT Control Module, catalog number 210148, Industrial instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-0389-2013·2012-11-28
Zimmer Recalls VerSys Provisional Femoral Heads for Surgical Technique Updates
Zimmer, Inc. is recalling VerSys Provisional Femoral Heads to update surgical instructions regarding the visual location of displaced heads and fit issues.
Product
Product 100789502202 VerSys Femoral Head Provisional 22mm +0 00789502203 VerSys Femoral Head Provisional 22mm +3.5 00789502220 VerSys Femoral Head Provisional 22mm -2 00789502230 VerSys Femoral Head Provisional 22mm +3 12/14 Neck Taper The provisional heads replicate final
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0312-2013·2012-11-28
BioMerieux BTA3D Combo Software Recall for Patient Mislabeling
BioMerieux is recalling 205 BTA3D Combo software kits worldwide due to a defect that may mislabel patient information on culture specimen bottles.
Product
bioMerieux Kit, USB HDW, BTA3D COMBO-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411957 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediat
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-0335-2013·2012-11-28
Superstat Modified Collagen Hemostatic Sponge Recalled Due to Missing Sterility Audit Records
Superstat Corp is recalling Modified Collagen Hemostatic Sponges because documentation to verify quarterly dose sterility audits is unavailable.
Product
Superstat Modified Collagen Hemostatic Sponge, 85mm x 85mm Pledget, 3.0%, Part# 9300-30. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, eit
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0420-2013·2012-11-28
King Systems Recalls Adult Silicone King LAD Devices Due to Sterilization Indicator Issues
King Systems Corp. is recalling 2,630 adult silicone King LAD devices because sterilization indicators failed to change color as expected.
Product
KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 4 / Adult Silicone King LAD¿ Patient Size: 50-70kg
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0398-2013·2012-11-28
Zimmer Recalls Provisional Femoral Heads for Enhanced Surgical Instructions
Zimmer, Inc. is recalling MIS 12/14 Slotted Femoral Head Provisional devices to update surgical instructions regarding the visual location of displaced heads.
Product
00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 MIS 12/14 Slotted Femoral Head Provisional +0X32 00780303203 MIS 12/14 Slotted Femoral Head Provisional +3.5X32 00780303204 MIS 12/14 Slotted Femoral Head Provisional +7X32 00780303205 MIS 12/14 Slotte
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0302-2013·2012-11-28
BioMerieux 3D B.40 Software Update Recalled for Patient Mislabeling
BioMerieux is recalling 1,336 units of 3D B.40 software due to a defect that may mislabel patient information on culture specimen bottles.
Product
bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML01, Clinical instrument software, English, Spanish, Italian, catalog number 411814 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-0402-2013·2012-11-28
Kerr Recalls Freedom Cordless LED Light System Due to Warmth
Kerr Corporation is recalling 1,330 Freedom Cordless LED Light Systems because an incorrect component may cause units to become warm to the touch.
Product
Freedom Cordless LED Light System. Freedom System, Standard Length, Part Number 910863-1, Serial Numbers 77001000-77003470 and Freedom System, Long Length, Part Number 910863-2, Serial Numbers 77001000-77003470. Freedom Cordless LED Light System is a Class I Medical Device. Th
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0309-2013·2012-11-28
BioMerieux 3D B.40 Software Update Recalled for Patient Mislabeling
BioMerieux is recalling 620 units of 3D B.40 software updates because a software error may mislabel patient information on culture specimen bottles.
Product
bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML01, Clinical instrument software, English, Spanish, Italian, catalog number 411818 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-0414-2013·2012-11-28
Kerr Laser Loupes Recalled Due to Wipeable Laser Frequency Markings
Kerr Corporation is recalling 639 Laser Loupes because the ink marking the laser frequency protection may wipe off, though the devices function correctly.
Product
The brand name of the device is Laser Loupes, a dentalloupe with laser eye protection. Laser Loupes have been assigned product code 79 FSP and are classified as a Class I Medical Devices. Laser Loupes are available with four (4) different filters of different colors. Each c
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0303-2013·2012-11-28
BioMérieux 3D B.40 Software Update Recalled for Patient Mislabeling
BioMérieux is recalling 860 units of 3D B.40 software updates due to a defect that may mislabel patient information on culture specimen bottles.
Product
bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML 02, Clinical instrument software, English, Spanish, Italian, catalog number 411815 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-0411-2013·2012-11-28
Gyrus Acmi Recalls Contaminated Silicone Tympanostomy Tubes
Gyrus Acmi is recalling one lot of tympanostomy tubes because the silicone was contaminated with ethylene vinyl acetate copolymer.
Product
PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy tube
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0300-2013·2012-11-28
BioMerieux BacT/ALERT Combo Modules Recalled for Software Mislabeling
BioMerieux is recalling 375 BacT/ALERT Combo Modules due to a software error that may mislabel patient information on culture specimen bottles.
Product
bioMerieux BacT/ALERT Combo Module, catalog number, 200290, Clinical instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, w
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-0384-2013·2012-11-28
ConMed Linvatec Recalls Sentinel Cannulated Drill Bits Due to Labeling Errors
ConMed Linvatec is recalling specific lots of Sentinel Cannulated Drill Bits because of incorrect labeling on the packages.
Product
"***SENTINEL***Cannulated Drill Bit***S8585***8.5 X 229mm (9")***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***LOT***2009-02***". This drill bit is an eccentric mono-fluted cutting edge for drilling bone tunnels in ACL and PCL reconstruction.
Category
Medical Device
Distribution
10 states
ModerateFDA (Devices)·Z-0316-2013·2012-11-28
BioMerieux 3D B.40 Software Update Recalled for Patient Mislabeling
BioMerieux is recalling 12 kits of 3D B.40 software updates because a software miscommunication may cause patient information to be mislabeled on culture specimen bottles.
Product
bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML05, Clinical instrument software, Lithuanian, Latvian, Russian, Slovak, catalog number 412621 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-0400-2013·2012-11-28
Zimmer Recalls Slotted Provisional Femoral Heads for Surgical Technique Updates
Zimmer, Inc. is recalling MIS 12/14 Slotted Provisional Femoral Heads to update surgical instructions regarding the visual location of displaced heads.
Product
00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780304002 MIS 12/14 Slotted Femoral Head Provisional +0X36 00780304003 MIS 12/14 Slotted Femoral Head Provisional +3.5X36 00780304004 MIS 12/14 Slotted Femoral Head Provisional +7X36 00780304005 MIS 12/14 Slotte
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0329-2013·2012-11-28
BioMerieux B.40 Software Update Recalled for Patient Mislabeling
BioMerieux is recalling B.40 software updates because a defect may cause patient information to be mislabeled on culture specimen bottles.
Product
bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML02, Industry instrument software update, English, Spanish, Italian, catalog number 413484 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric p
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-0345-2013·2012-11-28
Beckman Coulter Recalls UniCel Dxl 800 Access Immunoassay Systems
Beckman Coulter is recalling 1,756 UniCel Dxl 800 Access Immunoassay Systems due to confirmed field modifications to probe assemblies.
Product
UniCel Dxl 800 Access Immunoassay System, Part Numbers: 973100, A71456, and A71457. 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 bod
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0323-2013·2012-11-28
BioMerieux B.40 Dualt-ML Software Update Recalled for Mislabeling Risk
BioMerieux is recalling B.40 Dualt-ML software updates because a software miscommunication may cause patient information to be mislabeled on culture specimen bottles.
Product
bioMerieux Kit, Instrument & Update, B.40 Dualt-ML, Industry instrument software update, English, Spanish, Italian, German, French, Japanese, Brazilian, Portuguese, catalog number 412950 Software update for an instrument which is most commonly used to isolate and recover speci
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-0326-2013·2012-11-28
BioMerieux B.40 Software Update Recalled for Patient Mislabeling
BioMerieux is recalling 23 B.40 software update kits because a software miscommunication may cause patient information to be mislabeled on culture specimen bottles.
Product
bioMerieux Kit, Instrument & Update, B.40, 3D I USB-ML01, Industry instrument software update, English, Spanish, Italian, catalog number 413481 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric p
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-0319-2013·2012-11-28
BioMerieux BacT/ALERT Combo Module Recalled for Software Miscommunication
BioMerieux is recalling 26 BacT/ALERT Combo Modules due to a software issue that may mislabel patient information on culture specimen bottles.
Product
bioMerieux BacT/ALERT Combo Module, catalog number 200291, Industrial instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection,
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-0336-2013·2012-11-28
Superstat Modified Collagen Hemostatic Sponge Recalled for Missing Sterility Audit Documentation
Superstat Corp is recalling 26,422 units of Modified Collagen Hemostatic Sponge because documentation verifying quarterly dose sterility audits is unavailable.
Product
Superstat Modified Collagen Hemostatic Sponge, 2x2 Pledget, 1.5%, Part# 9105-00. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capil
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0426-2013·2012-11-28
King Systems Recalls Flexible ClearSeal Laryngeal Airway Devices
King Systems Corp. is recalling 2,630 Flexible ClearSeal Laryngeal Airway Devices due to sterilization indicators that failed to change color as expected.
Product
KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 3 / Child ClearSeal Flexible King LAD¿ Patient Size: 30-50kg " Product Usage: Laryngeal airway
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0331-2013·2012-11-28
Superstat Modified Collagen Hemostatic Sponge Recalled for Missing Sterility Audit Documentation
Superstat Corp is recalling Modified Collagen Hemostatic Sponges because documentation is missing to verify that required quarterly sterility audits were performed.
Product
Superstat Modified Collagen Hemostatic Sponge.115mmx115mm Pledget, 1.5%, Part#9500-15. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, eithe
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0387-2013·2012-11-28
Stryker Recalls 6.5mm Cancellous Bone Screws Due to Packaging Mix-Up
Stryker Howmedica Osteonics is recalling approximately 72 units of 6.5mm Cancellous Bone Screws because packaging may contain the wrong screw length.
Product
Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6525-1 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 spin
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0427-2013·2012-11-28
King Systems Recalls Flexible ClearSeal Laryngeal Airway Devices
King Systems Corp. is recalling 2,630 Flexible ClearSeal Laryngeal Airway Devices due to EtO sterilization indicators that failed to change color.
Product
KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 4 / Adult ClearSeal Flexible King LAD¿ Patient Size: 50-70kg " Product Usage: Laryngeal airway
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0322-2013·2012-11-28
BioMérieux 3D IND Software Update Recalled for Patient Mislabeling
BioMérieux is recalling 20 kits of the 3D IND USB-ML 02 software update because a software miscommunication may cause patient information to be mislabeled on culture specimen bottles.
Product
bioMerieux Kit, Instrument & Update, 3D IND USB-ML 02, Industry instrument software update, English, Spanish, Italian, catalog number 412006 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric pati
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-0304-2013·2012-11-28
BioMérieux 3D B.40 Software Update Recalled for Patient Mislabeling
BioMérieux is recalling 30 units of the 3D B.40 software update because a software miscommunication may cause patient information to be mislabeled on culture specimen bottles.
Product
bioMerieux Kit, Instrument & Update, 3D B.40 BTA3D-ZH01, Clinical instrument software, Chinese, catalog number 411816 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that ar
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-0342-2013·2012-11-28
Superstat Modified Collagen Hemostatic Sponge Recalled Due to Missing Sterility Documentation
Superstat Corp is recalling 26,422 units of Modified Collagen Hemostatic Sponge because documentation verifying quarterly dose sterility audits is unavailable.
Product
Superstat Modified Collagen Hemostatic Sponge, 32mm Disc, 3.0%, Part# 9100-30. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capilla
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0339-2013·2012-11-28
Superstat Modified Collagen Hemostatic Sponge Recalled Due to Missing Sterility Audit Records
Superstat Corp is recalling Modified Collagen Hemostatic Sponges because documentation verifying quarterly dose sterility audits is unavailable.
Product
Superstat Modified Collagen Hemostatic Sponge, 32mm Disc, 1.5%, Part# 9120-15, 9100-15. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, eithe
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-061-2013·2012-11-28
Orajel Kids Toothpaste Recalled for Incorrect Ingredient Substitution
Church & Dwight is recalling Orajel Kids My Way! toothpaste because Laureth-9 was mistakenly substituted for PEG during manufacturing.
Product
Orajel Kids My Way! Anticavity Fluoride (sodium fluoride) toothpaste, 0.24%, 3 oz (85 g) pump, Church & Dwight Col, Inc., Princeton, NJ 08543; UPC 3 10310 32370 7.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0317-2013·2012-11-28
BioMérieux 3D B.40 Software Update Recalled for Patient Mislabeling
BioMérieux is recalling 69 units of the 3D B.40 software update because a defect may cause patient information to be mislabeled on culture specimen bottles.
Product
bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML06, Clinical instrument software, Japanese, Korean, Norwegian, Brazilian, Portuguese, Turkish, catalog number 412622 Software update for the clinical instrument which is most commonly used to isolate and recover specimens draw
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-0391-2013·2012-11-28
Zimmer Recalls VerSys Provisional Femoral Heads for Surgical Technique Updates
Zimmer, Inc. is recalling VerSys Provisional Femoral Heads to update surgical instructions regarding the visual location of displaced heads.
Product
. 00789502801 VerSys Femoral Head Provisional 28mm -3.5 00789502802 VerSys Femoral Head Provisional 28mm +0 00789502803 VerSys Femoral Head Provisional 28mm +3.5 00789502804 VerSys Femoral Head Provisional 28mm +7 00789502805 VerSys Femoral Head Provisional 28mm +10.5 12/14
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0333-2013·2012-11-28
Superstat Modified Collagen Hemostatic Sponge Recalled Due to Missing Sterility Audit Documentation
Superstat Corp is recalling Modified Collagen Hemostatic Sponges because documentation verifying quarterly dose sterility audits is unavailable.
Product
Superstat Modified Collagen Hemostatic Sponge, 115mm x 115mm Pledget, 3.0%, Part# 9500-30. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, ei
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0425-2013·2012-11-28
King Systems Recalls Infant Laryngeal Airway Devices Due to Sterilization Indicator Issues
King Systems Corp. is recalling 2,630 infant laryngeal airway devices because sterilization indicators failed to change color as expected, raising concerns about proper ethylene oxide sterilization.
Product
KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 20 devices/case Size 2 / Infant ClearSeal Flexible King LAD¿ Patient Size: 10-20kg Product Usage: Laryngeal airway
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0415-2013·2012-11-28
Biomet Recalls Acetabular Shells Due to Label Color Code Conflict
Biomet, Inc. is recalling 16 Ranawat/Burnstein Acetabular Shells because the label color code conflicts with the liner size.
Product
Ranawat/Burnstein Acetabular Shell 54mm/Limited Holes/Porous Coated is a metallic, full-hemisphere, acetabular shell component. Intended Use: The shell utilizes a modular polyethylene liner and a femoral head component that is taper fit onto a femoral stem at the time of sur
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0305-2013·2012-11-28
BioMérieux 3D B.40 Software Update Recalled for Patient Mislabeling
BioMérieux is recalling 250 units of the 3D B.40 software update because a software miscommunication may cause patient information to be mislabeled on culture specimen bottles.
Product
bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML03, Clinical instrument software, Danish, Greek, Polish, Portuguese, catalog number 412623 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pe
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-0314-2013·2012-11-28
BioMérieux 3D B.40 Software Update Recalled for Patient Mislabeling
BioMérieux is recalling 29 units of the 3D B.40 USB-ML03 software update due to a defect that may mislabel patient information on culture specimen bottles.
Product
bioMerieux Kit, USB Instrument & Update, 3D B.40 USB-ML03, Clinical instrument software, Danish, Greek, Polish, Portuguese, catalog number 412559 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-0396-2013·2012-11-28
Zimmer Recalls Provisional Femoral Heads for Enhanced Surgical Instructions
Zimmer, Inc. is recalling 56,516 provisional femoral heads to update surgical instructions regarding the visual location of displaced heads.
Product
00780302601 MIS 12/14 Slotted Femoral Head Provisional -3.5X26 00780302602 MIS 12/14 Slotted Femoral Head Provisional +0X26 00780302603 MIS 12/14 Slotted Femoral Head Provisional +3.5X26 00780302604 MIS 12/14 Slotted Femoral Head Provisional +7X26 00780302605 MIS 12/14 Slotte
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0315-2013·2012-11-28
BioMerieux 3D B.40 Software Update Recalled for Mislabeling Risk
BioMerieux is recalling 28 software updates for the 3D B.40 instrument due to a defect that may mislabel patient information on culture specimen bottles.
Product
bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML04, Clinical instrument software, Czech, Estonian, Hungarian, Romanian, catalog number 412620 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older
Category
Medical Device
Distribution
19 states
ModerateFDA (Food)·F-0706-2013·2012-11-28
Beagle Bay Organics Raw Sauerkraut Recalled Due to Missing Mixer Bolt
Cracker Industries, LLC is recalling 65 jars of Beagle Bay Organics Raw Sauerkraut, Kimchi because a bolt was found missing from the rotation mixer.
Product
Beagle Bay Organics Brand Raw Sauerkraut, Kimchi Net. Wt. 16 oz (416g). Product is stored/distributed under refrigeration and is intended to be eaten raw as a condiment. Beagle Bay Organics, 4501 Manatee Ave W # 105, Bradenton, FL 34209
Category
Food
Distribution
1 state
ModerateFDA (Devices)·Z-0394-2013·2012-11-28
Zimmer Recalls VerSys Provisional Femoral Heads for Surgical Technique Updates
Zimmer, Inc. is recalling VerSys Provisional Femoral Heads to update surgical instructions regarding the visual location of displaced heads and fit issues.
Product
00789504001 VerSys Femoral Head Provisional 40mm -3.5 00789504002 VerSys Femoral Head Provisional 40mm +0 00789504003 VerSys Femoral Head Provisional 40mm +3.5 00789504004 VerSys Femoral Head Provisional 40mm +7 00789504005 VerSys Femoral Head Provisional 40mm +10.5 The prov
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0383-2013·2012-11-28
ConMed Linvatec Recalls Sentinel Cannulated Drill Bits Due to Labeling Errors
ConMed Linvatec is recalling specific lots of Sentinel Cannulated Drill Bits because of incorrect labeling on the packages.
Product
"***SENTINEL***Cannulated Drill Bit***S8580***8 X 229mm (9")***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***LOT***2012-03***". This drill bit is an eccentric mono-fluted cutting edge for drilling bone tunnels in ACL and PCL reconstruction.
Category
Medical Device
Distribution
10 states
ModerateFDA (Food)·F-0711-2013·2012-11-28
Schoep's Recalls Toasted Butter Pecan Ice Cream Due to Packaging Error
Schoep's Ice Cream Co. is recalling Toasted Butter Pecan ice cream packaged in Vanilla Bean containers due to a labeling error.
Product
Tub labeled as Kay's Classic Vanilla Bean ice Cream. UPC 87848-13021, 1.5 Quarts (1.42L). Lid labeled as Kay's Classic Toasted Butter Pecan ice cream
Category
Food
Distribution
3 states
ModerateFDA (Devices)·Z-0397-2013·2012-11-28
Zimmer Recalls Slotted Provisional Femoral Heads for Surgical Technique Updates
Zimmer, Inc. is recalling MIS 12/14 Slotted Provisional Femoral Heads to update surgical instructions regarding the visual location of displaced heads.
Product
00780302801 MIS 12/14 Slotted Femoral Head Provisional -3.5X28 00780302802 MIS 12/14 Slotted Femoral Head Provisional +0X28 00780302803 MIS 12/14 Slotted Femoral Head Provisional +3.5X28 00780302804 MIS 12/14 Slotted Femoral Head Provisional +7X28 00780302805 MIS 12/14 Slotte
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0341-2013·2012-11-28
Superstat Modified Collagen Hemostatic Sponge Recalled for Missing Sterility Audit Documentation
Superstat Corp is recalling 26,422 units of Modified Collagen Hemostatic Sponge because documentation verifying quarterly dose sterility audits is unavailable.
Product
Superstat Modified Collagen Hemostatic Sponge, 7.5mm x 19mm Cone, 3.0%, Part# 9015-30, 9003-30. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleedin
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0290-2013·2012-11-28
Mindray A3 Anesthesia Delivery System Recalled for Potential System Leak
Mindray is recalling 69 A3 Anesthesia Delivery Systems due to a potential system leak caused by a carbon dioxide absorber canister gasket issue.
Product
Mindray A3 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 This is a device used to administer to a patient continuously or intermittently a general inhalation anesthetic and to maintain a patient's ventila
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0408-2013·2012-11-28
Siemens Dimension Vista Theophylline Cartridge Recalled for Abnormal Reaction Errors
Siemens Healthcare Diagnostics is recalling Dimension Vista Theophylline cartridges due to 'Abnormal Reaction' errors triggered by atypical particle reagent aggregation.
Product
Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Regent Cartridge (K4071) The THEO method is an in vitro diagnostic test for the quantitative measurement of Theophylline in human serum and plasma on the Dimension Vista(R) system.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0432-2013·2012-11-28
OrthoPediatrics Recalls 4.5mm PLEO Osteotomy Guide Instruments
OrthoPediatrics Corp is recalling 24 units of the 4.5mm PLEO Osteotomy Guide because the device was not manufactured to design specifications and will not function as intended.
Product
4.5mm PLEO Osteotomy Guide. OrthoPediatrics Corp. markets a pediatric, extension osteotomy bone plate system. This system is marketed under the brand name OrthoPediatrics PediLock Extension Osteotomy Plate ( PLEO ). The product included in this recall is a Class I, 4.5mm PLEO
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0321-2013·2012-11-28
BioMerieux 3D IND ZIP-ML Software Update Recalled for Mislabeling
BioMerieux is recalling 288 units of the 3D IND ZIP-ML software update because a defect may cause patient information to be mislabeled on culture specimen bottles.
Product
bioMerieux Kit, Instrument & Update, 3D IND ZIP-ML 01, Industry instrument software update, English, Spanish, Italian, catalog number 412005 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric pati
Category
Medical Device
Distribution
19 states
ModerateFDA (Food)·F-0704-2013·2012-11-28
Dannon Activia LIGHT Nonfat Yogurt Recalled for Incorrect Labeling
The Dannon Company Inc is recalling Dannon Activia LIGHT Nonfat Yogurt Peach Flavor due to incorrect labeling. The product was distributed in 21 US states and Puerto Rico.
Product
Dannon Activia LIGHT Nonfat Yogurt Peach Flavor, Each unit 4-pack of 4-oz cups/6, 4-count pack to a case (24 cups/case) UPC 3663202633
Category
Food
Distribution
1 state
ModerateFDA (Devices)·Z-0416-2013·2012-11-28
Zimmer Recalls Trilogy Acetabular System Shells Due to Missing Threads
Zimmer, Inc. is recalling 95 units of the Trilogy Acetabular System Shell with Cluster Holes because they are missing polar hole threads. No injuries were reported.
Product
The Trilogy Acetabular System Shell with Cluster Holes Porous 56 mm O.D. Sterile The Trilogy Acetabular System is indicated for either cemented or uncemented use In skeletally mature Individuals undergoing primary or revision surgery for rehabilitating hips damaged as a r
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0399-2013·2012-11-28
Zimmer Recalls Provisional Femoral Heads for Enhanced Surgical Instructions
Zimmer, Inc. is recalling MIS 12/14 Slotted Provisional Femoral Heads to update surgical instructions regarding the visual location of displaced heads.
Product
00780303601 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780303602 MIS 12/14 Slotted Femoral Head Provisional +0X36 00780303603 MIS 12/14 Slotted Femoral Head Provisional +3.5X36 00780303604 MIS 12/14 Slotted Femoral Head Provisional +7X36 00780303605 MIS 12/14 Slotte
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0293-2013·2012-11-28
Ethicon Recalls Surgiflo Hemostatic Matrix Kits Due to Packaging Defect
Ethicon is recalling Surgiflo Hemostatic Matrix kits because a potential cut in the packaging could breach the sterile Tyvek pouch.
Product
ETHICON SURGIFLO HEMOSTATIC MATRIX Distributed by ETHICON ETHICON, Inc. Somerville, NJ 08876, USA SURGIFLO Hemostatic Matrix is a topical absorbable hemostat consisting of a flowable gelatin matrix (paste). This kit also contains components necessary for preparing and applyi
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0330-2013·2012-11-28
GE Healthcare Recalls Fetal Scalp Electrodes Due to Packaging Seal Issues
Vital Signs Devices is recalling 126 cases of Corometrics Qwik Connect Plus Spiral Electrodes because 30 units had incomplete package seals and missing lot numbers.
Product
Corometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0 A fetal scalp circular (spiral) electrode and applicator is a device used to obtain a fetal electrocardiogram during labor and delivery.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0395-2013·2012-11-28
Zimmer Recalls Provisional Femoral Heads for Enhanced Surgical Instructions
Zimmer, Inc. is recalling MIS Slotted Provisional Femoral Heads to update surgical instructions regarding locating displaced heads and reducing fit issues.
Product
00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X22 00780302202 MIS 12/14 Slotted Femoral Head Provisional +0X22 00780302203 MIS 12/14 Slotted Femoral Head Provisional +3.5X22 The provisional heads replicate final femoral implant geometry and are used to trial range
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0418-2013·2012-11-28
King Systems Recalls Infant Silicone Laryngeal Airway Devices
King Systems Corp. is recalling 2,630 infant silicone laryngeal airway devices due to potential EtO sterilization indicator failures.
Product
KING LAD SILI CONE SINGLE USE, King Systems devices/case, ETO Sterile. Size 2 / Infant Silicone King LAD¿ Patient Size: 10-20kg Product Usage: Laryngeal airway
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0332-2013·2012-11-28
Superstat Modified Collagen Hemostatic Sponge Recalled Due to Missing Sterility Audit Records
Superstat Corp is recalling Modified Collagen Hemostatic Sponges because documentation verifying quarterly dose sterility audits is unavailable.
Product
Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 1.5%, Part# 9200-15. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capilla
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0328-2013·2012-11-28
Biomerieux B.40 Software Update Recalled for Patient Information Mislabeling
Biomerieux Inc is recalling 33 B.40 software updates because a software miscommunication may cause patient information to be mislabeled on culture specimen bottles.
Product
bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML01, Industry instrument software update, English, Spanish, Italian, catalog number 413483 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric p
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-0200-2013·2012-11-28
GE Healthcare Recalls Mobile Radiographic Imaging Systems Due to Firmware Issue
GE Healthcare is recalling Brivo XR 285 and Optima XR series mobile radiographic systems due to a firmware issue affecting technique accuracy.
Product
GE Healthcare Brivo XR 285 Mobile general purpose radiographic imaging of the human head and body.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0301-2013·2012-11-28
BioMérieux BacT/ALERT 3D 60 Recalled for Software Mislabeling Error
BioMérieux is recalling 145 BacT/ALERT 3D 60 modules worldwide because a software error may mislabel patient information on culture specimen bottles.
Product
bioMerieux BacT/ALERT 3D 60, catalog number, 248009, Clinical instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which ca
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-0308-2013·2012-11-28
BioMerieux 3D B.40 Software Update Recalled for Patient Mislabeling
BioMerieux is recalling 671 units of the 3D B.40 software update because a software miscommunication may cause patient information to be mislabeled on culture specimen bottles.
Product
bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML06, Clinical instrument software, Japanese, Korean, Norwegian, Brazilian, Portuguese, Turkish, catalog number 412626 Software update for the clinical instrument which is most commonly used to isolate and recover specimens dra
Category
Medical Device
Distribution
19 states
LowFDA (Food)·F-0710-2013·2012-11-28
Postres de Aqui Oatmeal Recalled for Missing Phenylketonuria Warning
Postres de Aqui, Inc. is recalling 8-ounce boxes of Avena de Aqui Si Azucar Añadida because the packaging lacks a required warning for individuals with phenylketonuria.
Product
"***Avena de Aqu¿ Si Azucar A¿adida****8oz****Fabricado por Postres de Aqui, Inc. Calle B Parrio Plamas Cata¿o PR 00962***"
Category
Food
Distribution
1 state
LowFDA (Devices)·Z-0386-2013·2012-11-28
Zimmer Recalls Trilogy Longevity Constrained Liners Due to Packaging Error
Zimmer, Inc. is recalling Trilogy Longevity Constrained Liners because they were packaged in incorrect cartons, although the product labels are correct.
Product
Trilogy II Constrained Liner The Trilogy Longevity Constrained Liner serves as the articular surface for a femoral head in total hip arthroplasty.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0292-2013·2012-11-28
Ethicon Surgiflo Hemostatic Matrix Kit Packaging Defect Recall
Ethicon is recalling Surgiflo Hemostatic Matrix Kits due to a packaging defect that could breach the Tyvek pouch.
Product
ETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin distributed by ETHICON ETHICON Inc. Somerville, NJ 08876 USA Ref 2993 SURGIFLO Hemostatic Matrix, mixed with sterile saline or thrombin solution, is indicated for surgical procedures (except ophthalmic)
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0429-2013·2012-11-28
Horiba Medical Recalls Minotrol 16 Hematology Control Material
Horiba Medical is recalling Minotrol 16 lot MX090 (Level High) due to reports of high hemoglobin recovery values.
Product
Minotrol 16, Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels: Low, Normal, and High). Minotrol 16 is a tri-level control intended for in vitro diagnostic use in monitoring the accuracy and precision on HORIBA Medical hematology blood cell counters using HORI
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Food)·F-0705-2013·2012-11-28
Swanson Organic Fennel Seed Recalled Due to Insect Contamination
Swanson Health Products is recalling two lots of Organic Fennel Seed because some jars contain small, red beetle-type insects.
Product
Swanson Organic, 100% Certified Organic Fennel Seed, Net Wt 6 oz (45 grams), SWF092, UPC 0 87614 24092 3.
Category
Food
Distribution
4 states
SevereNHTSA·12V550000·2012-11-27
BMW Recalls 2009-2012 X5 xDrive 35d for Engine Belt Bolt Defect
BMW is recalling 2009-2012 X5 xDrive 35d diesel vehicles because an engine belt idler pulley bolt could break, potentially causing loss of power-assisted steering.
Product
BMW — BMW X5 SAV
Category
Vehicle
Distribution
Distributed nationwide
HighCPSC·13048·2012-11-27
Toro Z Master Riding Mowers Recalled Due to Fire Hazard
Toro is recalling 2012 Z Master Commercial 2000 Series riding mowers because a worn traction drive belt can puncture the fuel tank, causing a leak and fire hazard.
Product
Toro® Z Master® Riding Mowers
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·13047·2012-11-27
Harbor Freight Recalls Cordless Drills Due to Fire and Burn Hazard
Harbor Freight Tools is recalling about 108,000 cordless drills because the trigger switch can overheat, posing a fire and burn hazard.
Product
Cordless Drill
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·13049·2012-11-27
Step2 Recalls X-Rider Car Due to Fall Hazard
Step2 is recalling about 15,500 X-Rider Car toys because children can fall over the handlebar. The company is offering free replacements.
Product
Children's Riding Toy
Category
Consumer Product
Distribution
Distributed nationwide
SevereNHTSA·12V545000·2012-11-23
Mitsubishi Fuso Trucks Recalled for Fuel Pipe Cracking and Fire Risk
Mitsubishi Fuso is recalling 2005-2007 FE83D, FE84D, FE85D, and FG84D trucks because fuel pipes may crack or loosen, creating a fire hazard.
Product
MITSUBISHI FUSO — MITSUBISHI FUSO FE83D, FG84D, FE85D, FE84D
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·12V543000·2012-11-23
Forest River Recalls 2011-2012 Trailers Due to Wheel Torque Defect
Forest River is recalling 2011 and 2012 trailers equipped with specific Carlisle wheels that may not tighten to proper torque, risking wheel separation.
Product
CARGO MATE — CARGO MATE, RANCE ALUMINUM TRAILER, CONTINENTAL CARGO SNOWBIRD, TRAVEL COMPANION, LOW RIDER, OUTLAW
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·12V547000·2012-11-23
Setra Recalls 2009-2013 Motorcoaches Due to Wiring Fire Risk
Setra is recalling 198 model year 2009-2013 S417, S417TC, and S407CC motorcoaches because a ground wire may chafe and cause a short circuit or vehicle fire.
Product
SETRA — SETRA S407 CC, S417, S417 TC
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·12E053000·2012-11-23
PACCAR Recalls TRP Aluminum Wheels for Insufficient Rim Marking Depth
PACCAR is recalling specific TRP aluminum wheels because rim markings are etched too shallowly, failing federal safety standards and increasing crash risk.
Product
WHEELS:RIM recall
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·12V544000·2012-11-23
Temsa Recalls 2007-2010 TS35 Buses for Insufficient Emergency Exits
Temsa is recalling 2007-2010 TS35 buses because they may have too few emergency exits, potentially delaying evacuation during an emergency.
Product
TEMSA — TEMSA TS35
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·12V542000·2012-11-23
Toyota Recalls 2001-2004 Tacoma Trucks for Spare Tire Carrier Defect
Toyota is recalling 2001-2004 Tacoma trucks in cold climate states because the spare tire carrier lift plate may corrode and break, causing the tire to detach.
Product
TOYOTA — TOYOTA TACOMA
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·12V549000·2012-11-23
Nova Bus Recalls 2010 LFS Transit Buses for Egress Handle Defect
Nova Bus is recalling 2010 LFS transit buses because emergency egress window handles may break, potentially trapping passengers.
Product
NOVA BUS — NOVA BUS NOVA LFS
Category
Vehicle
Distribution
Distributed nationwide
CriticalFDA (Food)·F-0687-2013·2012-11-21
Dean Foods Recalls Western Family Ice Cream Due to Salmonella Ingredient
Dean Foods is recalling Western Family Peanut Butter Cup ice cream because it was made with an ingredient previously recalled for Salmonella contamination.
Product
Western Family "Creamery Select" Premium Ice Cream Peanut Butter Cup, 1.5 QTS (1.42 L), (vanilla ice cream with peanut butter cup pieces, fudge swirl, and peanut butter ribbon)
Category
Food
Distribution
11 states
CriticalFDA (Food)·F-0691-2013·2012-11-21
Kentucky Rose Blue Cheese Recalled for Possible Listeria Contamination
Kennys Farmhouse Cheese is recalling Kentucky Rose blue cheese due to possible Listeria monocytogenes contamination. The product was distributed in Kentucky, Tennessee, Florida, Illinois, Virginia, and Ohio.
Product
Kentucky Rose, blue cheese Sizes could be 8oz packages, 1.5lbs packages, 3.5lbs packages, 7lbs packages, or 15lb wheel Packaging could be vacuum packed bags, paper wrap, or plastic wrap
Category
Food
Distribution
6 states
CriticalFDA (Food)·F-0671-2013·2012-11-21
AdvancePierre Foods Recalls PB & Grape Jelly Wafers Due to Salmonella Risk
AdvancePierre Foods is recalling PB & Grape Jelly on Whole Grain Graham Wafers because they were made with peanut butter contaminated with Salmonella.
Product
PB & Grape Jelly on Whole Grain Graham Wafers, AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246.
Category
Food
Distribution
Distributed nationwide
CriticalFDA (Food)·F-0683-2013·2012-11-21
Toft Dairy Recalls Prime Time Buckeye Bites Ice Cream Due to Salmonella Risk
Toft Dairy Inc. is recalling Prime Time brand Buckeye Bites Ice Cream because it was manufactured using an ingredient recalled for Salmonella contamination.
Product
Prime Time brand Buckeye Bites Ice Cream in a paper carton 48 oz containers and 3 gallon tubs
Category
Food
Distribution
0 states
CriticalFDA (Food)·F-0686-2013·2012-11-21
Dean Foods Recalls Albertsons Peanut Butter Chocolate Ice Cream
Dean Foods is recalling Albertsons Peanut Butter Chocolate Ice Cream because it was manufactured using an ingredient recalled for Salmonella contamination.
Product
Albertsons Peanut Butter Chocoate Ice Cream, 1.5 QTS (1.42 L), (chocolate ice cream with a peanut butter swirl)
Category
Food
Distribution
11 states
CriticalFDA (Food)·F-0685-2013·2012-11-21
Dean Foods Recalls Albertsons Peanut Butter Cup Ice Cream
Dean Foods is recalling Albertsons Peanut Butter Cup Ice Cream because it was made with an ingredient contaminated with Salmonella.
Product
Albertsons Peanut Butter Cup Ice Cream, 1.5 QTS (1.42 L)(vanilla ice cream with peanut butter cup pieces, fudge and peanut butter swirls)
Category
Food
Distribution
11 states

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