Archive
766 recalls were announced in August 2016.
Of the 766 recalls this month scored against our rubric, 10% are Critical, 26% are Severe.
Which agencies issued them
Avid Medical is recalling 20 Pediatric Kidney Biopsy Trays because they contain a latex dressing that was not labeled as such.
Kerry Inc. is recalling Golden Dipt Jalapeño Breader because it was made with flour potentially contaminated with E. coli O121.
Biomet 3i is recalling 1,648,273 dental implants because pouches may not have been sealed during packing, potentially compromising sterility.
Medtronic is recalling Valleylab Laparoscopic Argon Modified Flat l Electrodes due to a potential sterile barrier breach.
Medtronic is recalling Valleylab Laparoscopic Wire L-Hook Electrodes due to a potential sterile barrier breach. The recall covers 63,320 units distributed worldwide.
Productos La Finca, Inc. is recalling Bacalaitos Codfish Fritter Mix in Puerto Rico due to undeclared FD&C Yellow #5, Red #40, and soy.
Medtronic is recalling Valleylab Laparoscopic Curved Spatula Electrodes due to a potential sterile barrier breach. The recall covers lots 209358X through 60870083X distributed worldwide.
TYRX Inc. is recalling 194 units of the TRYX Neuro Absorbable Antibacterial Envelope because manufacturing processes were not adequately validated.
Medtronic is recalling Valleylab Laparoscopic Curved Spatula Electrodes due to a potential sterile barrier breach. The recall affects 6,381 units distributed worldwide.
Medtronic is recalling Valleylab Laparoscopic Wire J-Hook Electrodes because the packaging may be compromised, potentially breaching the sterile barrier.
Merge Healthcare is recalling Merge Unity Z3D software because it cannot accurately determine calcium scores for scans with slice thicknesses other than 3 mm.
Biomet 3i is recalling Drill Stop Dental implants because pouches may not have been sealed during packing, potentially compromising sterility.
Ford is recalling 2017 Escape Titanium and SE vehicles because power windows may close on objects before auto-reversing, posing an injury risk.
Biomet 3i, LLC is recalling 1,648,273 Temporary Hexed Cylinder Dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling Twist Lock Coping Dental implants because pouches may not have been sealed during packing, potentially compromising sterility.
Medtronic is recalling Valleylab Laparoscopic Wire J-Hook Electrodes because the packaging may be compromised, potentially breaching the sterile barrier.
Ab Sciex is recalling 28 QTRAP 4500MD mass spectrometers because MultiQuant MD software may display incorrect quantitative results when using the Sum Multiple Ions feature.
TYRX Inc. is recalling 3,460 units of TRYX Antibacterial Envelopes because manufacturing processes were not adequately validated.
Medtronic is recalling Valleylab Laparoscopic Wire J-Hook Electrodes because the package may be compromised, potentially breaching the sterile barrier.
Biomet 3i is recalling Conical Abutment Dental implants because pouches may not have been sealed during packing, potentially compromising sterility.
Avid Medical is recalling 200 custom procedure trays that included latex-containing Telfa dressings without latex warnings. The products were distributed to Virginia and Massachusetts.
Volkswagen Group of America is recalling 2010-2013 Audi A8 vehicles because a coolant valve may leak, causing the engine to stall and increasing crash risk.
Synthes (USA) Products LLC is voluntarily recalling Titanium Single Vector Distractor Bodies because the fastener may separate prematurely from the Proximal Foot Plate.
Synthes (USA) Products LLC is voluntarily recalling 413 Titanium Single Vector Distractor Bodies because the fastener may separate prematurely from the Proximal Foot Plate.
Ab Sciex is recalling MultiQuant MD software for Triple Quad 4500MD systems because it may display incorrect quantitative results when using the Sum Multiple Ions feature.
Medtronic is recalling Valleylab Laparoscopic Wire J-Hook Electrodes due to a potential package compromise that could breach the sterile barrier.
Avid Medical is recalling 240 MOHS procedure kits that included a latex-containing dressing without proper labeling.
Nidek Inc. is recalling 17 Optical Biometer AL-Scan devices because they measured axial lengths as much shorter than actual values.
Dorel Juvenile is recalling Safety 1st Step and Go Travel Systems because the stroller tray can disengage, posing a fall hazard to infants.
Medtronic is recalling Valleylab Laparoscopic Flexible Argon Electrodes because the packaging may be compromised, potentially breaching the sterile barrier.
Medtronic is recalling Valleylab Laparoscopic Cylindrical Tip Electrodes due to a potential sterile barrier breach. The recall covers units distributed worldwide.
Synthes is recalling Titanium Single Vector Distractor Proximal Foot/Left devices because a fastener may separate prematurely from the plate.
Procesadora de Frutos y Vegetales del Caribe is voluntarily recalling specific lots of 13.5 oz canned coconut milk because the product was thermally under-processed.
Toshiba American Medical Systems is recalling 93 Xario 100 and 200 Diagnostic Ultrasound Systems because a software error may cause the devices to become hot.
Synthes is voluntarily recalling Titanium Single Vector Distractor Proximal Foot Plates because the fastener may separate prematurely from the plate.
TYRX Inc. is recalling 2,993 units of the TRYX Absorbable Antibacterial Envelope because key manufacturing processes were not adequately validated.
Stanmore Implants Worldwide Ltd. is recalling 3 units of METS SMILES Total Knee Replacements because the femoral plateau plates may not fit the intended mating component.
Cepheid is recalling specific lots of Xpert MRSA diagnostic kits because internal investigations found potential performance issues at lower positive sample concentrations.
Ford is recalling 2015-2016 Transit vehicles with 3.2L diesel engines because metallic debris may clog the fuel system, potentially causing the engine to stall and increasing crash risk.
Ab Sciex is recalling MultiQuant MD software for API 3200MD systems due to potential incorrect quantitative results when using the Sum Multiple Ions feature.
Eldorado is recalling 2011-2016 Aero Elite vehicles because intermediate side lamps may not stay illuminated, reducing visibility and increasing crash risk.
Medtronic is recalling Valleylab Laparoscopic Curved Spatula Electrodes due to a potential sterile barrier breach. The recall covers units distributed worldwide.
Straumann Manufacturing, Inc. is recalling 33 Bone Level Implants due to misalignment with the Loxim transfer piece markings, which may result in incorrect implant positioning.
Biomet 3i is recalling specific Gingihue dental implants because their pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling IOL Titanium Temporary Cylinder Dental implants because pouches may not have been sealed during packing.
Hospira is recalling Receptal liners because using incorrect sizes with canisters may prevent the lid from fitting properly, resulting in insufficient or inconsistent vacuum suction.
Biomet 3i, LLC is recalling Index Coping Surgical Dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling Conical EP Twist Lock TM Coping Dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling specific EP Healing Abutments because pouches may not have been sealed during packing, potentially compromising sterility.
LeMaitre Vascular is recalling 50 units of the 1.5 mm HYDRO LeMaitre Valvulotome because the wire may detach, rendering the device inoperable.
Biomet 3i is recalling Twist Lock Coping Dental implants because pouches may not have been sealed during packing, potentially compromising sterility.
Biomet 3i, LLC is recalling 1,648,273 dental implant cover screws because pouches may not have been sealed during packing.
Biomet 3i is recalling Preformance Temporary Cylinder Dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling Locator Replacement Housing dental implants because pouches may not have been sealed during packing.
Medtronic is recalling Valleylab Laparoscopic Flexible Argon Electrodes because the packaging may be compromised, potentially breaching the sterile barrier.
Biomet 3i is recalling specific lots of O-Ring Abutments for dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling 1.6 million dental implant protection caps because pouches may not have been sealed during packing.
Biomet 3i is recalling approximately 1.6 million non-hexed dental implants because pouches may not have been sealed during packing.
Medtronic is recalling Valleylab Laparoscopic AP Argon Blunt Needle Electrodes because the package may be compromised, potentially breaching the sterile barrier.
Medtronic is recalling Valleylab Laparoscopic Curved Spatula Electrodes due to a potential sterile barrier breach that could compromise the package integrity.
Biomet 3i, LLC is recalling Standard Abutment Dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling EP Healing Abutment dental implants because pouches may not have been sealed during packing, potentially compromising sterility.
Biomet 3i, LLC is recalling 1,648,273 Titanium Hexed Uniscrew Dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling Implant Twist Lock TM Coping Dental implants because pouches may not have been sealed during packing.
LeMaitre Vascular is recalling 1,992 units of the 1.5 mm HYDRO LeMaitre Valvulotome because the wire may detach at the handle, rendering the device inoperable.
Biomet 3i is recalling 1.6 million Straight Healing Abutment dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling Preformance 15 degrees pre-angled post dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling Standard Abutment Pick-Up Coping Dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling Gingihue 15 Degree Pre-Angled Post Dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling specific dental implant abutments because the packaging pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling 1,648,273 dental implant cover screws because pouches may not have been sealed during packing.
Biomet 3i is recalling specific O-Ring Abutments for dental implants because pouches may not have been sealed during packing.
Merge Healthcare is recalling iConnect Access software because it may display incorrect patient demographics after edits, potentially affecting medical specialists.
Green Bay Dressed Beef, LLC is recalling approximately 7,420 pounds of beef brain products that may be contaminated with specified risk materials (SRM). The products were shipped to a distributor in California.
Biomet 3i, LLC is recalling Temporary Hexed Cylinder Dental implants because pouches may not have been sealed during packing.
Medtronic is recalling 332 Valleylab Laparoscopic Flat L-Hook Electrodes because the packaging may be compromised, potentially breaching the sterile barrier.
Biomet 3i, LLC is recalling specific Gingihue Post dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling Locator Replacement Housing Kits because pouches may not have been sealed during packing. The recall affects 1,648,273 units distributed worldwide.
Biomet 3i is recalling Implant EP Pick-Up Coping dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling IOL Distal Extension dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling 1,648,273 Conical Healing Caps for dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling Twist Lock Straight Transfer Coping Dental Implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling Prep-Tite Post Dental implants because pouches may not have been sealed during packing.
Merge Healthcare is recalling iConnect Access software because it may display incorrect patient demographics for studies originating on Merge PACS or Ortho PACS.
Biomet 3i, LLC is recalling 1,648,273 Conical 25 degree Angled Abutment Dental Implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling Conical Abutment Gold Standard ZR Dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling DAL-RO Threaded Female Dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling Conical 17 degree Angled Abutment dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling 1,648,273 Temporary Healing Retention Cylinders because pouches may not have been sealed during packing.
Biomet 3i is recalling specific dental implants because their pouches may not have been sealed during packing, potentially compromising sterility.
Biomet 3i, LLC is recalling Conical EP Healing Caps for dental implants because pouches may not have been sealed during packing.
Golden State Medical Supply Inc. is recalling 40,631 bottles of Venlafaxine Hydrochloride Extended-Release Capsules, 75 mg, due to out-of-specification dissolution results.
Biomet 3i, LLC is recalling 1,648,273 LDA Screw SBL 3mm(D) dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling DAL-RO Abutment dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling 1.6 million conical abutment dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling 1,648,273 Provide Abutment Dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling Gold-Tite Square Uniscrew dental implants because pouches may not have been sealed during packing. The recall affects 1,648,273 units distributed worldwide.
Biomet 3i, LLC is recalling Conical 25 degree Angled Abutment dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling EP Twist Lock Coping Dental implants because pouches may not have been sealed during packing.
Zydus Pharmaceuticals is recalling 223,776 bottles of Venlafaxine Hydrochloride ER capsules because retained samples failed dissolution specifications.
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