Archive
500 recalls were announced in December 2020.
Of the 500 recalls this month scored against our rubric, 3% are Critical, 26% are Severe.
Which agencies issued them
Anticimex is recalling about 2,750 SMART Connect Mini Devices because the power supply can overheat, causing the plastic enclosure to fly off and posing fire and injury risks.
The USDA FSIS issued a public health alert for frozen chicken sriracha ravioli products that may contain undeclared soy, a known allergen. Approximately 49 pounds of these products are affected across multiple states.
Cook Inc. is recalling Flexor Check-Flo Introducer sheaths because the proximal bond site may separate, potentially causing life-threatening adverse events such as embolization or hemorrhage.
Maribel's Sweets, Inc. is recalling Cacao Market Marie Belle New York Dark Chocolate Pearls because the product contains undeclared milk.
SCA Pharmaceuticals is recalling 654 bags of Vasopressin 20 Units in 0.9% Sodium Chloride because the drug was subpotent.
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, potentially causing life-threatening adverse events.
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, potentially causing life-threatening adverse events.
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, posing a risk of life-threatening adverse events.
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, posing a risk of life-threatening adverse events.
Cook Inc. is recalling Flexor Tuohy-Borst Side-Arm Introducers because the sheath may separate at the proximal bond site, potentially causing life-threatening adverse events.
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, potentially causing life-threatening adverse events during use.
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, potentially causing life-threatening adverse events.
Cook Inc. is recalling 228 Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, potentially causing life-threatening adverse events.
ICU Medical is recalling specific ChemoLock administration sets because a molding defect may cause leaks. This could lead to fluid path contamination or exposure to hazardous medications.
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, posing a risk of life-threatening adverse events during use.
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, posing a risk of life-threatening adverse events.
Morton Grove Pharmaceuticals is recalling Hydroxyzine Hydrochloride Oral Solution because it failed impurity specifications, including an unknown degradant.
CryoLife, Inc. is recalling two units of CryoPatch SG Pulmonary Human Cardiac Patch due to post-processing microbial culture test failures.
Cook Inc. is recalling 458 Flexor Check-Flo Introducer sheaths because the proximal bond site may separate, potentially causing life-threatening adverse events such as embolization or hemorrhage.
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, potentially causing life-threatening adverse events.
Cook Inc. is recalling 631 Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, posing a risk of life-threatening adverse events.
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, potentially causing life-threatening adverse events during use.
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, potentially causing life-threatening adverse events during use.
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, potentially causing life-threatening adverse events.
The FDA is recalling the Flexor Check-Flo Introducer because its sheath may separate at the proximal bond site, potentially causing serious complications such as embolization, vessel injury, or hemorrhage.
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, potentially causing life-threatening adverse events.
Cook Inc. is recalling 902 Flexor Tuohy-Borst Side-Arm Introducers because the sheath may separate during use, potentially causing life-threatening adverse events.
Cook Inc. is recalling 383 Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, posing a risk of life-threatening adverse events during use.
ICU Medical is recalling specific oncology and administration sets because a molding defect in male luers may cause leaks, potentially leading to fluid path contamination or exposure to hazardous medications.
CryoLife, Inc. is recalling three CryoValve SG Pulmonary Human Heart Valves because post-processing microbial culture tests failed for allografts processed with the same TRIS saline solution lot.
Nova Ortho-Med is recalling Star 8 Rolling Walkers because the front fork may unscrew from the leg, creating instability and a risk of the fork falling off.
GE Healthcare is recalling two Revolution CT ES units due to a potential for unintended patient orientation or scan settings when using Intelligent Protocoling.
Boston Scientific is recalling 75 units of IceFORCE 2.1 CX Cryoablation Needles nationwide due to a complaint trend regarding needle shaft gas leaks.
GA Health Company Limited is recalling 10,000 STOPCON Suction Valves for GI endoscopes because the suction button is reported sticky or broken, which may cause prolonged procedures.
Boston Scientific is recalling 4,645 IceRod 1.5 PLUS 90° Cryoablation Needles nationwide because of a complaint trend regarding needle shaft gas leaks.
ConMed Corporation is recalling 73 units of the Infinity ACL Tibial Elbow Guide because the tips may be misaligned, potentially affecting the accuracy of the guide system.
Boston Scientific is recalling 117 IcePearl 2.1 CX Prostate Cryoablation Kits nationwide due to a complaint trend regarding needle shaft gas leaks.
George DeLallo Co. Inc. is recalling Provolini Antipasta due to mis-packaging that resulted in undeclared milk.
Boston Scientific is recalling 86 IcePearl 2.1 CX Cryoablation Needles nationwide because of a complaint trend regarding needle shaft gas leaks.
Boston Scientific is recalling 947 IceRod i-Thaw Prostate Cryoablation Kits nationwide due to a complaint trend regarding needle shaft gas leaks.
Boston Scientific is recalling 243 IceRod i-Thaw Prostate Cryoablation Kits nationwide because of a complaint trend regarding needle shaft gas leaks.
ICU Medical is recalling 900 units of Appx 1.7 ml Bag Spike w/Integrated Clave due to a molding defect that may cause leaks in male luers.
Boston Scientific is recalling 729 IceSphere 1.5 S 90° Cryoablation Needles nationwide because of a complaint trend regarding needle shaft gas leaks.
Siemens Healthcare Diagnostics is recalling ADVIA Gamma-Glutamyl Transferase (GGT) Reagent because it may show repeatability imprecision outside of listed performance data.
Vallarta Organics LLC is recalling Organic Basil due to possible contamination with Cyclospora. The product was distributed to direct accounts in Virginia and Florida.
Hardy Diagnostics is recalling Viral Transport Media due to potential contamination that may compromise COVID-19 test detection.
Boston Scientific is recalling 245 units of IceSphere 1.5 Cryoablation Needles nationwide due to a complaint trend regarding needle shaft gas leaks.
Boston Scientific is recalling 92 units of IceSphere 1.5 90° Cryoablation Needles nationwide due to a complaint trend regarding needle shaft gas leaks.
Boston Scientific is recalling 85 IceFORCE 2.1 CX Prostate Cryoablation Kits nationwide due to a complaint trend regarding needle shaft gas leaks.
Boston Scientific is recalling 419 Five IceSphere Prostate Cryoablation Kits nationwide due to a complaint trend regarding needle shaft gas leaks.
GA Health Company Limited is recalling 93,700 units of Andorate Disposable Endoscope Valves because the suction button may be sticky or broken, potentially prolonging medical procedures.
Boston Scientific is recalling 18,731 IceRod 1.5 CX 90° Cryoablation Needles nationwide because of a complaint trend regarding needle shaft gas leaks.
Boston Scientific is recalling 152 IceSeed 1.5 Cryoablation Needles nationwide due to a complaint trend regarding needle shaft gas leaks.
GA Health Company Limited is recalling 10,000 ScopeValet Guardian Disposable Endoscope Valves because the suction button may be sticky or broken, potentially prolonging procedures.
Boston Scientific is recalling 115 IceRod He-Thaw Prostate Cryoablation Kits nationwide due to a complaint trend regarding needle shaft gas leaks.
GA Health Company Limited is recalling Andorate Disposable Endoscope Valves because the suction button may be sticky or broken, potentially prolonging medical procedures.
Boston Scientific is recalling 8,453 IcePearl 2.1 CX 90° Cryoablation Needles nationwide because of a complaint trend regarding needle shaft gas leaks.
GA Health Company Limited is recalling 11,000 Stopcon Disposable Endoscope Valve Sets because the suction button may be sticky or broken, potentially prolonging medical procedures.
Boston Scientific is recalling 6,363 IceSphere 1.5 CX 90° Cryoablation Needles nationwide because of a complaint trend regarding needle shaft gas leaks.
Haag-Streit USA Inc. is recalling surgical floor stands and operating microscopes due to a software error that may cause focusing movement to continue after the footswitch is released.
ICU Medical is recalling Spiros male luer connectors and administration sets due to a molding defect that may cause leaks, potentially leading to fluid path contamination or exposure to hazardous medications.
ConMed Corporation is recalling 95 Infinity ACL Tibial Tip Guides because the tips may be laterally misaligned, potentially affecting the accuracy of the guide system.
GE Healthcare is recalling three Revolution CT systems due to a potential for unintended patient orientation or scan settings when using Intelligent Protocoling.
ICU Medical is recalling specific ChemoLock administration sets because a molding defect may cause leaks. This could lead to fluid path contamination or exposure to hazardous medications.
Boston Scientific is recalling 3,894 IceRod 1.5 MRI 90° Cryoablation Needles nationwide due to a complaint trend regarding needle shaft gas leaks.
GA Health Company Limited is recalling 25,000 units of STOPCON Disposable Valves because the suction button may be sticky or broken, potentially prolonging procedures.
Boston Scientific is recalling 52 IceSeed Prostate Cryoablation Kits nationwide due to a complaint trend regarding needle shaft gas leaks.
ICU Medical is recalling specific Spiros and Clave IV administration sets due to a molding defect that may cause leaks in spinning male luer components.
ICU Medical is recalling specific Spinning Spiros components due to a molding defect that may cause leaks, risking fluid path contamination or exposure to hazardous medications.
ICU Medical is recalling specific syringes and administration sets with spinning Spiros components due to a molding defect that may cause fluid leaks.
GA Health Company is recalling 12,800 units of STOPCON Disposable Valves because the suction button may be sticky or broken, potentially prolonging medical procedures.
ICU Medical is recalling 325 units of 30-inch IV administration sets because a molding defect in the male luer may cause fluid leaks, potentially leading to infusion delays or contamination.
Boston Scientific is recalling 26 units of IceRod 1.5 Cryoablation Needles nationwide due to a complaint trend regarding needle shaft gas leaks.
Zimmer Biomet is recalling 4,713 Spinal Rod Cutters because they may fracture during use. The devices were distributed domestically and internationally.
GA Health Company is recalling 20,000 units of Bulldog Disposable Endoscope Valves because the suction button may be sticky or broken, potentially prolonging medical procedures.
Beckman Coulter is recalling MicroScan Pos MIC Panel Type 34 because a portion of the lot failed quality control, potentially causing false elevated daptomycin results.
Boston Scientific is recalling 178 IceRod i-Thaw Prostate Cryoablation Kits nationwide due to a complaint trend regarding needle shaft gas leaks.
GA Health Company Limited is recalling ScopeValet Guardian Disposable Endoscope Valves because the suction button may be sticky or broken, potentially prolonging procedures.
GA Health Company is recalling 20,000 units of Bulldog Disposable Endoscope Valves because the suction button is reported sticky or broken, which may cause prolonged procedures.
Boston Scientific is recalling 2,429 IceSphere 1.5 90° Cryoablation Needles nationwide due to a complaint trend regarding needle shaft gas leaks.
Boston Scientific is recalling 215 IcePearl 2.1 CX Prostate Cryoablation Kits nationwide due to a complaint trend regarding needle shaft gas leaks.
B Braun Medical is recalling 85 APEX Compounding System Control Panel Modules because they may fail to detect air bubbles, potentially resulting in inaccurate drug compounding.
Boston Scientific is recalling 93 units of IceRod 1.5 90° Cryoablation Needles nationwide due to a complaint trend regarding needle shaft gas leaks.
Akebia Therapeutics is voluntarily recalling 2,170 bottles of Auryxia (ferric citrate) tablets due to CGMP deviations. The FDA classified this as a Class II recall.
Shenandoah Growers is recalling organic fresh cut basil due to possible Cyclospora contamination. The product was distributed to retail stores in six states.
Boston Scientific is recalling 627 IceSeed 1.5 MRI Cryoablation Needles nationwide due to a complaint trend regarding needle shaft gas leaks.
Boston Scientific is recalling 262 IceRod 1.5 i-Thaw Cryoablation Needles nationwide because of a complaint trend regarding needle shaft gas leaks.
Boston Scientific is recalling 64 IceRod Prostate Cryoablation Kits nationwide because of a complaint trend regarding needle shaft gas leaks.
B Braun Medical is recalling 16 APEX Compounding System Control Panel Modules because they may fail to detect air bubbles, potentially compromising drug accuracy.
Boston Scientific is recalling 1,526 IceSeed MRI Cryoablation Needles nationwide due to a complaint trend regarding needle shaft gas leaks.
ICU Medical is recalling specific infusion components due to a molding defect that may cause leaks, risking fluid contamination or exposure to hazardous medications.
Boston Scientific is recalling 740 IceFORCE 2.1 CX L 90° Cryoablation Needles nationwide due to a complaint trend regarding needle shaft gas leaks.
Target is recalling approximately 299,000 Cloud Island infant rompers because snaps can break or detach, posing choking, laceration, and pinching hazards to children.
Target is recalling Cat & Jack infant-toddler one-piece rashguard swimsuits because snaps can break or detach, posing choking and laceration hazards.
Baxter Healthcare is recalling 9,353 SIGMA Spectrum Infusion Pumps due to a potential software error during programming.
ICU Medical is recalling Spiros closed male luer devices due to a molding defect that may cause leaks. The defect could lead to infusion delays, fluid contamination, or exposure to hazardous medications.
Boston Scientific is recalling 788 IceSeed 1.5 90° Cryoablation Needles nationwide because of a complaint trend regarding needle shaft gas leaks.
Boston Scientific is recalling 261 IcePearl 2.1 CX L 90° Cryoablation Needles nationwide due to a complaint trend regarding needle shaft gas leaks.
ICU Medical is recalling Spiros administration sets due to a molding defect that may cause leaks, potentially leading to fluid path contamination or exposure to hazardous medications.
Boston Scientific is recalling 22,289 IceFORCE 2.1 CX 90° Cryoablation Needles nationwide because of a complaint trend regarding needle shaft gas leaks.
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