Massachusetts recalls

Encore Medical discovered that some packages of EMPOWR Acetabular System hip implant liners contained the wrong device inside—for example, a box labeled as one size contained a different size. This packaging error could force surgeons to delay surgery or perform additional procedures to swap out the correct implant.

Encore Medical discovered that some packages of knee tibial inserts and acetabular (hip socket) system components contain the wrong device inside. This packaging error could delay surgery or require unexpected revision surgery if the mismatch is not caught beforehand.

A software error allowed robotic instrument arms with bent or misaligned parts to remain in use during surgery. These parts can wear out and potentially fail during a procedure. Intuitive Surgical identified specific serial numbers of affected systems.

Vantive US Healthcare is recalling certain Prismaflex TPE2000 dialysis sets because the deaeration chamber may detach from the Prismaflex Control Unit during use. This could interrupt dialysis treatment. The recall affects units manufactured on or after June 2024.

The deaeration chamber in certain Prismaflex HF1000 dialyzer sets may become loose or detached from the Prismaflex Control Unit during use. This could affect the proper function of the dialysis equipment. The recall affects units manufactured on or after lot 24F0094CA.

Vantive US Healthcare is recalling Prismaflex HF1000 dialyzer sets because the deaeration chamber may come loose from the Prismaflex Control Unit during use. This affects units manufactured on or after lot 24G0034CA. No injuries have been reported.

Vantive US Healthcare is recalling Prismaflex M150 dialyzer sets because the deaeration chamber may separate from the Prismaflex Control Unit during use. This could disrupt dialysis treatment. The recall affects units manufactured on or after June 24, 2024.

Vantive US Healthcare is recalling Prismaflex M100 dialyzer sets because the deaeration chamber may separate from the control unit during use. This affects units manufactured on or after lot 24F0077CA. The FDA has classified this as a Class II recall.

Vantive US Healthcare is recalling certain OXIRIS dialyzer sets because a part called the deaeration chamber may come loose from the Prismaflex Control Unit during use. This could interrupt dialysis treatment. No injuries have been reported so far.

Vantive US Healthcare has recalled Prismaflex ST150 dialyzer sets because the deaeration chamber may become loose and detach from the control unit during use. This affects units manufactured on or after June 24, 2025. No injuries have been reported.

The deaeration chamber in certain Vantive Prismaflex ST100 dialyzer sets may detach from the control unit during use. This could interrupt treatment. The recall affects units manufactured on or after lot 24G0072.

Olympus is recalling its Single Use Electrosurgical Knife model KD-645L because the cutting tip can overheat, deteriorate, and break during surgery. This may occur in certain lot numbers manufactured between specific production runs. No injuries have been reported.

Olympus Corporation is recalling certain single-use electrosurgical knives (model KD-640L) used during endoscopic surgery. The cutting knife can overheat, burn, and break during use, which could affect the surgery. No injuries have been reported.

Beckman Coulter has recalled specific lots of COULTER DxH Diluent and COULTER DxH ECO Diluent used in blood cell analysis systems. These affected lots can produce inaccurate platelet count readings during daily quality checks, which may lead to unreliable test results.

Boston Scientific's AXIOS Stent (a medical device used in certain procedures) may fail to deploy or expand properly during use. If the stent does not expand as intended, patients may need additional procedures—either endoscopic or surgical—to remove the stent and repair the site.

Boston Scientific is recalling certain AXIOS Stents (8mm x 8mm) due to reports of deployment and expansion problems during use. If a stent fails to deploy properly, patients may need additional procedures to remove it and repair the puncture site.

Boston Scientific's HOT AXIOS Stent (6mm × 8mm) may fail to deploy or expand properly during placement. If the stent does not expand correctly, patients may need additional endoscopic or surgical procedures to remove it and repair the puncture site.

Boston Scientific is recalling certain AXIOS Stents (8mm x 8mm) used in medical procedures because they may not deploy or expand properly. If the stent fails to deploy correctly, additional procedures may be needed to remove it and repair the puncture site.

Boston Scientific has recalled certain AXIOS Stents (6mm x 8mm) due to reports of problems with stent deployment and expansion during procedures. In some cases, the stent may not deploy properly, potentially requiring additional procedures to remove it and repair the site. No injuries have been reported.

Boston Scientific has recalled specific lots of the AXIOS Stent and Electrocautery-Enhanced Delivery System (20mm x 10mm) due to reports of stent deployment and expansion problems. In some cases, the stent may not deploy or expand properly, which could require additional procedures to remove the stent and repair the puncture site.

B.C. Williams Bakery Service, Inc. is recalling Swiss Chocolate Cake Mix because it contains milk that is not listed on the label. This poses a serious risk to anyone with a milk allergy. The affected product was distributed nationwide in 50 lb. bags with lot codes 072925-220 and 071825-36.

B.C. Williams Bakery Service, Inc. is recalling Bread and Roll Mix in 50 lb. bags because they may contain milk that is not listed on the label. This poses a serious risk to people with milk allergies. The affected product was distributed nationwide.

B.C. Williams Bakery Service, Inc. recalled Spice Cake Mix (50 lb. bags, Batch 221) because it contains milk that is not listed on the label. This poses a serious risk to people with milk allergies or severe lactose intolerance. The recall affects 51 bags distributed nationwide.

Willy Pete's Chocolates Almond Despair dark chocolate contains almonds, but almonds are not listed in the ingredient statement. The product name and front label mention almonds, but people with tree nut allergies relying on the ingredients list may not know almonds are present.

Imu-Tek Immuno-5 Colostrum Powder (7 oz) contains milk that is not listed on the label. This poses a serious risk to people and pets with milk allergies or sensitivity. The affected product is Lot #216 with an expiration date of 4/16/2027.

Diva Fam Inc's orange Sea Moss Gel Superfood (16 FL OZ glass jars) may be contaminated with Clostridium botulinum, a bacteria that can cause botulism, a serious illness affecting the nervous system. The recall affects specific lot codes distributed nationwide and sold online.

Diva Fam Inc's Lemon Pie Sea Moss Gel Superfood may be contaminated with Clostridium botulinum, a bacteria that can cause serious illness. The product was sold nationwide through retailers and online. No injuries have been reported so far.

Diva Fam Inc is recalling its 16 FL OZ Soursop Sea Moss Gel Superfood due to potential contamination with Clostridium botulinum, a bacteria that can cause serious food poisoning. The affected product was sold nationwide through retail stores and online. No illnesses have been reported to date.

Diva Fam Inc is recalling its Sea Moss Gel Superfood (16 FL OZ glass jars) due to potential contamination with Clostridium botulinum, a bacteria that can cause botulism, a serious illness affecting the nervous system. The affected product was sold nationwide through retail stores and online.

Diva Fam Inc's Sea Moss Gel Superfood in Mango and Pineapple flavor may be contaminated with Clostridium botulinum, a bacteria that produces a dangerous toxin. The affected product was sold nationwide through retailers and online. No illnesses have been reported yet.