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News Archives

December 15, 2020: Penumbra Issues Urgent Recall of JET 7 Catheters with Xtra Flex Technology Due to Increased Risk of Serious Injury and Death

Penumbra’s JET 7 Xtra Flex Catheter Recall News – Penumbra issued a recall for all models of its JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7 Xtra Flex) due to unexpected deaths and serious injuries while being used for removing clots in stroke patients. Penumbra’s JET 7 Xtra Flex Catheter Recall Information On December 15, 2020, Penumbra issued an urgent recall for consumers and providers for all configurations of the JET 7 Xtra Flex due to “unexpected death or serious injury” while the affected product was being used for removing clots in stroke patients. Use of the JET 7 Xtra Flex should cease immediately and facilities should take the affected devices out of their inventory. The affected JET 7 Xtra Flex devices include: All lots of Penumbra JET 7 Reperfusion Catheter and Penumbra Hi-Flow Aspiration Tubing with Catalog Read More

December 12, 2020: MPM Medical Issues Nationwide Recall of Regenecare HA Hydrogel Due to Burkholderia cepacia Contamination

Regenecare HA Hydrogel Recall News – MPM Medical has issued a recall for one lot of Regenecare HA Hydrogel. Following customer complaints of visible contamination, the Regenecare product tested positive for Burkholderia cepacia (B. cepacia). Regenecare HA Hydrogel Recall Information On December 2, 2020, MPM Medical, of Mesquite, TX, issued a recall for one lot of its Regenecare HA Hydrogel product due to a B. cepacia contamination. The affected product was packaged in 3 oz. plastic tubes and distributed in boxes of 12. The recalled Regenecare HA Hydrogel can be identified by the following: NDC #66977-107-03; Lot #41262; Date: 2021-01 This product was distributed nationwide to wholesalers and healthcare facilities. Patients and healthcare facilities with this affected lot of Regenecare HA Hydrogel should stop use immediately. Consumers should contact their healthcare provider or physician if they have experienced any problems. Read More

December 4, 2020: WishGarden Herbs Issues Nationwide Recall of Cord Care and Goldenseal Powder Due to Bacterial Contamination

WishGarden Cord Care and Goldenseal Powder Recall News – WishGarden Herbs, Inc. (WishGarden) has issued a recall for its Cord Care Powder and Goldenseal Powder products due to being contaminated with Cronobacter sakazakii bacteria. The U.S. Food and Drug Administration (FDA) had previously warned the public on August 14, 2020 about Maison Terre’s similar Goldenseal Root Powder product. The product was contaminated with multiple microorganisms, one of which was Cronobacter sakazakii, leading to an infant death. Maison Terre recalled the affected product on August 17, 2020. WishGarden Cord Care and Goldenseal Powder Recall Information On December 4, 2020, WishGarden recalled 14 lots of Cord Care Powder and Goldenseal Powder products. These products were produced after July 26, 2018, with expiration dates between July 26, 2018 and September 1, 2020. WishGarden determined the affected Cord Care and Goldenseal Powder products were Read More

August 18, 2020: Maison Terre Issues Nationwide Recall of Organic Goldenseal Root Powder Due to Microbial Contamination

Maison Terre Goldenseal Root Powder Recall News – Maison Terre has issued a recall for its Organic Goldenseal Root Powder product due to a microbial contaminartion. On August 14, 2020, the U.S. Food and Drug Administration (FDA) issued a warning as to the affected Goldenseal Root Powder product. Maison Terre Goldenseal Root Powder Recall Information On August 17, 2020, Maison Terre, of North Little Rock, AR, recalled all lots of its Goldenseal Root Powder product due to being contaminated with multiple microorganism, including: Enterobacter cloacae, Cronobacter sakazakii, Cronobacter dublinensis, among others. These products were purchased by Maison Terre from Starwest Botanicals, of Sacramento, CA, and repackaged to consumers. One infant death has been reported in association with use of the contaminated Goldenseal Root Powder product. The recalled Goldenseal Root Powder product by Maison Terre was distributed nationwide in the U.S. to Read More

August 14, 2020: FDA is Advising consumers not to use Goldenseal Root Powder Distributed by Maison Terre

Goldenseal Root Powder FDA Warning News – The U.S. Food and Drug Administration (FDA) has issued a warning to consumers and health care professionals to avoid using Goldenseal Root Powder, repackaged and distributed by Maison Terre, due to a microbial contamination. Goldenseal Root Powder FDA Warning Information On August 14, the FDA warned consumers and health care professional not to use Goldenseal Root Powder, repackaged and distributed by Maison Terre of Little Rock, AK, due to being contaminated with various bacteria, including multiple pathogens. Lab analysis by the FDA uncovered the bacteria. Serious infections can arise through continued use of the contaminated Goldenseal Root Powder product. Severe outcomes could include death, especially in vulnerable patients with compromised immune systems and infants. The FDA is aware of an infant death associated with use of this contaminated product on the umbilical cord Read More

July 27, 2020: Resource Recovery & Trading, LLC., Initiates Nationwide Recall of Hand Sanitizer Due to Possible Presence of Methanol and Subpotency Ethyl Alcohol

Resource Recovery & Trading Hand Sanitizer Recall News – Resource Recovery & Trading, LLC. (Resource Recovery) issues recall for all lots of hand sanitizer manufactured by MXL Comercial S.A. de C.V. To date, 4e Brands, LIQ-E S.A. de C.V., and Soluciones Cosméticas, among others, have initiated recalls for their hand sanitizer products. The U.S. Food and Drug Administration’s (FDA) last recall update was on July 2, 2020. Resource Recovery & Trading Hand Sanitizer Recall Information On July 27, 2020, Resource Recovery initiated a recall for all lots of hand sanitizer products made by MXL Comercial S.A. de C.V. due to undeclared methanol (wood alcohol) and subpotent ethyl alcohol. The following information is associated with this hand sanitizer recall: 70% Ethyl Alcohol Disinfectant Gel; packaged in 6.7 FL. Oz. (200 ml) bottles, UPC 650240026020 Non-sterile Solution 70% Topical Solution; packaged in 20 L. (5.28 Gal.) Read More

July 27, 2020: 4e Brands North America Expands Nationwide Recall of Hand Sanitizer Due to Possible Presence of Undeclared Methanol

4e Brands Hand Sanitizer Recall Update News – 4e Brands North America (4e Brands), of San Antonio, TX, recalls all lots of its hand sanitizer products due to the potential presence of methanol (wood alcohol). 4e Brands had previously issued recalls for various hand sanitizer products on July 11, 2020. To date, LIQ-E S.A. de C.V., Soluciones Cosméticas, and AAA Cosmética, among others, have initiated recalls for their hand sanitizer products. The U.S. Food and Drug Administration’s (FDA) last recall update was on July 2, 2020. 4e Brands Hand Sanitizer Recall Update Information On July 24, 2020, 4e Brands recalled all lots of its hand sanitizer products due to possible methanol contamination. The affected hand sanitizer products come in clear plastic bottles with varying tops, including blue, white or clear pumps or caps. The chart found in the announcement outlines the hand sanitizer products Read More

July 21, 2020: Hostess Brands, LLC Initiates Recall of Hostess Raspberry Zingers Due to Potential Mold

Hostess Raspberry Zingers Recall News – Hostess Brands, LLC (Hostess Brands), of Lenexa, KS, has issued a recall for its Hostess Raspberry Zingers product due to the potential presence of mold. Hostess Raspberry Zingers Recall Information On July 20, 2020, Hostess Brands recalled its Hostess Raspberry Zinger products because the product has the potential to develop mold prior to the best by date. This recall affects various Raspberry Zinger products and batches. A table of the recalled products and info can be found in the company’s recall announcement. The affected Hostess Raspberry Zinger products were sold to merchandisers, grocery stores, distributors, dollar and discount stores, and convenience stores Nationwide in the United States. Consumers who have purchased the affected products should discontinue consumption and contact the place of purchase about returning them for a full refund. Contact The Weinberg Law Read More

July 20, 2020: LIQ-E S.A. de C.V. Issues Recall for Optimus Instant Hand Sanitizer Due to Possible Presence of Undeclared Methanol

LIQ-E S.A. de C.V. Optimus Instant Hand Sanitizer Recall News – LIQ-E S.A. de C.V. is recalling all lots and bottles sizes of its Optimus Instant Hand Sanitizer due to the potential presence of methanol (wood alcohol). To date, Soluciones Cosméticas, AAA Cosmética, and 4e Brands, among others, have initiated recalls for their hand sanitizer products. The U.S. Food and Drug Administration’s (FDA) last recall update was on July 2, 2020. LIQ-E S.A. de C.V. Optimus Instant Hand Sanitizer Recall Information On July 20, 2020, LIQ-E S.A. de C.V. issued a recall for all lots and bottle sizes of its Optimus Instant Hand Sanitizer product due to the potential presence of undeclared methanol. The affected products were manufactured between April 27, 2020 and May 8, 2020. The affected hand sanitizer is distributed in 55 Gal (208 L) plastic blue drums and in 8.5 Fl Read More

July 14, 2020: AAA Cosmética, S.A. de C.V. Issues Nationwide Recall of bio aaa Advance Hand Sanitizer Due to Potential Presence of Undeclared Methanol

AAA Cosmética Hand Sanitizer Recall News – AAA Cosmética, S.A. de C.V. (AAA Cosmética) has begun a recall of all lots of bio aaa Advance Hand Sanitizer due to the possible presence of undeclared methanol (wood alcohol). To date, 4e Brands, ITECH 361, and Transliquid Technologies, among others, have initiated recalls for their hand sanitizer products. The U.S. Food and Drug Administration’s (FDA) last recall update was on July 2, 2020. AAA Cosmética Hand Sanitizer Recall Information On July 14, 2020, AAA Cosmética recalled all lots of their bio aaa Advance Hand Sanitizer product due to the potential presence of undeclared methanol. The affected hand sanitizer product was packaged in 480 mL bottles, with expiration date of April 2022 and the following lot numbers: 20DF9001 20DF9002 20DF9003 20DF9004 20DF9005 20DF9006 20DF9007 20DF9008 20DF9009 20DF9010 20DF9011 20DF9012 20DF9013 20DF9014 20DF9015 20DF9016 Read More

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