Medical DeviceMay 8, 2019
Matrix Surgical Holdings OMNIPORE Surgical Implant Petite Paranasal - Left - Product Usage recall — FDA Z-1223-2019
Product mislabeling.
Class IIFDA: TerminatedMatrix Surgical Holdings, LLC
May 2019 recalls — page 14
These records include useful source details for the selected month.
Medical DeviceMay 8, 2019
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), product code recall — FDA Z-1248-2019
The flow rate test verification was not properly executed for certain Sigma Spectrum infusion pumps prior to release. The testing was performed for less than the required minimum run time.…
Class IIFDA: TerminatedBaxter Healthcare Corporation
Medical DeviceMay 8, 2019
Siemens Atellica IM aTG (100 test kit) Siemens Material Number (SMN): 10995461 recall — FDA Z-1235-2019
Positive bias anti-thyroglobulin with ADVIA Centaur aTG kit lots ending in 316 and lower and Atellica IM aTG kit lots ending in 317 and lower when compared to the standardization to World…
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Medical DeviceMay 8, 2019
Molnlycke Health Care EZ Derm Porcine Xenograft, labeled as the following: a recall — FDA Z-1243-2019
Intermittent heat seal failures on the outer pouch of some EZ Derm products.
Class IIFDA: TerminatedMolnlycke Health Care, Inc.
Medical DeviceMay 8, 2019
Randox Laboratories G-6-PDH Normal Control (G-6-PDH CONTROL N), Catalogue Number PD2618 recall — FDA Z-1255-2019
The target values and ranges in these lots are incorrect.
Class IIFDA: TerminatedRandox Laboratories Ltd.
Medical DeviceMay 8, 2019
GE Healthcare NM/CT 870 DR Product Usage: The GE Discovery NM/CT 670 system is a medical recall — FDA Z-1265-2019
During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one…
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceMay 8, 2019
GE Healthcare NM/CT 870 CZT, Model/Catalogue/Code # H3906CW Product Usage: The GE Discovery recall — FDA Z-1264-2019
During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one…
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceMay 8, 2019
Siemens Healthcare Diagnostics SiemensADVIA Centaur aTG (500 test kit) Siemens Material recall — FDA Z-1234-2019
Positive bias anti-thyroglobulin with ADVIA Centaur aTG kit lots ending in 316 and lower and Atellica IM aTG kit lots ending in 317 and lower when compared to the standardization to World…
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Medical DeviceMay 8, 2019
Roche Diagnostics cobas e 801 immunoassay analyzer recall — FDA Z-1249-2019
The firm has confirmed complaints regarding signal drops on the cobas e 801 module after a ProCell II M bottle changeover, which may lead to incorrect medical decisions with respect to…
Class IIFDA: TerminatedRoche Diagnostics Corporation
Medical DeviceMay 8, 2019
PerkinElmer Life and Analytical Sciences AutoDELFIA hCG Kit, In Vitro Diagnostic for the recall — FDA Z-1239-2019
hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.
Class IIFDA: OngoingPerkinElmer Life and Analytical Sciences, Wallac, OY
Medical DeviceMay 8, 2019
Siemens Medical Solutions USA SOMATOM Definition AS with Option syngo DE Scan for Single recall — FDA Z-1247-2019
Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens Healthineers CT scanners with a…
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
FoodMay 8, 2019
Frial SAS Trader Joe's Saucy Scallops with Mushrooms, NET Wt recall — FDA F-1316-2019
Scallop flavor used in the product contains low levels of crustaceans (1 ppm) that is not listed on the product label.
Class IIFDA: TerminatedFrial SAS
FoodMay 8, 2019
Wawa Net weight/number of units per package: 12 FL OZ recall — FDA F-1326-2019
WAWA has initiated a recall of Wawa Iced Tea Less Sugar, Net weight/number of units per package: 12 FL OZ. , Package type: Bottle Units per case: 24, Expiration date: April 29, 2019…
Class IIIFDA: TerminatedWawa, Inc.
FoodMay 8, 2019
Lamb Weston BSW item # H30, packaged in 5-pound unprinted KRAFT paper bags, 6 recall — FDA F-1321-2019
Formed Potato Tater Puffs (H30 s), sold as a foodservice item, are recalled due to contamination with plastic object.
Class IIFDA: TerminatedLamb Weston BSW LLC
FoodMay 8, 2019
Kingston Pharma DG health NATURALS For Infants 2+ Months+ baby Cough Syrup + recall — FDA F-1308-2019
Microbial contamination with Bacillius circulans and Bacillus cereus / thuringiensis / mycoides.
Class IIFDA: TerminatedKingston Pharma LLC
FoodMay 8, 2019
Harmless Harvest Dairy-Free Yogurt Drink recall — FDA F-1317-2019
Firm is voluntarily recalling specific lots of Harmless Harvest s Dairy-Free Yogurt Drink beverages after identifying a possible packaging defect that may result in premature spoilage
Class IIFDA: TerminatedHarmless Harvest Inc.
FoodMay 8, 2019
Harmless Harvest Dairy-Free Yogurt Drink recall — FDA F-1319-2019
Firm is voluntarily recalling specific lots of Harmless Harvests Dairy-Free Yogurt Drink beverages after identifying a possible packaging defect that may result in premature spoilage
Class IIFDA: TerminatedHarmless Harvest Inc.
FoodMay 8, 2019
Spagel Brothers Stanganellis Italian Foods, Pumpkin Cake Roll, Net Wt recall — FDA F-1324-2019
Stanganellis Italian Foods, is initiating a recall of Pumpkin Cake Roll, Net Wt. 24 oz. . One per package, because of product miss-labeling. The firm inadvertently left off the allergen…
Class IIFDA: TerminatedSpagel Brothers, Inc.
FoodMay 8, 2019
Harmless Harvest Dairy-Free Yogurt Drink recall — FDA F-1318-2019
Firm is voluntarily recalling specific lots of Harmless Harvests Dairy-Free Yogurt Drink beverages after identifying a possible packaging defect that may result in premature spoilage
Class IIFDA: TerminatedHarmless Harvest Inc.
FoodMay 8, 2019
Harmless Harvest Dairy-Free Yogurt Drink recall — FDA F-1320-2019
Firm is voluntarily recalling specific lots of Harmless Harvests Dairy-Free Yogurt Drink beverages after identifying a possible packaging defect that may result in premature spoilage
Class IIFDA: TerminatedHarmless Harvest Inc.
FoodMay 8, 2019
Rice Valley Net Wt, 14 oz recall — FDA F-1322-2019
FDA inspection at the facility found that the firm was using Yellow 5 & 6 which were not declared on product labeling.
Class IIFDA: TerminatedRice Valley
FoodMay 8, 2019
Fannie May Confections Brands Caramel and Pecan Clusters covered in Milk Chocolate 14 oz recall — FDA F-1315-2019
The products outer holiday wrap has an information panel that is incorrect. The information panel does not declare that pecans are in product. The actual box under wrapping correctly…
Class IIFDA: TerminatedFannie May Confections Brands, Inc.
FoodMay 8, 2019
Tom Sturgis Pretzels Little Ones Pretzels 4.5lb, 1 polyethylene bag per corrugated recall — FDA F-1314-2019
The box has in it a pretzel containing a milk allergen that was packaged in a box labeled for a pretzel that does not contain a milk allergen. Mislabeled product.
Class IIFDA: TerminatedTom Sturgis Pretzels, Inc.
FoodMay 8, 2019
Hercules Candy Company Cashew Brittle Bits in clear 4oz bag with a Best By date of recall — FDA F-1323-2019
Product may contain undeclared peanuts
Class IFDA: TerminatedHercules Candy Company
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.