Medical DeviceOct 26, 2022
BALT USA Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10 recall — FDA Z-0103-2023
Product pouch label does not match up with carton label
Class IIFDA: OngoingBALT USA, LLC
Monthly breakdown
2022 recalls by month
Select a month to review the recall records reported during that period.
December 2022318 records · 4 categoriesNovember 2022270 records · 4 categoriesOctober 2022288 records · 4 categoriesSeptember 2022318 records · 4 categoriesAugust 2022293 records · 4 categoriesJuly 2022334 records · 4 categoriesJune 2022348 records · 4 categoriesMay 2022227 records · 4 categoriesApril 2022205 records · 4 categoriesMarch 2022449 records · 4 categoriesFebruary 2022237 records · 4 categoriesJanuary 2022296 records · 4 categories
2022 recalls — page 26
Records are ordered by the best available source date.
Medical DeviceOct 26, 2022
Roche Molecular Systems cobas 5800 instrument, Material No. 08707464001 recall — FDA Z-0097-2023
Reported false positive and invalid results on the affected devices due to anomalous baselines. This may lead to erroneous or delayed diagnoses.
Class IIFDA: TerminatedRoche Molecular Systems, Inc.
Medical DeviceOct 26, 2022
Synthes (USA) Products SPEED 9X10X10mm Continuous Compression Implant, Product No recall — FDA Z-0100-2023
The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit.…
Class IIFDA: OngoingSynthes (USA) Products LLC
Medical DeviceOct 26, 2022
MEDLINE INDUSTRIES, LP - Northfield CENTURION SnagFree Chest Tube insertion Tray, Reorder recall — FDA Z-0106-2023
One lot of chest tube insertion trays, containing a silk suture component that is restricted to 1 cycle of sterilization, was processed though 2 cycles.
Class IIFDA: TerminatedMEDLINE INDUSTRIES, LP - Northfield
Medical DeviceOct 26, 2022
Abbott Vascular Product/Part: MitraClip XTR Clip Delivery System US/CDS0601-XTR, MitraClip recall — FDA Z-0115-2023
An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been observed. Contributing causes may be clip locking component material properties…
Class IIFDA: OngoingAbbott Vascular
Medical DeviceOct 26, 2022
SIEMENS HEALTHCARE DIAGNOSTICS N Antiserum to Human IgG, 5mL Variant for BN II System and BN recall — FDA Z-0094-2023
N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 648 mg/L for IgGU (urine) and up to 2290 mg/L for IgGC (CSF).
Class IIFDA: OngoingSIEMENS HEALTHCARE DIAGNOSTICS Inc.
Medical DeviceOct 26, 2022
SIEMENS HEALTHCARE DIAGNOSTICS N Antiserum to Human IgG, 2mL Variant for BN II System and BN recall — FDA Z-0093-2023
N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 648 mg/L for IgGU (urine) and up to 2290 mg/L for IgGC (CSF).
Class IIFDA: OngoingSIEMENS HEALTHCARE DIAGNOSTICS Inc.
Medical DeviceOct 26, 2022
Siemens Healthcare Diagnostics Atellica CH Lithium (Li), Siemens Material Number 11097535. recall — FDA Z-0105-2023
Potential for falsely elevated LITH_2 and Li results on the Atellica CH 930 Analyzer. In the worst case, there is a potential for erroneously elevated lithium patient results, which may…
Class IIFDA: OngoingSiemens Healthcare Diagnostics, Inc.
Medical DeviceOct 26, 2022
ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 recall — FDA Z-0102-2023
Mislabeling: the corrugate label, lidstock, banner card, and peel sticker accompanying the affected product incorrectly displays a double lumen 5.5 French catheter (and related priming…
Class IIFDA: TerminatedARROW INTERNATIONAL Inc.
Medical DeviceOct 26, 2022
Siemens Healthcare Diagnostics Dimension Vista High Density Lipoprotein Cholesterol (HDLC) recall — FDA Z-0089-2023
Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Potential for Erroneous Result. If an HDLC QC or patient result is obtained without an Abnormal Reaction [E145]: flag, a falsely…
Class IIFDA: OngoingSiemens Healthcare Diagnostics, Inc.
FoodOct 26, 2022
Karlsburger Foods Gluten Free recall — FDA F-0050-2023
undeclared non-wheat gluten, product labeled gluten-free
Class IIIFDA: TerminatedKarlsburger Foods, Inc.
FoodOct 26, 2022
Diamond Foods Rocky Road Trail Mix, 20 oz UPC: 021130 162550 Store in recall — FDA F-0071-2023
Glass pieces found in lot of chocolate covered peanuts.
Class IIFDA: TerminatedDiamond Foods, Inc.
FoodOct 26, 2022
Flowers Foods TASTYKAKE GLAZED APPLE PIE NET WT 4.5 OZ recall — FDA F-0067-2023
During an internal inspection the firm discovered that several products may contain soy lecithin which is not declared on the labels.
Class IIFDA: OngoingFlowers Foods (Corporate Offices)
FoodOct 26, 2022
Nestle-USA "***Nestle***STUFFED***CHOCOLATE CHIP COOKIE DOUGH***4 JUMBO recall — FDA F-0064-2023
Consumer complaints reported presence of white pieces of plastic in cookie product.
Class IIFDA: TerminatedNestle-USA, Inc. (Corporate Office)
FoodOct 26, 2022
Flowers Foods TASTYKAKE GLAZED CHERRY PIE NET WT 4.5 OZ recall — FDA F-0069-2023
During an internal inspection the firm discovered that several products may contain soy lecithin which is not declared on the labels.
Class IIFDA: OngoingFlowers Foods (Corporate Offices)
FoodOct 26, 2022
BEST NUTRITIONALS White plastic bottle with green, gold, and blue labeling recall — FDA F-0080-2023
Best Nutritionals LLC 120 Centennial Ave, Piscataway NJ 08854, is initiating a recall of Fenugreek 610 mg , 360 Capsules ,in White Plastic HDPE bottles because the product has the potential…
Class IFDA: TerminatedBEST NUTRITIONALS LLC
FoodOct 26, 2022
Lyons Ready Care Thickened Apple Nectar packaged in combi-bloc recall — FDA F-0052-2023
Indication of product spoilage
Class IIFDA: TerminatedLyons Magnus LLC
FoodOct 26, 2022
Snak King 16 oz recall — FDA F-0047-2023
Bags of Trader Joe's Organic Round Tortilla Chips were found to contain small amounts of Trader Joes Spicy Cheese Crunchies which includes the allergens of milk and soy which are not…
Class IIFDA: TerminatedSnak King Corporation
FoodOct 26, 2022
Flowers Foods Mrs recall — FDA F-0066-2023
During an internal inspection the firm discovered that several products may contain soy lecithin which is not declared on the labels.
Class IIFDA: OngoingFlowers Foods (Corporate Offices)
FoodOct 26, 2022
Karlsburger Foods Gluten Free recall — FDA F-0049-2023
undeclared non-wheat gluten, product labeled gluten-free
Class IIIFDA: TerminatedKarlsburger Foods, Inc.
FoodOct 26, 2022
Lyons Ready Care Thickened Apple Juice packaged in combi-bloc recall — FDA F-0062-2023
Indication of product spoilage
Class IIFDA: TerminatedLyons Magnus LLC
FoodOct 26, 2022
Lyons Ready Care Thickened Cranberry Nectar packaged in recall — FDA F-0055-2023
Indication of product spoilage
Class IIFDA: TerminatedLyons Magnus LLC
FoodOct 26, 2022
Flathau's Fine Foods Cheese Straws Delta Bred Cheese Straws recall — FDA F-0044-2023
Undeclared Allergens - Wheat & Milk
Class IIFDA: TerminatedFlathau's Fine Foods
FoodOct 26, 2022
Lyons Ready Care Thickened Sweet Tea with Lemon Nectar recall — FDA F-0057-2023
Indication of product spoilage
Class IIFDA: TerminatedLyons Magnus LLC
About the 2022 recall archive
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.