Michigan recalls
3693 federal recalls on file affecting Michigan - 616 Michigan-specific plus 3077 nationwide. Sourced from CPSC, FDA, USDA, and NHTSA.
- 2025-11-12FDA-DeviceTandem Diabetes CareClass INationwideTandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient s subcutaneous tissue. As with current insulin infusion pumps on the U.S. market, the desired timing and quantity of the insulin delivery is programmed by the user (i.e., the patient). Pump, Tandem Mobi,
Insulin pump includes a vibration motor that gives tactile feedback for any alerts, alarms, or malfunctions. Pump may exhibit false vibration motor failure due to a software issue causing Malfunction 12: "Pump cannot operate, the mobile app can no longer receive data from the pump. Insulin delivery and any active CGM Sessions have been stopped", which could result in hyperglycemia.
- 2025-11-12FDA-DeviceMozarc MedicalClass IINationwideMAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Safety Components: 12 Fr/Ch (4.0 mm) x 24 cm;
A potential issue with the seal integrity of header bag packaging.
- 2025-11-12FDA-DeviceMozarc MedicalClass IINationwideMAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 24 cm;
A potential issue with the seal integrity of header bag packaging.
- 2025-11-12FDA-DeviceMozarc MedicalClass IINationwideMAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;
A potential issue with the seal integrity of header bag packaging.
- 2025-11-12FDA-DeviceMozarc MedicalClass IINationwideMAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;
A potential issue with the seal integrity of header bag packaging.
- 2025-11-12FDA-DeviceMozarc MedicalClass IINationwideMAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 16 cm;
A potential issue with the seal integrity of header bag packaging.
- 2025-11-12FDA-DeviceMozarc MedicalClass IINationwideMAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13 cm;
A potential issue with the seal integrity of header bag packaging.
- 2025-11-12FDA-DeviceIntegra LifeSciencesClass IINationwideTruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01;
It was determined that when the navigation system is configured with specific revision combinations of the Multi Instrument Adapter together with the Patient Tracker the system may not meet its specified accuracy for visual verification of device location within the patient s anatomy.
- 2025-11-12FDA-DeviceZimmer BiometClass IIZimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 46 mm O.D., Size G, Bearing, Model/Catalog Number: 110031013; semi constrained hip prosthesis
Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E¿ Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and vice versa.
- 2025-11-12FDA-DeviceZimmer BiometClass IIZimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing, Model/Catalog Number: 110031012; semi constrained hip prosthesis
Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E¿ Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and vice versa.
- 2025-11-12FDA-DevicePrismatik DentalcraftClass IIBrand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with: Biomet 3i" Certain 3.4/4.1/5.0/6.0 mm Model/Catalog Number: 70-1047-COM0117
Incorrect titanium screw, packaged with dental implant.
- 2025-11-12FDA-DeviceSpacelabs HealthcareClass IINationwideBrand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software Version: 11.6.0 Product Description: Cardiology Information Management System Component: No The Sentinel Cardiology Information Management System is intended to connect to supported medical devices and analyzers in order to download, store, access and manage cardiovascular information and to manage patient and facility information.
Due to two distinct issues: 1. During patient admission, patient demographic fields may default to those of a previously viewed patient. 2. Systems configured with Resting/Rhythm ECG functionality, under specific navigation conditions, test data intended for one patient may be saved under another patient's record
- 2025-11-12FDA-DeviceIntegra LifeSciencesClass INationwideCODMAN Disposable Perforator 9mm. Cranial Perforator.
Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution.
- 2025-11-12FDA-DeviceIntegra LifeSciencesClass INationwideCODMAN Disposable Perforator 11mm. Cranial Perforator.
Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution.
- 2025-11-12FDA-DeviceOsstemClass IINationwideOsstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.
Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a required Certification Statement under 21 CFR Subchapter J (Radiological Health Regulations). Specifically, the following statement may have been omitted: Certification Statement: This electronic product complies with all applicable performance standards prescribed under 21 CFR Subchapter J, as enforced by the U.S. Food and Drug Administration at the date of manufacturing.
- 2025-11-12FDA-DeviceOsstemClass IINationwideOsstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.
Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a required Certification Statement under 21 CFR Subchapter J (Radiological Health Regulations). Specifically, the following statement may have been omitted: Certification Statement: This electronic product complies with all applicable performance standards prescribed under 21 CFR Subchapter J, as enforced by the U.S. Food and Drug Administration at the date of manufacturing.
- 2025-11-12FDA-DeviceOsstemClass IINationwideOsstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.
Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a required Certification Statement under 21 CFR Subchapter J (Radiological Health Regulations). Specifically, the following statement may have been omitted: Certification Statement: This electronic product complies with all applicable performance standards prescribed under 21 CFR Subchapter J, as enforced by the U.S. Food and Drug Administration at the date of manufacturing.
- 2025-11-12FDA-FoodTBCClass IILucky Foods Cinnamon Powder; 40g
Products may contain elevated levels of lead.
- 2025-11-12FDA-FoodIce Cream FactoryClass IIBakery Graham Pieces, 10 LB Label reads in part as "Ice Cream Factory, #10 Graham Pieces, Distributed by Ice Cream Factory, 1201 Ice Cream Way, Lebanon, MO 65536"
Foreign material fragments consisting of aluminum foil and packaging material were identified in brown sugar ingredient that may have been used in the products
- 2025-11-12FDA-FoodIce Cream FactoryClass IIStrawberry Cheesecake Ice Cream with graham crackers swirl, 12 oz pack, Single Cup Net Wt: 8.75oz, Case of 12 Strawberry Cheesecake with graham cracker swirl, 2.5-gal Tub, Net Weight 14 pounds Labels read in part as "Ice Cream Factory, Distributed by Ice Cream Factory 1201 Ice Cream Way, Lebanon, MO 65536"
Foreign material fragments consisting of aluminum foil and packaging material were identified in brown sugar ingredient that may have been used in the products
- 2025-11-12FDA-FoodAquaStarClass IINationwidePublix Large Shrimp Peeled & Deveined Tail On 31/40, net wt. 1.5 lbs. UPC 041415067455. Product was sold at Publix.
Shrimp may be contaminated with Cesium-137 (Cs-137).
- 2025-11-12FDA-FoodAquaStarClass IINationwidePublix Extra Large Shrimp Easy to Peel Deveined 21/25, net wt. 1.5 lbs. UPC 041415064454. Product was sold at Publix.
Shrimp may be contaminated with Cesium-137 (Cs-137).
- 2025-11-12FDA-FoodAquaStarClass IINationwideAquaStar 13/15 Raw Shrimp Easy Peel Deveined, net wt. 2 lbs. UPC 731149654051. Product was sold at Publix.
Shrimp may be contaminated with Cesium-137 (Cs-137).
- 2025-11-12FDA-FoodAquaStarClass IINationwideAquaStar 16/20 Frozen Raw EZ-Peel White Shrimp, net wt. 5 lbs. UPC 731149654075. Product was sold at WinCo.
Shrimp may be contaminated with Cesium-137 (Cs-137).
- 2025-11-12FDA-FoodAquaStarClass IINationwideWaterfront Bistro Frozen Raw EZ-Peel White Shrimp 21/25, net wt. 2lbs., UPC 021130123223. Product was sold at Shaw s and Star Market, Albertson's, Eagle, Carrs-Safeway, and Safeway.
Shrimp may be contaminated with Cesium-137 (Cs-137).
- 2025-11-12FDA-FoodAquaStarClass IINationwideBest Yet Frozen Raw EZ-Peel White Shrimp 16/20 (net wt. 1 lbs/pkg; 10 pkgs per case). UPC 04218700282 Best Yet Frozen Raw EZ-Peel White Shrimp 21/25 (net wt. 1 lbs/pkg; 10 pkgs per case). UPC 04218700286 Best Yet Frozen Raw EZ-Peel White Shrimp 26/30 (net wt. 1 lbs/pkg; 10 pkgs per case). UPC 04218700283 Best Yet Frozen Raw EZ-Peel White Shrimp 31/40 (net wt. 1 lbs/pkg; 10 pkgs per case). UPC 04218700287 Best Yet Frozen Raw EZ-Peel White Shrimp 41/50 (net wt. 1 lbs/pkg; 10 pkgs per cas
Shrimp may be contaminated with Cesium-137 (Cs-137).
- 2025-11-12FDA-FoodAquaStarClass IINationwideAquaStar Raw Peeled Tail-on Shrimp Skewers, net wt. 1.25lbs. UPC 731149390010. Product is packaged in a printed bag with a black top and blue bottom and printed pictures of the skewers inside.
Shrimp may be contaminated with Cesium-137 (Cs-137).
- 2025-11-12FDA-FoodAquaStarClass IINationwideKroger Mercado Cooked Medium Peeled Tail-Off Shrimp, net wt. 2lbs. UPC 011110626196. Product is packaged in clear plastic bag and has a white label with green stripes on top of each bag.
Shrimp may be contaminated with Cesium-137 (Cs-137).
- 2025-11-12FDA-FoodAquaStarClass IINationwideKroger Raw Colossal EZ Peel Shrimp, net wt. 2lbs., UPC 20011110643906. Product is packaged in transparent printed bag with a blue band on the top with yellow and red details.
Shrimp may be contaminated with Cesium-137 (Cs-137).
- 2025-11-12FDA-FoodTeasdaleClass ICasa Mamita Soft Taco Dinner Kit, Net Wt 13.4 OZ (379g), UPC: 4099100318715, DIST. & SOLD EXCLUSIVELY BY: ALDI BATAVIA, IL 60510 Product consists of 10 flour tortillas, 1 sauce packet, and 1 seasoning packet within a carton; 6 cartons are packed into a mixed case with 6 additional hard taco dinner kits
Undeclared allergen - milk
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