🏥 Medical Devices Class I - Dangerous
Due to labeling error. Incomplete ingredients listed. Labeling did not include castor oil or calamine.
All Recalls
95,064 total recalls in our database
Artelon FlexBand Plus Ref: 41054 & 41057
International Life Sciences
🏥 Medical Devices Class I - Dangerous
Augmentation devices failed bacterial endotoxin testing.
GEM Premier 5000; Part No. 00055430004.
Instrumentation Laboratory
🏥 Medical Devices Class I - Dangerous
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
Penner Pacific Bathing Spa, Model Numbers 760010-1, 770010-1
Penner Patient Care
🏥 Medical Devices Class I - Dangerous
The device does not bear a unique device identifier.
Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system.
🏥 Medical Devices Class I - Dangerous
The device does not bear a unique device identifier.
Penner Pacific Bathing Spa, Model Numbers 361910-1A, 361910-1A, 361910-XA, 361910-2I, 361910-1A, 361910-1, 361910-XI, 361910-1I, 361910-2A, 36191-1A, 361910-X
Penner Patient Care
🏥 Medical Devices Class I - Dangerous
The device does not bear a unique device identifier.
Endo-Model Replacement Plateau; Item Number: 15-0027/15;
Waldemar Link GmbH & Co. KG (Mfg Site)
🏥 Medical Devices Class I - Dangerous
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Penner Pacific Bathing Spa, Model Numbers 860010-1L
Penner Patient Care
🏥 Medical Devices Class I - Dangerous
The device does not bear a unique device identifier.
GEM Premier 5000; Part No: 00055415011.
Instrumentation Laboratory
🏥 Medical Devices Class I - Dangerous
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
Penner Pacific Bathing Spa, Model Numbers 560010-2L, 560010-XL, 560010-1L, 560010-XL
Penner Patient Care
🏥 Medical Devices Class I - Dangerous
The device does not bear a unique device identifier.
🏥 Medical Devices Class I - Dangerous
Product not cleared by the FDA.
10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk non-sterile units per case.
Becton Dickinson & Company
🏥 Medical Devices Class I - Dangerous
During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes.
Products contain undeclared milk and soy.
🍎 Food Class I - Dangerous
Potential contamination with patulin.
Products contain undeclared milk and soy.
VERGANI 1944 MILANO 'PANDORO CLASSICO' Gluten Free, 600g NET WT. 1 LBS. 5.2 OZ., packaged in paper cartons, 6 units per case. Lot 217666, UPC 8002114019833
Italianway Import
🍎 Food Class I - Dangerous
Potential contamination with foreign material (Teflon fragments) from flaking cooking molds.
Karns Foods, Mini Dark Chocolate Raspberry Cups, 8 oz Clear plastic tamper evident packs, 36-42 packed per breakout
Karns Prime And Fancy Foods
🍎 Food Class I - Dangerous
Product may contain undeclared peanuts.
Premium Food Jordan Almonds, packed in 2.0 oz and 3.5 oz clear flexible plastic packaging.
Bader Enterprises
🍎 Food Class I - Dangerous
Contains undeclared allergen (wheat) and colors (FD&C Blue 1 Lake and FD&C Blue 2 Lake).
🍎 Food Class I - Dangerous
Undeclared shrimp, crab, lobster, pollock (fish), whiting (fish), and soy.