Archive
608 recalls were announced in December 2022.
Of the 608 recalls this month scored against our rubric, 1% are Critical, 16% are Severe.
Which agencies issued them
Arrow International is recalling 1,394 units of the Arrow AutoCAT2 Intra-Aortic Balloon Pump worldwide due to a potential issue with short battery run-times.
Arrow AutoCAT2WAVE intra-aortic balloon pumps are recalled due to a potential issue with short battery run-times. Fifteen units distributed worldwide are affected.
Arrow International is recalling 127 units of the AutoCAT2WAVE Intra-Aortic Balloon Pump worldwide due to a potential issue with battery runtime.
Arrow International is recalling the AutoCAT2 Intra-Aortic Balloon Pump worldwide due to a potential issue with short battery run-times. All lot and serial numbers are affected.
ARROW INTERNATIONAL is recalling 1,275 units of Arrowg+ard Blue Plus CVC kits due to inadequate connections in Micro Clave Clear Connectors. Units distributed in six states.
Arrow AC3 Optimus Intra-Aortic Balloon Pumps worldwide are being recalled due to short battery run-times. All lot and serial numbers are affected.
ARROW INTERNATIONAL is recalling Arrow AutoCAT2 Intra-Aortic Balloon Pumps due to a potential issue with short battery run-times. Affected devices distributed worldwide may have reduced battery endurance.
Arrow International is recalling Arrow AC3 Optimus Intra-Aortic Balloon Pumps worldwide due to a potential issue with short battery run-times. The pumps may not operate for the intended duration during critical cardiac care.
Arrow AC3 Optimus Intra-Aortic Balloon Pump devices are being recalled worldwide due to a potential issue with short battery run-times. The FDA issued a Class I recall for these devices.
Arrow AC3 Optimus cardiac pumps may experience short battery run-times. The FDA has issued a Class I recall for all units worldwide.
Arrow International recalls AC3 Optimus intra-aortic balloon pumps worldwide due to short battery run-times. The FDA issued a Class I recall affecting all lot and serial numbers.
Arrow International is recalling the AutoCAT2 intra-aortic balloon pump (model AEROAUTOCAT 2 WAVE) due to a potential issue with short battery run-times that may affect patient cardiac support.
Arrow International is recalling 2,678 Arrow AutoCAT2 intra-aortic balloon pumps worldwide due to a potential issue with short battery run-times. The FDA classified this as a Class I recall.
Exela Pharma Sciences is recalling Sodium Bicarbonate Injection vials due to defective containers that may break and release glass fragments when pressurized during preparation. The recall affects 37,320 vials distributed nationwide.
Arrow International is recalling the AutoCAT2 Intra-Aortic Balloon Pump due to a potential issue with short battery run-times that could affect the device's ability to provide continuous cardiac support.
Exela Pharma Sciences is recalling 489,600 vials of sodium bicarbonate injection nationwide due to defective vials that break and release glass fragments when pressurized during preparation.
Arrow AutoCAT2WAVE IABP devices have been recalled due to a potential issue with short battery run-times. The recall covers 112 units distributed worldwide.
Arrow International is recalling Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump devices worldwide due to a potential issue with short battery run-times.
Arrow International is recalling the Arrow AutoCAT 2 Intra-Aortic Balloon Pump (IABP) due to a potential issue with short battery run-times. The recall affects 29 units distributed worldwide.
Volkswagen is recalling 2015-2016 Beetle and Beetle Convertible vehicles because the driver's side air bag inflator may explode, posing a risk of serious injury or death.
DeRoyal Industries Inc is recalling 14 shoulder kits (Lot 56580884, expiring 12/1/2024) distributed to healthcare facilities in 23 states. The company initiated a voluntary Class II recall with the FDA.
Stradis Healthcare is recalling Ablation Pack Item No. 682-130 due to incomplete outer bag seals that may compromise sterility. The defect may allow contamination of surgical kits.
Stradis Healthcare angioplasty procedure trays may have incompletely sealed outer bags, risking sterility compromise. Affected units should not be used pending further instructions.
A surgical procedure kit is being recalled due to manufacturing conditions that may result in an incompletely sealed outer bag, potentially compromising sterility. Affected kits were distributed in the US and Canada.
Zimmer is recalling NexGen Option Stemmed Tibial Components due to higher revision rates when used with certain femoral components in knee replacements.
Surgical procedure kits supplied by Henry Schein may have incompletely sealed outer bags, potentially compromising sterility. Affected units should not be used.
NuVasive is recalling the MAGEC 2 Rod spinal bracing system due to potential failure of the sterile packaging barrier, which could compromise device sterility.
DeRoyal Industries is recalling its BASIC NEURO PACK procedure packs because they contain 3M Health Care Steri Drapes that have been recalled. The recall affects 96 kits (lot 57287655, expires 9/1/2026) distributed to 23 states.
Stradis Medical is recalling 104 units of Henry Schein ENT surgical procedure trays due to incomplete sealing of the outer bag, which may compromise the sterility of the kit.
Zimmer Biomet is voluntarily recalling 284 NexGen tibial knee components due to higher revision rates when paired with specific femoral components. Patients with these implant combinations should contact their surgeon.
Arrow International is recalling 6 refurbished Arrow AutoCAT2 intra-aortic balloon pumps worldwide due to a potential issue with battery run-times. The affected devices may not operate for sufficient duration during medical use.
Stradis Medical is recalling a dental surgical pack because the outer bag may be incompletely sealed, potentially compromising sterility. Affected units should not be used.
Stradis Healthcare is recalling 400 units of Vein RF Pack surgical trays due to manufacturing defects that may result in incomplete outer bag sealing, potentially compromising sterility.
Stradis Medical is recalling Henry Schein GYN Pack surgical kits with potentially incompletely sealed outer bags that may compromise sterility. The affected kits were distributed nationwide in the US and Canada.
Stradis Healthcare is recalling Henry Schein labiaplasty procedure kits due to incomplete outer bag seals that could compromise sterility. The 42-unit recall affects products distributed nationwide in the US and Canada.
Stradis Medical is recalling medical and surgical procedure trays with incomplete outer bag sealing, which may compromise sterility. The recall affects 150 units distributed nationwide in the US and Canada.
St. Jean's Coast Mountain Resources Ltd. is recalling canned Wild Pacific Sardines in tomato sauce due to high histamine levels. The affected product was distributed wholesale to 148 retail customers in the western United States.
Stradis Medical is recalling Venous Access Packs because the outer bag may be incompletely sealed, potentially compromising the sterility of the kit. Affected units were distributed in the US and Canada.
DeRoyal Industries is recalling 90 kits of its Pacemaker ICD Pack (Lot 56705350, expiring June 1, 2026) distributed across 23 US states. The specific reason for this voluntary, firm-initiated recall is not disclosed in the FDA notice.
Stradis Medical is recalling surgical procedure kits with potentially incomplete outer bag seals that may compromise sterility. The recall affects 35 units distributed nationwide in the US and Canada.
Ethicon recalls PDS II violet monofilament sutures due to significantly reduced knot tensile strength, posing risk of intra-operative breakage in surgical procedures. The affected lot was distributed internationally to Canada, Japan, Australia, and New Zealand.
DeRoyal Industries Inc has recalled 19 anterior approach total hip replacement surgical kits distributed across 23 U.S. states. This Class II recall was initiated voluntarily by the manufacturer.
DeRoyal cataract procedure packs containing recalled 3M Health Care Steri Drapes are being recalled. The recall includes 520 kits distributed to healthcare facilities.
DeRoyal Industries voluntarily recalled 3 kits of its OPEN SHOULDER PROCEDURE PACK RF (Lot 56391733, expiring 3/1/2024) starting November 2022. The recall affects multiple U.S. states.
HENRY SCHEIN Amnio Trays (Item No. 570-3059) manufactured by Stradis Medical are being recalled because the outer bag may be incompletely sealed, potentially compromising the sterility of the medical kit.
Thoracic Phleb procedure kits from Stradis Healthcare are being recalled due to incomplete outer bag sealing during manufacturing, which may compromise kit sterility.
Stradis Healthcare recalls Henry Schein Rhino Pack surgical trays due to potentially incomplete outer bag sealing that may compromise kit sterility. The recall affects 328 units distributed in the US and Canada.
Stradis Medical is recalling approximately 300 Curved Tip Syringes because manufacturing defects may result in incomplete sealing of the sterile kit, potentially compromising product sterility.
Elekta's Oncentra Brachy radiation therapy planning software may experience reconstruction errors when using Catheter Bending functionality in versions 4.0 and above.
Stradis Medical is recalling STRADIS HEALTHCARE oral surgery trays because the outer bag may be incompletely sealed, risking sterility compromise. No illnesses have been reported.
Stradis Healthcare is recalling dental surgical procedure kits due to manufacturing issues that may result in incompletely sealed outer bags, potentially compromising kit sterility.
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump devices are being recalled worldwide due to a potential issue with short battery run-times. Healthcare providers and patients should contact the manufacturer for guidance.
OurPharma LLC is recalling 691 fentanyl citrate injection cassettes due to underfilled units. The recall affects lots distributed in Missouri with expiration dates between December 2022 and January 2023.
Stradis Medical recalls Henry Schein Basin Pack surgical trays due to potentially incomplete outer packaging seals that may compromise sterility of the medical kits.
DeRoyal Industries recalled 48 units of its shoulder pack medical device (Lot 57755295) on November 3, 2022. The specific reason for the recall was not disclosed in available documentation.
Stradis Medical recalls medical and surgical procedure trays and kits due to incomplete outer bag sealing that may compromise sterility. Units were distributed nationwide in the US and Canada.
Stradis Healthcare is recalling Angio Pack surgical trays due to manufacturing defects that may leave the outer bag incompletely sealed, compromising product sterility. Affected units were distributed nationwide in the US and Canada.
Stradis Medical recalls medical and surgical procedure trays due to manufacturing defects causing incomplete outer bag seals that may compromise kit sterility.
Stradis Healthcare is recalling dental implant trays with incomplete outer bag seals that may compromise sterility. Affected units were distributed in the US and Canada.
Stradis Healthcare is recalling surgical procedure kits for perioral surgery due to a manufacturing defect that may result in incomplete outer bag sealing. This could compromise the sterility of the kits.
DeRoyal Industries Inc has recalled 350 kits of the DeRoyal FOOT PACK medical device in a Class II FDA recall. The specific reason for the recall was not publicly disclosed in available agency records.
Leica surgical microscopes (M530 OHX) may experience power supply overheating due to component overstressing, which can cause unexpected device shutdown. 148 units nationwide are affected.
DeRoyal is recalling its Posterior Lumbar Fusion Pack medical device across 23 states. The voluntary recall affects specific lot numbers; patients should consult their healthcare provider.
Stradis Healthcare is recalling surgical and dental procedure kits due to manufacturing defects that may result in incomplete outer bag sealing and compromised sterility.
DeRoyal is recalling 144 shoulder arthroscopy procedure packs that contain recalled 3M Health Care Steri Drapes. The packs were distributed across 23 U.S. states.
DeRoyal Industries has recalled the DeRoyal CATARACT PACK (368 kits) in a voluntary Class II recall. Affected lot numbers are 55990451 and 56615717 with expiration 08/01/2024.
Stradis Healthcare is recalling cotton applicator 3 inch kits used in medical and surgical procedures due to incomplete outer bag sealing that may compromise kit sterility. Kits were distributed nationwide in the U.S. and Canada.
Stradis Medical recalls Vein & Laser surgical procedure kits due to incomplete outer bag sealing that may compromise sterility. The recall affects 10 units distributed in the US and Canada.
Stradis Healthcare is recalling surgical procedure trays and kits due to manufacturing defects that may result in incomplete sealing of the outer bag, potentially compromising sterility. Affected products were distributed nationwide in the US and Canada.
Stradis Healthcare is recalling 100 units of Henry Schein CATH PACK kits due to manufacturing defects that may leave outer bags incompletely sealed, potentially compromising sterility.
Stradis Medical recalls Henry Schein procedure trays because the outer bag may be incompletely sealed, risking sterility breach. The trays were distributed nationwide and in Canada.
Stradis Medical is recalling medical and surgical procedure kits with potentially incompletely sealed outer bags that may compromise sterility. Affected healthcare facilities should stop using these kits immediately.
DeRoyal is recalling 146 surgical procedure kits containing recalled 3M Steri Drapes. The kits were distributed to medical facilities in 23 US states.
Stradis Medical is recalling Henry Schein Basic Extended Pack procedure kits due to incomplete sealing of the outer bag, which may compromise sterility. Products were distributed in the US and Canada.
DeRoyal Industries Inc is voluntarily recalling DeRoyal HAND PACK kits (Lot 57685848) distributed across 23 US states. The reason for recall has not been publicly disclosed.
DeRoyal Industries initiated a voluntary recall of its PACEMAKER ICD PACK (Lot 57805969, exp. 11/1/2026). The specific reason for recall is not provided in available source documentation. Affected units were distributed across 23 U.S. states.
DeRoyal Industries is recalling 918 PICC line procedure packs containing 3M sterile drapes that were separately recalled. The affected kits were distributed across 23 U.S. states to healthcare facilities.
Stradis Medical is recalling surgical procedure trays due to incomplete sealing of the outer bag, which may compromise the sterility of the kit.
Stradis Healthcare is recalling medical surgical procedure trays and kits with potentially incomplete outer bag seals that could compromise sterility. These products were distributed nationwide in the US and Canada.
DeRoyal Industries is recalling 108 kits of Cannulated Hip Procedure Packs because they contain 3M Steri Drapes that have been recalled. Affected lots were distributed across 23 U.S. states.
DeRoyal Industries has recalled 480 units of its BIOPSY PACK (REF 89-9614.07) in a voluntary, firm-initiated recall affecting 23 US states. The specific reason for the recall has not been disclosed.
STRADIS HEALTHCARE surgical procedure trays and kits are being recalled due to a manufacturing condition that may result in incomplete sealing of the outer bag, potentially compromising kit sterility.
Henry Schein bone marrow kits may have incompletely sealed outer bags, compromising sterility. Affected units were distributed in the US and Canada.
DeRoyal Industries is recalling MAJOR ORAL PACK RF kits containing recalled 3M Health Care Steri Drapes. The affected lots were distributed to healthcare facilities in 23 US states.
Stradis Medical recalls Henry Schein temp stimulator supplies due to incomplete outer bag sealing that may compromise kit sterility. Affected units should not be used until reviewed.
Siemens Healthcare Diagnostics is recalling 560 allergy diagnostic kits (Lot 565) due to potential for falsely elevated mold allergen reactivity, which may result in incorrect test results.
DeRoyal Industries voluntarily initiated a Class II recall of 170 GEO-MED local anesthesia packs distributed across 23 US states. The specific safety concern is not detailed in the recall notice.
Stradis Medical is recalling HENRY SCHEIN ENT surgical kits distributed nationwide due to defective outer bag sealing that may compromise sterility. Affected kits were distributed across the US and Canada.
DeRoyal Industries is recalling 102 HEART PACK procedure kits (Lot 57367401, expiration 3/1/2025) distributed across 23 U.S. states because they contain recalled 3M Health Care Steri Drapes.
Stradis Medical is recalling 800 units of HENRY SCHEIN Vein Clinics 1 surgical trays because the outer bag may be incompletely sealed, potentially compromising sterility. No infections have been reported.
Stradis Healthcare is recalling Endovenous Packs due to incompletely sealed outer bags that may compromise kit sterility. No illnesses have been reported.
Stradis Healthcare is recalling surgical procedure trays that may have incompletely sealed outer bags, risking sterility breach. Sixteen units were distributed nationwide and in Canada.
DeRoyal Industries recalled 48 kits of the TOTAL KNEE PACK surgical product in November 2022. The specific reason for the recall was not disclosed in the public notice.
Stradis Healthcare is recalling surgical kits because the outer bag may be incompletely sealed, potentially compromising the sterility of the product.
DeRoyal TLIF procedure packs containing recalled 3M Health Care Steri Drapes are being recalled. The affected packs were distributed across multiple U.S. states.
Stradis Healthcare is recalling Henry Schein Major Extremity surgical kits due to incomplete outer bag sealing that could compromise kit sterility. Affected kits were distributed nationwide in the US and Canada.
Stradis Medical recalled 20 oral surgery implant packs with incomplete outer bag sealing that may compromise sterility. Affected lot numbers are 22228490663 and 22242491516, distributed in the US and Canada. No illnesses reported.
ACE Surgical Supply oral surgery tray kits are recalled because the outer packaging may be incompletely sealed, potentially compromising sterility. The kits were distributed throughout the United States and Canada.
Stradis Medical is recalling surgical procedure trays due to manufacturing defects that may leave outer bags incompletely sealed, potentially breaching kit sterility. No illnesses have been reported.
Stradis Medical recalls 675 Henry Schein Universal Trays due to incomplete outer bag sealing that may compromise sterility. The defect affects surgical procedures nationwide and in Canada.
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