FDA Recalls

The latest food, drug and medical device recalls reported by the U.S. Food and Drug Administration, newest first. Data updated Oct 21, 2026.

87,918 recalls · page 17 of 30

Class IIDeviceOngoing
Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000
Datex-Ohmeda, Inc. · Madison, WI

Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to the breathing system enabling continued controlled or manual ventilation and initiates audible and visual alarms. When this issue occurs, anesthetic agent delivery will be interrupted and requires clinician intervention. If this is not provided, the patient may experience decreased anesthetic agent effect.

Class IIDeviceOngoing
Oncology sets with drip chambers
ICU Medical, Inc. · San Clemente, CA
Class IIDeviceOngoing
Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N
Medline Industries, LP · Northfield, IL
Class IIDeviceOngoing
IV Sets with drip chambers
ICU Medical, Inc. · San Clemente, CA
Class IIDeviceOngoing
Happiest Baby, Inc SNOO Sleep Sack, X-Small Model/Catalog Number: S2101-101 S2101-108-6 S2101-133 S2102-112 S2107-101 S2107-110
Happiest Baby, Inc · Los Angeles, CA
Class IIDeviceOngoing
Centricity PACS Server V7, intended for managing digital medical images and associated data, All versions
GE Healthcare · Chicago, IL
Class IDeviceOngoing
Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, IN; Product Code: 0042-0000-IN. 4. Impella Controller, Packaged, JP; Product Code: 0042-0000-JP. 5. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 6. Impella Controller, Packaged, US; Product Code: 0042-0000-US.
Class IDeviceOngoing
Haylard UNIV IMAGING BIOPSY TRUCUSTOM; Model/Item Number (Kit): VARV042-03;
AVID Medical, Inc. · Toano, VA
Class IDeviceOngoing
StatStrip Glucose and B- Ketone meter. Model No: 63683. Glucose test system.
Nova Biomedical Corporation · Waltham, MA
Class IDeviceOngoing
StatStrip Glucose Hospital Meter System. Model No: 63685. Glucose test system.
Nova Biomedical Corporation · Waltham, MA
Class IIDeviceOngoing
Plum administration sets
ICU Medical, Inc. · San Clemente, CA
Class IIDeviceOngoing
IV Sets with drip chambers
ICU Medical, Inc. · San Clemente, CA
Class IIDeviceOngoing
Philips PIC iX Essentials REF:867093
Philips North America · Cambridge, MA
Class IDeviceOngoing
Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET, Catalog Number: DYKMBNDL199A
Medline Industries, LP · Northfield, IL
Class IIDeviceOngoing
SCORPIO C-DOME PATELLA 73-2710 73-2910 SCORPIO U-DOME PATELLA 73-3110 73-3508 73-3708 73-3710 73-3910 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
Class IIDeviceOngoing
Reign Medical Clench Staple System (Compression), Description/REF: 9mm x 7mm/152-30907; 11mm x 10mm/152-31110; 15mm x 12mm/152-31512; 18mm x 18mm/152-31818; 20mm x 20mm/152-32020; 9mm x 7mm/152-40907; 11mm x 10mm/152-41110; 15mm x 12mm/152-41512; 18mm x 18mm/152-41818; 20mm x 20mm/152-42020
Class IIDeviceOngoing
REF:B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X75MM
Stryker Sustainability Solutions · Tempe, AZ
Class IIDeviceOngoing
Captus 4000e Thyroid Uptake System, Models: 1. 5430-30151, 2. 5430-30152, 3. 5430-30154;
Mirion Technologies (Capintec), Inc. · Florham Park, NJ
Class IIDeviceOngoing
ABG I ACETABULAR INSERT HOODED 28mm ID X 48mm C-M079-2-801 ARC2F ACETABULAR INSERT 48/50/52mm OD x 28mm ID C-M071-6-700 ARC2F ACETABULAR INSERT 50mm OD x 28mm ID 10DEGREE HOOD C-M071-8-400 BEARING AND AXLE BUSHING ASSY STANDARD ELBOW C-M110-1-201 BUSHING AND BEARING USE C-MM100253-00 C-MM100253-02 DURACON TIB INSERT LG 12MM MED 14MM LAT C-M066-3-000 EXETER WINGLESS CENTRALISER FOR C-M082-7-302 C-M082-7-303 EXETER WINGLESS CENTRALIZER XSM C-M107-5-301 GMRS EXTRA SM ALL-POLY TIBIA SIZE 11mm C-MM100616-02 GMRS EXTRA SM ALL-POLY TIBIA SIZE 16mm C-MM100616-03 GMRS EXTRA SM ALL-POLY TIBIA SIZE 8mm C-MM100616-01 GMRS SML POLY TIBIA 11MM CASE 100520 C-MM100520-03 GMRS SML POLY TIBIA 16MM CASE 100520 C-MM100520-04 GMRS SML POLY TIBIA 8MM CASE 100520 C-MM100520-02 GMRS SML TIBIA 11MM WITH CASE 100411 C-MM100411-03 GMRS SML TIBIA 14MM WITH CASE 100411 C-MM100411-04 GMRS SML TIBIA 8MM WITH CASE 100411 C-MM100411-02 GMRS TIB INSRT SML 10MM WITH CASE 100507 C-MM100507-04 GMRS TIB INSRT SML 16MM WITH CASE 100507 C-MM100507-06 KALI TIBIAL INSERT LARGE RIGHT 8mm C-M071-6-601 KRH REV TIB INS 16mm THK .655 DIA STEM C-M113-5-603 MRH KNEE TIBIAL INSERT FOR THIN POST C-M067-3-103 MRS RADIAL BUSHING FORITH C-M107-7-800 C-M107-7-801 SELF-PRESSURIZING GLENOID SIZE 9 C-M064-4-300 TRIATHLON NO. 9 TIBIAL INSERT 11MM C-M067-5-003 TRIATHLON NO. 9 TIBIAL INSERT 9MM C-M067-5-002 TRIDENT ALL POLY CUP 44 X 66MM C-M066-0-901 TRIDENT CONSTRAINED ACETABULAR INSERT SIZE A X 22mm ID UH1 C-M104-2-002 TRIDENT CONSTRAINED ACETABULAR INSERT SIZE B X 22mm ID UH1 C-M104-2-003 UHR BIPOLAR 22X38MM UH1-38-22 UHR BIPOLAR 22X40MM UH1-40-22 UHR BIPOLAR 22X41MM UH1-41-22 UHR BIPOLAR 22X42MM UH1-42-22 UHR BIPOLAR 22X43MM UH1-43-22 UHR BIPOLAR 22X45MM UH1-45-22 UHR BIPOLAR 26X41mm UH1-41-26 UHR BIPOLAR 26X42mm UH1-42-26 UHR BIPOLAR 26X43mm UH1-43-26 UHR BIPOLAR 26X44mm UH1-44-26 UHR BIPOLAR 26X45mm UH1-45-26 UHR BIPOLAR 26X46mm UH1-46-26 UHR BIPOLAR 26X47mm UH1-47-26 UHR BIPOLAR 26X48mm UH1-48-26 UHR BIPOLAR 28X42mm UH1-42-28 UHR BIPOLAR 28X44mm UH1-44-28 UHR BIPOLAR 28X45mm UH1-45-28 UHR BIPOLAR 28X46mm UH1-46-28 UHR BIPOLAR 28X47mm UH1-47-28 UHR BIPOLAR 28X48mm UH1-48-28 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
Class IIDeviceOngoing
ACETABULAR CUP UHMWPE 61-3258 ALL POLY CONSTRAINED INSERT 44MM 69-2244 ALL POLY CONSTRAINED INSERT 46MM 69-2246 ALL POLY CONSTRAINED INSERT 48MM 69-2248 ALL POLY CONSTRAINED INSERT 50MM 69-2850 ALL POLY CONSTRAINED INSERT 52MM 69-2852 CONSTRAINED ACETABULAR INSERTS 22MM 50MM 2099-2250 CONSTRAINED ACETABULAR INSERTS 22MM 52MM 2099-2252 CONSTRAINED ACETABULAR INSERTS 22MM 56MM 2099-2256 CONSTRAINED ACETABULAR INSERTS 28MM 61MM 2099-2861 EIUS UNI TIB SMALL RM/LL 9MM 6636-0-419 PCA CONST LINER 32MM NEUTRAL C - SHELL 6299-N-332 SYS 12 CONST LINER 32ID 10 DEG P6 +4MM 6302-H-632 TRIDENT 0 DEG CONSTRAINED INSERT 22D 690-00-22D TRIDENT 0 DEG CONSTRAINED INSERT 22E 690-00-22E TRIDENT 0 DEG CONSTRAINED INSERT 28F 690-00-28F TRIDENT 0 DEG CONSTRAINED INSERT 28G 690-00-28G TRIDENT 0 DEG CONSTRAINED INSERT 32I 690-00-32I TRIDENT 0¿ POLY INSERT 28mm ID 620-00-28D TRIDENT CONSTR ACET INSERT 690-10-28K TRIDENT CONSTRAINED INSERT 690-10-22E 690-10-22F 690-10-28G 690-10-28H 690-10-28I Orthopaedic implant components manufactured from UHMWPE (polyethylene)
Class IIDeviceOngoing
REF:B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X100MM
Stryker Sustainability Solutions · Tempe, AZ
Class IIDeviceOngoing
Centricity PACS V2, V3, V4, V6, V7, software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from diagnostic imaging devices, All versions
Class IIDeviceOngoing
Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US
PI CARDIA LTD · Rehovot, N/A
Class IIDeviceOngoing
MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;
Bayer Medical Care, Inc. · Indianola, PA
Class IIDeviceOngoing
Brand Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Product Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Model/Catalog Number: HEMO-7, HEMO-10, HEMO-7-EU, HEMO-10-EU Software Version: N/A Product Description: Hemostatic device for endoscopic gastrointestinal use Component: No
Class IIDeviceOngoing
Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA), 701047384 (OUS);
Maquet Cardiopulmonary Gmbh · Rastatt, N/A
Class IDeviceOngoing
Impella Optical Controller with the below product descriptions and corresponding Product Codes. 1. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 2. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 3. Impella Optical Controller, Packaged, IN; Product Code: 0042-0010-IN. 4. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 5. Impella Optical Controller, Packaged, US; Product Code: 0042-0010-US.
Class IDeviceOngoing
Medline Convenience Kits: 1) DYNDH1193, Catalog Number: DYNDH1193; 2) DYNDH1487A, Catalog Number: DYNDH1487A
Medline Industries, LP · Northfield, IL
Class IIDeviceOngoing
OMNIFIT SERIES I ACET. INSERT 10¿ 22mm ID Catalog No. 2001-2246 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
Howmedica Osteonics Corp. · Mahwah, NJ
Class IIDeviceOngoing
TRIDENT 0¿ POLY INSERT 28mm ID 620-00-28D Orthopaedic implant components manufactured from UHMWPE (polyethylene)
Howmedica Osteonics Corp. · Mahwah, NJ
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Source: openFDA enforcement reports. Not for medical decisions; data may be incomplete or unvalidated.

Reported Sep 23, 2026 · Z-3190-2026

Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall that does not enter the fluid path, which if seen by a healthcare provider may lead to replacement of product before use, which could result in a delay in therapy.

Reported Sep 23, 2026 · Z-3158-2026

The kits contain a Retrograde Coronary Sinus Perfusion (RCSP) cannulae that has the potential for a sterile barrier breach. Sterility of the product cannot be assured. If a compromised pouch seal is not identified prior to use and the cannula is used, there is a potential risk of infection or other complications associated with the use of a non-sterile device, including hemolysis, foreign body reaction, thromboembolism, and/or organ dysfunction.

Reported Sep 23, 2026 · Z-3137-2026

Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out.

Reported Sep 23, 2026 · Z-3160-2026

Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.

Reported Sep 23, 2026 · Z-3175-2026

Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead to misdiagnosis or a delay in patient care.

Reported Sep 23, 2026 · Z-3169-2026

Abiomed, Inc. · Danvers, MA

The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.

Reported Sep 23, 2026 · Z-3148-2026

Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.

Reported Sep 23, 2026 · Z-3154-2026

A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification (ID) barcodes and quality control (QC) solution ID barcodes when a new barcode is scanned, resulting in the prior barcode information remaining displayed on the screen for the current test. When this defect occurs and the operator accepts the incorrectly displayed patient information without recognizing the mismatch, the current patient's glucose result will be incorrectly assigned to the previous patient's medical record and transmitted to the data management system (DMS), and the current patient's medical record will not receive a result, leaving their glucose status unrecorded and their clinical management without the information needed to guide treatment decisions. The previous patient, whose medical record now contains a glucose result that does not belong to them, may receive inappropriate clinical intervention based on that erroneous result, particularly in critically ill patients, neonates, and infants who cannot communicate symptoms or self-treat. The defect also affects QC barcode scanning: if a QC scan triggers the same retention behavior, QC results may be attributed to an incorrect identifier or QC tests may fail without the user recognizing the underlying cause. This defect does not affect the analytical accuracy of glucose measurements.

Reported Sep 23, 2026 · Z-3130-2026

A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification (ID) barcodes and quality control (QC) solution ID barcodes when a new barcode is scanned, resulting in the prior barcode information remaining displayed on the screen for the current test. When this defect occurs and the operator accepts the incorrectly displayed patient information without recognizing the mismatch, the current patient's glucose result will be incorrectly assigned to the previous patient's medical record and transmitted to the data management system (DMS), and the current patient's medical record will not receive a result, leaving their glucose status unrecorded and their clinical management without the information needed to guide treatment decisions. The previous patient, whose medical record now contains a glucose result that does not belong to them, may receive inappropriate clinical intervention based on that erroneous result, particularly in critically ill patients, neonates, and infants who cannot communicate symptoms or self-treat. The defect also affects QC barcode scanning: if a QC scan triggers the same retention behavior, QC results may be attributed to an incorrect identifier or QC tests may fail without the user recognizing the underlying cause. This defect does not affect the analytical accuracy of glucose measurements.

Reported Sep 23, 2026 · Z-3128-2026

Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out.

Reported Sep 23, 2026 · Z-3156-2026

Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out.

Reported Sep 23, 2026 · Z-3161-2026

Due to software malfunction, patient information system may freeze and become unresponsive.

Reported Sep 23, 2026 · Z-3142-2026

The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.

Reported Sep 23, 2026 · Z-3121-2026

Howmedica Osteonics Corp. · Mahwah, NJ

Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.

Reported Sep 23, 2026 · Z-3206-2026

F & A Foundation · Tulsa, OK

Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established.

Reported Sep 23, 2026 · Z-3211-2026

Reusable access port system may crack or seperate during use.

Reported Sep 23, 2026 · Z-3187-2026

Potential for failure of the tension bolt which would allow the spring arm to unexpectedly fall to its lowest position, which is approximately 25 inches (63.5 cm) from the ground.

Reported Sep 23, 2026 · Z-3193-2026

Howmedica Osteonics Corp. · Mahwah, NJ

Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.

Reported Sep 23, 2026 · Z-3199-2026

Howmedica Osteonics Corp. · Mahwah, NJ

Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.

Reported Sep 23, 2026 · Z-3201-2026

Reusable access port system may crack or seperate during use.

Reported Sep 23, 2026 · Z-3186-2026

GE Healthcare · Chicago, IL

Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead to misdiagnosis or a delay in patient care.

Reported Sep 23, 2026 · Z-3168-2026

Transfemoral catheter, positing arm may detached due to weld issue.

Reported Sep 23, 2026 · Z-3213-2026

Some devices may not have been properly sterilized due to a manufacturing sterilization issue.

Reported Sep 23, 2026 · Z-3147-2026

Wilson-Cook Medical Inc. · Winston Salem, NC

Due to issue with endoscope adherence and inability to spray powder. Firm will provide an updated Instruction for Use (IFU).

Reported Sep 23, 2026 · Z-3177-2026

The packaging may not consistently maintain sterile barrier integrity.

Reported Sep 23, 2026 · Z-3144-2026

Abiomed, Inc. · Danvers, MA

The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.

Reported Sep 23, 2026 · Z-3149-2026

The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.

Reported Sep 23, 2026 · Z-3126-2026

Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.

Reported Sep 23, 2026 · Z-3196-2026

Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.

Reported Sep 23, 2026 · Z-3204-2026