Medical device recalls
38685 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2023-01-18FDA-DeviceStradis HealthcareClass IIHCT 6 CC SYRINGE KIT, 25/TRAY, 4 TRAYS/BAG, 5 BAGS/CASE. Distributed by Health Care Technology.
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
- 2023-01-18FDA-DeviceStradis HealthcareClass IIHCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care Technology.
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
- 2023-01-18FDA-DeviceStradis HealthcareClass IIHCT 50mL EVA BAGS, 2 Port, Sterile, Tripple Packaged, 20 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology.
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
- 2023-01-18FDA-DeviceStradis HealthcareClass IIHCT 500mL BAGS, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology.
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
- 2023-01-18FDA-DeviceStradis HealthcareClass IIPICC KIT, 10/CS, ACCESS MEDICAL LABEL
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
- 2023-01-18FDA-DeviceStradis HealthcareClass IIHenry Shein GLOVES, packaged in the following sizes and descriptions: a. Glove 6.5 Pack, 25 Pairs, 10 packs per case; b. Glove 7.0 Pack, 25 Pairs, 10 packs per case; c. Glove 7.5 Pack, 25 Pairs, 10 packs per case; d. Glove 8.0 Pack, 25 Pairs, 10 packs per case; e. Glove 8.5 Pack, 25 Pairs, 10 packs per case; f. Glove 9.0 Pack, 25 Pairs, 10 packs per case;
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
- 2023-01-18FDA-DeviceStradis HealthcareClass IIHenry Shein CYSTO SET UP PACK, 20 per case. Distributed by Henry Schein.
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
- 2023-01-18FDA-DeviceStradis HealthcareClass IIPHS Lacertaion Tray, Sterile, 20 per case, Manufactured for Professional Hosptial Supply, Inc.
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
- 2023-01-18FDA-DeviceStradis HealthcareClass IIStradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
- 2023-01-18FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline CISION Sterile Blades. Labeled as follows with corresponding Item Number. a. STERILE BLADE NO. 10 CARBON STEEL, Item Number: CISION10CS; b. STERILE BLADE NO. 10 CARBON STEEL RIB, Item Number: CISION10CSR; c. STERILE BLADE NO. 11 CARBON STEEL, Item Number: CISION11CS; d. STERILE BLADE NO. 11 STAINLESS STEEL, Item Number: CISION11SS; e. STERILE BLADE NO. 11 CARBON STEEL RIB, Item Number: CISION11CSR; f. STERILE BLADE NO. 15 STAINLESS STEEL, Item Number: CISION15SS; g. S
Potential of the blade puncturing the outer foil layer causing a breach in the sterile packaging.
- 2023-01-18FDA-DeviceCareFusion 303, Inc.Class IIBD Pyxis MedBank System - Product Label/labeling pending
Due to customer complaints related to the MedBank software which may indicate that a different medication is loaded in a cubie (drawer) pocket than what is physically loaded and listed on the pocket label. As a result of this issue, a patient could receive the wrong medication or wrong dose of medication that could lead to patient harm.
- 2023-01-18FDA-DeviceDeRoyal Industries IncClass IIDeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10
DeRoyal is recalling certain lots of surgical procedure pack products that contain a Medtronic Non-Absorbable Suture. The recall is due to Medtronic determining a manufacturing error in the packaging of the non-absorbable sutures that may cause a gap or wrinkle in the breather seal resulting in a sterile barrier breach.
- 2023-01-18FDA-DeviceInternational Medical Industries, Inc.Class IIPrep-Fill Guarded Luer Connector (GLC): a. Part Number 57-400, Female Lock - Female Lock Guarded Luer Connector, Sterile; b. Part number 57-400W, Female Lock - Female Lock Guarded Luer Connector, Sterile; c. Part number 57-401, Female Lock - Male Lock Guarded Luer Connector, Sterile; d. Part number 57-402, Female Slip - Female Lock Guarded Luer Connector, Sterile; and e. Part number 57-403, Female Slip - Female Slip Guarded Luer Connector.
Blister package had an unsealed edge compromising sterility.
- 2023-01-18FDA-DeviceThe Anspach Effort, Inc.Class IIPediatric Craniotome Ref:CRANI-P-G1
Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury
- 2023-01-18FDA-DeviceThe Anspach Effort, Inc.Class II6.5 cm Pediatric Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-P Intended for cutting and shaping bone including the spine and cranium
Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury
- 2023-01-18FDA-DeviceThe Anspach Effort, Inc.Class II7.5 cm Large Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-L-R Intended for cutting and shaping bone including the spine and cranium
Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury
- 2023-01-18FDA-DeviceThe Anspach Effort, Inc.Class IIAdult Craniotome, Large Ref: CRANI-L-G1 Intended for cutting and shaping bone including the spine and cranium
Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury
- 2023-01-18FDA-DeviceThe Anspach Effort, Inc.Class II7.5 cm Large Craniotome Attachment Use with XMax¿, microMax, and eMax¿ Systems. Ref: CRANI-L Intended for cutting and shaping bone including the spine and cranium
Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury
- 2023-01-18FDA-DeviceThe Anspach Effort, Inc.Class II6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-A-R intended for cutting and shaping bone including the spine and cranium
Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury
- 2023-01-18FDA-DeviceThe Anspach Effort, Inc.Class IIAdult Craniotome Ref: CRANI-A-G1 Intended for cutting and shaping bone including the spine and cranium
Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury
- 2023-01-18FDA-DeviceThe Anspach Effort, Inc.Class II6.5 cm Adult Craniotome, Thin Foot Plate Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-A-01 intended for cutting and shaping bone including the spine and cranium by trained medical/surgical personnel
Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury
- 2023-01-18FDA-DeviceThe Anspach Effort, Inc.Class II6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems. Ref: CRANI-A Intended for cutting and shaping bone including the spine and cranium
Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury
- 2023-01-18FDA-DeviceMedtronic NeuromodulationClass IIVanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900E
Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303"
- 2023-01-18FDA-DeviceMedtronic NeuromodulationClass IIVanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900D
Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303"
- 2023-01-18FDA-DeviceMedtronic NeuromodulationClass IIVanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900C
Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303"
- 2023-01-18FDA-DeviceMedtronic NeuromodulationClass IIVanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900B
Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303"
- 2023-01-18FDA-DeviceMedtronic NeuromodulationClass IIVanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900A
Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303"
- 2023-01-18FDA-DeviceBayer Medical Care, Inc.Class IISource Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile Catalog number: INT CSS Affected material number: 86566621 Intended to deliver accurate doses of 18F Fluorodeoxyglucose (FDG) or 18F Sodium Fluoride (NaF) radiopharmaceuticals and commonly used flushing solutions to patients during molecular imaging (PET Positron Emission Tomography - nuclear medicine) diagnostic procedures.
Black specks may be present on the packaged needles
- 2023-01-18FDA-DeviceIntegra LifeSciences Corp.Class IICodman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457
Integra LifeSciences identified that one lot was released with out-of-specification endotoxin results. The worst-case risk for the use of affected Surgical Patties is potentially a minor transient fever.
- 2023-01-18FDA-DevicePhilips North America LlcClass IIPhilips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN: 989803137631
Fetal Spiral Electrode (FSE) spiral tip of the FSE breaking off during use and requiring surgical intervention to remove the broken tip from the neonate patient. Philips has decided to discontinue the distribution of this product.
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