Recalls & alerts

193 alerts recorded, refreshed every six hours. Filter by source or category.

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openFDA · August 26, 2026Moderate risk
American Contract Systems Inc : American Contract Systems medical procedure kits and trays labeled as: 1) ANTERIOR CERVICAL PACK - 205988, Model Item Number MHAC65AH; 2) SPINE PACK - 206013,…
Summary being prepared.
devices
openFDA · August 26, 2026Moderate risk
Intersurgical Inc : One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.
Summary being prepared.
devices
openFDA · August 26, 2026Moderate risk
AVID Medical, Inc. : Halyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visualization System (5303907).
Summary being prepared.
devices
openFDA · August 26, 2026Moderate risk
Boston Scientific Corporation : OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.
Summary being prepared.
devices
openFDA · August 26, 2026Moderate risk
Intersurgical Inc : One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.
Summary being prepared.
devices
openFDA · August 19, 2026Moderate risk
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. : Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, 722225, 722226, 722227, 722228, 722280*,…
Summary being prepared.
devices
openFDA · August 19, 2026Moderate risk
BioFire Diagnostics, LLC : BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic
Summary being prepared.
devices
openFDA · August 19, 2026Moderate risk
OBP Medical Corporation : OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF: C020130-1
Summary being prepared.
devices
openFDA · August 19, 2026Moderate risk
Covidien, LP : Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0 BLU 75CM C14 88861799-31
Summary being prepared.
devices
openFDA · August 19, 2026Moderate risk
Cardinal Health 200, LLC : Cardinal Health Presource Kits: 1) BASIC PACK , Catalog Number: SBA73BPGCA; 2) SPINE PACK , Catalog Number: SNE11SPHKC; 3) SPINE PACK , Catalog Number:…
Summary being prepared.
devices
openFDA · August 19, 2026Moderate risk
Covidien, LP : Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623
Summary being prepared.
devices
openFDA · August 19, 2026Moderate risk
Bioporto Diagnostics A/S : ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
Summary being prepared.
devices
openFDA · August 19, 2026Moderate risk
Straumann USA LLC : GM Helix Implant, Endosseous Dental Implant Article No. 109.984
Summary being prepared.
devices
openFDA · August 19, 2026Moderate risk
Cardinal Health 200, LLC : Cardinal Health Presource Kits: 1) SEPTO RHINO PACK , Catalog Number: SEN73NSKCF; 2) PACK NEURO MINOR CRANIOTOMY , Catalog Number: SNE30CNOHE; 3) NEURO MAJOR 2…
Summary being prepared.
devices
openFDA · August 19, 2026Moderate risk
Waldemar Link GmbH & Co. KG (Mfg Site) : Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16
Summary being prepared.
devices
openFDA · August 19, 2026Moderate risk
BD SWITZERLAND SARL : 60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235 MaxPlus Ext Set w/Needleless and Y-Site REF MPX5305-C UDI-DI code: 10885403274619…
Summary being prepared.
devices
openFDA · August 19, 2026Moderate risk
Spacelabs Healthcare, Inc. : Brand Name: Xhibit Product Name: Xhibit Central Station Model/Catalog Number: 96102 Software Version: N/A Product Description: The Spacelabs Healthcare…
Summary being prepared.
devices
openFDA · August 19, 2026Moderate risk
W L Gore & Associates, Inc. : GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common…
Summary being prepared.
devices
openFDA · August 19, 2026Moderate risk
Cardinal Health 200, LLC : Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMB
Summary being prepared.
devices
openFDA · August 19, 2026Moderate risk
Straumann USA LLC : Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form
Summary being prepared.
devices
openFDA · August 19, 2026Moderate risk
Covidien, LP : V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22 GS-25 VLOCM0436 VLOCM0436 VLOCM0003 V-LOC* 90 4-0 CLR 15CM P12X12…
Summary being prepared.
devices
openFDA · August 19, 2026Moderate risk
Erbe USA Inc : ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000
Summary being prepared.
devices
openFDA · August 19, 2026Moderate risk
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. : Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Version Numbers: R3.0 and R3.1;…
Summary being prepared.
devices
openFDA · August 19, 2026Moderate risk
Remel Europe Ltd. : Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics
Summary being prepared.
devices
openFDA · August 19, 2026Moderate risk
Medline Industries, LP : Medline Micro-Kill Bleach Germicidal Bleach Wipes,7" x 8", 150 count, 150 count, Product Number MSC351400AN
Summary being prepared.
devices
openFDA · August 19, 2026Moderate risk
Cardinal Health 200, LLC : Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC27; 2) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC28; 3) CHI…
Summary being prepared.
devices
openFDA · August 19, 2026Moderate risk
Ventana Medical Systems, Inc. : navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5. Material Number 09453733001 UDI-DI Code:…
Summary being prepared.
devices
openFDA · August 19, 2026Moderate risk
Cardinal Health 200, LLC : Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Number: 21-4720B; 2) TRAY FAT GRAFT ADD , Catalog Number: 21-4720C; 3) KIT,BOSC…
Summary being prepared.
devices
openFDA · August 19, 2026Moderate risk
Covidien, LP : Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX
Summary being prepared.
devices
openFDA · August 19, 2026Moderate risk
Galt Medical Corporation : Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP (Kit-075-03) Sheath with Dilator , Stiffen Dilator, Nitinol Mandrel Wire w/…
Summary being prepared.
devices
openFDA · August 19, 2026High risk
Baxter Healthcare Corporation : Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration Sets
Summary being prepared.
devices
openFDA · August 19, 2026High risk
Spectra Medical Devices, Llc : Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Catalog Number: AMPUL10MLK. Sodium Chloride…
Summary being prepared.
devices
openFDA · August 19, 2026Moderate risk
Medline Industries, LP : Medline Micro-Kill Bleach Germicidal Bleach Wipes, 6" x 5", 150 count, Product Number MSC351410AN
Summary being prepared.
devices
openFDA · August 19, 2026Moderate risk
Medline Industries, LP : Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count, Product Number MSC351450AN
Summary being prepared.
devices
openFDA · August 19, 2026Moderate risk
Terumo Medical Corporation : GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The Glidesheath Slender is used to facilitate placing a catheter through the…
Summary being prepared.
devices
openFDA · August 19, 2026Moderate risk
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. : Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system.
Summary being prepared.
devices
openFDA · August 19, 2026Moderate risk
Cardinal Health 200, LLC : Cardinal Health Presource Kits: 1) KIT, MER NEURO BACK , Catalog Number: PN33NBMYD; 2) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCH4; 3) KIT,CHP BASIC NEURO…
Summary being prepared.
devices
openFDA · August 19, 2026Moderate risk
Medline Industries, LP : Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count Bag, Product Number MSC351450BG4
Summary being prepared.
devices
openFDA · August 19, 2026Moderate risk
Cardinal Health 200, LLC : Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCC
Summary being prepared.
devices
openFDA · August 19, 2026Moderate risk
MICROVENTION INC. : BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US MV-BGA01095 For use in facilitating the insertion and guidance of an…
Summary being prepared.
devices
openFDA · August 19, 2026Moderate risk
Covidien, LP : V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY PASS FINAL BOX07405V1 BOX BYPASS CARDON BOX01056V2 BOX BYPASS DR LAGAE…
Summary being prepared.
devices
openFDA · August 19, 2026Moderate risk
Cardinal Health 200, LLC : Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726A; 2) KIT,SINUS , Catalog Number: PE13SPAJA; 3) KIT,SINUS , Catalog Number: PE13SPAJB; 4)…
Summary being prepared.
devices
openFDA · August 19, 2026Moderate risk
W L Gore & Associates, Inc. : GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common…
Summary being prepared.
devices

Data comes from official CPSC and FDA publications (United States). Summaries are generated automatically from those publications: the cited source prevails.

Recalls & alerts

American Contract Systems Inc : American Contract Systems medical procedure kits and trays labeled as: 1) ANTERIOR CERVICAL PACK - 205988, Model Item Number MHAC65AH; 2) SPINE PACK - 206013,…

Intersurgical Inc : One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.

AVID Medical, Inc. : Halyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visualization System (5303907).

Boston Scientific Corporation : OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.

Intersurgical Inc : One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. : Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, 722225, 722226, 722227, 722228, 722280*,…

BioFire Diagnostics, LLC : BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic

OBP Medical Corporation : OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF: C020130-1

Covidien, LP : Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0 BLU 75CM C14 88861799-31

Cardinal Health 200, LLC : Cardinal Health Presource Kits: 1) BASIC PACK , Catalog Number: SBA73BPGCA; 2) SPINE PACK , Catalog Number: SNE11SPHKC; 3) SPINE PACK , Catalog Number:…

Covidien, LP : Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623

Bioporto Diagnostics A/S : ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.

Straumann USA LLC : GM Helix Implant, Endosseous Dental Implant Article No. 109.984

Cardinal Health 200, LLC : Cardinal Health Presource Kits: 1) SEPTO RHINO PACK , Catalog Number: SEN73NSKCF; 2) PACK NEURO MINOR CRANIOTOMY , Catalog Number: SNE30CNOHE; 3) NEURO MAJOR 2…

Waldemar Link GmbH & Co. KG (Mfg Site) : Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16

BD SWITZERLAND SARL : 60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235 MaxPlus Ext Set w/Needleless and Y-Site REF MPX5305-C UDI-DI code: 10885403274619…

Spacelabs Healthcare, Inc. : Brand Name: Xhibit Product Name: Xhibit Central Station Model/Catalog Number: 96102 Software Version: N/A Product Description: The Spacelabs Healthcare…

W L Gore & Associates, Inc. : GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common…

Cardinal Health 200, LLC : Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMB

Straumann USA LLC : Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form

Covidien, LP : V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22 GS-25 VLOCM0436 VLOCM0436 VLOCM0003 V-LOC* 90 4-0 CLR 15CM P12X12…

Erbe USA Inc : ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. : Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Version Numbers: R3.0 and R3.1;…

Remel Europe Ltd. : Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics

Medline Industries, LP : Medline Micro-Kill Bleach Germicidal Bleach Wipes,7" x 8", 150 count, 150 count, Product Number MSC351400AN

Cardinal Health 200, LLC : Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC27; 2) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC28; 3) CHI…

Ventana Medical Systems, Inc. : navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5. Material Number 09453733001 UDI-DI Code:…

Cardinal Health 200, LLC : Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Number: 21-4720B; 2) TRAY FAT GRAFT ADD , Catalog Number: 21-4720C; 3) KIT,BOSC…

Covidien, LP : Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX

Galt Medical Corporation : Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP (Kit-075-03) Sheath with Dilator , Stiffen Dilator, Nitinol Mandrel Wire w/…

Baxter Healthcare Corporation : Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration Sets

Spectra Medical Devices, Llc : Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Catalog Number: AMPUL10MLK. Sodium Chloride…

Medline Industries, LP : Medline Micro-Kill Bleach Germicidal Bleach Wipes, 6" x 5", 150 count, Product Number MSC351410AN

Medline Industries, LP : Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count, Product Number MSC351450AN

Terumo Medical Corporation : GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The Glidesheath Slender is used to facilitate placing a catheter through the…

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. : Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system.

Cardinal Health 200, LLC : Cardinal Health Presource Kits: 1) KIT, MER NEURO BACK , Catalog Number: PN33NBMYD; 2) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCH4; 3) KIT,CHP BASIC NEURO…

Medline Industries, LP : Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count Bag, Product Number MSC351450BG4

Cardinal Health 200, LLC : Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCC

MICROVENTION INC. : BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US MV-BGA01095 For use in facilitating the insertion and guidance of an…

Covidien, LP : V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY PASS FINAL BOX07405V1 BOX BYPASS CARDON BOX01056V2 BOX BYPASS DR LAGAE…

Cardinal Health 200, LLC : Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726A; 2) KIT,SINUS , Catalog Number: PE13SPAJA; 3) KIT,SINUS , Catalog Number: PE13SPAJB; 4)…

W L Gore & Associates, Inc. : GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common…