Safety Recalls
RSS ↗15,379 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 13,451–13,500 of 15,379
- Class II
Medical Device Recall · February 28, 2024
Baxter Supple Peri-Guard Repair Patch (legacy product codes): a) PC0404SNBIO, b) PC0608NSBIO, c) PC0814SNBIO, d) PC1016SNBIOA new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for cerebrospinal fluid-contacting devices and Supple Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for cerebrospinal fluid-contacting devices.
- Class II
Medical Device Recall · February 28, 2024
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNLThe potential for trocar seal disengagement when using mesh products incorrectly with the device.
- Class II
Medical Device Recall · February 28, 2024
Covidien Auto Suture" Structural Balloon Trocar, Product Number OMS-T10SBThe potential for trocar seal disengagement when using mesh products incorrectly with the device.
- Class II
Medical Device Recall · February 28, 2024
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTSNLThe potential for trocar seal disengagement when using mesh products incorrectly with the device.
- Class II
Medical Device Recall · February 28, 2024
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTThe potential for trocar seal disengagement when using mesh products incorrectly with the device.
- Class II
Medical Device Recall · February 28, 2024
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTThe potential for trocar seal disengagement when using mesh products incorrectly with the device.
- Class II
Medical Device Recall · February 28, 2024
Baxter Peri-Guard Repair Patch (new product codes): a) PG0404, b) PG0608, c) PG0814, d) PG1016, e) PG1225A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for cerebrospinal fluid-contacting devices and Supple Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for cerebrospinal fluid-contacting devices.
- Class II
Medical Device Recall · February 28, 2024
SEASPINE ORTHOPEDICS CORPORATION
Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle screw systems.Screw heads, of pedicle screw systems, have partial thread within the screw head that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.
- Class II
Medical Device Recall · February 28, 2024
Baxter Peri-Guard Repair Patch (legacy product codes): a) PC0404NBIO, b) PC0608NBIO, c) PC0814NBIO, d) PC1016NBIOA new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for cerebrospinal fluid-contacting devices and Supple Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for cerebrospinal fluid-contacting devices.
- Class II
Medical Device Recall · February 28, 2024
CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version Number C.03.XIt was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play custom ringtones when iOS device screens were locked with a passcode.
- Class II
Medical Device Recall · February 28, 2024
Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and 866424 (PIC iX Hardware) running Software Version Number 4.XIt was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play custom ringtones when iOS device screens were locked with a passcode.
- Class II
Medical Device Recall · February 27, 2024
Karl Storz SE & CO. KG, REF 11003MB, Grasping Forceps, Flexible 1 mm, Rx OnlyInadequate reprocessing validation evidence
- Class I
Medical Device Recall · February 27, 2024
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 ( 21-2120 , 21-2125 , and 21-2127 ) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nervesThe CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: " For intravenous, intraarterial, subcutaneous, intraperitoneal, perineural, surgical site, epidural space, or subarachnoid space infusion.
- Class II
Food Recall · February 27, 2024
Powerade Zero Mixed Berry - 20 oz PET bottles 24 variety pack, 8 bottles of Powerade Grape within the variety pack.The potential presence of a foreign metal object in the product, i.e. a stainless-steel ring.
- Class II
Medical Device Recall · February 27, 2024
TRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-58FThe acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
- Class II
Medical Device Recall · February 27, 2024
TRIDENTII HEMI CLUSTER58F- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-58FThe acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
- Class I
Medical Device Recall · February 27, 2024
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidThe CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: " For intravenous, intraarterial, subcutaneous, intraperitoneal, perineural, surgical site, epidural space, or subarachnoid space infusion.
- Class II
Medical Device Recall · February 27, 2024
ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile. Packaged 1 dressing/immediate package, 5 packages/market unit.The product does not meet sterility assurance level.
- Class II
Medical Device Recall · February 27, 2024
TRIDENTII PSL CLUSTER48D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-48DThe acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
- Class II
Medical Device Recall · February 27, 2024
O.T.D - Optimum Traction Device - Street Orange. Single use traction splint.Failure of adhesive to secure the pole insert.
- Class II
Medical Device Recall · February 27, 2024
TRIDENTII HEMI CLUSTER66H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-66HThe acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
- Class II
Medical Device Recall · February 27, 2024
TRIDENTII HEMI CLUSTER48D-indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-48DThe acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
- Class II
Medical Device Recall · February 27, 2024
TRIDENTII HEMI CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-50DThe acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
- Class II
Medical Device Recall · February 27, 2024
TRIDENTII PSL CLUSTER52E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-52EThe acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
- Class I
Food Recall · February 27, 2024
Roland Tahini; 100% Ground Sesame Seeds; Net WT. 16 OZ. (1 LB.) 454gProduct may be contaminated with Salmonella.
- Class II
Medical Device Recall · February 27, 2024
TRIDENTII HEMI CLUSTER44B- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-44BThe acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
- Class II
Medical Device Recall · February 27, 2024
Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CEInadequate reprocessing validation evidence
- Class II
Medical Device Recall · February 27, 2024
TRIDENTII HEMI CLUSTER54E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-54EThe acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
- Class II
Medical Device Recall · February 27, 2024
Karl Storz SE & CO. KG, REF 723014, Uvula Retractor, For Veterinary Use Only, Rx OnlyInadequate reprocessing validation evidence
- Class I
Medical Device Recall · February 27, 2024
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, intoCADD-Solis Ambulatory Infusion Pumps, with software versions before v4.3, may have the following issues:1. Upstream Occlusion, 2. Stop and Power Keys Unresponsive, 3. Manual Mode Air Detector, 4. Single Bubble Air Detection, 5. Error Codes Not Displayed at Power Up, 6. Audible Alarm, 7. Low Sensitivity Air in Line Detection Threshold, 8. PharmGuard Server Password. Smiths Medical corrected many of the issues included in this notification in previous software updates and the corrections were carried forward into all subsequent software releases. Please ensure you have the most recent CADD software (v4.3 - 2023) installed on your pumps.
- Class II
Food Recall · February 27, 2024
Powerade Mountain Berry Blast - 20oz PET bottles 24 variety pack, 8 bottles of Powerade Grape within the variety packThe potential presence of a foreign metal object in the product, i.e. a stainless-steel ring.
- Class II
Medical Device Recall · February 27, 2024
TRIDENTII PSL CLUSTER64H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-64HThe acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
- Class II
Food Recall · February 27, 2024
Powerade Zero Fruit Punch - 20oz PET bottles 24 variety pack, 8 bottles of Powerade Grape within the variety packThe potential presence of a foreign metal object in the product, i.e. a stainless-steel ring.
- Class I
Food Recall · February 27, 2024
Chick-fil-a Polynesian Sauce Cup: 28g single serve food service cupUndeclared Allergens - Wheat and Soy
- Class II
Medical Device Recall · February 27, 2024
VITROS Performance Verifier IThe issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. This issue has the potential to cause erroneous Quality Control (QC) results that could lead to testing delays and erroneous patient results. This issue caused positive or negative bias in the quantification of sodium (Na+) and total carbon dioxide (ECO2). The incorrect diluent into the Performance Verifier II exhibited a potential negative bias of up to 6 mmol/L for ECO2 and Na+ testing.
- Class II
Medical Device Recall · February 27, 2024
TRIDENTII HEMI CLUSTER52E-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-52EThe acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
- Class II
Medical Device Recall · February 27, 2024
VITROS Performance Verifier IIThe issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. This issue has the potential to cause erroneous Quality Control (QC) results that could lead to testing delays and erroneous patient results. This issue caused positive or negative bias in the quantification of sodium (Na+) and total carbon dioxide (ECO2). The incorrect diluent into the Performance Verifier II exhibited a potential negative bias of up to 6 mmol/L for ECO2 and Na+ testing.
- Class II
Medical Device Recall · February 27, 2024
TRIDENTII PSL CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-50DThe acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
- Class II
Medical Device Recall · February 26, 2024
NaviNetics Skull Anchor Key and Drill Kit, REF NN1215Defective Skull Anchor Key. After attachment of the single use Skull Anchor Key to the patient, the user was unable to attach the CT Localizer to perform stereotactic Imaging. Attachment of the localizer is typically accomplished by fully screwing in the four thumbscrews of the localizer into the threaded holes found on the top surface of the Skull Anchor Key.
- Class II
Medical Device Recall · February 26, 2024
MEDLINE INDUSTRIES, LP - Northfield
Blood Pressure Unit, Model (REF) Numbers: a) MDS4001, b) MDS4001LA, c) MDS4001PLUSThe firm provided a set of specifications for the device, but some units of the device were manufactured non-compliant with the specifications. However, the firms Receiving Dept. accepted these units into inventory
- Class I
Medical Device Recall · February 26, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline Sub-G Endotracheal Tube with Subglottic Suctioning: (1) REF DYNJ18860, Polyurethane Cuff 6.0 mm ID; (2) REF DYNJ18865, Polyurethane Cuff 6.5 mm ID; (3) REF DYNJ18870, Polyurethane Cuff 7.Complaints have been received that the device inflation tube detached and/or tore from the main tube, resulting in potential moisture buildup, loss of pressure, or inability to inflate. There were also reports the suction pump is difficult to connect or detaches during use.
- Class II
Medical Device Recall · February 23, 2024
MEDLINE INDUSTRIES, LP - Northfield
Centurion manual surgical kits labeled as: a) STERILE 4-1/2" S/S SCISSOR (SS5031), Product Code 65145; b) STERILE S/B SCISSOR 4-1/2" (I142), Product Code 65940; c) STERILE S/B SCISSOR 5-1/2" (I1Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
- Class II
Medical Device Recall · February 23, 2024
Siemens Medical Solutions USA, Inc.
ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select, REF: 11711779, running software version VA10AOn ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are exported into the SR feature, then The SR viewer will display the LAST measured value, not min or max, which could contribute to patient condition misdiagnosis or negatively influence patient management decisions.
- Class II
Medical Device Recall · February 23, 2024
MEDLINE INDUSTRIES, LP - Northfield
Centurion manual surgical kits labeled as: a) STERILE TUBE OCCLUDING FORCEP (TO8256), Product Code 66225; b) ST. KELLY HEMO W/TIPS (SK8039), Product Code 66565; c) STERILE BUTTERFLY PROBE (P837)Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
- Class II
Medical Device Recall · February 23, 2024
MEDLINE INDUSTRIES, LP - Northfield
Centurion hook kits labeled as: a) STERILE SKIN HOOK FINE (EA3975F), Product Code 66660; b) STERILE SMALL 2 PRONG SKIN HOOK (25754), Product Code 67105; c) STERILE NEWS TRACH HOOK(83300), ProductProduct may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
- Class II
Medical Device Recall · February 23, 2024
MEDLINE INDUSTRIES, LP - Northfield
Centurion Manual surgical kits labeled as: a) STERILE S/B WIRE SCISSOR, Product Code 65140; b) SHARP/SHARP SCISSORS 41/2", Product Code 65840; c) STERILE WIRE CUTTER (WCS144), Product Code 6624Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
- Class II
Medical Device Recall · February 23, 2024
MEDLINE INDUSTRIES, LP - Northfield
Centurion DISP.UMBILICAL CORD CLAMP CUTTER(CTR300), Product Code 67335Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
- Class II
Medical Device Recall · February 23, 2024
MEDLINE INDUSTRIES, LP - Northfield
Centurion manual surgical kits labeled as: a) ST. VIRTUS SPLINTER FORCEP 6" (SF8246), Product Code 66580; b) DEBRIDEMENT TRAY, Product Code I86630; c) BIOPSY INSTRUMENT PACK, Product Code I86690Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
- Class II
Medical Device Recall · February 23, 2024
MEDLINE INDUSTRIES, LP - Northfield
Centurion STERILE ROUND EAR SPECULUM SET (3, 4, 5), Product Code I68505Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
- Class II
Medical Device Recall · February 23, 2024
MEDLINE INDUSTRIES, LP - Northfield
Centurion STERILE COTTON DENTAL ROLLS 6/PK, Product Code 9125ST6Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.