Medical DeviceAug 19, 2020
Linet Americas AVE 2 Birthing Bed - Product Usage: is designated to be used by mothers ready recall — FDA Z-2781-2020
The UDI on the device label indicates incorrect manufacturer.
Class IIIFDA: OngoingLinet Americas
August 2020 recalls — page 4
These records include useful source details for the selected month.
Medical DeviceAug 19, 2020
HF Acquisition Co STAT KIT Z-1000 emergency medical kit HealthFirst - Product Usage: is recall — FDA Z-2779-2020
A missing component (hand suction pump) in the emergency medical kits.
Class IIFDA: TerminatedHF Acquisition Co. LLC
Medical DeviceAug 19, 2020
Flower Orthopedics Calcaneus Plate, Extensile, Small, Right, Catalog Number CPF 201 recall — FDA Z-2785-2020
The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium).
Class IIFDA: TerminatedFlower Orthopedics Corporation
Medical DeviceAug 19, 2020
Philips HeartStart MRx, Monitor/Defibrillators with model numbers M3535A, M3536A, M3536M recall — FDA Z-2794-2020
The therapy switch may fail, resulting in the device exhibiting the following behaviors: the device may not perform the selected function, the therapy knob may not change to the energy…
Class IIFDA: TerminatedPhilips North America, LLC
Medical DeviceAug 19, 2020
Arrow International Cannon II Plus Replacement Hub Set - Product Usage: is indicated for use recall — FDA Z-2802-2020
The lidstock states the incorrect expiration date for the product. This issue could result in use of a device that is expired which could potentially lead to an increased risk of infection…
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceAug 19, 2020
Bioseal Trachea Extender 1/pl 50pk/Cs, REF TRAX01/50, LOT XXXX, STERILE EO, Single Use Only recall — FDA Z-2795-2020
The reported stress crack in the port of the swivel elbow where the flip cap is inserted could result in leakage from the breathing system resulting in the prescribed ventilation not being…
Class IIFDA: TerminatedBioseal Corporation
Medical DeviceAug 19, 2020
Shanghai United Imaging Healthcare Co uEXPLORER PET/CT Diagnostic Imaging System - Product recall — FDA Z-2799-2020
1) 1) Potential intermittent issue may cause image data problems, may lead to artifacts; 2) Potential intermittent scout scanning interruption due to angle signal drift caused by external…
Class IIFDA: TerminatedShanghai United Imaging Healthcare Co., Ltd.
Medical DeviceAug 19, 2020
NeuroLogica OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems with recall — FDA Z-2772-2020
There are potential issues related to the operational state of the scanner, specifically for transport and inadvertent system shutdowns. There could be a possibility of potential delay in…
Class IIFDA: TerminatedNeuroLogica Corporation
Medical DeviceAug 19, 2020
Luminex Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Culture recall — FDA Z-2775-2020
An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negative (BC-GN) false negative call.
Class IIFDA: TerminatedLuminex Corporation
Medical DeviceAug 19, 2020
HF Acquisition Co STAT KIT, Model SM30 recall — FDA Z-2789-2020
Instead of 2 doses, packaged 1 dose of nasal spray in an emergency kits.
Class IIFDA: TerminatedHF Acquisition Co., LLC
Medical DeviceAug 19, 2020
Wright Medical Technology Screw Removal Case Assembly, Part Number 1985BASE - Product Usage recall — FDA Z-2797-2020
Hardware removal kit does not include drivers to remove Dart-Fire 2.5 and 3.0mm Headless screws.
Class IIFDA: TerminatedWright Medical Technology, Inc.
Medical DeviceAug 19, 2020
Intrinsic Therapeutics Barricaid Annual Closure Device (ACD) BAR-A8-8MM - Product Usage: The recall — FDA Z-2798-2020
The catalog ( REF ) number on the peelable inner labels (patient sticker) that is on the inner container (box) is incorrect. It states BAR-A8-10MM instead of BAR-A8-8MM.
Class IIFDA: TerminatedIntrinsic Therapeutics, Inc.
Medical DeviceAug 19, 2020
HF Acquisition Co STAT KIT Model 550 Emergency Medical Kit P/N: 1009580 containing various recall — FDA Z-2790-2020
Instead of 2 doses, packaged 1 dose of nasal spray in an emergency kits.
Class IIFDA: TerminatedHF Acquisition Co., LLC
Medical DeviceAug 19, 2020
HF Acquisition Co STAT KIT Model 550AI Emergency Medical Kit recall — FDA Z-2791-2020
Instead of 2 doses, packaged 1 dose of nasal spray in an emergency kits.
Class IIFDA: TerminatedHF Acquisition Co., LLC
Medical DeviceAug 19, 2020
Anjon Bremer Molded Crown. bone fixation fastener for spinal use recall — FDA Z-2778-2020
High rate of galling of one threaded component.
Class IIFDA: TerminatedAnjon Holdings
Medical DeviceAug 19, 2020
Flower Orthopedics Calcaneus Plate, Extensile, Large, Right, Catalog Number CPF 203 recall — FDA Z-2787-2020
The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium).
Class IIFDA: TerminatedFlower Orthopedics Corporation
Medical DeviceAug 19, 2020
Flower Orthopedics Calcaneus Plate, Extensile, Medium, Left, Catalog Number CPF 102 recall — FDA Z-2783-2020
The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium).
Class IIFDA: TerminatedFlower Orthopedics Corporation
Medical DeviceAug 19, 2020
Luminex Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Culture recall — FDA Z-2776-2020
An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negative (BC-GN) false negative call.
Class IIFDA: TerminatedLuminex Corporation
Medical DeviceAug 19, 2020
Smith & Nephew PERI-LOC TARGETER 4.5MM DISTAL FEMUR, HANDLE, LEFT, NON-STERILE - Product recall — FDA Z-2777-2020
The 4.5MM PeriLoc Targeter right hand part was anodized green and was marked as a left-hand part.
Class IIFDA: TerminatedSmith & Nephew, Inc.
FoodAug 19, 2020
San Francisco Street Bakery Cinnamon Raisin Bagel, San Francisco Street Bakery brand, keep recall — FDA F-1319-2020
The firm used pan release spray, which contains soy lecithin, on equipment and finished products labels do not declare soy lecithin.
Class IIFDA: TerminatedSan Francisco Street Bakery Inc.
FoodAug 19, 2020
San Francisco Street Bakery Cheddar Bagel, San Francisco Street Bakery brand, keep at recall — FDA F-1318-2020
The firm used pan release spray, which contains soy lecithin, on equipment and finished product label does not declare soy lecithin.
Class IIFDA: TerminatedSan Francisco Street Bakery Inc.
FoodAug 19, 2020
San Francisco Street Bakery French Bread, San Francisco Street Bakery brand, keep at recall — FDA F-1329-2020
The firm used pan release spray, which contains soy lecithin, on equipment and finished products labels do not declare soy lecithin.
Class IIFDA: TerminatedSan Francisco Street Bakery Inc.
FoodAug 19, 2020
San Francisco Street Bakery Salt Bagel, San Francisco Street Bakery brand, keep at ambient recall — FDA F-1326-2020
The firm used pan release spray, which contains soy lecithin, on equipment and finished products labels do not declare soy lecithin.
Class IIFDA: TerminatedSan Francisco Street Bakery Inc.
FoodAug 19, 2020
San Francisco Street Bakery Sourdough Rye Bread, San Francisco Street Bakery brand, keep recall — FDA F-1334-2020
The firm used pan release spray, which contains soy lecithin, on equipment and finished products labels do not declare soy lecithin.
Class IIFDA: TerminatedSan Francisco Street Bakery Inc.
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.